Ajman University of Science & Technology
Faculty Of Pharmacy & Health Sciences
.………………….
TRAINING MANUAL FOR
PHARMACEUTICAL TECHNOLOGY
Central Committee
Department of Pharmaceutics
…………………..
2000 - 2001
1
From The President
In The Name of Allah, Most Merciful, Most Compassionate,
And Peace be Upon Mohammed.
Dear Students,
The Strategic vision of Ajman University of Science and Technology as
an Open System where the environment of a conventional university overlaps
with the employment market is committed to train and educate the pharmacy
practitioners of tomorrow, in spite of all difficulties that we might face.
The University was able to overcome many difficulties by adhering to our
strategic vision that is based on accurate and clear-cut work plan. The implementation of
Euro–Arab Research Network on July 24, 2000 have set the infrastructure of the
Innovative Medical Environment needed for pharmacy practice and clinical training of
current B. pharmacy programme. In addition, the university made agreements with nine
hospitals in different Emirates supplement the clinical facilities provided. These
agreements shall give our students the chance to interact with enough practitioners and
preceptors needed for our programme during study course.
The university has been guided by a well-established vision that is based on
precise curricula related to a tangible real world. This vision can only bear its fruit
creatively through consistent continuing work to have automatic interaction with higher
education systems by breaking the barrier between the university and the employment
market.
I am pleased to introduce to you, the Faculty of Pharmacy and Health Sciences “TRAINING MANUAL
FOR PHARMACEUTICAL TECHNOLOGY”. Through this training process in all branches of the
university, students will complement their academic knowledge with pharmaceutical technology training
concept.
Assalam alaikum
Dr. Saeed Salman
President of Ajman University of Science and Technology
and President of Arab Private Institutions for Higher Education.
2
TABLE OF CONTENTS
Section
Section
1
2
Section
3
Section
4
From the President (H.E. Dr. Saeed Salman)
Objective of the training programe
 pre-requisites
 description
 justification
 objectives
 student activity report
 Student Evaluation
 Distribution of the evaluation marks
 Evaluation Marks Sheet
 Alternatives for special students
Review of Pharmaceutical Calculation Used In
Extemporaneous Preparations.
Pre-formulation training in pharmacy
laboratory
 Solution
Strong Sodium Salicylate mixture BPC
Preparation of peppermint water B.P
Solutions For Internal use
6
11
21
21
Solutions For Internal use
Solutions For External use:
Aqueous Iodine Solution
Preparation of Lysol
Section
5
 Syrups
Preparation of Syrup B.P
25
Acacia Syrup USP
Cough Syrup
Cough Syrup for diabetic
Aromatic Elixir USP
Section
6
Section
7
3
 Ear drops
Sodium Bicarbonate ear drops B.P
Starch Glycerol ear drops
 Emulsions
1- Emulsion For Internal use :
Acacia Emulsion
28
29
Section
8
2-Emulsions for External use :
White Liniment B.P
Calamine Lotion B.P
 Cosmetic preparation
1- Cosmetic Creams :
Vanishing Cream B.P
 Acid conditioning Creams
Cold Cream
 Cleansing cream
2- Shampoos :
 Shampoo Paste or Creams
 Dandruff
32
Shampoo
Hair Conditioners
Section
9
Section
10
Section
11
4
3- Make –Up Preparations :
 Lipsticks
Eye Make-up
 Preparation of Deodorant Stick
 Powders
1- Properties of powders :
2- Classification of powders:
Preparation of divided powder
Preparation of dusting powder
 Granules
1-Preparation of some granulating agents and
preparation of simple granulation by wet method.
2-Preparation of Effervescent Granulation :
Preparation of sodium citra tartarate ( B.P.C.)
 Tablets
1- Tablet Exciepients
2- Single Punch Tablet Machines
3-Tablets Preparation Methods
Preparation of Asprin Tablet by Direct
Compression
 Preparation of Asprin Tablet byDry
Granulation Method
 Preparation of Chewable Antacid Tablet by
Wet Granulation Method
4- Evaluation of Tablets
40
46
51
Unofficial Tests
Official Standards
Section
12
Section
13
Section
14
5
 Capsules
1- Hard Gelatin Capsules
2- Methods od Preparation of Capsules
Preparation OF Ephedrin Sulfate and
Phenobarbital Capsules
 Suppositories
1- Method of Preparation
2- Suppository Bases
3- Calibration of Molds
4- Standardization of Suppositories
Preparation of Glycerogelatin Bases
APPENDIX (A) Latin Terms and Common
Abbreviations
APPENDIX (B) General “Good Compounding
Practice “ for Non-sterile Products
65
70
700415 Pharmaceutical Technology Training (0+3):
Pre-requisite: successful completion of the six Levels (i.e 100 Cr. Hr.) and 700413
Supervision: Faculty member
Assessment: A-F grade
The purpose of this training is to introduce the student to the
DESCRIPTION:
pharmacist’s role in the industrial setting. Students are expected
to spend 120 contact hours in a pharmaceutical company
under the supervision of a faculty member and represantitive
members of the company. Training should be rotated in the
different production lines, quality control, quality assurance,
raw material handling and marketing departments.
JUSTIFICATION: To train students in all departments of the factory, to be aware
of all steps that ensure high quality production. In addition,
students should learn how to discover defects of the products if
any, so that quality of marketed products will be ensured.
Students shall spend 120 hrs (15 working days) at the different
departments divided as follows:
1
 Two days at Warehouse (Raw material handling Department) to learn
the specification, testing, handling and storage requirements of raw
material and packing.
2
 Seven days in the drug Production Department of different dosage
forms to learn all production stages such as preparation of raw
material that will be used in drug formulation, calculation needed for
accurate formulation, steps of manufacturing and handling of
machinery and products. In case of preparation of sterile products,
students should learn the proper environments and conditions
required for production
3
 Six days Quality Control, Quality Assurance and marketing:

Students shall spend three days in Quality Control
where they get exposed to methods used to test the raw
materials,
packing
materials,
semi-manufactured
materials and final production. These tests could be
chemical, physical or biological. The trainee should be
exposed to different analytical equipments and official
FDA and USA requirements.

4
6
Students shall spend two days in Quality Assurance where
they learn from inspectors and assurance officers how to
fill forms to check that all processes in the industry have
been carried according the specified instructions.
 Students shall spend one day in marketing department to
learn steps and methods used to promote drug products,
techniques involved to ensure the stability of these products
and bookkeeping of soled products.
Assessment forms that should be signed are form 7, student, site and
academic adviser’s reports
Activity:
The student will submit a report on all the training areas i.e. preformulation, production, quality control, quality assurance, packaging
and marketing.
Student Evaluation
Student should submit the activity report of the pharmaceutical technology
training, student report on the training and site advisor report to the central
training committee or to its representative in Ajman, Abu-Dhabi, and Al-Ain.
(Forms are enclosed in section 11)
Distribution of the evaluation marks :
Attendance
Adherence to professional attitude
Activity report
Evaluation of the central committee on the form 7
(see form 7 , section 11 )
Site advisor evaluation
Total Marks
Refer to the evaluation marks sheet in section 11
7
10%
10%
30%
30%
20%
100
FORM 7
Ajman University of Science and Technology
Faculty of Pharmacy and Health Sciences
Training committee
Acceptance of the Pharmacy
Student training through the Pharmaceutical Technological Training
Course No. 700415
Progress report: to be submitted at the end of the Pharmaceutical Technology Training
Student Name
:
ID #
:
Pharmaceutical Factory name
:
Academic Advisor name
:
Pharmaceutical Factory Advisor name
:
Starting date of the training
:
End date of the training
:
Student Evaluation Work During The Training Period
How would you rate the student with respect to his/her pharmaceutical technology training
knowledge?
Student's Performances:
1-
Research and Development
Excellent
2-
Poor
Very Good
Good
Average
Poor
Very Good
Good
Average
Poor
Good
Average
Poor
Dispensing and warehousing
Excellent
8
Average
In process control and manufacturing oral liquids
Excellent
4-
Good
In process control and manufacturing oral solid
Excellent
3-
Very Good
Very Good
PHARMACEUTICAL TECHNOLOGY TRAINING
(700415)
Evaluation Marks Sheet
Student’s Name :----------------------Students ID :-------------------------
NO.
Profession
Attendance al Attitude
(10%)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Total
9
(10%)
Preparations
Activity
Report
&Evaluation
(30%)
(50%)
Total
(100%)
Alternatives for special students
In accordance with the provision given by H.E. Dr. Saeed A. Salman, The
President of the University to students that wants to be trained in the summer
in a pharmaceutical company at their country or to female students that they
wish to be trained in Faculty of Pharmacy Laboratories; the central committee
adopted the following:
1.
Students wants to be trained in the summer in a pharmaceutical
company at their country have to get the approval, in writing, that the
company will follow the requirement of our training and has to appoint
supervisor for his training. The central committee will then sent its
recommendation to the Dean. The Dean’s acceptance letter will be forwarded
to the company. After the completion of training, all reports should be
submitted to the central committee. The central committee appoints a
subcommittee to evaluate the student following the same rules to ensure
uniformity of training.
2.
In Site Training :Students that they wish to be trained in Faculty of
Pharmacy Laboratories shall take tutorial interactive lectures using
multimedia, video and assigned seminar to cover quality assurance, quality
control and marketing. The faculty supervisor shall evaluate the students
(30%) including a written Examination. In addition, students shall prepare the
formulations listed in this manual (Sections 4-12) and pas an examination
according the evaluation mark sheet.
10
Section (3)
Review of Pharmaceutical Calculation Used In
Experaneous Preparations.
Introduction:
Prescription compounding is a rapidly growing component of pharmacy
practice. This can be attributed to a number of factors, including
individualized patient therapy, lack of commercially available products, home
healthcare, intravenous admixture programs, total parenteral nutrition
programs and "problem solving" for the physician and patient in enhancing
compliance with a specific therapeutic regimen. Pharmacists are creative and
should have the ability to formulate patient-specific preparations for providing
pharmaceutical care. Most compounded prescriptions require a number of
calculations as part of preparation, packaging and dispensing.
Potential for Error:
One of the greatest potentials for error in prescription compounding is in the
area of pharmacy math, or pharmacy calculations. Even though most of the
processes are relatively simple, a misplaced decimal or "estimated" value for a
medication can have serious consequences, including death. There is no
excuse for ignorance in this area and, an individual unprepared to do the
necessary calculations should not be involved in pharmaceutical
compounding. It is of utmost importance that pharmacists be extremely wellgrounded in the practice of pharmaceutical calculations as there is "zerotolerance" allowed in these vital operations.
This issue of Secundum Artem is provided as a review and reference source
for commonly performed compounding calculations.
Solubility Expressions :
Solubility expressions in the literature and in the United States Pharmacopeia
(USP) are "x:y" and "x in y", such as 1:4 and 1 in 4. This is stated as one part
of solute plus 4 parts of solvent. This results in a 1:5 solution, or 1 part of
solute in 5 parts of solution. A solubility expression is different than a ratio
expression as just described. Let's look at it again. A solubility of 1:3 is l g
solute + 3 mL solvent. This results in a 1:4 solution (1 part of solute in 4 parts
of solution), a 1:3 solution is l g in 3 mL solution (sufficient solvent to make).
11
Least Measurable Quantities (Volume/Weight):
A pharmacy has a torsion balance with a 5 mg sensitivity. What is the smallest
quantity that can be accurately weighed with a maximum of 5% error?
(5 mg x 100) / 5% error = 100 mg
Their electronic balance has a sensitivity reading of 0.1 mg. What is the
smallest quantity that can be reasonably weighed?
A digital balance does not change its readout until the largest unit of material
is placed on the balance pan. If the readability of a balance is 0.1 mg, the
change in the digit on the right does not occur until 0.1 mg is added. In other
words, 0.04 mg will not result in a digit change. If one tries to weigh 0.1 mg,
one might actually place 0.14 mg of drug on the pan but the readout will only
be 0.1. Therefore, use the same general principal as with torsion balances and
weigh not less than 20 times the readability (2 mg) of the balance.
Calibration of Droppers:
An anticholinergic liquid has been presented for a toddler at a dose of 0.25
mL. The dropper dispensed with the medication delivers 56 drops of the liquid
per 2 mL. How many drops shall the parents be instructed to give the toddler?
56/2 = 28 drops/mL
0.25/1 = x/28
,
x = 7 drops
Reducing/Enlarging Formulas:
A formula for 100 mL of an Ibuprofen gel requires 2 g of Ibuprofen powder.
What quantity of the gel would be required for 240 mL of the product?
2 /100 = X240
12
,
X = 4.8 g
Partial dosage units:
Rx
Indomethacin 5 mg/5 mL
Ora Plus
60 mL
Ora Sweet qs
120 mL
How would you obtain the quantity of indomethacin required for this Rx using
indomethacin 25 mg capsules?
5 mg/5 mL
= 1 mg/mL
1 mg/mL x 120 mL
= 120 mg needed
120 mg/25 mg/capsule = 4.8 capsules required
Empty the contents of 5 capsules onto a tared weighing paper and weigh (Ex:
1.6 g).
The contents weigh 1.6 g. You need to remove:
4.8/5 = 0.96 x 1.6 g = 1.536 g
of the mixture for the prescription.
Stock Solutions:
A pharmacist is preparing an ophthalmic decongestant solution in batch form.
Each of three bottles will contain 15 mL. The preservative to be incorporated
is 0.01% benzalkonium chloride (BAK). The pharmacist has a stock solution
containing 17% BAK. How much of this stock solution would be required for
the three bottles?
15 x 3
= 45 mL
45 x .0001
= .0045 g
0045/ x
=17/100
x
= 0.026mL
Specific Gravity in Weighing/Measuring:
A pharmacist receives a prescription for 120 mL of a 3% w/v Hydrochloric
Acid solution. The density of concentrated hydrochloric acid (37%) is 1.18
g/mL. How many milliliters of the concentrated acid would be required for the
Rx?
3% = .03
.03 x 120 mL = 3.6 g required
Volume =3.6 g/1.18 g/mL= 3.05 mL
37% = 0.37
13
, 3.05 mL /0.37= 8.24 mL
Mixing Products of Different Strengths:
A pharmacist receives an order for 120 g of a 0.1% corticosteroid ointment.
On hand are 1 oz of 0.1%, 2 oz of 0.15% and 2 ½ oz of 0.005%, all in the
same ointment base. If these three ointments are mixed together, how much
additional corticosteroid powder should be added to prepare the prescription?
Assume the quantity of corticosteroid added will be negligible compared to
the 120 g total weight.
120 x .001
=
120 mg needed
30 x 0.001
=
30 mg
15 x .0015
=
22.5 mg
75 x .00005
=
3.8 mg
-----56.3 mg
Total
120 mg - 56.3 mg = 63.7 mg
In what quantities could a 50% dextrose in water be mixed with a 5% dextrose
in water to obtain 900 mL of 15% dextrose in water?
50
10 ÷ 5 = 2
15
5
35 ÷ 5 = 7
------Total:
9 parts
(2/9)x 900 = 200 mL of D50W
(7/9)x 900 = 700 mL of D5W
------------900 mL Total Volume
Powders for Reconstitution:
The directions to constitute an amoxicillin suspension 250 mg/5 mL, 150 mL,
state that 111 mL of Purified Water are required. The physician has requested
the product be constituted at a concentration of 500 mg/5mL. How much
Purified Water would be required?
150 mL - 111 mL
= 39 mL occupied by powder
250 mg/5 mL
14
= 50 mg/mL
50 mg/mL x 150 mL
7.5/0.5
= 7.5 g of powder
= 15 doses
15 doses x 5 mL
= 75 mL volume
75 mL - 39 mL
= 36 mL required
MilliEquivalents:
A prescription calls for 25 milliequivalents of sodium chloride. What quantity,
in mg, would be required? 1 equivalent NaCl = 58.5 gm, 1 milliequivalent =
58.5 mg;
25 mEq x 58.5 mg/mEq = 1.463 g
A pharmacist receives an order for 10 mEq of Ca+. How much of a standard
10% CaCl2 solution should be used for this order?
Ca = 40/2 = 20 mg/mEq
1/10 mEq = 20 mg/ x
,
x = 200 mg Ca required
,
x = 555 mg CaCl2 required
CaCl2 = 40 + 71 = 111
40/111 =200/ x mg
10 /100ml = 0.555 g / x ,
x = 5.55 mL of the 10% CaCl2 solution
Millimoles:
How many millimoles of NaCl are contained in 1 liter of 0.9% Sodium
Chloride Solution? (Formula weights: Na=23, Cl=35.5, NaCl=58.5).
0.009 x 1000 mL = 9 g NaCl
1 mole NaCl weighs 58.5 g
1/58.5g = x /9g
15
,
x = 0.154 mole = 154 millimoles
Osmolality:
What is the osmolality (number of milliosmoles) of 1 liter of 0.9% sodium
chloride solution? (Assume complete dissociation)
Na=23, Cl=35.5, NaCl=58.5, NaCl --> Na+ + Cl
# millimoles NaCl present per liter = 154 from previous problem
154 millimoles NaCl x 2 species (Na + Cl) = 308 mOsmol/liter
What is the osmolality of 10% CaCl2 solution? (Assume complete
dissociation) (Formula weights: Ca=40, Cl=35.5, CaCl2=111g/L)
10% CaCl2 = 100 g/1000 mL
100 / 111 g
=
x / 1 mole
x = 0.9 moles/liter = 900 millimoles
CaCl2 ----> Ca++ + 2 Cl = 3 species
900 millimoles CaCl2/L x 3 species = 2700 mOsmol/Liter
Units to Weight Conversions:
A Rx order calls for 150,000 units of nystatin per gram of ointment with 60
grams to be dispensed. How much nystatin would be weighed? (4400 USP
Nystatin units/mg)
150,000 u/g x 60 g
= 9,000,000 units needed
9,000,000/4400 u/mg
= 2.045 g required
Shelf Life Estimates:
Shelf life estimates can be made using the equation:
t90 Orig
t90New = -------3∆T/10
where ∆T = change in temperature
3 is a reasonable estimate for the "Q" value,
based on energies of activation from the Arrhenius equation.
16
An antibiotic solution has a shelf-life of 96 hours when in a refrigerator. If it is
necessary that a patient use it in an ambulatory pump at approximate body
temperature (30oC) over 6 hours, would it still retain at least 90% of its
original potency during the entire period of administration?
t90 =96 /325/10
= 6.16 hours Ans. = yes
A prescription is received for an ophthalmic solution with a shelf-life of 4
hours at room temperature. The preparation is to be administered in a
physicians office at 12:00 noon the next day. Can it be prepared the evening
before at about 8:00 pm and still retain at least 90% of its shelf life if stored in
a refrigerator?
t90 = 4 / 3-20/10 = 4 / 3-2 = 36 hours
Ans. Yes
A reconstituted antibiotic has a shelf-life at room temperature of 3 days. How
long would the preparation be good if stored in a refrigerator? (A reasonable
estimate based on (t90).
t90 = 3d / 3 2
= 3 X 9 = 27 days
Ophthalmic and Nasal Solutions-Sodium Chloride Equivalents:
How much sodium chloride is required to render the following Rx isotonic?
Rx
Lidocaine HCl
1%
(NaCl equiv. = 0.22)
Cocaine HCl
1%
(NaCl equiv. = 0.16)
Epinephrine Bitartrate 0.1% (NaCl equiv. = 0.18)
Sterile Water
qs
50 mL
Sodium Chloride qs
50 x .01 = 0.5 x .22 =
0.110
50 x .01 = 0.5 x .16 =
0.080
50 x .001 = .05 x .18 =
0.009
----0.199 g
17
The ingredients represent the equivalent of 0.199 g of NaCl.
50 x .009 = 0.45 g
NaCl to make 50 mL water isotonic
0.45 - 0.199 = 0.251 g
NaCl needed to add to this Rx to make it isotonic
Ophthalmic and Nasal Solutions-Buffer Solutions & pH:
Rx
Optimycin
1%
NaCl
qs
Phosphate Buffer pH 6.5 qs
100 mL
Sorensen Modified Phosphate Buffer
Acid Stock Solution (1/15 M)
Alkaline Stock Solution (1/15 M)
Sodium Biphosphate, Anhy. 8.006 g
Sodium Phosphate, Anhy. 9.473
g
Purified Water qs
1000
Purified Water qs
1000 mL
pH
mL of 1/15 M Sodium
Biphosphate Solution
mL of 1/15 M Sodium
Phosphate Solution
5.9
90
10
6.2
80
20
6.5
70
30
6.6
60
40
6.8
50
50
7.0
40
60
7.2
30
70
7.4
20
80
7.7
10
90
8.0
5
95
To prepare 100 mL of pH 6.5 phosphate buffer solution, use 70 mL of 1/15
Molar Solution Biphosphate Solution and 30 mL of 1/15 Molar Sodium
Phosphate Solution.
Nasal Solutions-Calibrating a Dropper/Sprayer:
A nasally administered product has a dose of 25 µg. A 0.5% solution is
prepared and placed in a nasal spray bottle. Ten "squeezes" into a plastic bag
by the patient weighed 500 mg. How many squeezes are required to
18
administer the 25 Fg dose? (assume weight of solution is 1 gram per mL, i.e.,
500 mg = 0.5 mL).
0.5% = 0.5 g/100 mL
0.5 g
------ =
mL)
100 mL
xg
-----
x = .0025 g/0.5 mL or 2.5 mg/0.5 mL (2,500 µ/0.5
0.5 mL
Since 10 squeezes expels 2,500 µg, there would be 250 µg in 1 squeeze.
Capsule Filling-Powder Displacement:
A pharmacist receives a prescription for forty-eight 15 mg piroxicam capsules.
A #1 capsule filled with piroxicam weighs 245 mg tare weight; a capsule
filled with lactose weighs 180 mg tare weight. How much piroxicam and
lactose are required for the prescription? Prepare sufficient powder for 50
capsules (2 extra).
50 X 15 = 750 mg piroxicam
15 / 245 = x / 180
x = 11 mg
15 mg piroxicam occupies a similar volume as does 11 mg lactose
180 mg - 11 mg = 169 mg lactose/capsule
169 x 50
= 8.45 g lactose required
Suppositories/Troches/Lozenges-Displacement Factors:
Rx
Zinc Oxide
300 mg
Cocoa Butter
qs
If the density factor for cocoa butter is 0.9 and for zinc oxide is 4.0, and the
suppository mold holds 2.0 g of cocoa butter, how much cocoa butter would
be required to prepare 12 of the suppositories for this prescription?
Solution:
Total weight if just cocoa butter was used:
12 x 2.0 g = 24 g
19
The density ratio is:
4/0.9 = 4.44
The weight of zinc oxide required is 3.6 g
The amount of suppository base displaced by the active drug is:
3.6 g/4.44 = 0.81 g
The weight of the suppository base for the prescription is:
24 g - 0.81 g = 23.19 g
Emulsions-Nucleus:
Rx
Mineral Oil
30%
Acacia
Flavor, QS
Purified Water, QS
120 mL
Using a 4:2:1, Continental Method, how much Acacia is required for this Rx?
30% x 120 mL
= 36 mL
Oil:Water:Acacia
= 4:2:1
36 /4 = x/1
x = 9 grams of Acacia required.
20
,
Pre-formulation training in pharmacy laboratory
All these Preparations Should Be Done By Students.
Section (4)
 SOLUTIONS
Strong Sodium Salicylate mixture BPC
Rx
Sodium Salicylate
10g
Sod.metabisulphate
1g
Double strength chloroform water 525ml
Water ad
1000ml
Send 50ml
Note:
Double strength chloroform water :
Rx
Chloroform
5ml
Purified water ad
1000ml
Note:
i-make your calculation and be sure it will be as follows
Rx
Sodium Salicylate
0.5g
Sod.metabisulphate
0.05
Double strength chloroform water 26.25ml
Water ad
50ml
ii-That the limitation of prescript balance is
120g X
120g
So you should use Alginate method to accurately deliver
Sod.metabisulphate
(0.05g/50ml) preparation ) (i.e dissolve 0.2g of Sod.metabisulphate in
4ml
of distilled water & use one ml
iii-Role of ingredients & use should be known.
Preparation of peppermint water B.P
21
Rx
Peppermint
Talc
Purified water ad
Sent 100ml
2ml
15g
1000ml
Procedure:
1-Weigh 1.5g of talc and put it into a mortar
2-add 0.2 ml of peppermint & levigate to adsorb the oil onto the finely
talc
powder to ensure dispersion .
3-add water to the mortar & mix will
4- transfer to the bottle and add the remaining water & shake it for 10
min.
5- filter & place it in dispersing bottle & adjust volume.
Use as carminative & flavor agent
Solutions For Internal use
Rx
Potassium iodide
Iodine
Alcohol 90%
Water
Peppermint oil
Glycerol…upto
Sent to 40ml
25g
12.5g
40ml
25ml
4ml
1000ml
Label: Use as directed.
Method:
Dissolve required amount of Potassium iodide in Water in a conical flask.
Then
add Iodine to the above solution.
(Although Iodine is slightly soluble in Water put it is readily soluble in
aqueous
solution of Iodine)
22
Dissolve Peppermint oil in Alcohol 90% and then add to Iodine mixture and
mix well. Make up to volume with Glycerol and mix thoroughly. Transfer in
to a wide mouth bottle, label and dispense.
Role of Ingredients:
Potassium iodide
Iodine
Iodine
Alcohol 90%
Water
Peppermint oil
Glycerol
:
Expectorant and to increase the solubility of
:
:
:
:
:
Expectorant
Solvent of Peppermint oil
Solvent of Potassium iodide and Iodine
Flavoring agent
Humectants, Emollient and vehicle
:
:
Store in cool place
Shake well before use, not to be swallowed in
a large amount.
Use: Expectorant
Storage
Direction
Solutions For External use:
Aqueous Iodine Solution
Rx
Iodine
Potassium iodide
Water up to
Sent 100ml
50g
100g
1000ml
Method:
Potassium iodide and Iodine are dissolved in small portion of purified
Water by stirring & shaking till dissolve completely.
sufficient Water is added to make the required volume
Use: disinfectant
23
Preparation of Lysol
Rx
m-Cresol
Vegetable oil
(lin seed oil)
Potassium Hydroxide
purified Water ad
Sent 50ml
500ml
180ml
42g
1000ml
Method:
Weigh Potassium Hydroxide & dissolve it in small portion of Water and
add 18ml of lin seed oil. Heat in Water path with constant stirring. After
saponificat add m-Cresol with constant agitation till clean solution
results.
Complete the volume to 1000ml with water.
Use : External disinfectant
24
Section (5)

SYRUPS :
Preparation of Syrup B.P
Rx
Sucrose
Purified Water Q.S
667g
1000g
Sent 300ml
Procedure:
Dissolve the Sucrose in Purified Water in beaker by careful heating on
Water path. Stir frequently until dissolved & adjust volume. Cool it and
filter through gawz.
Note: it is preferred to add 10% Glycerol to act as preservative & to
prevent
crystallization.
Acacia Syrup USP
Rx
Acacia
Sod. Benzoate
Vanilla Tincture
Sucrose
Purified Water Q.S
Procedure:
1.
2.
3.
4.
25
1g
0.01g
0.05ml
8g
100ml
Mix Acacia, Sod. Benzoate & Sucrose.
Add small portion of Purified Water and mix well.
Heat the mixture on a water path until solution is completed.
When cool, add the Vanilla Tincture & complete with water to
100ml
Cough Syrup
Rx
Diphenyl hydramine Hcl
Ammonium chloride
Sod. Citrate
Aqueous (H2O)
Flavor & Colour
Syrup
gr.v V 5*0.065=0.325g
gr VL 45*0.065=2.925g
gr XX 0.065*20=1.300g
flz ii
4*2=8ml
Q.S.
Q.S.
Procedure:
- Dissolve in 8ml of H2O (in a beaker)
- Transfer the solution to a measure cylinder(100ml).
- Complete with syrup to 100ml.
- Transfer the preparation to glass bottle, add flavor & colour (1 drop of
rose oil & 2drops of colour)
Role of each Ingredient
i. Diphenyl hydramine Hcl
ii. Ammonium chloride
iii. Sod. Citrate
iv. Syrup
v. Water
:
:
:
:
:
antihistamine
Expectorant
Expectorant
Vehicle, solvent & Sweeting agent
Solvent
Use:
For cough
Cough Syrup for diabetic
Rx
Diphenyl hydramine Hcl
Ammonium chloride
Sod. Citrate
Aqueous (H2O)
Saccharine Sod.
Methyl cellulose (0.5%w/v)
Flavor & Colour
Sig: one table spoon to be taken
26
gr.v V 0.325G
gr VL 2.9859
gr XX 1.3g
flz ii
4*2=8ml
0.084g
Q.S.
Q.S.
Procedure:
As in cough syrup (except the prepared of Methyl cellulose(0.5%w/v)
Use:
cough syrup for diabetic
N:B prepared of Methyl cellulose (0.5%w/v)
i. Put 50ml boiling water in beaker &
Aromatic Elixir USP
Rx
Rose Oil
Peppermint oil
Syrup
Talc
Alcohol
purified Water Q.S
0.6ml
0.6ml
375ml
30g
30g
1000ml
Sent 100ml
Calculation: factor use = 100/1000 = 0.1
Rx
Rose Oil
Peppermint oil
Syrup
Talc
Alcohol
purified Water Q.S
0.0ml
0.0ml
37.5ml
3.0g
25ml
100m
Procedure:
1. Put Rose Oil, Peppermint oil, Talc and Alcohol in a dispensing
bottle and
shake very well.
2. Add 20ml of purified Water and shake well
3. filter using buchner funnel.
4. transfer the filtrated into a measuring cylinder and all syrup &
complete volume to 100ml by purified Water
5. Write label.
27
Section (6)
 EAR DROPS
Sodium Bicarbonate ear drops B.P
Rx
Sodium Bicarbonate
Glycerol
Distilled water ad
Sent 50ml
5g
30ml
100ml
Calculation : factor = 0.5
Procedure:
1) Dissolve Sodium Bicarbonate in a portion of water & shake well
2) Add 15ml of Glycerol & shake & complete volume with water to
50ml
3) Write label
Starch Glycerol ear drops
Rx
Starch (soluble)
Glycerin
Water ad
10ml)
Sent 50ml
Calculation : factor = 50/100 =
100g
700ml
1000ml
0.05
Procedure:
1. Dissolve 5g of starch in 7ml of water
2. Add 35ml of glycerin and shake well
3. adjust volume to 50ml with water
4. Write label.
28
after cal.
5g
32ml
50ml(i.e
Section (7)
 EMULSIONS
In pharmacy it is generally accepted that the term ‘emulsion’ as a
dosage form refers only to products for oral adminstration.
Emulsion for oral use are almost invariably o/w and are a convenient
means of administering oils and fats or oily solution of unstable drug of
low aqueous solulibilty
1- Emulsion For Internal use :
Acacia Emulsion
Unless otherwise specific, extemporaneously prepared emulsion
for Internal use are made with acacia gum. To prepare acacia emulsions
using a pestle and mortar, thin (primary) emulsion must be made first.
The quantities for primary emulsions have been determined by
experience and are given in Table-1
Table-1 Quantities for primary emulsions
Type of
oil
Fixed
Mineral
Volatile
Oleoresin
29
Example
Quantities for primary emulsions
(parts)
Oil
Water
Gum
4
2
1
Almond oil
A rachis oil
Castor oil
Cod-liver
Liquid paraffin 3
Turpentine oil 2
Cinnamon oil
Peppermint oil
Male fern
1
extract
2
2
1
1
2
1
Rx
Almond oil
Double strength chloroform water
Water
Sent 100ml
50ml
100ml
200ml
Procedure:
1) Almond oil is a fixed oil, therefore, the qualities for primary
emulsion are (oil: water: gum =4:2:1)
Almond oil
Water
Acacia
25ml
12.5ml
6.25g
2) use the dry gum technique for Acacia Emulsion as follow



weigh the Acacia powder and place it in dry mortar
dispense the Acacia powder lightly in the water
add 25ml oil at once and triturate until the primary
emulsion is well established
 the primary emulsion is then diluted with the remaining
ingredients and transfer to measuring cylinder to adjusted
volume with water.
3) Use amber dispensing bottle with a wide mouth
4) Write label & add “shake the bottle before use” label.
Use: Demulcent and mildly laxative
30
2-Emulsions for External use :
White Liniment B.P
Rx
Ammonium chloride
Dilute Ammonia solution
Oleic acid
Turpentine oil
purified Water
12.5g
42ml
85ml
225ml
625ml
after cal.
0.625g
2.25ml
4.25ml
12.25ml
31.25ml
Sent 50ml
Calculation : factor = 50/1000 = 0.05
1. Make emulsifier (Ammonium Oleate) the reaction between dilute Ammonia
and oleic acid as follow
a- Take 4.25 of Oleic acid & 12.5 of Turpentine oil and 2.2ml of
Dilute Ammonia solution (2.5%) and 10ml of water.
b- Shake vigorously to form TurpentineH2O emulsion
2. Dissolve 0.625g Ammonium chloride in the remaining water and mix it
with to produce the preparation after adjusting the volume with H2O to 50ml
3. Write label as follow :
Use : counter – irritant and rubefacient.
Calamine Lotion B.P.
Rx
Calamine
Zinc Oxide
Bentonite
Sod. Citrate
Liquid phenol
Glycerin
Purified Water
31
15g
5g
3g
0.5g
0.5g
5ml
100ml
Procedure:
1) Dissolve Sod. Citrate in 35ml Purified Water
2) Weigh Calamine, Zinc Oxide and Bentonite & triturate it with
Sod. Citrate solution.
3) Add Liquid phenol, the Glycerin and sufficient quantity of water
to make up the required volume.
4) Write Label
Use: Astringent & protective.
Section (8)
 COSMOTIC PREPARATIONS
1- Cosmotic Creams :
Vanishing Cream B.P
Rx
Stearic acid
Oleic acid
Glycerin
Boric acid
Potassium hydroxide
Purified Water Q.S
Sent 50g
120g
40g
50ml
10g
8g
1000g
Procedure:
1.
1.
2.
3.
Calculation factor = 50/1000 = 0.05
weigh all the ingredient accurately
Mix the oily substance together and heat on water path.
Mix the aqueous phase together and heat at the same water path with
stirring
4. Dispense in container & shake well
Use: as protective when necessary
6. Make label
32
 Acid conditioning Creams
Rx
Cetyl alcohol
150g
Sod. Lauryl Sulfate
5g
Citric acid
20g
Water
825ml
Perfume 0.3-0.5%
Methyl Para hydroxyl benzoate
Sent 50g
Preparation:
Factor = 50/1000 = 0.050
1.
2.
3.
4.
5.
6.
Calculate the intergradient
Melt to gather Cetyl alcohol with small portion of water.
Prepare solution of Sod. Lauryl Sulfate with water
Warm gently and with slow stirring to Cetyl alcohol
Continue stirring to form stable cream
Finally add a solution of citric acid dissolved in the remaining
water.
Cold Cream
Rx
Mineral oil
Been Wax
Borax
Water
Perfume 0.3-0.5%
Methyl paraben
Propyl paraben
Sent 25g
33
450ml
160g
10g
380ml
0.12% { preservative}
0.02%
{preservative}
Procedure:
1. Make the calculation (F= 50/1000)
2. Heat to gather the Mineral oil & Been Wax to temperature
75OC
3. In the separate container dissolve the borax in water and heat
to 75OC
4. Add Borax
slowly, with continuous stirring to oil/wax
mixture
5. Cool with stirring, adding the perfume when temperature
reduced 35 OC.
 Cleansing cream
Are basically cold creams slightly modified in some cases to be some what
softer , to melt quickly and facilitate ease of application and spreading.
The cream is effective cleansing agent and a thin residual film can be left on
the skin when extra emolliency is required .
Rx
Mineral oil
Stearic acid
Lanolin
Triethanolamine
Distilled Water
500ml
100 g
50 g
12.5 g
337.5ml
Sent 50g
Preparation:
1. Make the calculation (F= 50/1000)
2. Heat to gather the Mineral oil ,Stearic acid and Lanolin to
temperature of 75OC
3. In separate container dissolve the Triethanolamine in the water
and heat to 75OC
4. Add Triethanolamine solution slowly, with continuous stirring to
Oil/Stearic acid/Lanoline mixture
5. Cool with stirring,adding the perfume when temperature reduced
35 OC.
34
2- Shampoos :
 Shampoo Paste or Creams
Rx
Sod. Lauryl Sulfate
Cetyl Alcohol
Water
450g
50g
500ml
Sent 25g
Preparation:
1. Make calculation (f = 25/1000)
2. Sod. Lauryl Sulfate is heated to gather with water to about
80OC(on water path).
3. Add Cetyl Alcohol with stirring for about 15 min.
4. the mixture is allowed to cool to about 40-45 OC.
5. Add any perfume or colour ; stir to mix uniformly.
6. pour it into the container while worm
 Dandruff Shampoo
Rx
Alkyl trimethyl ammonia bromide(cetrimide)
Cetyl Alcohol
Water
150g
150g
700ml
Sent 25g
Preparation:
1. Warm gather Cetyl Alcohol & Alkyl trimethyl ammonia bromide
(cetrimide)with 8ml Water.
2. Stir gather until homogenous and add the remain Water to about
40OC
3. Add perfume & colour & mix.
N.B. For use, the hair is first through wetted with warm water and about
teaspoon of cream or lotion is managed well into the scalp with finger, the hair
is then rinsed thoroughly and application repeated Finally the hair is
thoroughly raised with warm water.
35
Hair Conditioners
Rx
Stearyl dimethyl benzyl ammonium Cl
Cetyl alcohol
Mineral Oil
Water `
`
Perfume 0.3-0.5%
Methyl Para hydroxyl benzoate 0.5%
35g
25g
5ml
935ml
Procedure:
1. Melt together the fully materials and heat to 70-80 OC
2. Dissolve Stearyl dimethyl benzyl ammonium Cl in water in a separate
container and to 70-80OC
3. Add the aqueous solution to the fully materials while stirring slowly to
avoid air entrapments.
4. Continue cooling at about 35OC
36
3- Make–Up Preparations :
 Lipsticks
The lipsticks consist of coloring material dispensed and suspended in a base
prepared from a blend of a oils and waxes adjusted to yield the desired
melting point and viscosity. The most appropriated melting point range is 5575 OC.
Rx
Carnuba Wax
Bees Wax
Lanolin
Cetyl alcohol
Castor Oil
Pigment (Sudan III)
Perfume
10g
15g
5g
5g
65g
Sent 25g
Procedure:
1- Melt together Carnuba Wax, Bees Wax, Lanolin and Cetyl
alcohol on a water path .
2- Heat Castor Oil in separated container to 75OC and then
dissolve the required amount of Sudan III (or caramine as
Pigment) which give the desired red or pink colour
respectively.
3- Add Castor Oil, Pigment solution while it is hot on the melted
base and mix well.
4- Pour into the mould after adding the Perfume and leave to
cool.
37
Eye Make-up
Cosmetic preparations for the eye are now an inertial feature of the facial
make-up, assuming as much important as the use of lipsticks. Eye shadows are
prepared in wax base as creams, in stick form, as loose powder, or as
compressed powder.
Emulsion type eye shadow:
Rx
Stearic acid
Triethanolamine
Petrolatum
Lanolin
Propylene glycol
Water
Pigment
Perfume
Sent 20g
Procedure:
1.
2.
3.
4.
5.
16g
4ml
25g
5g
5g
45ml
Q.S
Q.S
Make the calculation (F= 20/1000 = 0.2)
Melt and heat Stearic acid, Petrolatum, Lanolin to70OC
Mix Triethanolamine, Propylene glycol and water and to 70OC
Add aqueous phase to the oily phase with continue stirring.
Remove from bath and stir until complete cooling (add Perfume
at
35 OC.
N.B:
The Pigment is dissolve in aqueous phase if is water soluble and in oily
phase if it is oily soluble before mixing.
38
 Preparation of Deodorant Stick
Rx
Stearic acid
Sod. hydroxide
Distilled Water
Glycerol
Cetrimide
Ethanol
Perfume
Sent 20g
3.4g
0.6g
1.0ml
7.5g
0.75g
75ml
Q.S
Procedure:
1. Melt Stearic acid at 75-80OC
2. Dissolve Sod. Hydroxide and Cetrimide in water –Glycerol
mixture, heat at 75-80OC
3. Add ½ quantity of ethanol to the melt Stearic acid, stir to dissolve
.
4. Add gradually solution (2) to Stearic acid solution with stirring,
wash the container of Sod. Hydroxide, Cetrimide solution with
second ½ of Ethanol and add to Stearic acid solution. This step
should take about 5 times to avoid excessive volatilization of
Ethanol.
5. White mixing on water – bath add Perfume, remove from heat
and quickly pour onto the stick container.
39
Section (9)
 POWDERS
1- Properties of powders :
The word "powder" refers to a chemical or mixture that is solid in physical
state. In compounding, "powder" refers to a dosage formulation that is solid in
physical state. But the formulation may be composed of only the active drug
or may be a mixture of the active drug and other ingredients.
Powders offer some unique advantages:
 each dose can contain a different amount of active drug
 can be administered easily to infants and young children who cannot
swallow tablets or capsules
 drug will have a rapid onset of action since disintegration is not
required
 can be applied to many body cavities such as ears, nose, tooth socket,
throat
 drugs tend to most stable as a solid
 can be made into many different dosage formulations (capsules, tablets,
powders for reconstitution, dusting powders, bulk powders, powders for
inhalation, etc.)
Pharmaceutical powders are formulated to be exist as fine particles. The
powders are then smooth to the touch and nonirritating to the skin. Powders
generally range from 0.1 to 10 micron in size. The size of the particles are
often expressed as a number which corresponds to the mesh screen size of a
sieve. The screen size indicates the number of openings in the mesh screen per
inch. For example, a # 40 sieve has 40 openings per inch in the screen mesh.
Particles that can sift through that mesh are said to be "40 mesh" size.
Below is a list of mesh sizes and the size of the mesh opening in millimeters
(1/1000 of a meter) or microns (1/1,000,000) of a meter. Of coarse there is a
correlation between the size of the mesh opening and the particle size of the
sifted powder. As the opening becomes smaller, so will be resulting particle
size. Most of the particles of a sifted powder will have approximately the size
as the mesh opening.
40
Mesh Opening Size
Mesh Size
Number
2
4
8
10
20
30
40
50
60
70
80
100
120
200
millimeters
microns
9.52
4.76
2.38
2.00
0.84
0.59
0.42
0.297
0.250
0.210
0.177
0.149
0.125
0.074
9520
4760
2380
2000
840
590
420
297
250
210
177
149
125
74
The USP 24/NF19 uses descriptive terms to define powder fineness. The table
below shows the correlation their classification
Description Term
Very Coarse
Coarse
Moderately Coarse
Fine
Very Fine
Mesh Opening Size (microns)
> 1000
355 -1000
180 – 355
125 – 180
90 - 125
Mesh Size Number
2 – 10
20 – 40
40 – 80
80 – 120
120 - 200
A good powder formulation has an uniform particle size distribution. If the
particle size distribution is not uniform, the powder can segregate according to
the different particle sizes which may result in inaccurate dosing or
inconsistent performance. A uniform particle size distribution insures an
uniform dissolution rate if the powder is to dissolve, an uniform sedimentation
41
rate if the powder is used in a suspension, and minimizes stratification when
powders are stored or transported.
Reducing the particle size of a powder will result in an uniform distribution of
particle sizes. The process of reducing the particle size is called comminution.
In extemporaneous compounding, there are three methods of comminution:
 Trituration is the continuous rubbing or grinding of the powder in a
mortar with a pestle. This method is used when working with hard,
fracturable powders.
 Pulverization by Intervention is used with hard crystalline powders
that do not crush or triturate easily, or gummy-type substances. The first
step is to use an "intervening" solvent (such as alcohol or acetone) that
will dissolve the compound. The dissolved powder is then mixed in a
mortar or spread on an ointment slab to enhance the evaporation of the
solvent. As the solvent evaporates, the powder will recrystallize out of
solution as fine particles.
 Levigation reduces the particle size by triturating it in a mortar or
spatulating it on an ointment slab or pad with a small amount of a liquid
in which the solid is not soluble. The solvent should be somewhat
viscous such as mineral oil or glycerin. This method is also used to
reduce the particle size of insoluble materials when compounding
ointments and suspensions.
2- Classification of powders:
Bulk Powders:
Bulk powders are nonpotent and can be dosed with acceptable accuracy and
safety using measuring devices such as the teaspoon, cup, or insufflator. This
practically limits the use of orally administered bulk powders to antacids,
dietary supplements, laxatives, and a few analgesics. Many bulk powders are
used topically.
Douche Powders:
Douche powders are used to prepare solutions that cleanse the vagina. Most
douche powders are used for their hygienic effects, but a few contain
antibiotics.Douche powders are prescribed as a matter of convenience for the
42
patient, since a powder is more portable than a bulky solution. The formula is
developed so that a teaspoonful or tablespoonful of powder dissolved in a
specified volume of water provides the desired concentration. The pH usually
ranges from 3.5 to 5 when the solution is prepared. Feminine bulb syringes or
fountain syringes are used for vaginal irrigation. Since many of the ingredients
are volatile (e.g., menthol, thymol, and volatile oils), douche powders should
be packaged in glass jars with a wide mouth. Some commercial douche
powders are available in metal foil packets, which contain the proper amount
of powder for a single douche. Many douches are also available as prepared
unit of use solutions in disposable applicators.
Insufflations:
Insufflations are extremely fine powders to be introduced into body cavities.
To administer an insufflation, the powder is placed in the insufflator, and
when the bulb is squeezed, the air current carries the fine particles through the
nozzle to the region for which the medication is intended. All
extemporaneously compounded insufflations must be passed through a 100
mesh sieve. Pressurized packages provide an elegant approach to the
administration of insufflations.
Powder Sprays:
In contrast to dusting powders, powders dispensed under pressure will deliver
targeted and uniform application at the desired site. Also, in an aerosol
container medicated powders may be maintained in a sterile condition. The
powder particles must be a definite size range to prevent clogging of the valve
orifice and to provide uniformity of application. In general, powders that are
to be packaged as powder sprays must not contain particles greater than 50
microns if they are to be sprayed successfully.
43
Preparation of divided powder
Divided powders or charts are single doses of powdered medicinals
individually wrapped in cellophane, metallic foil, or paper. The divided
powder is a more accurate dosage form than bulk powder because the patient
is not involved in measurement of the dose. Cellophane and foil-enclosed
powders are better protected from the external environment until the time of
administration than paper-enclosed powders. Divided powders are
commercially available in foil, cellophane or paper packs.
All drugs are reduced to a fine state of subdivision before weighing , the
weighed powders are blended by geometric dilution or mixing in ascending
order of amount.
Rx
Magniesium trisilicate
Tribasic calcium phosphate
Activated charcoal
aa 0.19 G
Fiat, pul. , mitte IV
SIG.: One Chartula T.I.D.P.C.
Use : Antacid ,antiflatulent .
Procedure:
1. Mix the ingredients to full homogenity.
2. Divided as mentioned above ( by weighing ).
3. Fill in packets as follows :
a- Fold down 1 cm margin from the weighing paper .
b- Distribute the divided dose over the paper
c- left and fold the lower end of the paper until it lies exactly in the
crease of the original top fold.
d- Make additional fold.
e- Bring the two ends to each other dividing the paper to three equal
parts .
44
Preparation of dusting powder
Dusting powders are fine medicinal (bulk) powders intended to be dusted on
the skin by means of sifter-top containers. A single medicinal agent may be
used as a dusting powder; however, a base is frequently used to apply a
medicinal agent and to protect the skin from irritation and friction. Bentonite,
kaolin, kieselguhr, magnesium carbonate, starch, and talc are used as inert
bases for dusting powders. Powder bases absorb secretions and exert a drying
effect, which relieves congestion and imparts a cooling sensation. All
extemporaneous dusting powders should be passed through a 100-200 mesh
sieve to ensure that they are grit free and will not further mechanically irritate
traumatized areas.
Rx
Camphor
Starch
Zinc
0.1 G
0.6 G
0.3 G
Send 20 G
Sig. : To be used U.D.
Use : Counter irritant.
Procedure:
1- Weigh the camphor and try to pulverize in the mortar with pestle
2- Add few drops of alcohol and pulverize .
3- Mix starch and zinc oxude and gradually add to camphr while
trituration until uniformity .
4- pass through 90-mesh sieve.
45
Section (10)
 GRANULES
Granules are particles ranging in size from about 4 to 10 mesh. Granules
generally are made by first blending the powders together and then moistening
the mixture to form a pasty mass. The mass is passed through a sieve and then
dried in air or in an oven. They are prepared as a convenience for packaging,
as a more stable product due to less surface exposure, and as a popular dosage
form. Granulations are also used as intermediates in the preparation of
capsules and tablets, since they flow more smoothly and predictably than do
small powder particles.
The most popular compounded granulation is the effervescent powder
(sometimes called effervescent salts). These granulations are popular due to
their taste and psychological impression. When added to water, the
granulation effervesces ("fizzes") as carbon dioxide is liberated.
Methods of preparation :
There are two methods of preparation of granules :
- Dry fusion method
- Wet method
Fusion method:
In the fusion , the one molecule of water present in each molecule of citric
acid acts as the binding agent for the powder mixture . After weighing the
required amount of powder \s they are mixed together to ensure the uniformity
of the mixture. Then the powder is placed on a porcelain dish on boiling water
bath and stirred with the help of a glass
Rod . The heat causes the release of the water of crystallization from the citric
acid which in turn dissolves a portion of the powder mixture, setting of the
chemical reaction and the consequent release of some carbon dioxide. This
causes the sofened mass of powder to become somewhat spongy, and when of
the proper consistency as bread dough ,it is removed from the oven and
rubbed through an acid resiste=ant sieve to produce granules are dried at
temperature not more than 54 – 60 o c and transferred to containers which are
then promptly and tightly sealed . the fused method is used in the preparation
of most commercial effervescent powder .
46
1-Preparation of some granulating agents and preparation of simple
granulation by wet method :
Procedure:
1. Prepare the binders by the appropriate method:
 Starch paste: add the starch slurry dropwise to boiling water while
keeping stirring with a glass rod.
 Soak the polymer (Methyl cellulose in warm water) for about 10
min. and start solution process by stirring while heating (methyl
cellulose dissolve while keeping cold in an ice-bath).
2. Mix the antacid powder with appropriate amount of the binder in the
palnetary mixer till the formation of a cohearent mass.
3. Sieve the mass by through the oscillating granulator.
4. Dry the obtained granules in an oven at 50-60ºC.
2-Preparation of Effervescent Granulation :
It has been found that citric acid monohydrate and tartaric acid used in the
ratio of 1:2, respectively, produces a powder with good effervescent
properties. Citric acid monohydrate is not used alone because it results in a
sticky mixture that will not easily granulate. Tartaric acid is not used alone
because the granules are too friable and crumble. The amount of sodium
bicarbonate to be used may be calculated from the reaction which occur when
the granules come in contact with water. The reaction equation between citric
monohydrate and sodium bicarbonate is given below:
47
Setting up a proportion to determine the amount of sodium bicarbonate that
will react with 1 gm of citric acid, one has:
Similar calculations show that 2.24 gm of sodium bicarbonate react with 2 gm
of tartaric acid
Thus, with the acids in a ratio of 1:2, it has been calculated that 3.44 g (1.2 g +
2.24 g) of sodium bicarbonate is necessary to react stoichiometrically with the
3 g of combined acids. To enhance the flavor, the amount of sodium
bicarbonate may be reduced to 3.4 gm to allow for a small amount of
unreacted acid to provide a tart taste.
The ratio of two acids should be sdjusted as excess tartaric acid will lead to
tough mass , while excess of citric acid will lead to soft mass .
48
The liberated carbon dioxide has the following advantages :
- It masks the bitter and naseaous taste.
- It promotes gastric secretions.
- It acts as a carminative.
Preparation of granules using Wet method :
1- all powders are dried to constant wt. At temp. 100-105 o c .
2- pulverize each powder through sieve No.90 weigh the calculated amount
separately.
3- Pass the pulverized powder through sieve No. 90 and weigh the
calculated amount from each powder separately .
4- Mix the powder together and by the aid of alcohol 96 % ( drop adding )
make the mass coherent between your fingers and the mixing is continued
until the mass will retain its shape when moulded into a ball .
5- The mass is forced through sieve No. 10 then dry in ovens at temp. not
exceeding 50 O C .
6- After drying the granules sieved through sieve No. 20 to leave the fine
particles, and packed in well closed wide mouth bottles.
Calculation :
Calculate for slight excess due to the mechanical loss ( loss arised from
handling the materials and during the preparation ) and the chemical loss (
arised from liberation of CO2 & H2O , the chemical loss nearly equals to 1/7
formula).
Prepartion of sodium citra tartarate ( B.P.C.)
Rx
Sodium bicarbonate
Tartaric acid
Citric acid
Sucrose
510 g
270 g
180 g
150 g
These amounts of the ingredient base will give 1000 g only , thus 110 g
which is lost due to liberated CO2 & H2O ( chemical lss).
For calculation:
49
- mechanical loss ( lies between 15-20% ) , so,
- for mechanical loss we take ( (25 x 20 ) / 100 + 25 )
= (5+25) = 30 g. from the base.
- for NaHCO3 (30 x 510)/1000
=15.3 g
- Tartaric
(30 x 2700)/1000
= 8.1 g
- Citric acid
( 30 x 180 )/1000
= 5.4 g
- Sucrose
(30 x 150)/1000
= 4.5 g
Total
= 33.3 g
Thus 33.3 g is the total amount of ingredient after adding the amounts which
can loose during handling and during chemical reactions.
If the amount of sodium bicarbonate is not known , calculate it as follows
Amount of Sod. Bicarbonate =
( amount of citric acid x Eq. wt. Of sod. bicarb.) / Eq. wt. Of citric acid
+( amount of tartaric acid x Eq. wt. Of sod. bicarb.) / Eq. wt. Of tartaric acid
=
( (180 x 84)/70 + (180 x 84)/75 ) = 519.4
- In the prescription the amount used is 510 g so the final solution will
slightly acidic.
50
Section (11)
 TABLETS
1-Introduction :
Without question, the compressed tablet is one of the most popular dosage
forms today. About one-half of all prescriptions dispensed are for tablets.
Usually one considers a compressed tablet as an oral medication; however,
tablets have many other uses. The sublingual tablet, the pellet, the wafer, the
troche, and the vaginal insert are manufactured by the same procedure as an
oral tablet.
Tablets contains certain excipients selected to aid the processing and improve
the properties of the product .
Tablet Excipients :
1) Fillers : used to increase the bulk of the tablet . it is generally not
feasible to make tablets with a weight of loss than about 70 mg. It is essential
that fillers be inert and stable .
A - Soluble : lactose , sucrose , mannitol , sorbitol .
B – Insoluble: calcium sulphate , dicalcium phosphate , tricalcium
phosphate , starch , calcium carbonate .
2) Binders : the substance that glue powders together and cause them to form
granules are the bimders or adhesives. They are either sugars or
polymeric materials.
Examples
- Water ,
- Ethanol ,
- Acaccia mucilage (10-20%) and it gives hard ,friable granules ,
-Tragacanth mucilage (10-20%) ,
- Gelatin solutions (2-10%) , they are strong sdhesive ,use warm.
-Starch mucilage
warm.
- Glucose syrup
high humidity
51
(5-10 %) , one of the best general adhesieves ,use
(25-50%) , strongly adhesieve , tablet may soften in
- PVP
(3-15%) - Cellulose derivative (5-10 %)
3) Lubricants ,glidents and anti – adherents :
Three of the problems associated with tablet manufacture are the flow of
granulation , the adhesion of material to the punches and dies , and release of
the tablet from the press.
Lubricants :
Are those agents that the friction between the tablet edge and die wall
during the ejection cycle . e.g. magnesium stearate - Lubricants are usually
added at the very last step before compression , since they must be present on
the surfaces of the granules between them and the parts of the tablet press .
Glidants :
Are materials that improve the flow characteristics of granulation e.g.
talc.
Anti – adherents :
Function to prevent tablet granulation from sticking to faces of the
punches and the die walls e.g. talc .
Disintegrants :
Is a term applied to substance added to a tablet granulation for the
purpose of causing the compressed tablet to break apart when placed into an
aqueous environment .
Method of adding disintegrant :
It is better to add it in two portions , one half is added to the powdered
components before the wet granulation process and the remaining portion is
added to the finished granulation just prior to the compression . This method
hold that a disintegrent is required between the granules as well as within
them Some of the commonly used disintegrant
- Starch
(5-20% w/w )
- Avicel
(5-20 % w/w)
- Algenic acid
(5-10 %w/w)
- Veegum
(5-15 % w/w)
- Bentonite
( 5-15 % w/w)
52
Single-punch Tablet Machines
Tableting machines are commonly used in pharmaceutical industry. They are
high-speed machines that create thousands of tablets in a small period. The
compounding pharmacist uses a variation of these machines. It is called a
single-punch tablet press and makes one tablet at a time. A "punch" has two
pieces of casted tubular metal. The bottom metal piece has a small cavity in
one end of the tube; the top metal piece has one end that is tapered into a small
rod that will just fit into the small cavity in the other piece. The rod does not
go all the way to the bottom of the cavity, but leaves a small gap. The punch is
fitted into a press so that when the handle is depressed and released, the rod
goes into and then comes out of the bottom piece. To make a tablet, the
powder material is placed into the bottom piece, and the handle is depressed
and released. The powders are compressed and occupy the size of the gap
designed in the punch.
Punches come in many sizes which allows the production of tablets of
different sizes and compression strengths. But each punch is a matched set; it
is not possible to interchange the top and bottom pieces of different punches.
Chewable tablets, effervescent tablets, and compressed tablets can be made
using a tablet press. Chewable tablets are generally made using mannitol
because it has a sweet, cooling taste and is easy to manipulate. Other
ingredients may include binders (e.g., acacia), lubricants (e.g., stearic acid),
colors, and flavors. The powder mixture is prepared, the desired quantity of
mixture is weighed, and then pressed with a single-punch tablet machine.
Effervescent tablets generally contain ingredients such as tartaric acid, citric
acid, and sodium bicarbonate. These powders would be appropriately mixed
and pressed into tablets using the same procedure as chewable tablets. They
will not require a disintegrant since they will effervesce when placed in water.
Compressed tablet mixtures generally contain the active drug, a diluent (e.g.,
lactose), a disintegrant (e.g., starch), and a lubricant (e.g., 1% magnesium
stearate).
53
There are three methods of commercially making compressed tablets:
a) The direct compression method
A compressible vehicle is blended with the medicinal agent, and if necessary,
with a lubricant and a disintegrant, and then the blend is compressed.
Substances that are commonly used as directly compressible vehicles are:
anhydrous lactose, dicalcium phosphate (Emcompress), granulated mannitol,
microcrystalline cellulose (Avicel), compressible sugar (Di-Pac), starch (StaRx 1500), hydrolyzed starch (Celutab), and a blend of sugar, invert sugar,
starch and magnesium stearate (Nutab).
Preparation of Aspirin tablet by direct compression
Ingredient
Composition
Aspirin (granular) (mesh 40)
90%
325
32.5
Starch (Disintegrant)
7%
25
2.5
Talc (Glident )
2.4%
9
0.9
Srearic acid
0.6%
2
0.2
Total Tablet Weight
Quantity
Quantity
per tab.(mg) per 100 tab.
(g)
361
Procedure :
1)
Screen aspirin on 40 mesh sieve to remove the fine particles.
2)
Blend all the ingredients in a mortar using plastic spatula.
3)
Compress into tablets using 9 mm standard concave punches.
54
b) The dry granulation method (slugging method)
The ingredients in the formulation are intimately mixed and precompressed on
heavy duty tablet machines. The slug which is formed is ground to a uniform
size and compressed into the finished tablet.
However, when direct compression is not possible due to the properties and
those of the drug ,and wet granulation cannot be used because the drug is
sensitive to mositure and heat, then dry granulation remains the only method
available.
Preparation of Aspirin tablet by dry granulation
Ingredient
Composition
Quantity
Quantity
per tab.(mg) per 100 tab.
(g)
Aspirin (fine powder)
90%
325
32.5
Starch (Disintegrant)
7%
25
2.5
Talc (Glident )
2.4%
9
0.9
Srearic acid (lubricant)
0.6%
2
0.2
Total Tablet Weight
361
Procedure :

Mix all the above ingredients (except) 50 % of starch, talk and
magnesium stearate.

Compress into slug using 18 mm flat face punishes.

Grind the slugs using 20 mesh screen.


55
Transfer into cubic mixture and the reminder disintegrant and lubricant,
mix for 10 minutes.
Compress to weight using 9 mm concave punishes.
C) The wet granulation method
This method has more operational manipulations, and is more time-consuming
than the other methods. The wet granulation method is not suitable for drugs
which are thermolabile or hydrolyzable by the presence of water in the liquid
binder. The general steps involved in a wet granulation process are:

The powdered ingredients are weighed and mixed intimately by
geometric dilution.

The granulating solution or binder is prepared.

The powders and the granulation solution are kneaded to proper
consistency.

The wet mass is forced through a screen or wet granulator.

The granules are dried in an oven or a fluidized bed dryer.

The dried granules are screened to a suitable size for compression.

A lubricant and a disintegrating agent are mixed with the granulation.

The granulation is compressed into the finished tablet.
Preparation of Chewable antacid tablets
Ingredient
Quantity
Quantity
per tab.(mg) per 100 tab.
(g)
Aluminum Hydroxide
300
30
Calcium Carbonate
150
15
Mannitol
100
10
Gelatin ( as 10% solution)
20
Magnesium Stearate
15
Talc
15
Oil of Peppermint
0.2
Total Tablet Weight
600
56
Procedure:
1) Mix the first three ingredients and moisten with a 10 % gelatin solution
until formation of coherent mass.
2) Granulate by passing through 10 mesh screen.
3) Dry at 50o C. Overnight, screen the drug granules through 20/35 mesh.
4) Add the oil of peppermint mixed with talc and finally the magnesium
searate.
5) Mix for 5 minutes in a cubic mixer.
6) Compress using 12 mm flat face punishes.
2- Evaluation Of Tablets :
Tablets are evaluated by a variety of methods.
A.

Unofficial tests :
Tablet hardness: The tablets must be hard enough to withstand
mechanical stress during packaging, shipment, and handling by the
consumer. Section <1216> of the USP 24/NF19 outlines a standard tablet
friability test applicable to manufactured tablets. Most compounding
pharmacy would not have the apparatus specified in Section <1216>.
However, there are several hand operated tablet hardness testers that might
be useful. Examples of devices are the Strong Cobb, Pfizer, and Stokes
hardness testers. The principle of measurement involves subjecting the tablet
to an increasing load until the tablet breaks or fractures. The load is applied
along the radial axis of the tablet. Oral tablets normally have a hardness of 4
to 8 or 10 kg; however, hypodermic and chewable tablets are much softer (3
kg) and some sustained release tablets are much harder (10-20 kg).
57
Determination of Tablet Hardness
Using a hardness tester ( Erweka ) , determine the hardness of the four (4)
different types of tablets supplied. Use an average of three measurements for
each determination and comment on your results.
Hardness Tester _______________
Tablet
Type
Hardness 1 Hardness 2 Hardness 3
Mean
Hardness
Comment on Results

Friability Test : This test is designed to measure the ability of the
tablet to withstand handling and transportation.
Procedure : ( using Roche Friabilator ):
1. Take 20 tablets dedust and weigh them (wo)
2. Place tablets in friability drum , switch on the apparatus adgusting the
timer to 4 min. , and the speed at 25 r.p.m.
3. At the end of thid operation the tablets are removed , dedusted and reweighed (w) . should any tablet break the batch is rejected .
4. Friability B is expressed as a percentage loss in weight :
B =100 (1 - (w/wo ) )
5. If value of B is 1.0 % or less , the batch is accepted .
58
B.

Official standards :
Weight Variation
The total weight of a tablet is determined by the depth of the die cavity,
bulk density of granules or powder, and uniformity of particulate flow.
Even with a proper granulation having uniform flow, a volume fill is
not as accurate as a fill based on weight. Therefore, tablet weight
variations must fall within certain specifications established by the
USP.
Tablets are required to meet a weight variation test where the active
ingredient comprises a major portion of the tablet , tablets containing 50
mg or less of active ingredients , comprising less than 50% by weight of
the tablet should pass a content uniformity test.
Procedure :
Select 30 tablets and proceeds as follows :
1) Weigh accurately 10 tablets indiidually and calculate the average weight .
2) Calculate the average value of drug content as % following the asay
procedure using another sample obtained from the same batch .
3) Calculate the relative standard deviation (RSD)
Tablet
#
1
2
3
4
5
6
7
8
9
10
Weight of Tablet
(mg)
% Labeled
Claim
Note: Labeled claim is 750 mg
Mean (as % of labeled claim) _________
Standard Deviation __________
RSD __________
59
( Assay procedure of Aspirin tablets : )
Powder 10 tablets , weigh 0.5 g of powdered tablets , put in conical flask , add
25 ml of 0.5 N NaOH , boil gently for 5 min. , cool and titrate excess alkaline
with 0.5 N HCL using phenol red as indicator
- Each ml of 0.5 N HCL is equivalent to 0.045 g Aspirin
- Repeat the operation without aspirin
- Amount of Aspirin = ( B – Exp. ) x 0.045 = A
- % of Aspirin in tab. =( A / 0.5 ) x 100
(average content )
4) Calculate the content of active ingredient
in each 10 tablets = tab. Wt. X average content
100

Content Uniformity
NOTE: Tablets should be analyzed in the same order as the weight variation
test so that a comparison between weight variation and content uniformity can
be made.
Determine the content of active ingredient of the tablets by the procedure
given below.
- Select 30 tabs and proceed as follows :
- Assay 10 tablets individually as directed in the assay in the individual
monograph unless otherwise specified in the test for content uniformity
- Calculate RSD as befor.
60
Criteria : ( apply the following criteria , unless otherwise specified in the
individual monograph )
A) If the average of the limits specified in the potency definition in the
individual monograph is 100 % or less :
For weight variation , or content uniformity :
The requirements are met if the amount of the active ingredient in each of
10 tablets tested lies within the range of 85 % to 115 % of the label claim and
relative standard deviation is less than or equal to 6.0% .
If one tablet is outside the range of 85% to 115 % of the label claim and
no tablet is outside the range of75 % to 125 % of the label claim or if RSD is
greater than 6 , or if both conditions prevail , test 20 additional units the
requirements are met if not more than one tablet of the 30 is outside the range
of85 % to 115 % if the label claim and no tablet is outside the range of 75 %
to 125 % of the label claim and RSD of the 30 tablets does not exceed 7.8 % .
B) If the average of the limits specified in the potency definition in the
individual monograph is greater than 100 % :
1. If the average value of the tablets tested is 100 % or less , The
requirements are as in (A) .
2. If the average value of the tablets tested is greater than or equal to the
average of the limits specified in the potency definition in the individual
monograph , the requirements are as in (A) . except that the word s “ label
claim “ are replaced by the words “label claim multiplied by the average
of the limits specified in the potency definition in the individual
monograph is divided by 100 “ .
If the average value of the tablets tested is between 100 % and the average of
the limits specified in the potency definition in the individual monograph , the
requirements are as in (A) , except that the word s “ label claim “ are replaced
by the words “label claim multiplied by the average value of the tablet tested (
expressed as % of label claim ) divided by 100 “
61

Tablet disintegration: is an essential attribute for tablets intended
for administration by mouth , except those intended to be chewed before
being swallowed and except some types of sustained release tablets.
Disintegration (for uncoated tablets )
This test is provided to determine compliance with limits on disintegration
stated in the individual monograph . Disintegration does not imply complete
solution of the tablet or even its active constituent .
Complete disintegration is defined as that state in which any residue of the
tablet remaining on the screen of the test apparatus is a soft mass havong no
palpably firm core.
Procedure:
1. Place one tablet in each of the six tubes of the basket , add a disk to each
tube
2. Operate the apparatus , using water maintained at (37+2) o C . as the
immersion fluid unless another fluid is specified in the individual
monograph .
3. At the end of the time limit specified in the individual monograph , left the
basket from the fluid ,and observe the tablets : all of the tablets have
disintegration completely . if one or two tablets fail to disintegrate
completely , repeat the test on 12 additional tablets : not less than 16 of the
total of 18 tablets tested disintegrate completely .
Apparatus : refer to USP for details.

Tablet dissolution: Disintegration time determination is a useful tool
for production control, but disintegration of a tablet does not imply that the
drug has dissolved. A tablet can have a rapid disintegration time yet be
biologically unavailable. The dissolution rate of the drug from the primary
particles of the tablet is the important factor in drug absorption and for
many formulations is the rate-limiting step. Therefore, a dissolution time is
more indicative of the availability of a drug from a tablet than the
disintegration test. Even though this is an important parameter to measure.
62
Place the stated volume of dissolution medium in the vessel of the apparatus
specified in the individual monograph, assemble the apparatus, equilibrate the
dissolution medium to 37 + 0.5 o C and remove the thermometer. Place one
tablet in the apparatus, and operate at the specified rate of the monograph. At
the time specified, withdraw a sample and perform the analysis as in the
monograph. Repeat the test with additional tablets.
Unless otherwise specified in the individual monograph and the requirements
are met if the quantities of active ingredient dissolved from the tablets tested
conform to the accompanying acceptance table.
ACCEPTANCE TABLE
Stage
Number
Tested
Acceptance Criteria
S1
6
Each Tablet is not less than Q + 5%
S2
6
S3
12
Average of 12 tablets (S1+S2) is equal to or
greater than Q, and no unit is less than Q-15 %
Average of 24 tablets (S1+S2+S3) is equal or
greater than Q and not more than two tablets are
less than Q-15%
Continue testing through the three stages unless the results conform at
either S1 or S2. The quantity Q, is the amount of dissolved active ingredient
specified in monograph expressed as a percentage of the labeled content. Both
the 5% and 15% value in the acceptance table are percentages of the labeled
content.
63
Dissolution Test For Aspirin Tablets (Uncoated)
- Medium : 0.05 M acetate buffer having pH of 4.5; 500ml
- Time : 30 min
- Q : 75 %
Assay Procedure :
1) At the time specified, 2 ml aliquote is pipetted out through a Millipore
filtration unit and placed in a 50 ml volumetric flask. Then add 2 ml
dissolution medium to the dissolution vessel.
2) After adjusting volume to 50 ml with 0.1N sulphuric acid, the absorbance
of each solution is measured at 228 nm.
3) The amount of Aspirin dissolved ( C ) =
(Absorbance X Conc.Factor X Dil Factor X Dissolution Medium Volume) =
(Absorbance X 0.02 X 25 X 500 ) mg.
4) Percentage of Aspirin dissolved at time specified =
5) C/ Label Claim X 100 = C/325 X 100
64
Section (12)
 CAPSULES
1- Introduction :
Capsules are gelatin shells filled with the ingredients that make up an
individual dose. Dry powders, semi-solids, and liquids that do not dissolve
gelatin may be encapsulated. Capsules account for about 20% of all
prescriptions dispensed. Capsules have several advantages as pharmaceutical
dosage forms:
1. They may be used to mask the unpleasant tastes, aromas, or appearance of a
drug.
2. They allow powders to be dispensed in an uncompressed form, thus
allowing for quicker dissolution and absorption of the drug following oral
dosing (as compared with tablets).
3. They offer the pharmacist versitility to prepare any dose desired for a
variety of administration routes (e.g. oral, inhalation, rectal, or to be diluted
for vaginal, rectal, oral or topical use).
4. They may be easier than tablets for some people to swallow.
5. They can be make to alter the release rate of the drug.
Their disadvantages or limitations include the following:
 They are easily tampered with (although techniques exist for preventing
this).
 They are subject to the effects of relative humidity and to microbial
contamination.
 They may be difficult for some people to swallow.
 More expensive (commercially).
HARD GELATIN CAPSULES
The hard gelatin capsule consists of a base or body and a shorter cap, which
fits firmly over the base of the capsule. For human use, eight sizes of
capsules are available. The capacity of each size varies according to the
combination of drugs and their apparent densities. Capsules are available as
65
clear gelatin capsules or in a variety of colors. The pharmacist can use the
different colored capsules to distinguish two capsule formulations for the
same patient, or to encapsulate unattractive ingredients.
The pharmacist can add a dye to the powder before filling a clear capsule to
impart a color for identification or esthetics.
Some types of hard gelatin capsules have a locking cap, which makes it more
difficult to reopen the capsule.
To aid in the selection of the appropriate size, a table, with the capacity of five
common drugs for that particular size capsule, is printed on the box of the
capsules. As a guide, the relative sizes and fill capacities of capsules are given
below. By knowing the bulk density of fill material, proper choice of capsule
size is usually made easier; however, trial and error soon develops the
judgment of the beginning pharmacist.
Capsule Size
000
00
0
1
2
3
4
5
Volume ( ml)
1.37
0.95
0.68
0.50
0.37
0.30
0.20
0.13
Mg of Lactose
1340
929
665
489
362
293
195
127
Mg of Aspirin
1000
600
500
300
250
200
125
60
2- Methods of preparation of capsules :
"Punch" Method
To hand fill capsules at the prescription counter, the pharmacist generally uses
the "punch" method. The ingredients are triturated to the same particle size
and then mixed by geometric dilution. The powder is placed on a powder
paper or ointment slab and smoothed with a spatula to a height approximately
half the length of the capsule body. The base of the capsule is held vertically
and the open end is repeatedly pushed or "punched" into the powder until the
capsule is filled; the cap is then replaced to close the capsule. Each filled
capsule is weighed using an empty capsule as a counterweight. Powder is
added or removed until the correct weight has been placed in the capsule. The
filled capsule is tapped so that no air spaces are visible within the contents.
66
It is a good practice to remove from the stock container the exact number of
empty capsules needed before you begin filling them. In this way you avoid
preparing the wrong number of capsules and at the same time avoid
contaminating the empty capsules with drug particles that cling to your hands.
Also, since some fill material will likely be lost in the process of punching
capsules, the pharmacist generally calculates for the preparation of at least one
extra capsule to insure enough fill for the last capsule.
The simplest method by which a capsule may be kept free of moisture during
compounding is to wash the hands well, dry them, and keep the fingers dry by
stripping a towel through the cleansed fingers until warmth is felt. An
alternative method is to use the base of one capsule as a holder for other bases
during the filling operation. The capsules do not come in contact with the
fingers. The most sure method of protecting the capsule is to wear finger cots
or rubber gloves.
Capsule Machines
Capsule machines are available for filling 50, 100, and 300 capsules at a time.
Each manufacturer's machine is slightly different in its operation, but the
series of operations is the same. Capsules are first loaded into the machine.
Most machines come with a capsule loader which correctly aligns all of the
capsules in the machine base. There are plates on the machine base that can be
adjusted. First, the plates are adjusted to hold the capsule bodies in place while
the caps are removed all at one time. The caps remain in place in the top of the
machine for later use. Then the plates are adjusted again so that the capsule
bodies will "drop" into place so that the tops are flush with the working
surface of the plate.
The formulation powder is poured onto the plate and special spreaders and
combs are used to fill the individual capsules. Some manufacturer's have
special shakers that will also help spread the powder and fill the capsules. The
powder is spread evenly over the plate, and the comb is used to tamp and pack
the powder into the capsules. These two processes are repeated over and over
again until the capsule bodies are filled with the powder. All of the caps are
then simultaneously returned to the capsule bodies, and the closed capsules
are removed from the machine.
67
The machine has the advantage of filling many capsules in a timely manner.
However, there is a tendency to pack the capsules in the middle of the plate
with more powder than the capsules along the periphery. It takes practice to
ensure that each capsule has the same amount of drug. A quality control
procedure should be executed with each batch of capsules produced with the
machine.
Final Processing
Once the capsules have been compounded and the capsule closed, the
pharmacist may want to "seal" the capsule. The best way is to use "locking"
capsules, where the body and cap lock together, making it very difficult to
open the capsule again. If using locking capsules, during the filling process
the cap is not completely closed onto the body in the weighing procedure to
determine the weight of powder in the capsule. The locking is done only one
time and that is after the capsule is correctly filled.
If locking capsules are not used, a seal can be made by touching the outer
edge of the body with a moist towel to soften the gelatin. Alternatively, a
cotton swab dipped in warm water can be rubbed around the inner edge of the
cap. When the cap is closed on the body, it is slightly twisted to form the seal.
When compounding and sealing are complete, the capsules may need cleaning
to remove fingerprints, traces of body oils, or loss powder from the capsule.
Fingerprints and oils cannot be effectively cleaned from capsules so the best
way to prevent these problems is to wear gloves during the compounding
process. Any clinging powder can be removed by rolling the capsules between
the folds of a towel.
Another proposed cleaning method is to put the capsules in a container filled
with sodium bicarbonate, sugar, or sodium chloride, and gently roll the
container. Then the container contents can be poured into a ten-mesh sieve
where the "cleaning salt" will pass through the sieve.
Capsules should be visually inspected and checked for:
 Uniformity - check capsules for uniformity in appearance and color.
 extent of fill - check capsules for uniformity of extent of fill to ensure
that all capsules have been filled.
 locked - check capsules to ensure that they have all been tightly closed
and locked.
68
Preparation of Ephedrine Sulfate and Phenobarbital Capsules
Rx
Ephedrine Sulfate
Phenobarbital
0.025 g.
0.015 g.
Make 6 capsules
Sig.: one cap. q.i.d.
Procedure :
1- The powders are triturated intimately and mixed by geometric dilution .
2- The resting powder is placed on a powder paper and smoothed with a
spatula to a height approximately half the length of capsule body.
3- The open end of the capsule base is repeatedly pushed into the powder
until the capsule is filled
4- The cap. is then placed back to close the capsule .
5- Each filled capsule is weighed using empty capsule as counterpoise,
powder is added or removed until the correct weight is obtained .
6- Finally the capsule is cleaned to remove any trace of powder trapped on the
surface
Use : treatment of bronchial asthma .
Calculation:
Calculate for 10 capsules using no. 0 capsules
1. Fill one capsule with lactose in previously described manner and determine
the exact capacity of capsule by weighing suppose it is 0.5 g.
2. Calculate the amounts drugs for 10 capsules and substrate from total
amount of lactose (0.5 g x 10 ) to get amount of lactose which you will use
e.g. ( 0.5 g x 10 – (0.025 x 10 + 0.015 x 10 ) ) = 4.6 g lactose
3. Weigh the calculated amounts of lactose ( 4.6 g ) , ephedrine sulphate (0.25
g ) and phenobarbital ( 0.15 g ) .
69
Section (13)

SUPPOSITORIES
1-Introduction:
Suppositories are medicated, solid bodies of various sizes and shapes suitable
for introduction into body cavities. The medicament is incorporated into a
base such as cocoa butter which melts at body temperature, or into one such as
glycerinated gelatin or PEG which slowly dissolves in the mucous secretions.
Suppositories are suited particularly for producing local action, but may also
be used to produce a systemic effect or to exert a mechanical effect to
facilitate emptying the lower bowel.
The ideal suppository base should be nontoxic, nonirritating, inert, compatible
with medicaments, and easily formed by compression or molding. It should
also dissolve or disintegrate in the presence of mucous secretions or melt at
body temperature to allow for the release of the medication. As with the
ointment bases, suppository base composition plays an important role in both
the rate and extent of release of medications.
2- Methods of preparation :
Suppositories can be extemporaneously prepared by one of three methods.
Hand Rolling is the oldest and simplest method of suppository
preparation and may be used when only a few suppositories are to be
prepared in a cocoa butter base. It has the advantage of avoiding the
necessity of heating the cocoa butter. A plastic-like mass is prepared by
triturating grated cocoa butter and active ingredients in a mortar. The mass is
formed into a ball in the palm of the hands, then rolled into a uniform
cylinder with a large spatula or small flat board on a pill tile. The cylinder is
then cut into the appropriate number of pieces which are rolled on one end to
produce a conical shape.
Effective hand rolling requires considerable practice and skill. The
suppository "pipe" or cylinder tends to crack or hollow in the center,
especially when the mass is insufficiently kneaded and softened.

Compression Molding is a method of preparing suppositories from a
mixed mass of grated suppository base and medicaments which is forced into
a special compression mold. The method requires that the capacity of the
molds first be determined by compressing a small amount of the base into
the dies and weighing the finished suppositories. When active ingredients are
added, it is necessary to omit a portion of the suppository base, based on the
density factors of the active ingredients.

70
Fusion Molding involves first melting the suppository base, and then
dispersing or dissolving the drug in the melted base. The mixture is removed
from the heat and poured into a suppository mold. When the mixture has
congealed, the suppositories are removed from the mold. The fusion method
can be used with all types of suppositories and must be used with most of
them.

3- Suppository bases :
Suppository bases may be conveniently classified as according to their
composition and physical properties:
 Oleaginous (fatty) bases
 Water soluble or miscible bases (hydrophyllic)
a) Oleaginous Bases include Theobroma Oil and synthetic triglyceride
mixtures.
Theobroma Oil or cocoa butter is used as a suppository base because, in
large measure, it fulfills the requirements of an ideal base. At ordinary
room temperatures of 15° to 25°C (59° to 77°F), it is a hard, amorphous
solid, but at 30° to 35°C (86° to 95°F), i.e., at body temperature, it melts to
a bland, nonirritating oil. Thus in warm climates, theobroma oil
suppositories should be refrigerated.
Particular attention must be given to two factors when preparing
suppositories with cocoa butter base. First, this base must not be heated
above 35°C (95°F) because cocoa butter is a polymorphic compound
and if overheated will convert to a metastable structure that melts in the
25° to 30°C (77° to 86°F) range. Thus, the finished suppositories would
melt at room temperature and not be usable.
The second factor is the change in melting point caused by adding
certain drugs to cocoa butter suppositories. For example, chloral hydrate
and phenol tend to lower the melting point. It may be necessary to add
spermaceti or beeswax to raise the melting point of finished
suppositories back to the desired range.
The newer synthetic triglycerides consist of hydrogenated vegetable oils.
Their advantage over cocoa butter is that they do not exhibit
polymorphism. They are, however, more expensive. Some of the bases are
single entity formulations. Some of the names may denote a series of
bases. In a series, the bases are varied to give a range of melting points. For
example, Fattibase® is a single entity base that consists of triglycerides
71
from palm, palm kernel, and coconut oils. Wecobee® is a series of bases.
Wecobee FS, M, R, and S are all made from triglycerides of coconut oil.
b) Water Soluble/Water Miscible Bases are those containing glycerinated
gelatin or the polyethylene glycol (PEG) polymers.
Glycerinated Gelatin is a useful suppository base, particularly for vaginal
suppositories. It is suitable for use with a wide range of medicaments
including alkaloids, boric acid, and zinc oxide. Glycerinated gelatin
suppositories are translucent, resilient, gelatinous solids that tend to
dissolve or disperse slowly in mucous secretions to provide prolonged
release of active ingredients.
Suppositories made with glycerinated gelatin must be kept in wellclosed containers in a cool place since they will absorb and dissolve in
atmospheric moisture. In addition, those intended for extended shelf-life
should have a preservative added, such as methylparaben or
propylparaben, or a suitable combination of the two. To facilitate
administration, glycerinated gelatin suppositories should be dipped in
water just before use.
Calibration of Suppository Molds with Glycerinated Gelatin Base
Glycerinated Gelatin Suppositories have the following proportions of glycerin,
gelatin, and water. Use 75 g of the suppository base for this calibration
exercise.
Ingredients
Glycerin
Gelatin
Purified Water
Percenta
ge
70%
20%
10%
Amt./Vol. to
measure
__________ g _________ ml
__________ g _________ g
__________ g _________ ml
Weight Basis
To calibrate the mold with glycerinated gelatin suppository base:





72
Clean mold with soap and water.
Dry the mold.
Have the mold at room temperature.
Lubricate the mold with light mineral oil.
Mix the glycerin and water together and heat on a steam bath or hot
plate for 5 minutes. Gently stir in the gelatin to avoid incorporating air
in the mixture. After the gelatin has been added, continue heating for




another 40 - 50 minutes. Do not allow the temperature to get above 90 95°C, as the color will darken.
Remove from the heat and allow the mixture to cool near the melting
point before pouring into the mold.
Overfill the cavities in the mold, cool at room temperature for 30
minutes, and then place in a refrigerator 15-20 minutes if the
suppositories have not completely congealed.
Carefully remove excess with a hot spatula or knife. Remove
suppositories from mold.
Using only perfect specimens, weigh the suppositories and record the
total weight. Calculate the average suppository weight.
Mold #
__________
Total weight for ____ suppositories =
_________ g
Average weight for one suppository =
_________ g
Mold lubricant used
_____________________
Inspection of Final Product
_____________________
N.B.
- Gelatin base is incompatible with many of the substances prescribed in
supp. E.g. Tannic acid , Ferric chloride , Gallic acid , and for this
another reasons this base is less frequently use than coca butter .
- Glycerin supp. Containing Ichthammol became insoluble on storage
- Gelatoglycerin bases used mainly for preparing supp. Containing
boric acid , chloral hydrate , ichthamol , iodine (dissolved by the aid of
KI )
Standardization of suppositorise :
The Standardization of any supp. Involves the following determinations:
a- Determination of DISPLACEMENT VALUE of the active ingredients
b- Determination of FRACTURE POINT of the prepared supp. ( the weight
under which the supp. Sample collapses under given conditions is taken as a
measure of the strength of the supp. Tested .
c- determination of MELTING TIME of the prepared suppository .
d- determination of UNIFORMITY OF WEIGHT of the prepared suppository
.
73
Preparation of the glycerogelatin bases :
- In a prcelin dish soak the gelatin powder with amount of H2O present in
the formula for about 5 – 10 min. till it completely wetted and swelled
- add the amount of glycerin to the soaked gelatin.
- Put the dish on boiling water bath .
- Stirr gently till complete solubility of gelatin and the formulation of a
translucent mass, avoid air bubbles formation during stirring
- Pour the translucent mass into mould (previusly lubricated with liquid
paraffin or any other oil ) after adding the medicament (if the formula
containing medicament ) and – Take care that preferably JUST FILL the
cavities because the mass does not contract upon cooling .
Preparation of Boroglycerin Suppository
Rx
Boric acid
Gelatin
Glycerin
Water
7.5 g
15.0 g
62.5 g
15.0 g
Fiat supp. Mitte III
Calculation :- The formula gives 100 g of suppository mass.
- To prepare 3 supp. Calculate for 5 .
- If we use mould of 1 g capacity the amounts are as follows :
Boric acid = (1 x 5 x 7.5 ) / 100 = 0.375 g
Gelatin
= ( 1 x 5 x 15 ) / 100 = 0.750 g
Glycerin = ( 1 x 5 x 62.5 ) / 100 = 3.125 g
Water
= ( 1 x 5 x 15 ) / 100 = 0.750 g
-If we use mould of 2 g capacity the amounts given above multiplied by (2)
and so on.
74
Prepartaion :
- In a porcelin dush soak gelatin in water , then transfer to dish over a water
bath .
- Dissolve boric acid in glycerin by the aid of gentle heat .
- Add the dissolved boric acid the gelatin solution and continue heating over
a water bath until a clear solution produced and constant wt is attained .
N.B.
- Boric acid reacts with glycerin on heating giving glyceryl borate which
has an antiseptic action .
75
76
Section(14)
APPENDEX (A)
Latin Terms and Common Abbreviations
Common
Abbreviation
Translation
ad
ad lib.
add
agit
alt. h.
a.a. or aa
a.
a.c.
a.m.
amp.
aq.
aq. ad.
ag. dest; aqua dist.
aur.; a
a.d.
a.l.
a.s.
a.u.
aurist
a.t.c.
to, up to
at pleasure
add (thou)
shake, stir
every other hour
of each
before
before food, before meals
morning
ampule
water
water up to
distilled water
ear
right ear
left ear
left ear
each ear
ear-drops
around the clock
bis
bis in die
brachium
b.
b.i.d.
brach.
BSA
twice
twice a day
the arm
body surface area
capsula
caps
c.c.
a capsule
cubic centimeter
Latin Term
a...
ad
adde
agita
alternis horis
ana
ante
ante cibum
ante meridien
aqua
aqua ad
auris
auris dexter
aurix laevus
auris sinister
auris utro
auristillae
b...
c...
77
chartulae
charts
cibus
collunarium
collutorium
collyrium
compositus
congius
cum
cum cibus
cib.; c.
collun
collut.
collyr.
comp.
cong.; C.
c or c.
c.c.
powder papers; divided
powders
food
a nose wash
a mouthwash
an eyewash
compound
gallon
with
with food; with meals
dentur
dentur tales doses
dexter
diebus alternis
dilutus
d.
d.t.d.
d.
dieb. alt.
dil.
disp.
div.
DW
give (thou); let be given
give of such doses
right
every other day
dilute, diluted
dispense
divide
distilled water
emulsum
et
elix.
emuls.
et
ex modo prescripto
e.m.p.
elixir
emulsion
and
in the manner prescribed; as
directed
fac, fiat, fiant
f.; ft.
f.; fl.
let it be made; make
fluid
granum
guttae
g.; G.; gm.
gr.
gtt.
gram
grain
a drop
hora
hora somni
h
h.s.
at the hour of
at bedtime
injectio
i.m.
inj.
intramuscular
injection
d...
e...
f...
g...
h...
i...
78
i.v.; IV
i.v.p.; IVP
IVPB
intravenous
intravenous push
intravenous piggyback
laevus
linimentum
liquor
l.
lin.
liq.
lot.
left
liniment
a solution
lotion
minimum
misce
min; Mx
m.; M
mcg.
mEq.
mg.
ml.
minum
mix
microgram
milliequivalent
milligram
milliliter
nocte
naristillae
nebule
n.
narist.
neb.
N.F.
non.rep.
NS
at night
nasal drops
a spray
National Formulary
do not repeat
normal saline
octarius
oculentum
oculus
oculus dexter
oculus laevus
oculus sinister
oculus utro
omni mane
O.
occulent.
o.
o.d.
o.l.
o.s.
o.u.
o.m.
pint
eye ointment
eye
right eye
left eye
left eye
both eyes, each eye
every morning
parti affectae
p.a.a.
to be applied to affected part
j...
k...
l...
m..
.
n...
non repetatur
o...
p...
79
applicandus
per os
post cibum
pro re nata
pulvis
p.o.
p.c.
p.r.
p.r.n.
pulv.
by mouth
after meals
per rectum
as needed
powder
quater in die
quaque
quaque die
quaque hora
quantum sufficiat
quantum sufficiat ad
q.i.d.
q.
q.d.
q.h.
q.s.
q.s. ad
four times a day
each, every
every day
every hour
a sufficient quantity
a sufficient quantity to make
secundum artem
s.a.
S.C.; subc; subq
ss
Sig.
s
s.o.s.
sol.
stat.
supp.
syr.
according to the art
subcutaneously
one-half
write, label
without
if necessary
solution
immediately
suppository
syrup
tabella
tab.
tbsp.
tablet
tablespoonful
ter in die
t.i.d.
three times a day
tinc.; tr.
tincture
trochiscus
troche
lozenge
tussis
tuss.
a cough
ungentum
ung.
an ointment
ut dictum
ut dict.; u.d.
as directed
q...
r...
s...
semis
signa
sine
si opus sit
statim
suppositorum
syrupus
t...
u...
80