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Lab Manual Dosage Form Sciences

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EXPERIMENT NO: 1
AIM: To prepare and submit 50 ml of concentrated peppermint water BP.
Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.
Materials: peppermint oil, alcohol (ethanol), purified water.
Formula:
Rx
Peppermint oil
20 ml
Alcohol (90%)
600 ml
Purified water q. s to make
1000 ml
Procedure:
Peppermint oil is dissolved in alcohol. Sufficient purified water is then added in
successive portions, shaking vigorously after each addition. Final volume is then made
up with more purified water. However, purified talc or other filtering aid may be adde d
and the mixture shaken occasionally for a few hours and finally filtered.
Storage: it should be stored in well closed container, in a cool place.
Dose: 0.3 to 1 ml.
Theory: main active constituent of peppermint oil are methyl acetate, an ester and fre e
menthol.
Formula:
Pippermint oil : 1 ml
Alcohol (90%) : 30 ml
Purified water qs : 50 ml
Uses: carminative
Dose : 0.3-1 ml
Secondary Label: shake
well before use
Storage : Store in tight closed
container , in cool place.
Batch No: A-301
Date of Manufacturing:
Date of Expiry:
Manufactured By: Your name or ID no
28-Sep-11
Experiment No. 2
AIM: To prepare and submit 20 g of Dusting Powder
Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and
glass rod
Materials: castor oil, gum acacia, water.
Rx
Camphor
Starch
Zinc oxide
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 pulverize in the mortar with pestle
2- Add few drops of alcohol and pulverize.
3- Mix starch and zinc oxide and gradually add to camphor while
trituration until uniformity.
4- Pass through 90-mesh sieve.
Storage:
Store in a cool and dry place
Experiment No. 3
AIM: To prepare and submit 40 ml of castor oil emulsion
Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and
glass rod
Materials: castor oil, gum acacia, water.
Fixed Oil
Formula:
Castor Oil Emulsion
Rx
Castor oil
16.0 ml
Gum acacia
02.0 g
Water
80.0 ml
Uses: Castor oil is administered orally as a purgative.
Castor oil is a fixed oil. Therefore, the primary emulsion formula used is:
Oil: Water:
Gum
4:
2:
1
Either the dry gum method or the wet gum method can be used, but the former is more
suitable.
Method of preparation.
1. Select a sample-sized mortar and a suitable pestle.
2. Place 2 g. acacia (very finely pulverized) in the mortar.
3. Measure 8 ml of oil in a dry measure and pour on the gum allowing some time for the
measure to drain.
4. Triturate the oil and gum together for a few seconds.
5. Measure exactly 4 ml of water in another measure.
6. Begin to triturate the oil and, gum again using whipping motion, but not a grinding action.
While triturating, add water all at once.
7. As the water reaches the oil-gum mixture, increase the rate of trituration, taking care to
maintain the whipping motion and work in one direction only.
8. Continue trituration till the primary emulsion is formed. This is when the mixture becomes
white in colour and cracking sound is heard.
9. Continue to triturate for a little longer before attempting to dilute.
10. Measure small amount of water and add them drop wise, with continuous trituration, to
the primary emulsion and then dilute with remaining amount of water and transfer to a
measure.
11. Rinse the mortar with more water and adjust the volume.
Castor oil emulsion USP (40 ml)
Formula:
Castor oil : 6.4 ml
gum acacia : 1.6 g
Water : 28.8 ml
Uses: used as purgative
Direction for Use:
immediately
Dose : swallow in one
time
Secondary Label: shake
well before use
Storage : Store in tight closed
Container.
Batch No:
Date of Manufacturing:
Date of Expiry:
Manufactured By:
Experiment No. 4
AIM: To prepare and submit 50 ml of Sodium Bicarbonate ear drops B.P
Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and
glass rod
Rx
Sodium Bicarbonate
5g
Glycerol
30ml
Distilled water ad
100ml
Sent 50ml
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
Experiment No. 5
AIM: To prepare and submit 50 g of Granules
Preparation of granules
THEORY:
Granules are prepared agglomerates. They are prepared by adding binding agents that
on passing through a specific sieve give a compact mass of irregular shape. The size of
granules varies according to requirement n applications. They can prepare by two methods.
Methods of preparation of granules
There are two methods of preparation of granules;
1. Wet granulation method.
2. Dry granulation method.
Characteristics of Granules:
1. The flow properties of granules are much better as compare to powder.
2. The surface area of granules is les as compared to powders that protect then
from atmospheric degradation.
3. Affect of atmospheric humidity is less.
4. Granules can easily be wetted with water as compare to powders.
Preparation of granules:
Ingredients:
Starch……………………………….50 gm
Lactose …………………………….500gm
Colour……………………………….few drops
Distilled water…………………..500ml
Procedure:
Take all ingredients and weigh them carefully. Take the starch in a beaker add little
amount of water. Stir it until the formulation of smooth paste. Known as slurry. Start boiling
the remaining water in another beaker. When it starts boiling add small amount of color in it.
when it starts roaring then add this colored water into the slurry that is prepared already. Stir
vigorously until the formation of gel form. Now spread the lactose in the tray and add small
amount of gel paste on different portions of lactose. Mix the starch paste until the formation of
cracking balls.
This moist mass is passed through the sieve number 10 or 12 to produce granules of required
size. Then spread on tray and place the tray in oven for 2-3 hours to dry.
Precautions:
1. Mixing should be proper
2. During mixing stirring should be vigorous.
3. Mixing of starch should not be more than required amount.
Experiment No. 6
TITLE:
Determination of Bulk density of granules
THEORY:
Granules are prepared agglomerates. They are prepared by adding binding agents
that on passing through a specific sieve give a compact mass of irregular shape. The size
of granules varies according to requirement n applications.
Bulk density
Density of a substance can be defined as ratio of mass per unit volume.
Types of density:
1. Bulk density.
2. Tap density.
In tap density the solid mass consist of one unit where in bulk density the surface
is divided into many units. This cause formation of ‘air space’ which may call as voids. The
air entrapped into the voids is responsible for capping (the hole of upper layer of tablet). Thus
tapping is helpful to emit the air spaces inside the granules.
Requirements:
I.
II.
III.
Procedure:
Granules
Measuring cylinder
Electronic balance
Take 50 gm of granules in a measuring cylinder. Note the volume with tapping and
again note the volume with tapping. Bulk density is measured by the following formula:
Bulk density = mass/volume
without tapping
Tap density = mass/volume
with tapping
Porosity; It may be defined as the reciprocal of density is called porosity and can be
calculated by;
Porosity= 1/density
Calculations:
Bulk density:
Volume of granules = 95ml
Mass of granules = 50gm
Bulk density = mass/volume = 50/95 = 0.52g/ml
Tap density:
Volume of granules (after tapping) = 85ml
Mass of granules = 50gm
Tap density = mass/volume = 50/85 = 0.58g/ml
Result:
Bulk density is 0.52g/ml
Tap density is 0.58g/ml
According to B.P specification the bulk density should be less or equal to one.
Experiment No. 7
TITLE:
Determination of flow rate of granules
THEORY:
Granules are prepared agglomerates. They are prepared by adding binding agents that on
passing through a specific sieve give a compact mass of irregular shape. The size of granules
varies according to requirement n applications.
Flow rate:
It is the time of flow of granules through the fennel.
Requirements:
I.
II.
III.
Procedure:
Granules
Stop watch
fennel
Take 100 grams of granules placed in the funnel and allow them to flow. Note the time
taken by granules to flow in funnel with the help of stop watch.
Calculations: Flow rate can be calculated by following formula
Flow rate=mass/time
Mass = 100 gm
Time=11.65 sec
Flow rate=100/11.65
=8.58 gm/sec
Result:
Flow rate of granules is 8.58 gm/sec
According to B.P specification the flow rate should be 7- 10 gm/sec.
Experiment No. 8
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.
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 adjusted as excess tartaric acid will lead to tough mass, while
excess of citric acid will lead to soft mass.
The liberated carbon dioxide has the following advantages:
- It masks the bitter and nauseous taste.
- It promotes gastric secretions.
- It acts as a carminative.
Preparation of granules using Wet method:
1- All powders are dried to constant weight at temperature 100-105°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 molded into a ball.
5- The mass is forced through sieve No. 10 then dry in ovens at temperature not exceeding
50°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 raised from handling the materials
and during the preparation) and the chemical loss (raised 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.
For calculation:
- 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 lose during
handling and during chemical reactions.
If the amount of sodium bicarbonate is not known, calculate it as follows
-
In the prescription the amount used is 510 g so the final solution will slightly acidic.
PREPARATION OF EFFERVESCENT
EFFERVESCENT GRANULES
GRANULES
Rx
Sodium phosphate (anhydrous) 500 g
Sodium bicarbonate 500 g
Tartaric acid 240 g
Citric acid 210 g
Color Q. S.
Make effervescent granules. Send 20 g.
Sig.: One teaspoonful in a half glass of water to be taken while
effervescence when needed.
SODIUM
PHOSPHATE
Calculations:
Calculate for 30 g to compensate for the loss in the sieve.
Procedure:
(1) Read the prescription carefully, check the calculations for the amounts to be used and check
the balance and be sure that it is ready for weighing.
(2) Mix the weighed powders in an ascending order of weights starting with the smallest
weight.
(3) Add coloring solution, taking great care to distribute it evenly.
(4) Moisten the powder mixture with alcohol 96 %, which will act as a binder to form a damp
mass.
(4) Add extra binder if needed and mix continuously until the mass will retain its shape when
molded into a ball.
(5) Force the mass through a sieve of suitable size (2.8 mm).
(6) Dry the moist granules in a temperature not exceeding 55°C or in an open-air if the humidity
is low.
(7) Transfer the dried granules into a wide-mouthed glass bottle, close and stick on the label.
NOTES:
(1) Effervescent granules prepared with tartaric acid only produce granules which are powdery
and the final product will have a salty taste. On the other hand, if only citric acid is used, the
mass will be sticky and difficult to manipulate. Therefore, a combination of the two acids is
used to make a better granulation mixture.
(2) The label should stress the importance of storage in a dry place.
Uses of the prescription ingredients:
(1) Sodium bicarbonate reacts with the acids when the preparation is added to water. The
evolved carbon dioxide produces the effervescence.
(2) Citric and tartaric acids: The quantity of these acids is slightly more than is necessary to
neutralize the sodium bicarbonate because effervescent preparations are more palatable if
slightly acidic.
(3) Sodium phosphate is used as saline purgative.
Experiment No. 9
AIM: To prepare and submit 30 ml of antacid Suspension.
Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and
glass rod
Materials/ formula
Rx
Magnesium sulphate
5.0 g
Light Magnesium carbonate
1.0 g
Peppermint water q. s to make
15.0 ml
Procedure:
(1) Finely powder magnesium sulphate, then mix well with light magnesium carbonate.
(2) Measure about three-quarter of the peppermint water, pour a portion of it into the mortar
containing the powder and triturate to form a smooth cream; then gradually add the
remainder of the vehicle measured out.
(3) Examine the contents of the mortar and if particles of foreign matter are visible, spread
a piece of muslin over the mouth of the container, and pour the content of the mortar
through it.
(4) Rinse the mortar with a little of the vehicle, and then pass the liquid through the muslin.
(3) Finally make up the volume
Uses: Laxative and antacid in case of liver cirrhosis.
Dose: 30 ml.
Storage: store in well closed container
Secondary (auxiliary) label: shake well before use.
Experiment No. 10
Aim: To prepare and submit 20 g of tooth paste.
Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and
glass rod
Materials/formula (Tooth paste):
Rx
Precipitated chalk (calcium carbonate)
57.0 g
Sod. Lauryl sulphate 11504
1.0 g
Glycerin
21.0 g
Gum Tragacanth
1.5 g
Water
20.0 g
Method of preparation:
1) Triturate precipitated chalk, sod. lauryl and gum in a mortar and mix gradually with
levigation.
2) Then add glycerin to (1) with levigation until paste is formed, and
3) add amount of water according to desired consistency.
Uses: use for dentifrices.
Packaging and Storage:
Fill on wide mouthed plastic or glass container and or collapsible tubes and store at temperature
not more than 25 °C.
Label:
For External use only
Experiment No. 11
AIM: To prepare and submit 50 ml of scar phenol ear drops by using following formula.
Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.
Materials: phenol, glycerin.
(A)
To prepare 50 ml of Phenol Glycerin BPC
Phenol Glycerin BPC
Rx
Phenol
160.0 g
Glycerin q. s to make
1000.0 g
Density:
Phenol
= 1.07 g/cm3, Glycerin = 1.261 g/cm3
Procedure: Dissolve phenol in glycerin
(B) Scar Phenol ear drops BPC
Rx
Phenol glycerin
15.0 ml
Glycerin q. s to make
50.0 ml
Procedure: Take the measured amount of phenol and diluted with sufficient amount of
glycerin up to 50 ml.
Uses: used as antiseptic Ear drops
Storage: store in tightly closed container
Dose: 2-3 drops, three times in a day to each ear.
Theory:
Precautions

The ear should not be damp.

Water should not be added to this preparation. It reacts with phenol to produce a
preparation which is caustic, and consequently, damaging the area of application.
Experiment No. 12
MOUTH-WASHES
Definition: These are usually aqueous solutions in concentrated form of a substance with
deodorant, antiseptic, local anesthetic, or astringent properties.
COMPOUND SODIUM CHLORIDE MOUTH WASH (B. P. 1993)
Rx
Sodium chloride 1.5 g
Sodium bicarbonate 1.0 g
Concentrated Peppermint emulsion 2.5 ml
Chloroform water, double strength 50 ml
Water to 100 ml
Send 50 ml
Sig.: To be diluted with an equal volume of warm water before use.
Calculation:
Procedure:
(1) Read the prescription carefully, check the calculations for the amounts to be used and check
the balance and be sure that it is ready for weighing.
(2) Dissolve the given amount of sodium chloride and sodium bicarbonate in 3/4 the given
volume of water in a beaker.
(3) Add the concentrated peppermint emulsion, chloroform water and mix well
(4) Transfer to the measuring cylinder and adjust the volume with the remaining amount of
water.
(5) Transfer to a bottle, close and stick on the label.
Uses of the prescription ingredients:
Concentrated Peppermint emulsion: Flavoring agent.
Notes :
(1) Mouth washes are used to clean and deodorize the buccal cavity.
(2) Mouth washes may be a simple preparation (e.g. Compound Sodium Chloride Mouthwash),
or may contain antibacterial agents, (e.g. Alkaline phenol mouthwash), astringents (e.g. zinc
sulphate and zinc chloride Mouth wash).
CONCENTRATED PEPPERMINT EMULSION (B. P 1993)
Rx Peppermint oil 20 ml
Polysorbate 20 1 ml
Double strength chloroform water 500 ml
Purified water, freshly boiled and cooled ad 1000 ml
Send 50 ml.
Experiment No. 13
Aim: - Preparation of glycerobgelatin base suppositories
Rx
Gelatin 14 g
Glycerin 70 g
Water QS to 100g
Equipment Required: Mortar and pestle, Porcelain crucible, water-bath, 2 g x 6 mold
Chemicals:
Gelatin 84g, Glycerin 420 g, water 96 ml.
Procedure:
1. Calculate for 6 supp., that is the amount of Gelatin = 6 x 14 = 84 g.
2. Weigh the required amount of gelatin and soak it in enough water until thoroughly softened.
3. Put the soaked gelatin on the calculated amount of glycerin previously weighed in a tared
crucible and on a water bath until gelatin dissolves and a constant weight is obtained.
4. During evaporation the liquid mass should be only gently stirred, rapid stirring produce air
bubbles which may appear in the finished suppositories.
5. Remove any skin formed on the surface before pouring.
6. Pour the mass while still hot, into the holes lubricated with liquid paraffin, do not let the
melted mass to overflow.
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