PHARMACEUTICS-II

(INDUSTRIAL AND COMMUNITY

PHARMACY)

DR. SIDRATUL MUNTAHA

LECTURER
AT
KAMYAB INSTITUTE OF MEDICAL
SCIENCES
PRACTICAL NO.1
DEFINITIONS OF ALL DOSAGE FORMS:
1: TABLETS:
Tablet is a pharmaceutical, solid dosage form. It comprises a mixture of active
substances and excipients, usually in powder form, pressed or compacted.
It is the most popular dosage form, about 70% of total medicines are dispensed in
the form of tablets.
2: CAPSULES:
Capsules are solid preparations with hard and soft shells of various shapes and
capacities, usually containing a single dose of active ingredients.
Capsules are of two types:
i. Hard gelatin capsules.
ii. Soft gelatin capsules.
3: LOZENGES:
Lozenges are solid dosage forms containing a drug along with flavoring and
sweetening agents.
These solid preparations are intended to dissolve or disintegrate slowly in the
mouth.
These are mostly used for local effects in oral cavity. Also for systemic effects if it
is well absorbed in buccal linings and pharynx.
4: SYRUPS:
Syrups are concentrated aqueous preparations of sugar and sugar substitute with or
without flavoring and medicinal agents.
When syrup contains some added medicinal substance, it is call medicated syrups.
Non-medicated syrups are the flavored syrups that contain flavor substances and
used as a vehicle.
5: ELIXIRS:
Elixirs are liquid, sweetened, hydro-alcoholic preparations intended for oral use
and usually flavored for palatability.
Alcoholic content may vary from 10%-12% and up to 40%.
These are highly stable than syrups.
Examples: chloral hydrate elixirs, piperazine elixir.
6: TINCTURES:
Tincture is typically an alcoholic or hydro alcoholic extract/solution of non-volatile
drug of vegetable or animal or chemical origin.
It contains 1 part of drug and 5 parts of solvent.
Alcoholic content may vary from 25%-60% of ethanol. Sometimes the alcoholic
concentration is high as 90%.
25% concentration is most common.
Examples: Opium tincture: 17-21%, Benzoin tincture: 74-80%
7: OINTMENTS:
Ointments are semisolid preparations intended for topical application. They are
used to provide protective and emollient effects on the skin or carry medicaments
for treating certain topical ailments.
They are also used to deliver drugs into eye, nose, vagina, and rectum.
Ointments intended for ophthalmic purposes are required to be sterile. When
applied to the eyes, they reside in the conjunctival sac for prolonged periods
compared to solutions and suspensions and improve the fraction of drug absorbed
across ocular tissues.
Ointments are absorbed slowly from the site of application.
8: CREAMS:
Creams are basically ointments which are made less greasy by incorporation of
water. Presence of water in creams makes them act as emulsions and therefore are
sometimes referred as semisolid emulsions.
Hydrophilic creams contain large amounts of water in their external phase (e.g.,
vanishing cream) and hydrophobic creams contain water in the internal phase (e.g.,
cold cream).
As ointments, creams are formulated to provide protective, emollient actions or
deliver drugs to surface or interior layers of skin, rectum, and vagina.
Creams are softer than ointments and are preferred because of their easy removal
from containers and good spread ability over the absorption site.
Drugs from creams are absorbed rapidly from the site of application.
9: LINIMENTS:
A semi-solid or liquid preparation that is thinner than ointments intended to apply
externally to skin with friction (rubbing) to relieve muscular stiffness and pain. But
don’t apply on broken skin.
It contains irritant substance such as camphor, salicylates, menthol etc.
Liniments are of two types:
i- Alcoholic liniments.
ii- Oleaginous liniments.
Examples: liniments of arnica for healing.
10: SUPPOSITORIES:
A suppository is a solid dosage form that is inserted into the rectum (rectal
suppository), vagina (vaginal suppository) or urethra (urethral suppository), where
it dissolves or melts and is absorbed into the blood stream. They are used to deliver
both systemically and locally acting medications.
MANUFACTURING
OF
DIFFERENT
DOSAGE FORMS
PRACTICAL NO:2
Manufacturing of Tablets by wet granulation:

Ingredients:
• Paracetamol --------------250mg
• Avicel ----------------- q.s
• Starch ----------------------10% (w/w)
• Aerosol -------------------- 3%(W/W)
• Magnesium stearate------1-1.5%(W/W)
• Water------------------------q.s
Procedure:
Steps involved in wet granulation are:
I-Weighing
II-Mixing
III-Granulation
IV-Screening of damp mass
V-Drying
VI-Dry screening
VII-Lubrication
VIII-Compression
Preparation of starch solution:
• Starch is added in a beaker in 20ml of hot water and stir well to make
suspension while heating in a water bath with continues stirring until a
translucent paste is formed.
• Then separately mix paracetamol, avicel and aerosol.
• For small batch, the ingredients are mixed in a stainless steel bowel or
mortars.
• Then add the powder mixture into the solution of starch with stirring.
• The powder mass become wet with starch solution and damp mass is
formed.
➢ If damp mass is over wetted then granules will be hard, require considerable
pressure to form tablets.
➢ If the powder mixture is wetted sufficiently the resulting granules will be too
soft, break down during lubrication and causing difficulty during
compression.
• After that, the damp mass is forced through mesh size 16.
• The moist material/ granules are placed on large sheets of paper on shallow
wire trays and then placed in a drying cabinets with circulating air
thermostat.
• Particle size distribution can be controlled by varying the speed of rotation
and drying temperature.
• After drying, particle size of granules can be reduced by passing through a
smaller mesh screen.
• After drying, lubrication of granules is done with magnesium stearate.
• Then lubricated granules are compressed by using single punch machine.
Role of ingredients:
Paracetamol: Active pharmaceutical ingredients.
Avicel: used as a diluent (used to require bulk of tablet).
Starch: as a binder.
Aerosil: as a disintegrating agent.
Magnesium stearate: as a lubricant.
Water: as a solvent.

RESULT:
After passing through mesh screen no.16 and drying, we obtained fine granules of
paracetamol for tableting.
PRACTICAL NO:3
Manufacturing of w/w Syrup by B.P (British Pharmacopoeia)

Theory:
Syrups are concentrated aqueous preparations of sugar and sugar substitute with or
without flavoring and medicinal agents.
Ingredients:
Sucrose______________66.7g
Purified water_________100g
Apparatus:
Beakers
Stirrers
Weighing balance
Procedure:
1. Wash the apparatus and let it dry.
2. Weigh the ingredients by using weighing balance.
3. First of all, take the beaker of appropriate size and add small quantity of
water (approximately 10g).
4. Then add sucrose into it and mix it well.
5. When sucrose is completely dissolved, then add water to make up volume up
to the mark.
6. Label it.
Uses:
1. It is used as a sweetener.
2. It is used as a vehicle.
Precautions:
1. Weighing balance should be properly calibrated.
2. Weigh all the ingredients carefully.
3. It should not be administered to diabetic patient.
Directions:
Shake well before use.
Use as directed by Pharmacist.
Storage:
Store at dry and cool place.

Label:
PRACTICAL NO: 4
PREPARATION OF W/V SYRUP BY USP (UNITED STATE
PHARMACOPOEIA)

Theory:
Syrups are concentrated aqueous preparations of sugar and sugar substitute with or
without flavoring and medicinal agents.
Ingredients:
Sucrose______________85g
Purified water_________100ml
Apparatus:
• Beakers
• Stirrers
• Weighing balance
Procedure:
1. Wash the apparatus and let it dry.
2. Weigh the ingredients by using weighing balance.
3. First of all, take the beaker of appropriate size and add small quantity of
water (approximately 10g).
4. Then add sucrose into it and mix it well.
5. When sucrose is completely dissolved, then add water to make up volume up
to the mark.
6. Label it.
Uses:
1. It is used as a sweetener.
2. It is used as a vehicle.
Precautions:
1. Weighing balance should be properly calibrated.
2. Weigh all the ingredients carefully.
 3. It should not be administered to diabetic patient.
Directions:
Shake well before use.
Use as directed by Pharmacist.
Storage:
Store at dry and cool place.
Lable:
PRACTICAL NO:5
Manufacturing of Simple Suspensions
Theory:
A pharmaceutical suspension may be defined as a coarse dispersion containing
finely divided insoluble material suspended in a liquid medium.
Ingredients:
Paracetamol__________25mg
Flavored syrup base____quantity sufficient
Water _______________ quantity sufficient
Color _______________q.s
Apparatus:
• Weighing balance
• Beakers
• Pestle mortar
• Stirrer
• Measuring cylinder
Procedure:
1. Weigh all the ingredients by using weighing balance.
2. Add paracetamol and triturate it in pestle and mortar.
3. Add small quantity of syrup into pestle and mortar and again triturate it to
form a smooth paste.
4. Then transfer the mixture into a 100 ml of measuring cylinder and made up
to volume with syrup.
5. Then shaken vigorously for 2 min.
Role of ingredients:
Paracetamol: it acts as an analgesic.
Simple syrup: as a base.
Dosage:
As directed by physician.
Directions:
Shake well before use.
Use as directed by Pharmacist.
Storage:
Store at dry and cool place.
Away from sunlight.
Precautions:
Keep the medicine out of the reach of children.
Label:
PRACTICAL NO:6
Manufacturing of castor oil Emulsions

Theory:
An emulsion formulation is a liquid disperse system that uses small globules of a
liquid (dispersed phase) distributed through another liquid in which it is
immiscible.
Apparatus:
• Weighing balance
• Beakers
• Pestle mortar
• Stirrer
• Measuring cylinder
Ingredients:
Acacia powder______________10g
Castor oil__________________ 37.5ml
Cinnamon water_____________100ml

Procedure:
First of all, weight the ingredients.
Triturate the weighed amount of acacia and castor oil by using pestle and mortar.
Then add cinnamon water.
Again triturate it.
Volume make up with cinnamon water.
Label it properly.
Role of ingredients:
Acacia: as a emulsifying agent.
Castor oil: as an active ingredient.
Cinnamon water: as a flavoring agent.
Uses:
It is used as a laxative.

Warings:
Do not use when abdominal pain, nausea, or vomiting are present unless directed
by a doctor.

Ask a doctor before use

if you have noticed a sudden change in bowel habits that persists over a period of 2
weeks. Laxative products should not be used for a period of longer than 1 week
unless directed by a doctor. Frequent or prolonged use may result in the
dependence on laxatives.

When using this product

Discontinue use and consult a doctor if you have rectal bleeding or failure to have
a bowel movement after the use of a laxative. The symptoms may indicate a
serious condition.

If pregnant or breast feeding

ask a health professional before use

Directions
• Preferably take on an empty stomach. May be taken with juice to improve
taste.
• Adults and children 12 yrs. of age and older: 1 to 4 tablespoonful in a single
daily dose or as directed by a doctor.
• Children 2 to under 12 yrs. of age: 1 to 3 teaspoonful in a single dose or as
directed by a doctor.
• Children under 2 yrs. of age: Consult a doctor before use.
Label:
QUALITY CONTROL TESTS
FOR
TABLETS
PRACTICAL NO:7
WEIGHT VARIATION TEST FOR TABLETS

THEORY:
Weight variation or uniformity of weight is an official test in all current
pharmacopoeias. Weight variation test is one of the In-Process tests during
production of tablets in any pharmaceutical industry. Any variation in weight of
tablets ultimately leads to variation in doses.

REQUIREMENTS:
Tablets
Analytical balance
PROCEDURE:

1. Select 10 tablets randomly and weighed them all using a digital balance.
2. Determine the average weight of tablets.
3. Now each tablet is weighed individually (prescribes limits already calculated)
4. Not more than two tablets should be deviated from the allowed limits.
5. None of the tablets should deviate from twice the percentage limits.

USP Weight Variation Tolerances for Uncoated Tablets

S. No Average wt. of tablet(mg) Max. % difference allowed

1 130mg or less +/-10%

2 130-324mg +/-7.5%
3 More than 324mg +/-5%
 B.P Weight Variation Tolerances for Uncoated Tablets
S. No: Average weight of tablets Deviation allowed from average
weight
1 80 or less +/-10%
2 80-250mg +/-7.5%
3 More than 250mg +/-5%
PRACTICAL NO: 8
THEORY:
It is physical parameter which indicates resistance of tablets against mechanical
shock during packaging, transport or stripping.

REQUIREMENTS:
Friabilator, Analytical balance, Tablets, Calculator

PROCEDURE:
1. For tablets having weight equal or less than 650mg, take sample of 20 tablets.
2. For tablets having weight more than 650mg, take sample of 10 tablets.
3. De-dust the tablets with addition of air pressure or soft brush.
4. Accurately weighed the tablets and placed in the drum of the Friabilator. 5.
Operate the Friabilator for 4 minutes at 25 rpm to complete 100 rotations.
6. Collect, de-dust and weighed the tablets again.
7. The percentage friability can be determined by using following formula:
Where,
% age Friability = W1 – W2 / W1 x 100
W1 = initial weight
W2 = final weight

Limits
U.S.P = not more than 1%
B.P= not more than 0.8%
PRACTICAL NO: 9
TO DETERMINE THICKNESS OF TABLETS

THEORY:
Tablet thickness is an important quality control test for tablet packaging. The
thickness of tablet can affect the therapeutic effectiveness of tablets. Very thick
tablet affects packaging either in blister or plastic container. Tablet thickness is
determined by the die of the tableting machine and is generally controlled to
minimize appearance problems.
• Thickness is an unofficial test.
It can be dimensionally described & controlled. The thickness of a tablet is only
variable. Tablet thickness can be measured by Vernier caliper or by other device.
Tablet thickness should be controlled within a ±5% variation of standard value as
per U.S.P specifications.
• Thickness of the tablet is inversely proportional to hardness i.e. increase in
hardness decrease the thickness & vice versa.
• Thickness of tablet is measured by Vernier caliper Digital tester.
It is determined for 10 tablets.

REQUIREMENTS:
Tablets, Vernier caliper or Digital Tester

PROCEDURE:
1. Turn on the Instrument. 10 tablets are selected and then the test for thickness is
carried out by using the Digital Tablet Testing Instrument HT-0607 by clicking
Mode button and adjusting operating mode to thickness. Turn ON the hardness
tester and set its mode to the specifications as required.
2. Place the tablet between its jaws and start the apparatus.
3. The jaws will apply force on the tablet till it breaks.
4. The force will be displayed on the screen of tester, note that value along with its
unit.
5. Repeat the same procedure for 10 tablets and note their readings and then
average was calculated.
PRACTICAL NO. 10
HARDNESS TEST FOR TABLETS
(NON-OFFICIAL Test)

THEORY:
Hardness (crushing strength): It is the load required to crush the tablet when placed
on its edge.
• Hardness is measured:
To determine the need for pressure adjustments on the tableting machine.
Hardness can affect the disintegration. So if the tablet is too hard, it may not
disintegrate in the required period of time. And if the tablet is too soft, it will not
withstand the handling during subsequent processing such as coating or packaging.
In general, if the tablet hardness is too high, we first check its disintegration before
rejecting the batch.
If the disintegration is within limit, we accept the batch.
If Hardness is high disintegration is within a time accept the batch.
• Factors Affecting the Hardness:
Compression of the tablet and compressive force.
Amount of binder (More binder à more hardness).
Method of granulation in preparing the tablet (wet method gives more hardness
than direct method, Slugging method gives the best hardness).

LIMITS:
5 kilograms minimum and 10 kilograms’ maximum.
Make hardness test on 5 tablets and then take the average hardness.
REQUIREMENTS:
Sample -- 10 tablets
Hardness tester (Digital Hardness Tester)

PROCEDURE:
1. Tum ON the hardness tester and set its mode to the specifications as required.
2. Place the tablet between its jaws and start the apparatus.
3. The jaws will apply force on the tablet till it breaks.
4. The force will be displayed on the screen of tester, note that value along with its
unit.
5.Repeat the same procedure for 10 tablets and note their readings.

NORMAL LIMITS:
Minimum limit 5 kg
Maximum limit 10 kg
PRACTICAL NO. 11
DISINTEGRATION TEST FOR UNCAOTED TABLETS

THEORY:
It is the time required for the tablet to break into particles, the disintegration test is
a measure only of the time required under a given set of conditions for a group of
tablets to disintegrate into particles. Disintegration test is an official test.
It is performed to identify the disintegration of tablet in particular time period.
Disintegration test is not performed for controlled & sustained release tablets.

APPARATUS USED:
Disintegration apparatus consists of Basket rack assembly supporting six
cylindrical glass tubes. The assembly is attached with a device for lowering and
raising the assembly in the medium placed in a cylindrical vessel having 1000 ml
capacity. This whole apparatus is placed in a water bath for maintaining the desired
temperature of 37 deg * C plus/minus 1 deg * C

REQUIREMENTS:
• Sample --- --- 6 tablets
• Disintegration apparatus

PROCEDURE:
1. Turn ON the apparatus and maintain the temperature at 37 deg * C plus/minus 1
deg * C
2. Remove the Basket-rack assembly from the water.
3. Select six tablets randomly from the sample and place one in each of the tubes of
the Basket-rack assembly.
4. Now reset the assembly in the apparatus and set the machine in motion.
5. Note the disintegration time and compared it with that of prescribe time. The
tablets must disintegrate within the prescribed time.
6. Repeat the same procedure for coated and effervescent tablets.
According to the test the tablet must disintegrate and all particles must pass
through the 10 mesh screen in the time specified. If any residue remains, it must
have a soft mass.

Liquids used in disintegration

Water, Simulated gastric fluid (pH = 1.2HCl) or Simulated intestinal fluid pH = 7.5
, KH2PO4 (phosphate buffer) + pancreatic enzyme + NaOH).

U.S.P. method for uncoated tablets:

Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate completely within 30min
repeat the same test on another 12 tablet. (i.e. the whole test will consume 18
tablets).
• less than 16 tablets disintegrate completely within the time.
• if more than two tablets (from the 18) fail to disintegrate, the batch must be
rejected.

TABLETS DISINTEGRATION TIME

Soluble tablets 3 minutes

Uncoated tablets 3-15 minutes

Film coated tablets 30 minutes

Sugar coated tablets 1 hour

Enteric coated tablets 2-3 hours

PRACTICAL NO. 12
DISINTEGRATION TEST FOR FILM CAOTED TABLETS

REQUIREMENTS:
Tablets. Water, Disintegration Test Apparatus.

PROCEDURE:
Start the disintegration test apparatus on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate completely within 30 min
repeat the same test on another 12 tablet. (i.e. the whole test will consume 18
tablets).
Not less than 16 tablets disintegrate completely within the time, if more than two
tablets (from the 18) fail to disintegrate, the batch must be rejected.