Tablets Manufacturing

 Shmmon Ahmad,
 Asst. Professor, (Faculty of Pharmaceutics)
 Glocal University, Saharanpur
 Former Q.A Officer Ind-Swift Ltd. (WHO, GMP, MHRA-UK, EME-Europe)
 INTRODUCTION
• Tablets may be defined as the solid unit dosage form of
medicament or medicaments with suitable excipients and
prepared either by molding or by compression. It
comprises a mixture of active substances and excipients,

• Tablets formation process consist of a series of steps

(unit processes)– weighing, milling, mixing,
granulation, drying, compaction, (frequently) coating
and packaging. Regardless of the method used the unit
processes – weighing, milling and mixing, are the
same; subsequent steps differ.

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Primary goals of tablet manufacturing process

• To formulate tablets that are strong and hard to withstand

mechanical shock encountered during manufacturing, packing,
shipping, dispensing and use.
• To formulate tablets that are uniform in weight and in drug content.
• To formulate tablets that are bioavailable according to indication
requirements.
• To formulate tablets that are chemically and physically stable over a
long period of time.
• To formulate tablets that have elegant product identity which is free
from any tablet defects.
Categories of tablets for oral use

1. — uncoated tablets;
2— coated tablets;
3— gastro-resistant tablets;
4. — modified-release tablets;
5. — effervescent tablets;
6. — soluble tablets;
7. — dispersible tablets;
8. — orodispersible tablets;
9. — chewable tablets;
10.— oral lyophilisates.
Dispensing of API & Excipient

Sieving/screening

Size reduction

Blending

Granulation

Compression

Coating

Packaging

Tablets Dispatch in market

Processing of Granulation (tablets Granules)

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 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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 3. Mixing equipment e.g.,
pneumatic mixers diffusion/
tumbling mixers (e.g., V-
blender, double cone blender,
cubic mixer, drum blender),

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4.Granulators e.g. , Rotating
shape granulators , dry granulator ,
high shear granulator etc
5.Drying equipment e.g. spray
dryer , rotary dryer , fluidized bed
dryer etc
6.Tableting machine e.g. single
punch tablet press and multi station
/rotary tablet press Exp. Fette
Press, CardPress etc

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7. Evaluation /Quality control (QC) equipment
e.g., disintegration equipment , USP Dissolution Tester,
Tablet Hardness Tester, Tablet Thickness Tester, Tablet
Friability Testers etc.
8.Coating and polishing machines for coated tablets
e.g., standard coating pan, perforated pan, fluidized bed/
Air suspension coating system etc.

8. Packaging machines e.g., blister packing machine,

aluminium foil packaging machine, etc. Machine
name Dph-220/260 High Speed Blister Packing
Machine

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 Tablet Manufacturing Equipment/ Machines

Common equipment used in pharmaceutical

tablet manufacturing include:
1. Size reduction equipment
e.g., Hammer mill , roller mill , fluidized
energy mill , cutter mill and ball mill
2. Weighing balance/ balances e.g., bulk
weighing balance (weighs in kilogram),
electronic weighing balance (weighs in
grams and milligrams).

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

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 WET GRANULATION
• Wet granulation is a widely used method for
the production of compressed tablet. It is
essentially a process of size enlargement
involving several steps and the use of an
adhesive substance known as binder.
• The granules produced using this method of
granulation has a greater probability of
meeting all the physical requirements for
tablet formation.

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 Methods:
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 disintegrates
8. Compression of granules into tablets
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 DRY GRANULATION
• The formation of granules by compacting
powder mixtures into large pieces or compacts
which are subsequently broken down or sized
into granules (often referred to as dry
granulation, double compression or pre-
compression) is a possible granulation method
which, however, is not widely used in the
manufacture of tablets.

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Dry granulation method

• Weighing and Milling of formulation

ingredients (drug substance and excipients)
• Mixing of milled powders.
• Compression of mixed powders into slugs.
• Milling and sieving of slugs.
• Mixing with disintegrate and lubricant.
• Compression into tablet.

JSS College of Pharmacy, Mysuru 19

 DIRECT COMPRESSION
• direct compression involves direct
compression of powdered materials into tablets
without modifying the physical nature of the
materials itself.
• Direct compression avoids many of the
problems associated with wet and dry
granulations.

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Compression
Tablets are being formed by compressing the
granules by using the compression machine.

Tablet formed in compression machine by

pressing the granules in die with lower and
upper punch. Tablet formation takes place by
the combined pressing action of two punches
(lower and upper) and a die.

Now it is possible to produce more than

500,000 tablets per hour due to different’s
innovations to tablet compression machines.
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
• Weighing Balance
• Friability Tester
• Hardness Tester
• Disintegration time tester
• Dissolution tester

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Percentage weight variation Limit for Tablets
Disintegration testing condition
Sr. Type of tablets Medium Temperatu Limit
No re

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

monograph
2 Film coated Water 37 °±2 °C 30 min or as per individual
Disintegratio monograph
3n testing
Sugar coated Water/0.1 N 37 °±2 °C 60 min or as per individual
HCl monograph
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condition and
Dispersible Water 25 °±1 °C 03 min or as per individual
interpretatio
Tablets monograph
5n (IP)
Effervescent Water 25 °±5 °C 05 min or as per individual
Tablets monograph
6 Enteric-coated 0.1 M HCl 37 °±2 °C 02 hour in HCl: no disintegration
Tablets mixed 60 min in buffer : disintegrate
phosphate
buffer pH 6.8

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

JSS College of Pharmacy, Mysuru
Disintegration testing condition
Sr. Type of tablets Medium
(USP
Temperatu Limit
)
No re
1 Uncoated Water/as specified 37 °± 2 °C As per individual monograph
in monograph
2 Coated Water/as specified 37 °±2 °C As per individual monograph
in monograph
4 Enteric-coated Simulated gastric 37 °±2 °C 01 hour in Simulated gastric fluid
Tablets fluid TS As per individual monograph:
Simulated Simulated intestinal fluid TS
intestinal fluid TS
5 Buccal Tablets Water/as specified 37 °± 2 °C 4 hour
in monograph
6 Sublingual Water/as specified 37 °± 2 °C As per individual monograph
tablets in monograph

JSS College of Pharmacy, Mysuru

 Packaging and storing of tablets
Before tablets are sent out for distribution, they
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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Tablet Packaging Machine

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