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

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• 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.

Primary goals of tablet manufacturing process

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• 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

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Processing of Granulation (tablets Granules)

Procedure for Manufacturing of

Tablets

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• 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.

3. Mixing equipment e.g.,

pneumatic

tumbling

mixers diffusion/

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, TabletFriability Testers etc.

8.Coating and polishing machines for coated tabletse.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

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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).

• Powder

suitable

JSS College of Pharmacy, Mysuru 12

blending: Powders

blender to obtain

are mixed using a

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

• 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

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Tablets are commonly manufactured by

• Wet granulation

• Dry granulation or

• Direct compression

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WET GRANULATION

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• Wet granulation is a widely used method forthe production of compressed tablet. It isessentially a process of size enlargementinvolving several steps and the use of anadhesive substance known as binder.

• The granules produced using this method of

meeting allgranulation has a greater probability of

the physical requirements fortablet formation.

Methods:

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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 granules6.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

DRY GRANULATION

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• 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.

Dry granulation method

JSS College of Pharmacy, Mysuru 19

• 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.

DIRECT COMPRESSION

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• direct compression involves direct

compression of powdered materials into tablets

without modifying the physical nature of the

materials itself.

• Direct compression

problems associated

avoids

with

many of the

wet and dry

granulations.

CompressionTablets 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

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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

Percentage weight variation Limit for Tablets

Disintegration testing condition

JSS College of Pharmacy, Mysuru

Disintegration testing condition and interpretation (IP)

Sr.

No

Type of tablets Medium Temperature

Limit

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

monograph

3 Sugar coated Water/0.1 N

HCl

37 °±2 °C 60 min or as per individual

monograph

4 Dispersible

Tablets

Water 25 °±1 °C 03 min or as per individual

monograph

5 Effervescent

Tablets

Water 25 °±5 °C 05 min or as per individual

monograph

6 Enteric-coated

Tablets

0.1 M HCl

mixed

phosphate

buffer pH 6.8

37 °±2 °C 02 hour in HCl: no disintegration

60 min in buffer : disintegrate

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

JSS College of Pharmacy, Mysuru

Disintegration testing condition(USP

)Sr.

No

Type of tablets Medium Temperatu

reLimit

1 Uncoated Water/as specified

in monograph

37 °± 2 °C As per individual monograph

2 Coated Water/as specified

in monograph

37 °±2 °C As per individual monograph

4 Enteric-coated

Tablets

Simulated gastric

fluid TS

Simulated

intestinal fluid TS

37 °±2 °C 01 hour in Simulated gastric fluid

As per individual monograph:

Simulated intestinal fluid TS

5 Buccal Tablets Water/as specified

in monograph

37 °± 2 °C 4 hour

6 Sublingual

tablets

Water/as specified

in monograph

37 °± 2 °C As per individual monograph

Packaging and storing of tablets

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.30

Before tablets are sent out for distribution, theyare usually packaged using

packaging materials. The type of

appropriate

packaging

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Tablet Packaging Machine

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