Tablet production process by ranjeet singh

Tablet production process and drying equipments

2. Tablets are solid dosage forms consisting of active
ingredient(s) and suitable pharmaceutical excipients.
They may vary in size, shape, weight, hardness,
thickness, disintegration and dissolution
characteristics, and in other aspects.
They may be classified, according to the method of
manufacture, as compressed tablets or molded
tablets
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3. Production aspect :-
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stability
User aspect (doctor, pharmacist, patient):-
 Easy to handling
 Lightest and most compact
 Greatest dose precision & least content
variability
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4. Some drugs resist compression into dense compacts.

Drugs with poor wetting, slow dissolution, intermediate to
large dosages may be difficult or impossible to formulate
and manufacture as a tablet that provide adequate or full
drug bioavailability•

Bitter taste drugs, drugs with an objectionable odour, or
sensitive to oxygen or moisture may require
encapsulation or entrapment prior to compression or the
tablets may require coating.
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5. The term “direct compression” is defined as the
process by which tablets are compressed directly
from powder mixture of API and suitable
excipients.

It involves only two unite operations powder
mixing and tableting.
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6. Reduced production time &cost.
Product stability can be improved.
Faster drug dissolution due to fast disintegration into
primary particles.
less number of equipment are required, less process
validation
Elimination of heat and moisture, thus increasing not
only the stability but also the suitability of the process
for thermo-labile and moisture sensitive API’s.
The chances of batch-to-batch variation are
negligible, because the unit operations required for
manufacturing processes is fewer.
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7. Many active ingredients are not compressible either in
crystalline or amorphous forms.
Needs directly compressible filler that is usually expensive,
e.g. microcrystalline cellulose (Avicel), spray dried lactose
Problems in the uniform distribution of low dose drugs.
High dose drugs having high bulk volume, poor flowability
and poor compressibility are not suitable for direct
compression. For example, Aluminium Hydroxide,
Magnesium Hydroxide
Non-uniform distribution of colour, especially in tablets of
deep colours
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8. Drug is added to the granulator and grinded.
The suitable adjuvants( eg: diluents and others excipients) are
added and mixed in a blender.
After mixing the powder mixture is slugged or compressed into
large flat tablets or pellets about 1inch diameter. On large
scale, roller compactor is preferred.
These slugs are broken down by hand or by milling to form
granules.
The granules under go dry screening through a desired mesh
for sizing.
Finally, the lubricating agents is added and mixed thoroughly
in a blender.
The resultant granules are compressed by machine tooling of
a table press.
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10. Advantage:-
The compression granulation need less space and equipment.
It is suitable for moist and heat sensitive drugs.
It takes less time.
Disadvantage:-
The compression granulation produces loads of dusts.
The prolonged compression rates may results in hard tablets
with poor disintegrating properties.
It produces friable tablets.
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11. Drug is added to the granulator and grinded.
The suitable diluents and other excipients are added mixed in
a blender.
Granulating liquid are added to form a damp mass of the
powder material which resembles agglomerates.
The mass is screened to form pellets or granules.
These pellets or granules are dried to removes excess of the
liquid.
Dry screening of granules results in comminution (size
reduction).
The lubricating agents are added and the mixture is mixed
thoroughly in a blender.
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13. The resultants granules are compressed by machine tooling of
the tablet press.
Advantage:-
Wet granulation is suitable for high dose drugs which have poor
flowability.
It is suitable for bulky and dust producing powders.
By selecting a suitable granulating liquid, the dissolution rate of
insoluble drugs can be enhanced.
Proper selecting a suitable granulating liquid enables the
preparation of sustained release dosage forms.
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14. The wet granulation requires large space.
It is unsuitable for hydrolysable, thermolabile and
moisture sensitive.
This method is expensive.
Tacky material are difficult to transfer and so offer
problem during processing.
The wetting and drying steps makes this technique
time consuming.
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1.Drum dryer (Film drying)
2.Spray dryer
3.Freeze Dryer
4.Tray drier
5.Fluidized Bed Dryer
6.Vacuum Dryer

17. It consists of a drum of about 0.75-1.5 m in diameter and 2-4 m
in length, heated internally, usually by steam and rotated on its
longitudinal axis.
Operation: The liquid is applied to the surface and spread to a
film, this may be done in various ways, but the simplest method
is that shown in the diagram, where the drum dips into a feed
pan. Drying rate is controlled by using a suitable speed of
rotation and the drum temperature.
The product is scraped from the surface of the drum by means
of a doctor knife.
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19. The spray dryer provides a large surface area for heat
and mass transfer by atomizing the liquid to small
droplets.
These are sprayed into a stream of hot air, so that
each droplet dries to a solid particle.
The drying chamber resembles the cyclone ensuring
good circulation of air, to facilitate heat and mass
transfer, and that dried particles are separated by the
centrifugal action.
Spray dryer can be operated efficiently at various feed
rates.
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21. Freeze drying is a process used to dry extremely heat
sensitive materials. It allows the drying , without excessive
damage, of proteins, blood products and even
microorganisms, which retain a small but significant viability.

In this process the initial liquid solution or suspension is
frozen, the pressure above the frozen state is reduced and
the water removed by sublimation.

Thus a liquid to vapour transition takes place, but here three
states of matter involved: liquid to solid, then solid to vapour.
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23. Air flows in direction of the arrows over each shelf in turn.
The wet material is spread on shallow trays resting on the
shelves.

Electrical elements or steam-heated pipes are positioned as
shown, so that the air is periodically reheated after it has
cooled by passage over the wet material on one shelf before
it passes on the next.
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25. ‘Fluidized’ means something that behaves like liquid. In the
fluidized bed dryer, the mixture of solids and gas behave like
a liquid and solid are called fluidized.
It provides good contact between hot air and particles to
obtain efficient drying.
The hot air is passed through a mesh, which supports the
conical vessel with a porous base.
This vessel is filled with powder to be dried.

It has wheels and can be clipped to the central plate by
means of a rapid acting ring closure.
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27. This equipment is a good example of conduction drier. The
vacuum oven consists of a jacketed vessel to withstand
vacuum within the oven.

There are supports for the shelves giving a larger area for
conduction heat transfer. The oven can be closed by a door.

The oven is connected through a condenser and liquid
receiver to a vacuum pump.

Operating pressure can be as low as 0.03-0.3 bar, at which
pressures water boils at 25-35°C.
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29. Capping is the partial or complete separation of the top
or bottom crowns of a tablet from the main body of the
tablet.

Lamination is separation of a tablet into two or more
distinct layers. Both of these problems usually result
from air entrapment during processing.

Picking is removal of a tablet’s surface material by a
punch.
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30. Sticking is adhesion of tablet material to a die wall.

•These two problems result from excessive moisture
or substances with low melting temperatures in the
formulation
Mottling is an unequal color distribution on a tablet,
with light or dark areas standing on otherwise uniform
surface. This results from use of a drug with a color
different from that of the tablet excipients or from a
drug with colored degradation products.

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31. Weight variation-granule size distribution, poor
flow, punch variation
Hardness variation

Double impression:- the problem happen when
the punches have a monogram or other engraving on
them. During compression the tablet receive the
imprint on the punch.
•To prevent this problem anti turning device is used.
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32. L Lachman, HA Lieberman, Joseph LK ,The theory
& practice of industrial pharmacy , 3
rd
edition
Varghese publishing, Bombay;1990:293-345.
Gilbert SB, Christopher TR, Modern pharmaceutics ,
4
th
edition marcel dekker,newyork;2002;287-334.
Roop KK, SP Vyas, Farhan JA, Gaurav KJ.
Industrial pharmacy, 4
th
edition CBS
publisher;2016:449-88.
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33. Thank You…
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