1. Ta ble ts
 Definition.
 Half of all pharmaceutical products
are for oral use (tablets or capsules)
 The advantage is that they have
high patient compliance, relatively
easy to produce, easy to market
 Disadvantage the conditions in the
GI tract is difficult for some
substance and all substances are not
absorbed

2. What is a tablet
A compressed
dispersion of
particles.

3. Different types of tablets
Tablets that are taken  Other oral
intact
 Conventional tablets
formulations
 Coated Tablets  Capsules
Tablets that are not  Oral solutions
taken intact
 Chewable tablets
 Effervescent tablets
 Lozenges
 Sublingual and buccal
tablets
 Fast dissolving tablets

4. Tablet Manufacture
 Procurement of raw Material
 Preformulation Studies
 Formulation
 Mixing/Blending
 Granulation
 Compression
 Coating
 Packaging

5. Three Principle Methods Of Developing
Powders For Tablet Making
 Direct Compression
 Wet Granulating
 Dry Granulating

6. WHY GRANULATE?
 To improve powder flow.
 To improve compressibility.
 To reduce fines.
 To control the tendency of powders to
segregate.
 To control density.
 To capture and fuse small quantities
of active material.

7. WET GRANULATING PROCESS STEPS
 Pre-mix
 Wet massing
 Screening
 Drying
 Milling (Sieving)
 Final blend (Lubricant is added)

8. GRANULE FORMATION IN THE WET
GRANULATING PROCESS
 Nucleation
 Transition in the
.
funicular and
capillary stage
 Ball growth

9. Rapid Mixer
Granulator
(Wet Granulation)

10. DRY GRANULATING
 Powders can be
compacted
using a tablet
press; this is
called Slugging.

11. Why Dry Granulating?
 Granulate materials which are sensitive to
heat and/or moisture.
 Produce a uniform particle size range.
 Improve flow properties.
 Control dust.
 Control bulk density.
 Produce uniform blends
 Control particle hardness.

12. HOW GRANULES ARE TESTED
 LOD- water content (Loss on drying)
 Bulk Density, gm/ml
 Particle Size Distribution
 Angle of Repose.

13. What are a tablet composed of
 Active substances
 Filler
 Disintegrant
 Binder
 Gliadant
 Lubricant
 Antiadherent
 (Coating)
 (Colour, humectants)

14. Filler / Diluent
 Give a reasonable size for  Sugars
the tablet ≥50 mg  Lactose
 Properties  Sucrose
 Chemical inert  Mannitol
 Non-hygroscopic  Salts
 Water soluble or  Calcium phosphate
hydrophilic  Calcium carbonate
 Good mechanical  Polymers
properties
 Cellulose
 Acceptable taste
 Cheap

15. Dissintegrant
 Ensure that the tablet  Surfactants “small”
breaks into small pieces molecules that are both
when in contact with water water loving (hydrophilic)
 Addition of Disintegrant and oil loving
 Intragranular addition (hydrophobic)
 Extragranular addition  They will adsorb to
 Disintegration through interfaces and in water
wetting increase the hydrofilicity of
 Surfactant that interface
 Disintegration through  They will tend to form
rupture associated structures
 Starch above a certain
 Cellulose derivates concentration

17. How to increase the release rate
 Increase the surface
area (Disintegrant)
 Starch
 Cellulose materials
(Avicel)
 Include wetting agents
 Surfactants
 Increase solubility
 Avoid drug-excipient
interactions
 Use solid dispersions
or solid solutions

20. Binder
 A binder is added to  Dry powder that is mixed
in with the granulate and
increase the partly dissolved during
cohesion between granulation
 Wet binders that are
particles in dissolved in granulation
granulates to liquid
 Gelatin and starch
ensure mechanical
 Polividon and cellulose
stability of the  Dry binders that are used
granulate in dry granulation
 Normal  Cross linked PVP
 Microcrystalline
concentration of cellulose
binder is 2-10%

21. Lubricants and gliadants
 Gliadants included  Lubricants
to increase included to
flowability of facilitate tabletting
powder and ejection of
 Excipients formed tablets
 Colloidal silica  Excipients
 Magnesium  Magnesium
stearate stearate
 Polyethylene glycol

23. General Formula for a Direct
Compression Tablet
 DRUG 1 PART
 FILLER-BINDER 2 - 3+ PARTS
 DISINTEGRANT
STARCH 10 - 20%
OR
SUPER DISINT. 2 - 5%
 GLIDANT
COLLOIDAL SILICA 0.5 - 1%
 LUBRICANT
MAG. STEARATE 0.5 - 1%

24. Advantages of Direct
Compression over Granulation
 More economical (less  Disadvantages
time, space, materials,
 Problem of content
personnel, fewer steps)
uniformity for low dose
 Avoids heat and moisture drugs
of wet granulation
 Not practical for large
 Disintegrate more dose poorly
directly into primary compactible /poorly
particles flowing drugs
 Requires tight control
over physical properties
of filler-binder

30. High Speed Production
Rotary Tablet Press
55 stations
495,000 tabs/hour

31. Thank You…