123® tablet vs syrup
123® tablet vs syrup
1. The name of active ingredient
2. The excipients for both dosage forms
3. The use of each excipient
4. The method of manufacturing of each dosage form
5. Advantage and disadvantage of one dosage form over the other
6. Administration
7. Counselling tips for patient
8. Storage and precautions
123® COLD TABLET ACTIVE INGREDIENTS
§ Caffeine
§ Carbinoxamine
§ Codeine
§ Paracetamol
The name of
active ingredient
§ Phenyl epinephrine
123® SYRUP ACTIVE INGREDIENT
§ Chlorpheniramine maleate
§ Paracetamol (Acetaminophen)
§ Pseudoephedrine Hydrochloride
123® COLD TABLET EXCIPIENTS
the excipients for
both dosage forms
and the use of each
excipient
§
Croscarmellose sodium (disintegrate)
§
Magnesium stearate(lubricant)
§
Microcrystalline cellulose(stabilizer)
§
Polyethylene glycol(plasticizer)
§
Polyvinyl alcohol(lubricant)
§
Pregelatinized corn starch (stabilizer,
thickener)
§
Magnesium silicate(anticaking)
§
Titanium dioxide(opacifying)
§
Silicone dioxide(disintegrate)
123® SYRUP EXCIPIENTS
1) Wet granulation process
§
Method of
manufacturing of each
dosage form
Wet granulation
2.
Dry granulation
3.
§
1-Weighing, milling and mixing of the APIs with powdered excipients (excluding the lubricant)
§
2-Preparation of binder solution
§
3-Mixing of binder solution with powders to form a damp mass
§
4-Screening the dampened powder into pellets or granules (wet screening) using 6- to 12-mesh screen
§
5-Drying of moist granules
§
6-Sizing the granulation by dry screening using 14- to 20-mesh screen
§
7-Mixing of the dried granules with lubricant and disintegrants
§
8-Compression of granules into tablets.
2) Dry granulation process
§
123® tablet manufacturing:
1.
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the wet
granulation method are listed below.
Direct compression
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry
granulation method are listed below.
§
1-Weighing and Milling of formulation ingredients (drug substance and excipients)
§
2-Mixing of milled powders.
§
3-Compression of mixed powders into slugs.
§
4-Milling and sieving of slugs.
§
5-Mixing with disintegrants and lubricant.
§
6-Compression into tablets.
3) Direct compression process
§
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry
granulation method are listed below.
§
1-Milling of therapeutic agent and excipients
§
2-Mixing of milled powders, disintegrants and lubricants
§
3-Compression into tablets.
§ Four methods are employed in making syrups. The
Method of
manufacturing of each
dosage form
123® Syrup manufacturing
choice depending on the physical and chemical
characteristics of the substances entering into the
preparation:
§ 1-Solution by heat
§ 2-Agitation without heat
§ 3-Addition of medicating liquid to syrup
§ 4-Percolation
ADVANTAGES OF TABLETS OVER SYRUPS :
§
tablets were cost effective
§
atmospheric conditions like
because they can be kept for a long period of
time, unlike syrups ( one week of use)
Advantage and
disadvantage of
one dosage form
over the other
§
Air
§
Moisture (unlike syrups)
§
light
§
easy to handle
§
attractive and elegant appearance
§
Packing and production is cheap
§
Provide protection of medicaments from
§
Not require more space for storage.
ADVANTAGE OF 123® SYRUP OVER TABLET
§
Syrup has faster absorption rates
§
no disintegration process
§
Higher optimization rates
§
no 1st bypass like the tablet
§
Is more easily digestible.
§
Easy to swallow
§
More quickly absorbed than the tablet
§
§
more absorbed into the system.
Syrups take 1-4 minutes to assimilate while the
tablets take from 20-30 minutes just to break
down, before the body can even start to
assimilate them.
DISADVANTAGES OF TABLET 123®
Disadvantage of
one dosage form
over the other
§
1st pass, so it has high absorbance in GI tract
§
Tablet is not suitable for Unconscious patients.
§
It is bitter and has an unpleasant taste.
§
§
problem in bioavailability.
absorption of therapeutic agents from tablets is
dependent on physiological factors.
§
tables are not suitable for children or old man
because they cannot take it easily.
§
‪Finding of good compatibility between active
and inactive ingredients for tablets formulation
require huge hit and trial experimentation.
§
Patients with vomiting and diarrhea cannot take
it or absorb it.
DISADVANTAGES OF 123® SYRUP:
§
Sedimentation of solids occasionally gives poor §
form of product. It may lead to caking.
§
Sometimes microbial contamination takes place
§
if preservation not added in accurate
proportion.
§
A suspension being a bulky product,
transportation cost is high.
§
Not suitable for emergency
§
§
Not suitable for unconscious people
Can’t avoid 1st pass metabolism
Not convenient for patients with diarrhea,
constipation, ulceration.
It is a bulk formulation so there are chances of
inaccuracy in single dosing
123® TABLETS
§ Adults : One tablet 3 or 4 times daily for 2 or 3 days.
§ Most effective treatment when started at the onset of
symptoms.
§ Never exceed the recommended dose.
Administration
123® SYRUPS
§ For Children :
§ 4-11 months:
§ 4-8 years:
½ teaspoonful (2.5mL)
1 ½- 2 teaspoonful (7.5-10mL) 3-4
3-4 times daily.
times daily.
§ 1-3 years:
§ 9-11 years:
¾ - 1 teaspoonful (3-5mL) 3-4
times daily.
2-3 teaspoonful (10-15 mL) 34 times daily.
123® COLD TABLET AND SYRUP IMPORTANT
INFORMATION :
§ In case you miss a dose, use it as soon
§ Do not use more than prescribed dose
as you notice.
because may cause poisoning or
serious side-effects.
§ If it is close to the time of your next
Counselling tips
for patient
dose, skip the missed dose and resume §
your dosing schedule.
§ Do not use extra dose to make up for a
missed dose.
§ If you are regularly missing doses,
consider setting an alarm or asking a
family member to remind you.
§ Please consult your doctor to discuss
changes in your dosing schedule if you
have missed too many doses recently.
If you suspect overdose of 123 syrup,
please go to the emergency department
of the closest hospital or nursing home.
Bring a medicine box, container, or
label with you to help doctors with
necessary information.
§ Do not give your medicines to other
people even if you know that they have
the same condition or it seems that they
may have similar condition. This may
lead to over dosage.
123® TABLET SHOULD BE STORED AT :
§ 15-30°C
§ away from excess moisture,
§ away from light.
Storage
123® SYRUP SHOULD BE STORED AT :
§ At room temperature(25 °C)
§ Away from heat and light.
§ Don’t freeze it unless if required by package insert.
§ If you want to discard them, do not flush it down the toilet or pour them
into drainage unless instructed to do so.
§ If discarded in this manner may contaminate the environment.
BEFORE USING 123® SYRUP :
§
Ask a doctor before using it if you have
breathing problems, glaucoma or difficulty
urinating.
§
Asthma
§
Chronic bronchitis
§
Chronic obstructive pulmonary disease
§
Avoid taking this drug too close to bedtime
BEFORE USING 123® COLD TABLET, INFORM
YOUR DOCTOR IF YOU HAVE:
Precautions
§
Acute pancreatitis
§
Addison’s disease
§
Avoid exposing to excessive heat
§
Biliary tract disease
§
Constipation is a side effect and
Not use with prescription drug for
§
depression
§
monoamine oxidase
restlessness or sleeplessness
occurs.
inhibitor (MAO)
§
§
can be relieved by stool softeners
§
§
§
other products containing
acetaminophen
Rare sensitivity reactions to drug
occur, the drug should be stopped. §
§
Do not give to children under 12 or
exceed recommended dosage.
§
Reduce dosage if nervousness
high blood pressure,
Do not take this product for more
than 7 days or for fever for more
than 3 days unless directed by a
doctor
If sore throat is severe, persists for
more than 2 days, is accompanied
or followed by fever, headache,
rash, nausea or vomiting, consult a
doctor promptly.
AVOID BOTH IF:
§
allergy to paracetamol
§
breastfeeding for women
§
Breastfeeding
§
don’t consume alcohol
§
Avoid driving a car
§
Pregnancy category C
§
smoking and use of tobacco
§
Avoid exposing medication to
excess heat