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1. Presented by -:
Darpan Kalra
1418806
Manufacturing of
tablets

2. CONTENTS
• INTRODUCTION
• ADVANTAGES &
DISADVANTAGES
• TYPES OF TABLETS
• TABLET EXCIPIENTS
• MANUFACTURING
PROCESS
• DEFECTS IN TABLETS
• EVALUATION OF TABLETS

3. INTRODUCTION
• Tablets are compressed solid unit dosage
form containing medicament or
medicaments usually circular in shape
and may be flat or biconvex.
• Tablet is defined as a compressed solid dosage
form containing medicaments with or without
excipients.
• It is the most popular dosage form and 70% of the
total medicines are dispensed in the form of
Tablet.

4. ADVANTAGES &
DISADVANTAGES
• Advantages of
tablets:
 Easy to administered.
 Easy to dispense.
 More stable.
 Accuracy in dose.
 Bitter and nauseous substance can be easily dispensed.
 Light and compact.
 Economical.
 Sustained release product is possible by enteric coating.
• Disadvantages of tablets:
 Problem with compression to crystalline drug.
 Hygroscopic drugs are not suitable for compressed tablets.
 Drugs with low or poor water solubility, slow dissolution, may be
difficult to formulate.
 Cost of production may be increase because of coating and
encapsulation to
remove bitter and unpleasant taste.
 Swallowing is difficult especially for children and ill (unconscious)
patients.

5. 1. Compressed
tablet, e.g.
Paracetamol
tablet
2. Multiple
compressed
tablets,
3. Delayed
release tablet,
e.g. Enteric
coated
Bisacodyl
tablet
4. Sugar
coated
tablet, e.g.
Multivitamin
tablet
(A) Tablets
ingested
orally
1. Buccal tablet,
e.g.
Vitamin-c tablet
2. Sublingual
tablet,
e.g. Vicks
Menthol
tablet
3. Troches
or
lozenges
4. Dental
cone
(B) Tablets
used in oral
cavity
1.
Implantatio
n tablet,
e.g.
Testosterone
tablet
2. Vaginal
tablet,
e.g.
Clotrimaz
ole tablet
(c) Tablets
administered
by
other route
1. Effervescent
tablet, e.g.
Disprin
tablet (Aspirin)
2. Dispensing
tablet, e.g.
Enzyme
tablet (Digiplex)
3.
Hypoder
mic
tablet
4. Tablet
triturates
e.g. Enzyme
tablet
(Digiplex)
(D) Tablets
used to
prepare
solution:
TYPES OF
TABLET

6. EXCIPIENTS IN TABLET
FORMULATION
1. Diluents: The diluent is needed to increase the bulk
when quantity of medicament is very small in each
tablet. e.g. Lactose, sucrose, sodium chloride,
dextrose and starch etc.
2. Disintegrating agents: To break the tablet in smaller
particles when swallowed. These acts by three ways:
swelling, by producing effervescence and by melting at
body temperature. The disintegrating agent is divided
into two parts. One part is mixed with other excipients
before granules formation and the other is mixed with the
dry granules before compression. e.g. Potato, maize,
wheat starch etc.
3. Granulating agents: These provides moisture to convert
the fine powder into damp mass which after passing
through sieve forms granules. e.g Starch paste, acacia,
tragacanth. gelatin solution, iso propyl alcohol etc.
4. Glidants: To improve the flow properties of
granules. e.g magnesium stearate &Talc

7. 5. Lubricants: To reduce the interparticular friction during
compression and between tablet and die wall during
ejection of tablet. e.g. Talc & magnesium stearate.
6. Binding agents: these provides strength to the
granules to keep the tablet intact and selection of
which depends on the type of tablet.e.g. gum
tragacanth, methyl cellulose etc.
7. Adsorbing agents: these are used to adsorb volatile
oil, liquid extracts and tincture etc. Prevent sticking e.g.
Mg stearate, steraric acid etc.
8. Colors, flavors and sweetening agents: All coloring
agents must be approved and certified by FDA. Two
forms of colors are used in tablet preparation – FD &C
and D & C dyes. These dyes are applied as solution in
the granulating agent or Lake form of these dyes.

8. Granulation: Theprocessin which the primary powders particles aremade
adhereto form larger Multi particle entities called granulation.
• To avoid powder segregation.
• To enhance the flow ofpowder.
• To produce uniform mixtures.
• To produce dust freeformulations.
• To eliminate poor contentuniformity
• To improve compaction characteristics of mix.
GRANULATION

9. Manufacturing of granules
Dry granulation method wet
granulation
method
Direct
compression
compression
granulation. Wet
granulation
.

10. Compaction of powder
Milling
screening
Dry granulation

11. • DRY GRANULATION
• ¨ By the dry granulation method, the powder mixture is
compacted in large pieces and subsequently broken
down or sized into granules.
• For this method, either the active ingredient or the
diluent must have cohesive properties
• ¨ Dry granulation is especially applicable to materials
that cannot be prepared by wet granulation because
they degrade in moisture or the elevated temperatures
required for drying the granules.

13. Direct compression
SomeCrystalline substancescan compressdirectly.
Directly compressible diluent isan
Inert
Compactable
other ingredients.
Direct compressionmaterials shouldposses
Good flow andcompressibility
Inert
Tastelessa
Reworkable
Inexpensive
Able todisintegrate.

14. On a large scale compression
granulation can also be performed
ona roller compactor.
Granulation by dry compaction can
also be achieved by passing powders
between two rollers that compact
the material at pressure of up to 10
tons per linearinch.
Roller compactor

15. • Advantages
1. These methods are not generally associated with
alterations in drug morphology during processing.
2. No heat or solvents are required.
• Disadvantages
1. Specialist equipment is required for granulation by
roller compaction.
2. Segregation of components may occur mixing.
3. There may be issues regarding powder flow.
4. The final tablets produced by dry granulation tend to be
softer than those produced by wet granulation
5. Slugging and roller compaction lead to the
generation of considerable dust.

16. • PREPARATION OF GRANULES FOR COMPRESSION:
• Methods includes:
• WET GRANULATION
• Wet granulation is a widely employed method for the
production of compressed tablets.
• The steps required are:
1. Weighing and blending the ingredients
2. Preparing a dampened powder or a damp mass
3. Screening the dampened powder or damp mass into
pellets or granules
4. Drying the granulation
5. Sizing the granulation by dry screening
6. Adding lubricant and blending
7. Forming tablets by compression.
MANUFACTURING OF COMPRESSED TABLETS

18. • Advantages:
1. ¨ Reduced segregation of formulation components
during storage and/or processing
2. ¨ Useful technique for the manufacture of tablets
containing
low and or high concentrations of therapeutic agent
3. ¨ Employs conventional excipients and therefore is
not dependent on the inclusion of special grades of
excipients
• Disadvantages:
1. Often several processing steps are required
2. Solvents are required in the process: this leads to a
number of
concerns:
• Drug degradation may occur in the presence of the
solvent.
• The drug may be soluble in the granulation fluid.
• Heat is required to remove the solvent.

19. • COMPRESSION OF GRANULES INTO
TABLET:
• Tablet compression machine consist of:
1.Hopper for holding and feeding granulation to
be compressed
2. Dies that define the size and shape of the
tablet
3.Punches for compressing the granulation
within the dies
4.Cam tracks for guiding the movement of
the punches
5.Feeding mechanisms for moving granulation
from the hopper into the die
6. Tablet ejector

20. • Types of compression machine:
A. Single punch machine
• The compression is applied by the upper punch
making the single punch machine a“stampingpress.”
B. Multi-station rotary presses

21. • Multi-station rotary presses
Rotary tablet press is a mechanical device that unlike the single punch
tablet press has several tooling station which rotates to compress
granules/powder mixture into tablets of uniform size, shape
(depending on the punch design) and uniform weight. It was developed
to increase the output of tablets.
In rotary tablet press, the compaction force on the fill material is
exerted by both the upper and lower punches leaving the powder
granules to be compressed in the middle. This is known as accordion
type of compression. The capacity of a rotary tablet press is
determined by the rotation speed of the turrent and the number of
stations on the press.

24. DEFECTS IN
TABLETS
1. Capping:
• In this there is partial or complete removal of top or bottom
portion
of tablet.
• Reason
s:
1. Excessive fine.
2. Defective punch die.
3. High speed of machine.
4. Granules too dried.
• Defect can be removed:
1. Setting the die and punch properly.
2. Reduce % of fine.
3. Punches should be polished.
4. Maintain the desire moisture in granules.
5. Maintain the speed at optimum & regulate the pressure of
punches.

25. 2. Picking and sticking:
• The material is removed or picked up by upper punch from the
upper surface of the tablet. In the sticking he material stick to the
wall of the die cavity.
• Reasons:
1. Use of worn out die and punch.
2. Use of small quantity of lubricants.
3. Presence of excess moisture in the granules.
4. Scratches on the surface of the face of the punches.
5. Defect in formulation.
• Defect can be removed:
1. Using new set of die and adding proper quantity of
lubricants in granules.
2. Dry granules.

26. 3. Mottling:
• An unequal distribution of colour on the surface of a coloured tablet.
• Reasons:
1. Migration of dye in the granules during drying.
2. Use of different coloration of medicaments and excipients.
3. Defect can be avoided:
4. Drying the granules at low temperature.
5. Using the dye which can mask the colour of all medicaments.
4. Weight variation:
• Weight variation occur during the compression of granules in a tablet
machine and the tablet do not have the uniform weight.
• Reasons for this defect:
1. Granules are not in uniform size.
2. Presence of excess amount of powder in the granules.
3. No proper mixing of lubricants and no uniform flow of granules.
4. During compression change in capacity of die.
5. Variation in the speed of the tablet machine.

27. 5. Hardness variation:
• The tablet do not have a uniform hardness.
• It depends on the weight of the material and space
between the upper and lower punch during the stage of
compression.
• If volume of the material varies and distance varies between
punches, the hardness also varies.
6. Double impression:
• This effect occur when the lower punch has a monogram or
some
other engraving on it.
• During compression, tablet receive an imprint of the punch.
• Due to some defect in he machine lower punch move
slightly upward before ejection of tablet and give
second impression.
• This can be controlled by managing the movement of
punch.

28. EVALUATION OF
TABLET
• Official tests:
1.Size and shape and appearance of
tablet.
2. Content of active ingredient.
3. Uniformity of weight/weight variation
test
4. Uniformity of content
5. Disintegration.
6. Dissolution.
• Unofficial tests:
1. Hardness test.
2. Friability

29. Thank
You