Tablet manufacturing process

JSS College of Pharmacy, Mysuru
Tablet manufacturing process
Prepared by :
Avinasha S
1st M Pharm (QA)
JSSCP
Submitted to:
Mr Hemanth Kumar S
Dept of Pharmaceutics
JSSSCP

INTRODUCTION
• Tablets are commonly manufactured by wet granulation, dry
granulation or direct compression. These methods may be
considered to 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.
2

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.
3

Personnel requirements during manufacture of
pharmaceutical tablets
• Production pharmacists/ supervisors
• Manufacturing chemist
• Analytical chemist
• Quality assurance manager
• Machine operators
• Mechanics
4

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).
5

3. Mixing equipment e.g.,
pneumatic mixers diffusion/
tumbling mixers (e.g., V-
blender, double cone blender,
cubic mixer, drum blender),
6

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
7

7. Quality control 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.
9. Packaging machines e.g., blister
packaging machines, strip packing
machine, aluminium foil packaging
machine, etc.
8

Layout of Tablets manufacturing
section
9

Procedure for Manufacturing 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.
10

• 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
11

• 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.
12

Methods used in tablet Formulation
Tablets are commonly manufactured by
• Wet granulation
• Dry granulation or
• Direct compression
13

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.
14

FLOW CHAT OF WET GRANULATION
15

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
16

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
17

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.
18

Flow chat of dry granulation
19

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.
20

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.
21

Its successful application in tablet formulation
rests on two fundamental issues:
• The availability of suitable excipients
• The availability of suitable machinery.
22

Flow chat of direct compression
23

Dry granulation method .
• Milling of therapeutic agent and excipients
• Mixing of milled powders, disintegrates and
lubricants
• Compression into tablet
24

JSS College of Pharmacy, Mysuru 25

Quality control of tablets
Official tests
• Content of active ingredient/ absolute drug
content test/ assay of active ingredient.
• Weight uniformity test/ weight variation test
• Content uniformity test
• Disintegration time test
• Dissolution test
26

• UNIFORMITY OF CONTENT
As per IP : 10mg / less than 10% w/w of active
ingredient
As per BP/USP : 25mg /less than 25%w/w
• DISINTEGRATION TEST
As per IP : 28-32 cycle per min
As per BP/USP : 29-32 cycle per min

Disintegration testing condition and interpretation (IP)
Sr.
No
Type of tablets Medium Temperatu
re
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

Disintegration testing condition (USP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
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

non-official tests
• hardness test
• Friability test
30

Packaging and storing of tablets
Before tablets are sent out for distribution, they
are usually packaged using appropriate
packaging materials. The type of packaging
material used is a matter of choice and is
dependent on several factors including:
• The degree of protection required
• Compatibility of the packaging material
with the formulation.
31

• Presentation, particularly for those products
which may be the subject of impulse buying
• Customer convenience in terms of size,
weight, method of opening or reclosing
legibility of printing, etc.
• Filling method and Cost
32

Tablet manufacturing process

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