INTRODUCTION 3

• Tablets may be defined as the solid unit dosage form of Primary goals of tablet manufacturing process
medicament or medicaments with suitable excipients and • To formulate tablets that are strong and hard to withstand
prepared either by molding or by compression. It mechanical shock encountered during manufacturing, packing,
comprises a mixture of active substances and excipients, shipping, dispensing and use.
• To formulate tablets that are uniform in weight and in drug content.
• Tablets formation process consist of a series of steps • To formulate tablets that are bioavailable according to indication
requirements.
(unit processes)– weighing, milling, mixing, • To formulate tablets that are chemically and physically stable over a
granulation, drying, compaction, (frequently) coating long period of time.
and packaging. Regardless of the method used the unit • To formulate tablets that have elegant product identity which is free
processes – weighing, milling and mixing, are the from any tablet defects.
same; subsequent steps differ.

Categories of tablets for oral use Dispensing of API & Excipient

Sieving/screening
1. — uncoated tablets;
2— coated tablets; Size reduction
3— gastro-resistant tablets;
4. — modified-release tablets; Blending
5. — effervescent tablets;
Granulation
6. — soluble tablets;
7. — dispersible tablets; Compression
8. — orodispersible tablets;
9. — chewable tablets; Coating
10.— oral lyophilisates.
Packaging

Tablets Dispatch in market

 Processing of Granulation (tablets Granules) Procedure for Manufacturing of
Tablets
• Dispensing: Each ingredient in the tablet formula is
weighed and accurately dispensed as per dose. This is
one of the critical steps in any type of formulation
process and should be done under technical supervision.
• Sizing: Formulation ingredients must be in finely
divided form, otherwise, size reduction should be carried
out for better flow property and easy mixing.

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4.Granulators e.g. , Rotating

shape granulators , dry granulator ,
high shear granulator etc
3. Mixing equipment e.g., 5.Drying equipment e.g. spray
pneumatic mixers diffusion/ dryer , rotary dryer , fluidized bed
tumbling mixers (e.g., V- dryer etc
blender, double cone blender,
6.Tableting machine e.g. single
cubic mixer, drum blender),
punch tablet press and multi station
/rotary tablet press Exp. Fette
Press, CardPress etc

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 7. Evaluation /Quality control (QC) equipment Tablet Manufacturing Equipment/ Machines
e.g., disintegration equipment , USP Dissolution Tester,
Tablet Hardness Tester, Tablet Thickness Tester, Tablet
Friability Testers etc. Common equipment used in pharmaceutical
8.Coating and polishing machines for coated tablets tablet manufacturing include:
e.g., standard coating pan, perforated pan, fluidized bed/
Air suspension coating system etc. 1. Size reduction equipment
e.g., Hammer mill , roller mill , fluidized
8. Packaging machines e.g., blister packing machine, energy mill , cutter mill and ball mill
aluminium foil packaging machine, etc. Machine 2. Weighing balance/ balances e.g., bulk
name Dph-220/260 High Speed Blister Packing weighing balance (weighs in kilogram),
Machine electronic weighing balance (weighs in
grams and milligrams).

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• Powder blending: Powders are mixed using a • Tablet compression: This step involves the
suitable blender to obtain a uniform and compression of granules into a flat or convex, round,
homogeneous powder mix. The drug substance and oblong, or unique shaped, scored or unscored tablets;
excipients are mixed in geometric dilution. engraved with an identifying symbol and/ or code
• Granulation: Here small powder particles are number using tablet press.
gathered together into layers, and permanent • Coating: Tablets and granules are coated if there is
aggregates to render them into free-flowing states. need to mask the unpleasant taste/odour of some drug
• Drying and dry screening: Screened wet granules substance or to increase the aesthetic appeal of
need to be dried for a particular time period in tray uncoated tablets as well as to modify the release or
dryer or fluid bed dryer at controlled temperature not control the release of drug substance from tablets.
exceeding 550 degree C . Dried granules are screened This is achieved by enclosing or covering the core
through the appropriate mesh screen tablet or granules with coating solutions.
JSS College of Pharmacy, Mysuru 12 13
 Methods used in tablet Formulation
Tablets are commonly manufactured by
• Wet granulation
• Dry granulation or
• Direct compression

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WET GRANULATION Methods:

1.Weighing, milling and mixing of the APIs with powdered
excipients (excluding the lubricant)
• Wet granulation is a widely used method for
2. Preparation of binder solution
the production of compressed tablet. It is
essentially a process of size enlargement 3.Mixing of binder solution with powders to form a damp mass
involving several steps and the use of an 4.Screening the dampened powder into pellets or granules (wet
adhesive substance known as binder. screening) using 6- to 12-mesh screen
• The granules produced using this method of 5. Drying of moist granules
granulation has a greater probability of 6.Sizing the granulation by dry screening using 14- to
20-mesh screen
meeting all the physical requirements for
tablet formation. 7.Mixing of the dried granules with lubricant
and disintegrates
8. Compression of granules into tablets
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 DRY GRANULATION Dry granulation method
• The formation of granules by compacting
powder mixtures into large pieces or compacts • Weighing and Milling of formulation
which are subsequently broken down or sized ingredients (drug substance and excipients)
into granules (often referred to as dry • Mixing of milled powders.
granulation, double compression or pre- • Compression of mixed powders into slugs.
compression) is a possible granulation method • Milling and sieving of slugs.
which, however, is not widely used in the
• Mixing with disintegrate and lubricant.
manufacture of tablets.
• Compression into tablet.

18 JSS College of Pharmacy, Mysuru 19

Compression
DIRECT COMPRESSION Tablets are being formed by compressing the
granules by using the compression machine.
• direct compression involves direct
compression of powdered materials into tablets Tablet formed in compression machine by
pressing the granules in die with lower and
without modifying the physical nature of the upper punch. Tablet formation takes place by
materials itself. the combined pressing action of two punches
(lower and upper) and a die.
• Direct compression avoids many of the
problems associated with wet and dry Now it is possible to produce more than
granulations. 500,000 tablets per hour due to different’s
innovations to tablet compression machines.

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Tablets compression Processing steps

Evaluation of tablets
Official tests
• Content of active ingredient/ absolute drug
content test/ assay of active ingredient.
• Weight uniformity test/ weight variation test
• Friability Test
• Hardness Test
• Disintegration time test
• Dissolution test
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 Tablets/QC test Equipment Percentage weight variation Limit for Tablets
• Weighing Balance
• Friability Tester
• Hardness Tester
• Disintegration time tester
• Dissolution tester

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Disintegration testing condition Disintegration testing condition

Sr.
No
Type of tablets Medium Temperatu Limit
re Sr. Type of tablets Medium
(USP
Temperatu Limit

1 Uncoated Water/buffer 37 °± 2 °C 15 min or as per individual

)
No re

monograph 1 Uncoated Water/as specified 37 °± 2 °C As per individual monograph

in monograph
2 Film coated Water 37 °±2 °C 30 min or as per individual
Disintegratio monograph 2 Coated Water/as specified 37 °±2 °C As per individual monograph
in monograph
3n testing
Sugar coated Water/0.1 N 37 °±2 °C 60 min or as per individual
HCl monograph 4 Enteric-coated Simulated gastric 37 °±2 °C 01 hour in Simulated gastric fluid

4
condition and
Dispersible Water 25 °±1 °C 03 min or as per individual
Tablets fluid TS As per individual monograph:
Simulated Simulated intestinal fluid TS
interpretatio
Tablets monograph intestinal fluid TS
5n (IP)
Effervescent Water 25 °±5 °C 05 min or as per individual 5 Buccal Tablets Water/as specified 37 °± 2 °C 4 hour
Tablets monograph in monograph
6 Enteric-coated 0.1 M HCl 37 °±2 °C 02 hour in HCl: no disintegration 6 Sublingual Water/as specified 37 °± 2 °C As per individual monograph
Tablets mixed 60 min in buffer : disintegrate tablets in monograph
phosphate
buffer pH 6.8

7 Soluble Tablets Water 20 °±5 °C 03 minutes

JSS College of Pharmacy, Mysuru JSS College of Pharmacy, Mysuru
 Packaging and storing of tablets
Before tablets are sent out for distribution, they Tablet Packaging Machine
are usually packaged using appropriate
packaging materials. The type of packaging
 The Different Types of Tablet Packing Machines
 Strip Packing Machine.
 Blister Packaging Machines.
 Aluminium foil packaging machine.
 LFA Automatic Tablet Counting Machine.
 Automatic Pouch Packing Machine.
 Vertical tablet packing machinery.
 Economical Tablet Packaging Equipment.
 Fill & Sealing Machine.
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