2.

1) TABLET PRODUCTS OF COMPANY

• Calcium lactate 300mg I.P.

• Polycid-s tablets (Dried Aluminium Hydroxide gel 300mg I.P.)

• Paracetamol 500mg I.P.

• Metronidazole 400mg I.P.

 • Ibuprofen 400mg I.P.

• Aspirin 300mg I.P.

• Vit B Complex I.P.

• Chlorpromazine hydrochloride 25mg I.P.

2.1.1) INTRODUCTION TO TABLETS

Tablets are solid dosage forms containing drug substances with or without diluents and
tablets represent unit dosage form in which one usual dose of the drug has been
accurately placed. These are usually flat or bi-convex discs prepared by either
compression or molding method.

2.1.1.1) Compressed Tablets:

 Sugar coated tablets
 Film coated tablets
 Enteric coated tablets
  Multiple compressed tablets
 Sustained release tablets
 Tablet for solution
 Effervescent tablets
 Buccal and sublingual tablets

2.1.1.2) Molded tablets:

 Dispensing tablets
 Hypodermic tablets

ADVANTAGES OF TABLETS -

a) They are a unit dose form, and they offer the greatest capabilities of all oral dosage
forms for the greatest dose precision & the least content variability.

b) Their cost is lowest of all oral dosage forms.

c) They are the lightest & most compact of all oral dosage forms.

d) They are in general the easiest and cheapest to package & ship of all oral dosage
forms.

DISADV
ANTAGES OF TABLETS

a) Some drugs resist compression into tablet form due to their low density character or
amorphous

nature.

b) They are not useful for unconscious patient.

c) They are not convenient for small children.

2.1.2) FORMULATION OF TABLET

All the raw materials of tablet formula weighed & called from store room in
presence of Q.C. chemist, production & store incharge.

Sieving of all the raw material

Mixing of material according to specified process

 Paste formulation, granulation and drying

Passing through mill

(Milling of large granule)

Lubrication

Compression

Quality Control Department

Packaging and labeling

Stored in bulk store room (BSM)

2.1.3) MANUFACTURING OF GRANULATION

2.1.3.1) WET GRANULATION :-

Wet granulation is of two types

- Aqueous (water used)
- Non-aqueous (water not used, alcohol used)

2.1.3.1.1) PROCESS OF WET GRANULATION :-

Dry blending of the material

 Paste addition

Multi Mill

Drying

Sieving

Lubrication

In process sampling to Q.C.

GRANULATION SECTION

S.no. Name and number of Brief Description

Application Equipment

(1) Mass Mixer-3 Capacity of 50 Kg. A single for mixing

and binding of active ingredients and
exipients.
(2) Fluid Bed Dryer -2 Capacity of 50 Kg. and 100 Kg. for
Drying wet granules.

(3) Cad Mill -1 Capacity one horsepower for sizing of

dry granules.

(4) Multi Mill - 1 Capacity two horsepower for sizing wet &
dry
granules.

(5) Granulator -1 For mixing & sizing of granules

(6) Tray Dryer - 1 Capacity 48 tray for drying wet granules,

the material which is stable below 50°C

(7) Sifter 750mm. dia sieves for sifting of active

ingredients, excipients & granules.

(8) Grinder - 2 For cutting and polishing.

(9) Balance -2 Capacity- for weighing.

METHOD OF WET GRANULATION:-

 Granulation is the process of converting the fine particles in aggregate
of particle. This process is used for the manufacturing of compressed tablets of good
quality because granular form of medicaments has many advantages over powdered form.
Wet granulation forms the granules by binding the powders together with
an adhesive, instead of by compaction. The wet granulation technique employs a
solution, suspension, or slurry containing a binder, which is usually added to the powder
mixture; however, the binder may be incorporated dry into the powder mix, and the liquid
may be added by itself.
Liquid bridges are developed between particles, and the tensile strength of
these bond increases as the amount of liquid added is increased. Mixing continuous until
the uniform dispersion is attained and all the binder has been activated.
The wet screening process involves converting the moist mass into coarse,
aggregates by passing through a hammer mill or oscillating granulator. The purpose is to
further consolidate granules, increase particle contact point ant increase the surface area
to drying. A drying process are required in all wet granulation procedures to remove the
solvent that was used in forming the aggregates and to reduce the moisture content to an
optimal level of concentration within the granule.

2.1.4) TABLET COMPRESSION OPERATION

Tablets are made by compressing a formulation containing a drug or drugs with
excipients on stamping machines called presses.
For tablet compression single rotary or double rotary machines are used.
Following type of rotary machine studied during training.
 16-station rotary tablet machine (about 50000 tablet/hour)
 27-station rotary tablet machine
 29- station rotary tablet machine(about 9lacs tablet/6 hour, speed 19-50 rpm)
 35-station single track machine (about 567000 tablet/6 hour)

2.1.4.1) PARTS OF ROTARY TABLET MACHINE

  Hopper for holding & feeding granulation to be compressed.
 Dies that define the size & shape of the tablet.
 Punches for compressing the granulation within the dies:
a) Upper punches,
b) Lower punches
 Cam tracks for guiding the movement of the punches.
 A feeding mechanism for moving granulation from the hopper into the dies.

2.1.4.2) PROCESSING STEPS

 Cleaning process.
 Granule flow in hopper.
 Die filling.
 Removal of air.
 Compression (movement of top & bottom punches)
 Ejection of tablets.

2.1.4.3) COMPRESSION SECTION -

S.No. Name and number of Brief Description

Application equipment

(1) Compression machine – 3 16 station double rotatory machine for

compression of tablets with the
capacity of 25000 per hour.

(2) Balance – 1 For weighing tablets

 (3) Hardness tester – 1 For checking hardness of tablets

(4) D.T. Machine-1 With six tubes

2.1.5) IN-PROCESS QUALITY CONTROL

In the quality control process following tests are performed:-

2.1.5.1) WEIGHT VARIATION

All the tablet of particular batch should be uniformed in weight. The
prescribed generally +/- 10% for tablets weighing 120mg.
If 20 tablet for the test not more then one tablet falls outside the range. The
difference in weight in tablet can lead to variation in dosage.
For the test generally 20 tablets at random are taken & weight, the average
is calculated, then each tablet is weight individually & weight noted. The weight of
individual tablets are then compared with average weight already calculated & see that
not more two tablet fall outside this range.
Table- Weight variation tolerance for uncoated tablets
Average weight Maximum % difference
of tablets (mg) allowed

130 or less 10
130-324 7.5
More than 324 5

2.1.5.2) THIKNESS
For this purpose vernier’s calipers are used. Differences in thickness is
generally arises due to difference in density of granules, pressure applied for compression
& the speed of compression. The thickness variation limit allowed is +/- 5% of the size of
tablets.

2.1.5.3) HARDNESS
It depend on the weight of the material used, space between the upper &
the lower punch at the time of compression. It also depends on the nature of the
excipients used. For this purpose Monstanto hardness tester is used.

2.1.5.4)FRIABILITY
It is performed to evaluate the ability of the tablet to withstand abrasion
in packing, handling & transporting.The instrument used for this test is Friability Test
Apparatus. The acceptable limits of weight loss should not be more than 0.8%.

2.1.5.5)RATE OF DISI This test is performed to find out that within how much time
the tablet disintegrates. The test is necessary for all the tablets, coated or uncoated to be
swallowed because the dissolution rate depends upon the time of disintegration, which
ultimately affect the rate of absorption of drug. The apparatus used for this test is
Disintegration Test Apparatus.

NTEGRATION
2.1.6) PACKAGING OF TABLETS

Mainly two types of machine are used for packaging of tablet in CLICK PHARMA
 Strip packing machine
 Blister packing machine (about 60000-100000 strips/8 hours)

2.1.6.1) Types of packing

(a) Double track packing

(b) Single track packing

2.1.6.2) PACKING DEFECTS UNDER STRIPPING

(i) Text & Colour
(ii) Coding
(iii) Punctures
(iv) Empty Pocket
(v) Cracking
(vi) Chipping
(vii) Denting
(vii) Staining on surface
(ix) Leakage
2.2) CAPSULE PRODUCTS OF COMPANY

 Ampicillin capsule 250mg I.P.

 Cephalexin capsule 250mg I.P.

 Tetracycline hydrochloride capsule 500mg I.P.

 Amoxycillin trihydrate 250mg I.P.

2.2.1) INTRODUCTION TO CAPSULE
Capsule is a unit solid dosage form in which one usual dose of the drug has been
accurately placed. A capsule consists of a dose of drug enclosed in a water-soluble shell
or envelope.

2.2.1.1) TYPES OF CAPSULES

a) Hard gelatin capsules

b) Soft gelatin capsules
Hard gelatin capsules are used for the administration of powders of
particular solids. They are also known as dry filled capsules. They are made up of
sugar, gelatin, water & with or without suitable colouring agent. Hard gelatin
capsules are available in various sizes from 0 to 5.
Soft gelatin capsules consist of shells of gelatin to which glycerin,
sorbitol or a similar polyol is added which imparts elastic property to gelatin. They
are also referred as “soluble elastic” or “soft elastic capsule”. They are used to
enclose liquids, oils, ointments, cosmetics, etc.

2.2.1.2) ADVANTAGES OF CAPSULES

 The unpleasant taste and odour of medicaments can be masked by enclosing in

capsules.
 Microencapsulation provides the sustained release dosage forms.
 Enteric coating, releases the medicament in the intestines.
 They are easy to handle & carry during transportation.
 They are smooth & become slippery, on moistening, therefore, they are easily
swallowed.

2.2.1.3) EQUIPMENTS

 Capsule filling machine

 Capsule locking machine
2.2.1.4) CONDITIONS FOR CAPSULE AREA
 It should have sufficient space for filling, locking, sorting, polishing
& packaging of capsule.
 The room should be fully air conditioned or dehumidified.
 Temperature needed is 20-25°C & humidity is 20-55°C (below this
humidity shell becomes brittle & above this humidity shell becomes sticky).
 Wt. variation limit acco. to I.P.
o Wt. less than 130mg = + 7.5 or + 5 %
o Wt.above 130mg = + 5 %

2.2.2) CAPSULE FORMULATION

Collection of raw materials from the store

Weighing and measuring

Sieved all the raw materials

Mixed all the raw materials

Filled in empty capsule

(With the help of automatic filling machine)

Sample sends to Q.C.

Polishing

Packaging and labeling

Finished product stored in the store.

2.2.3)IN PROCESS QUALITY CONTROL

The following tests are carried out for the evaluation of the
capsules:

 Weight variation test

 Disintegration test
 Content uniformity test
 Dissolution test

2.2.4) PACKAGING OF CAPSULES -

Mainly Blister Packing Machine is used for the packaging of capsules.

 Primary Packing – Strip Packing or Blister Packing

 Secondary Packing – In small Carton
 Tertiary Packing – In Big Carton

2.2.5) TYPES OF PACKING

 Double track packing

 Single track packing
PICTURES OF TABLET SECTION DURING TRAINING

Blister packing of tablet in process

Cone blender Fluidized bed dryer

Compression machine Mixer

Shifter Tablet counter

 Multi mill

PICTURES OF CAPSULE SECTION DURING TRAINING

Automatic capsule filling machine

Manual capsule filling machine

3.1) GAS CHROMATOGRAPHY MASS SPECTROS