Experiment No - 1

Aim :-
To study and construct hand operated hard gelatin capsule filling machine with their working mechanism.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. 9-10
Requirements :-
A hand operated capsule filling machine
Theory :-
Capsules are solid preparations with hard or soft shells of various shapes and capacities, usually containing
a single dose of active substance(s). They are intended for oral administration.
Hand operated hard gelatin capsule filling machines:
Hand operated and electrically operated machines are in practice for filling the capsules but for small and
quick dispensing hand operated machines are quite economical. A hand operated gelatin capsule filling
machine consists of the following parts.

• A bed with 200-300 holes.

• A capsule loading tray.
• A powder tray.
• A pin plate having 200 or 300 pins corresponding to the number of holes in the bed and capsule
loading tray.
• A lever.
• A handle.
• A plate fitted with rubber top.
All parts of the machine are made up of stainless steel. The machines are generally supplied with additional
loading trays, beds, and pin plates with various diameters of holes so as to Fill the desired size of the
capsules. These machines are very simple to operate, can be easily dismantled and reassembled.
Working :-
➢ The empty capsules are filled into the loading tray which is then placed over the bed.
➢ By opening the handle, the bodies of the capsules are locked and caps separated in the loading tray
itself which is then removed by operating the liver.
➢ The weighed amount of the drug to be filled in the capsules is placed in powder tray already kept
in position over the bed.
➢ The powder is spread with the help of a powder spreader so as to fill the bodies of the capsules
uniformly.
➢ Collect excess of the powder on the platform of the powder tray.
➢ Lower the pin plate and move it downward so as to press the powder in the bodies.
➢ Remove the powder tray and place the caps holding tray in position.
➢ Press the caps with the help of plate with rubber top and operate the lever to unlock the cap and
body of the capsules.
➢ Remove the loading tray and collect the filled capsules in a tray from machine

Diagram :-

Result :-
The aim to study and construct hand operating hard gelatin capsule filling machine was successfully studied
and constructed.
Experiment No - 2

Aim :-
To prepare and submit granules by wet granulation method.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. 103-106.
Requirements :-
Glassware’s: Beaker, Funnel, Motar and pestle
Chemicals: Lactose, Starch (paste), Starch (dry), Talc.
Drug: Paracetamol
Theory :-
Granulation may be defined as a size enlargement process which converts small particles into
physically stronger & larger agglomerates.
Granulation method can be broadly classified into three types:

• Wet granulation.
• Dry granulation
• Dry Granulation incorporating bound moisture
The ideal characteristics of granules include uniformity, good flow, and compactibility. These are usually
accomplished through creation of increased density, spherical shape, narrow particle size distribution with
sufficient fines to fill void spaces between granules, adequate moisture (between 1-2%), and incorporation
of binder, if necessary.
The effectiveness of granulation depends on the following properties
a) Particle size of the drug and excipients
b) Type of binder (strong or weak)
c) Volume of binder (less or more)
d) Wet massing time (less or more)
e) Amount of shear applied to distribute drug, binder and moisture.
f) Drying rate (Hydrate formation and polymorphism)
Advantage of granulation:-
➢ Renders the material free flowing
➢ Densify materials
➢ Prepare uniform mixtures that do not separate
➢ Improve the compression characteristics of the drug
➢ Control the rate of drug release
➢ Facilitate metering or volume dispensing
➢ Reduce dust
➢ Improve the appearance of the tablet
Wet granulation method:-
Wet granulation forms the granules by binding the powder together with an adhesive instead of compaction.
The wet granulation technique employs a solution, suspension or slurry containing a binder, which is
usually added to the powder mixture, however, a binder may be incorporated dry into powder, mixed and
then the liquid may be added. In wet granulation, the bonding property of the liquid binders available is
usually sufficient to produce bonding with a minimum of additives.

Important steps involved in the wet granulation

1. Mixing of the drug(s) and excipients
2. Preparation of binder solution
3. Mixing of binder solution with powder mixture to form wet mass.
4. Coarse screening of wet mass using a suitable sieve (6-12 # screen)
5. Drying of moist granules.
6. Screening of dry granules through a suitable sieve (14-20 # screen)
7. Mixing of screened granules with disintegrant, glidant, and lubricant

Formula :-

Ingredient Quantity
Paracetamol 500mg
Lactose (fine powder) 40mg
Starch(paste) 4mg
Starch(dry) 10mg
Talc 10m
Procedure :-

• All the ingredients were weighed.

• 2. Model drug, Lactose monohydrate, Starch (dry), Talc sifted through 40 #.
• 3. Dry mix was granulated by starch paste.
• 4. Granules were dried in oven at 60ºC for 35 mins.
• 5. These dried granules were then evaluated

Result :-
The aim preparation of granules by wet granulation method was done successfully.

Experiment No - 3

Aim :-
To prepare and submit Chewable Antacid tablet.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ……….
Requirements :-
A. Equipment’s: Multiple rotatory tablet punching machine
B. Glassware’s: Beaker, Funnel
C. Chemicals: Aluminium hydroxide (dried gel, magnesium hydroxide (fine powder),
sucrose, mannitol, Polyvinylpyrrolidone
Theory :-
Chewable tablets are intended to be chewed in the mouth prior to swallowing and are not intended to be
swallowed intact. The purpose of chewable tablet is to provide a unit dosage form of medication which
can be easily administered to infants and children or to the elderly, who may have difficulty swallowing a
tablet intact. The most common chewable tablet on the market is the chewable aspirin tablet intended for
use in children. Bitter or foul tasting drugs are not good candidates for this type of tablet, and this fact
restrict the use of chewable tablet dosage form. Many antacid tablet products are of the chewable type. The
chewable tablet offers two major advantages to the delivery of a solid antacid dosage form. First the dose
of most antacid is large, so that the typical antacid tablet would be too large to swallow. The activity of
antacid is related to its particle size .If the tablet is chewed prior to swallowing. Better acid neutralization
may be possible from a given antacid dose.

Formula :-
Ingredient Quantity per tab
Aluminium hydroxide 400mg
Magnesium hydroxide 80mg
Sucrose 20mg
Mannitol 180mg
Polyvinylpyrrolidone 30mg

Procedure :-

• Mixed aluminium hydroxide, magnesium hydroxide, sucrose and mannitol.

• Moistened with a 10% PVP solution in 50% ethanol.
• Granulate by passing through # 14.
• Dried the granules at 140 to 150ºF.
• Added peppermint oil mixed with the talc or Cab-O-Sil and finally the magnesium stearate.
• Mixed well and compressed using ½ in flat-face beveled –edge punches.
• Finally the prepared antacid tablets are formulated.
Result :-
The aim preparation of Chewable Antacid tablet was done successfully.
Experiment No - 4

Aim :-
Prepare, and submit 20 tablets of Diclofenac Sodium by wet granulation method.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. 103-106.
Requirements :-
A. Equipments: Multiple rotatory tablet punching machines, hot air oven
B. Glassware’s: Beaker, Funnel, motar pestle, sieve no 16, 22, 44, spatula
C. Chemicals: Starch, magnesium stearate, aerosol, talc, lactose
D. Drug: Diclofenac
Theory :-
In the tablet –pressing process, it is important that all ingredients be dry powdered and of uniform grain
size as much as possible. The main guideline in manufacture is to ensure that the appropriate amount of
active ingredient is equal in each tablet so ingredient should be well mixed. Great pressure is applied to
compact the material. If a sufficiently homogenous mix of the components cannot be obtained with simple
mixing, the ingredients must be granulated prior to compression to assure an even distribution of the active
compound in the final tablet. Two basic techniques are used to prepare powders for granulation into a tablet
wet granulation and dry granulation Powders that can be mixed well do not require granulation and can be
compressed into tablets through direct compression.

Wet granulation:

Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The amount of
liquid can be properly managed, and over wetting will cause the granules to be hard and under wetting will
cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than
solvents. Procedure includes following steps:

Step 1: Weighing and blending-the active ingredient, filler, disintegrating agents are weighed and mixed.
Step 2: The wet granulate is prepared by adding the liquid binder/adhesive. Examples of binders/adhesives
include aqueous preparations of corn starch, natural gums such as acacia, cellulose derivatives such as
methyl cellulose, CMC, gelatin and povidone. Ingredients are placed within a granulator which helps ensure
correct density of the compression.
Step 3: Screening the damp mass into pellets or granules.

Step 4: Dry the granulation.

Step 5: Dry screening: After the granules are dried, pass through the screen of smaller size than the one
used for the wet mass to select granules of uniform size to allow even fill in the die cavity.

Step 6: Lubrication: dry lubricants, anti-adherent and glidant are added to the granules either by dusting
over the spread-out granules or by blending with the granules. It reduces friction between the tablet and the
walls of the die cavity. Antiadherant reduces sticking of the tablet to the die and punch.

Step 7: Liquid binder, but sometimes many actives are not compatible with water. Water mixed into the
powder can form bonds between powder particles that are strong enough to lock them in together. However,
once the water dries, the powder may fall apart and through might not be strong enough to create and hold
a bond. Povidone also known as polyvinyl pyrrolidone (PVP) is one of the most commonly used
pharmaceutical binders. PVP and a solvent are mixed with the powders to form a bond during the process,
and the solvent evaporates. Once the solvent evaporates and powders have formed densely held mass, then
the granulation is milled which results in formation of granules.

Formula :-
Ingredient Quantity per tab
Diclofenac sodium 50mg
Starch powder 5%
Starch paste 5%
Magnesium stearate 1%
Aerosil 1%
Talc 2%
Lactose 405mg

Procedure :-
1. Prepared starch paste by dissolving starch in minimum volume of water and heat on a hot plate with
continuous stirring with a glass rod in order to get starch paste.
2. Took drug, lactose, aerosil, starch powder, and mix them in a motar with pestle in geometric
progression.
3. Add starch paste in order to get dough like consistency.
4. Passed the material through sieve no 16 and dry the granules in hot air oven at 50ºC for 4 hours.
5. Mix remaining half of starch powder, a portion of fine, talc, magnesium stearate and mix well and
compress to the tablet.
Result :-
The aim Prepare, and submit 20 tablets of Diclofenac Sodium by wet granulation method was done
successfully.
Experiment No - 5

Aim :-
To evaluate Diclofenac Sodium Tablets.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. 123-137.
Requirements :-
A. Equipments: Pfizer hardness tester, Disintegration apparatus, Roche Friabilator, Electronic balance
B. Drug: Diclofenac
Theory :-
Evaluation is done to assess chemical, physical strength of the tablet. The chemical breakdown or
interaction between tablet components may alter physical tablet properties, generally changing the
bioavailability of a tablet system.

Tablet Thickness

Tablet thickness is an important characteristic in reproducing appearance and also in counting by using
filling equipment. Some filling equipment utilizes the uniform thickness of the tablets as a counting
mechanism. Ten tablets were taken and their thickness recorded using Vernier calliper. The size of the
tablet can be dimensionally described, monitored and controlled.

Disintegration

Disintegration time is the time to pass through a sieve while agitated in a specified fluid Indicates the time
to break down into small particles. Not necessarily solution. In the process of tablet manufacturer, the drug
is often formulated into granular state particles. This is done as the granule often has better flow properties
than the fine powder and there is less de-mixing leading to better uniformity. The granules are then
compressed to produce the tablet. The disintegration test may lead to an end point of tablet to granule only.

Dissolution

The time is takes for the drug to dissolve from the dosage form. Numerous factors affect dissolution. Thus
the dissolution medium, agitation, temperature are carefully controlled. The dissolution medium may be
water, simulated gastric juice or 0.1 M HCl. The temperature is usually 37ºC. The apparatus and
specifications may be found in the U.S.P. The U.S.P methods are official however there is a wide variety
of methods based on other apparatus. These are used because they may be faster, cheaper, easier, sensitive
to a particular problem for a particular drug, or developed by a particular investigator. Dissolution tests are
used as quality control to measure variability between batches which may be reflected by in vivo
performance. Thus the in vitro tests may be a quick method of ensuring in vivo performance. Thus there
has been considerable work aimed at defining the invitro/ in-vivo correlation.

Weight variation

With a tablet designed to contain a specific amount of drug in a specific amount of formula, the weight of
a tablet being made is routinely measured to ensure that a tablet contains proper amount of drug. USP
procedure for uniformity of weight was followed. Twenty tablets were taken and their weight determined
individually and collectively on a digital weighing balance. The average weight of one tablet was
determined from the collective weight. The weight variation test would be a satisfactory method of
determining the drug content uniformity.

Specification of weight variation as per IP

Average wt. of tab (mg) Maximum % deviation weight allowed
80 or less 10
80-250 7.5
More than 250 5

Procedure of weight variation

1. The individual weight of the tablets is taken (usually 10).
2. The mean weight is calculated.
3. Difference of average weight to individual tablet weight is calculated.
4. Corresponding percentage weight variation is calculated.
5. Results are observed for compliance with the stated limits of IP/BP/USP
Friability

• Friability is tested using Roche Friabilator.

• Ten numbers of tablets are first weighed and then placed in the plastic chamber of Roche
• friabilator that revolves at 25 rpm.
• Dropping the tablets at a distance of six inches with each revolution.
• This is done for 100 rpm.
• After completion of 100 revolutions, tablets were collected and reweighed.
• Difference in weight before and after friability test is recorded and compared with standard limits.

Hardness test
It is done by Pfizer hardness tester and results are recorded and average hardness is calculated.
Result & Observations
1. Weight variation:
S. No. Weight of tablet (gm) Weight variation (gm) Weight variation (%)
1
2
3
4
5
6
7
8
9
10

Average weight =
2. Disintegration test

Disintegration time of tablet was found to be………….….min

3. Friability
Weight of 10 tablets before friability=

Weight of 10 tablets after friability=

Weight lost= Weight of 10 tablets before friability –Weight of 10 tablets after friability=

Percentage weight lost =

(Weight lost) × 100
Weight before friability)

4. Hardness test
Hardness of tablet 1=
Hardness of tablet 2=
Hardness of tablet 3=
Average Hardness=
Result :-
The aim evaluation of Diclofenac Sodium tablets was done successfully.
Experiment No - 6
Aim :-
To prepare and submit 10 paracetamol (100 mg) tablets by wet granulation method.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ………….
Requirements :-
A. Equipments: Mortar and pestle, spatula, beaker, Sieve
B. Drug: Paracetamol
Theory :-
Tablet is an important solid dosage form which is usually prepared with the aid of suitable pharmaceutical
excipients. Tablets may vary with size, shape, cut, hardness, thickness. Their disintegration and dissolution
characteristics and other aspects change depending on their intended use and method of manufacturing.
Compressed tablets are mainly prepared by 3 basic methods
➢ Wet granulation
➢ Dry granulation
➢ Direct compression
Wet granulation is the widely used method for the production of compressed tablets. Steps involved in wet
granulation method are

• Weighing and blending of ingredients

• Preparing a damp mass by adding wet binder
• Converting the damp mass into wet granules
• Drying of granules
• Sizing the granules by dry screening
• Addition of lubricants
• Formation of tablets by compression
During the preparation process each step may influence the quality of tablet produced. In this preparation
paracetamol used as API (antipyretic), lactose as adjuvant, starch (purified) as binding agent, starch
monohydrate as disintegrant, magnesium stearate as lubricant and talc as Glidant.
Formula:

S. No. Ingredients For 1 tablet For 10 tablets Purpose

1 Paracetamol 70mg Analgesic & Antipyretic
2 Starch 10mg Binding agent
3 Lactose Monohydrates 5mg Diluent
4 Starch Monohydrates 4mg Disintegrant
5 Talc 6mg Glidant
6 Magnesium Stearate 5mg Lubricants
Procedure:

➢ Preparation of starch mucilage: Dissolve 5mg of starch in 100ml of distilled water then resulting
mixture is heated on a water bath until the starch is gelatinized by the formation of mucilage.
➢ Divide disintegrating agent (starch monohydrate) into 2 portions to incorporate during wet
granulation and after drying of granules to act as an intragranular and extra granular disintegrant.
➢ Wet Granulation: Accurately weigh and mix the specified amount of paracetamol and other
excipients (except half of the disintegrating agent and lubricant) until uniform powder is formed by
geometric mixing.
➢ A damp mass of the mixture is prepared by adding appropriate amount of the 5% starch mucilage
and kneading by hand.
➢ Wet mass is subsequently passes through a 6/10 mesh sieve/screen to form wet granules. Resulted
granules are spread evenly on a large piece of paper in a tray and dried at 40⁰C60⁰C for 30min in an
oven.
➢ Dried granules are passed through a sieve 16 or 20 # and mixed with remaining half of the
disintegrating agent and lubricant.
➢ Resulting granules mixture is compressed in a tablet compression machine to obtain tablets.
➢ Prepared tablets are stored properly for further evaluation.

Result :-
The aim to prepare and submit 10 paracetamol (100 mg) tablets by wet granulation method was done
successfully.
Experiment No -7
Aim :-
To evaluate prepared paracetamol tablets.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ………….
Requirements :-
A. Equipments: Monsanto harness tester, Friability apparatus , D.T. apparatus, Dissolution apparatus
etc.
B. Glasswares: Beaker, Test tube with holder
C. Drug: Paracetamol
Theory :-
Tablet is an important solid dosage form which is usually prepared with the aid of suitable pharmaceutical
excipients. Tablets may vary with size, shape, cut, hardness, thickness. Their disintegration and dissolution
characteristics and other aspects change depending on their intended use and method of manufacturing.
Compressed tablets are mainly prepared by 3 basic methods
➢ Wet granulation
➢ Dry granulation
➢ Direct compression
Evaluation Parameters
Appearance:
Tablet from each formulation were randomly selected and organoleptic properties such as color, taste, and
shape were evaluated.
Hardness test:
The tablet hardness is defined as the force required to break a tablet in a diametric direction. A tablet was
placed between two anvils. Force was applied to anvils and crushing strength that causes the tablet to break
was recorded. The hardness was measured using Monsanto hardness tester.
Thickness:
The thickness of tablets was determined using a Vernier calliper. Three tablets from each batch were used,
and average values were calculated.
Friability test:
The friability of tablets was determined using Roche Friabilator. It is express in percentage (%). Ten or
twenty tablets were initially weighed and revolved at 25 rpm for 4 min. The tablets were then reweighed
after removal of fines and the percentage of weight loss was calculated. The % friability was then calculated
by, F = (Winitial – Wfiinal) x 100 / Winitial
Acceptance criteria for % friability % weight loss should be less than 1%.
Weight variation test:
Average weight % difference
130 mg or less 10
130 – 324 mg 7.5
More than 324 mg 5

Twenty tablets were selected randomly from each batch and weighed individually on electronic balance.
The individual weighed is then compared with average weight for the weight variations. The following
percentage deviation in weight variation is allowed (U.S.P).
Disintegration time testing:
It was determine using USP tablet disintegration test apparatus, using 900 ml of distilled water without disk
at room temperature. Test was performed on 6 tablets. One tablet each is kept in all six tubes. The tubes
travel upward and downward in water at 37⁰C±2⁰C. The time taken for all the six tablets to break down and
pass through the mesh at the bottom of the tube is noted. The tablets pass the test if all the six tablets
disintegrate within the prescribed time ( Less than 30 mins for uncoated tablets as per U.S.P).
In-vitro drug release study:
The release rate of paracetamol from tablets was determined using United States Pharmacopeia (USP)
Dissolution Testing Apparatus Type-II. The dissolution test was performed using 900ml of 5.8pH
phosphate buffer, at 37⁰C±0.5⁰C and 50 rpm. A sample (10ml) of the solution was withdrawn from the
dissolution apparatus hourly and the samples were replaced with fresh dissolution medium. The samples
were filtered through a 0.45µ membrane filter. Absorbance of these solutions was measured at 243 nm
using a Thermospectronic-1 UV/V double-beam spectrophotometer. Cumulative percentage drug release
was calculated using an equation obtained from a standard curve.

Result :-
The aim to evaluation of prepared paracetamol tablets was done successfully.
Experiment No - 8
Aim :-
To prepare and submit 10 Aspirin (200 mg) tablets by wet granulation method.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ………….
Requirements :-
A. Equipments: Mortar and pestle, spatula, beaker, Sieve, Punching Machine
B. Drug: Aspirin
Theory :-
Tablet is an important solid dosage form which is usually prepared with the aid of suitable pharmaceutical
excipients. Tablets may vary with size, shape, cut, hardness, thickness. Their disintegration and dissolution
characteristics and other aspects change depending on their intended use and method of manufacturing.
Compressed tablets are mainly prepared by 3 basic methods
➢ Wet granulation
➢ Dry granulation
➢ Direct compression
Wet granulation is the widely used method for the production of compressed tablets. Steps involved in wet
granulation method are

• Weighing and blending of ingredients

• Preparing a damp mass by adding wet binder
• Converting the damp mass into wet granules
• Drying of granules
• Sizing the granules by dry screening
• Addition of lubricants
• Formation of tablets by compression
During the preparation process each step may influence the quality of tablet produced. In this preparation
paracetamol used as API (antipyretic), lactose as adjuvant, starch (purified) as binding agent, starch
monohydrate as disintegrant, magnesium stearate as lubricant and talc as Glidant.
Formula:

S. No. Ingredients For 1 tablet For 10 tablets Purpose

1 Aspirin 150mg Treat pain, fever, inflammation
2 Acacia 20mg Binding agent
3 Lactose Monohydrates 10mg Diluent
4 Starch Monohydrates 8mg Disintegrant
5 Talc 8mg Glidant
6 Magnesium Stearate 4mg Lubricants
Procedure:

➢ Divide disintegrating agent (starch monohydrate) into 2 portions to incorporate during wet
granulation and after drying of granules to act as an intragranular and extra granular disintegrant.
➢ Wet Granulation: Accurately weigh and mix the specified amount of Aspirin and other excipients
(except half of the disintegrating agent and lubricant) until uniform powder is formed by geometric
mixing.
➢ A damp mass of the mixture is prepared by adding appropriate amount of the acacia and drop wise
addition of water.
➢ Wet mass is subsequently passes through a 6/10 mesh sieve/screen to form wet granules. Resulted
granules are spread evenly on a large piece of paper in a tray and dried at 40⁰C60⁰C for 30min in an
oven.
➢ Dried granules are passed through a sieve 16 or 20 # and mixed with remaining half of the
disintegrating agent and lubricant.
➢ Resulting granules mixture is compressed in a tablet compression machine to obtain tablets.
➢ Prepared tablets are stored properly for further evaluation.

Result :-
The aim to preparation of Aspirin (200 mg) tablets by wet granulation method was done successfully.
Experiment No - 9
Aim :-
To prepare 10 tablets of paracetamol film coated tablets.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ………….
Requirements :-
A. Equipments: Tablet coating pan, Mortar and pestle, Sieve, Beaker, Glass rod
B. Coating Polymer: Cellulose acetate, PEG 400, Acetone, Deionized water
Theory :-
All drugs have their own characteristic, like some drugs are bitter in taste or have an unpleasant odor, some
are sensitive to light or oxides, some are hygroscopic in nature. Because of this reasons, tablet coating is
the choice of option to solve such problems in conventional dosage form. Tablet film coating is performed
by two types, one is aqueous film coating (generally water is used as a solvent) and non-aqueous film
coating (generally organic solvents are used). Some problems are associated with the non-aqueous film
coating like safety of employees (as most of the solvents are dangerous, smell, and they are not good to
breathe), atmospheric pollution etc. But key problem is with the approval of the regulatory authority. High
quality aqueous film coating must be smooth, uniform and adhere satisfactorily to the tablet surface and
ensure chemical stability of a drug. Coating may be applied to a wide range of oral solid dosage forms,
including tablets, capsules, and multiparticulate and drug crystals. When coating composition is applied to
a batch of tablets in a coating pan, the tablet surfaces become covered with a tacky polymeric film. Before
the tablet surface dries, the applied coating changes from a sticky liquid to tacky semisolid and eventually
to a non-stick dry surface. The entire coating process is conducted in a series of mechanically operated
acorn-shaped coating pans of galvanized iron stainless steel or copper. The smaller pans are used for
experimental, developmental, and pilot plant operations, while the larger pans for industrial production.

Necessity of Tablet Coating:

➢ A number of reasons can be suggested, like: The core contains a material which has a bitter taste
in the mouth or has an unpleasant odour. Coating will protect the drug from the surroundings with
a view to improve its stability.
➢ Coating will increase the ease by which a tablet can be ingested by the patient.
➢ Coating will develop the mechanical integrity; means coated products are more resistant to
mishandling (abrasion, attrition, etc.)
➢ The core contains a substance which is incompatible in the presence of light and subject to
atmospheric oxidation, i.e. a coating is added to improve stability.
➢ The coated tablets are packed on high-speed packaging machine. Coating reduces friction and
increases packaging rate.
➢ Coating can modify the drug release profile, e.g., enteric coating, osmotic pump, pulsatile delivery

Formula:
S. No. Ingredients Quantity (%w/w)
1 Cellulose acetate 6.3
2 PEG 400 0.7
3 Acetone 89
4 Deionized water 4

Procedure:

Paracetamol uncoated tablets are prepared by wet granulation method. The prepared tablets are then coated
with film coating solution prepared as below.

Film coating solution preparation: The coating solution was prepared by dissolving PEG in water followed
by addition of this solution to acetone. Cellulose acetate was then added to the above mixture and stirred to
achieve a clear solution. The coating process was performed in a Vector Hi-Coater LDCS (batch size, 1.5
kg, with inclusion of placebo tablets) at a product temperature of 28ºC. Coated tablets were dried in a
vacuum drying oven at 40ºC for 24 hours to remove residual solvent and moisture.

Result :-
The aim preparation of 10 tablets of paracetamol film coated tablets was done successfully.
Experiment No - 10
Aim :-
To prepare 10 tablets of enteric coated tablets of omeprazole.
Reference :-
Agarwal Gaurav, Kaushik Atul, A Text book of Pharmaceutical Technology - II, CBS Publications &
Disturbers, First edition-2012, page no. ………….
Requirements :-
A. Equipments: Tablet coating pan, Mortar and pestle, Sieve, Beaker, Glass rod
B. Coating Polymer: Cellulose acetate, PEG 400, Acetone, Deionized water
C. Drug: Omeprazole
Theory :-
Enteric coatings are primarily used for the purpose of:

➢ Maintaining the stability of APIs that are unstable when exposed to the acidic conditions of the
gastric milieu. Such API’s include erythromycin, pancreatic, and the class of proton pump
inhibitors, such as omeprazole.
➢ Minimizing the side effects (eg, nausea, and gastric irritation and bleeding) that can occur with
APIs such aspirin and certain nonsteroidal inflammatory compounds.
➢ Creating opportunities for “night-time dosing” strategies, where the intent is to allow the dosage
form to be consumed at bed-time, and permit effective blood levels of the API to be attained just
prior to waking.
➢ Facilitating colonic drug delivery. The functionality of enteric coatings is, for the most part,
mediated by a change in pH of the environment to which the enteric-coated product is exposed.
Enteric polymers remain unionized (and thus, insoluble) at low pH values, and begin to dissolve
at a pH value of approximately 5.0–5.5.
Formula:
S. No. Ingredients Quantity (mg)
Dry Mix
1 Omeprazole 20
2 Lactose hydrate 92.86
3 Sodium starch glycolate 4
4 Sodium lauryl sulphate 1.5
5 Magnesium hydroxide 6
Binding Solution
6 Hydroxyl propyl cellulose and water 1
Lubrication
7 Talc 1.32
8 Mg. stearate 1.32
Seal Coating
9 HPMC E15 & Purified water 3
Enteric Coating
10 HPMC Phthalate 7
11 Triacetin 0.394
12 Talc 0.394
13 Isopropyl alcohol q.s.
14 Acetone q.s.

Procedure:

Wet granulation:

▪ Weigh accurately require quantity of Omeprazole, Lactose , Sodium starch glycolate , Sodium
Lauryl Sulfate, Magnesium hydroxide and pass through sieve no #40
▪ Prepare a binding solution by dissolving HPC in water and stir binder solution for 10 minutes, this
solution is added to dry mix to form granules.
▪ The prepared granules are dried and lubricated with lubricants.
▪ The lubricated granules are then compressed to form immediate release tablets.

Seal Coating:

Prepare sub coating solution using HPMC or PVA in Purified water. Coat the uncoated tablets with the
seal coating suspension to achieve required weight gain.

Enteric coating:

Prepare enteric coating suspension using HPMC Phthalate, Triacetin, and Talc in Acetone-IPA mixture.
Coat the uncoated tablets with the enteric coating suspension to achieve required weight gain.

.Result :- The aim preparation of 10 tablets of Omeprazole enteric coated tablets was done successfully.