mohd_kaleemullah

@msu.edu.my
PREPARATION OF
TABLETS
OR
TABLETTING
3
WET GRANULATION:

Raw materials → Weighing → Screening → Wet massing → Wet Sieving/Milling

→ Drying → Dry Screening → Mixing → Compression

 The powder mass is wetted with the binding solution until the mass has the

consistency of damp snow. If the granulation is over wetted the granules will be
hard, if not wetted sufficiently, the resulting granules will be too soft, breaking
down during lubrication.

 The wet mass is forced through a suitable sieve. Moist materials from wet

milling steps is placed on large trays and placed in drying chambers.

 After drying granulation, the lubricant or glidants are added as fine powder to

promote flow of granules. These granules then compressed to get tablet.

DRY GRANULATION:
 Raw material → weighing → Screen → Mixing → Slugging

→ Milling → Screening → Mixing → Compression

 Compression granulation involves the compaction of the

components of a tablet formulation by means of flat punch.
These compact masses are called slug and the process is called
slugging.

 Slugs are then milled and screened to produce a granular form.

Roller compactor
"Chilsonator”

Compact Powder to be
compacted

Size reduction of
compacts into
granules
Wet granulation vs
dry granulation
DIRECT COMPRESSION:
 Raw material → Weighing → Screening → Mixing
→Compression.

 This method is applicable for crystalline chemicals having good

compressible characteristics and flow properties such as:

Potassium salt (chlorate, chloride, bromide), Sodium chloride,
Ammonium chloride, Methenamine etc.

 Tablets are compressed directly from powder blends of the active

ingredient and suitable excipients

 Advantages of Direct Compression

 Economy in labor, time, equipment, operational energy, and

space.

 Problems due to heat and moisture eliminated.

 Greater physical stability provided; hardness and porosity

changes less with time when direct compression is broadly
compared to wet granulation systems.
A comparative processing chart of different
techniques
Methods of Preparation of Tablets
 Equipment's used for Mixing, blending and
lubrication

 High share mixers

 Tumbling mixers

 Y-cone

 Rotating cube

 Double cone

 Fluidized bed

 Agitator mixers

 Ribbon blender
 Granulator mixer

Diosna mixer
RMG
Equipment's used in sieving
Compression: Compression is the
process of applying pressure to a
material with the help of a Tablet
punching machine.
 Compression
Tableting procedure
 Filling
 Compression
 Ejection

Tablet compression machines

 Hopper for holding and feeding granulation to be compressed
 Dies that define the size and shape of the tablet
 Punches for compressing the granulation within the dies
 Cam tracks for guiding the movement of the punches
 Feeding mechanisms for moving granulation from the hopper
into the dies
Upper and
Lower Collar

Collar locker
Single Punch Machine
Common stages occurring
during compression
 Stage 1: Top punch is
withdrawn from the die by the
upper cam. Bottom punch is
low in the die so powder falls
in through the hole and fills
the die
 Stage 2: Bottom punch moves
up to adjust the powder
weight-it raises and expels
some powder
 Stage 3: Top punch is driven
into the die by upper cam.
Bottom punch is raised by
lower cam. Both punch heads
pass between heavy rollers to
compress the powder
 Stage 4: Top punch is
withdraw by the upper cam.
Lower punch is pushed up and
expels the tablet. Tablet is
removed from the die surface
by surface plate
 Stage 5: Return to stage 1
 Multi-station rotary presses

 The head of the tablet machine that holds the upper

punches, dies and lower punches in place rotates.
 As the head rotates, the punches are guided up and
down by fixed cam tracks, which control the sequence
of filling, compression and ejection.
 The portions of the head that hold the upper and lower
punches are called the upper and lower turrets.
 The portion holding the dies is called the die table.
 Dies & punches

Upper punch Lower punch

Dies
 Compression cycle

 Granules from hopper empty in the feed frame (A) containing several
interconnected compartments.

 These compartments spread the granulation over a wide area to

provide time for the dies (B) to fill.
 The pull down cam (C) guides the lower punches to the bottom,
allowing the dies to overfill
 The punches then pass over a weight-control cam (E), which reduces
the fill in the dies to the desired amount
 A swipe off blade (D) at the end of the feed frame removes the excess
granulation and directs it around the turret and back into the front of the
feed frame

 The lower punches travel over the lower compression roll (F) while
simultaneously the upper punches ride beneath the upper compression
roll (G)

 The upper punches enter a fixed distance into the dies, while the lower
punches are raised to squeeze and compact the granulation within the
dies

 After the moment of compression, the upper punches are withdrawn as

they follow the upper punch raising cam (H)

 The lower punches ride up the cam (I) which brings the tablets flush
with or slightly above the surface of the dies
 The tablets strike a sweep off blade affixed to the front of the feed
frame (A) and slide down a chute into a receptacle

 At the same time, the lower punches re-enter the pull down cam (C)
and the cycle is repeated
HIGH SPEED ROTARY MULTI ROTARY MACHINE
MACHINE
EVALUATION OF TABLETS

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32
1.GENERAL APPEARANCE :

The general appearance of a tablet is essential for consumer

acceptance. it involves:
 Size & Shape : Tablet thickness should be controlled
within a ± 5% variation of standard value.
 Unique identification marking: These markings include
company name or symbol, product code, product name etc.
 Organoleptic properties: Color distribution must be
uniform in comparison with the color of the standard.

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2.WEIGHT VARIATION TEST:

weigh randomly 20 tablets individually in a batch.

Determine the average weight of 20 tablets.

Compare individual tablet weight to average weight

• As per I.P. ,
 If the tablet weight is,
 < 80mg , % deviation allowed up to 10%
80-250mg , % deviation allowed up to 7.5%
> 250mg , % deviation allowed up to 5%
If any of the tablet deviates, another 10 tablets are selected
from the same batch and the procedure is repeated.

Of 30 tablets , not more than 1 tablet should deviate.

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3.Content uniformity test:
It is used to ensure that every tablet contains the amount of drug
substance intended with little variation.
Procedure:
o 10 tablets are assayed,
o 9 tablets should have % limit of 85-115%.
o If more than 1 tablet deviates from 85-115%,
o Another 20 tablets are assayed
o Not more than 1 tablet should have the % limit of 75-125%

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4. Hardness test:
It is defined as the force required to break a tablet in a
diametric compression . Tablet requires a certain amount of
strength or hardness and resistance to friability to withstand
mechanical shocks of handling in manufacture, packaging and
shipping
Types of hardness testers used.
1. Monsanto hardness tester .
2. Strong cob tester.
3. Pfizer tester.
For, Conventional tablets hardness : 2.5- 5 kg/cm2
Dispersible/ chewable tablets hardness: 2.25- 2.5 kg/cm2
Extended release tablets hardness : 5- 7.5 kg/cm2

36
5. Friability test:
• The instrument used is Roche friabilator.
• It consists of a drum having 280-290mm diameter with a
thickness of 30mm. A drum is mounted on a horizontal axis
of a drive motor.
• Drum is operated at a speed of 25rpm.&Allowed revolutions
for each tablet is 100.
• Allowable range: loss 0.5 - 1% weight

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6.Disintegration test:
Disintegration is the breakdown of tablet crust into
finely divided particulate matter or into granules
once the tablet is exposed to the gastric fluids .

Type of tablets Time Of disintegration

uncoated conventional tablets 15min

sugar coated tablets 60 min.

film coated tablets 30 min

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7.Dissolution Test (U.S.P.): It is the solubilization of the drug or

active moiety in to the dissolution media.

Different types of dissolution apparatus:

Apparatus -I-Rotating Basket type.
Apparatus -II- Rotating Paddle type.
Apparatus-3-Reciprocating cylindrical type.
Apparatus-4-Flow through cell.
Apparatus-5-Paddle over disk.
Apparatus-6-Cylindrical apparatus.
Apparatus-7-Reciprocating disc apparatus.

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 Conclusion
• Tablets are the most preferred and accepted class
of oral dosage forms which comprises about 2/3rd
of the prescribed products.

• Tablets serve as dosage forms which are simple,

convenient to use, portable dosage forms
acquirable for all ailments.

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