GRANULATION

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 CONTENTS

INTRODUCTION

METHODS OF GRANULATION

ADVANCED GRANULATION TECHNIQUES

CONCLUSION

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 Introduction

Granules

Granulation

Granulation Technology

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Why we prepare granules when
we have powders….?

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To avoid powder segregation.

To enhance the flow of powder.

To produce uniform mixtures.

To produce dust free formulations.

To eliminate poor content uniformity.

To improve compaction characteristics of mix.

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To avoid powder segregation. Contd...

-Segregation may result in weight variation.

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 Contd...

To enhance the flow of powders.

(Higher flowability gives better filling of the dies or containers)

To produce uniform mixtures.

(Mixtures of various particles tend to segregate in
transport or handling because of differences in particle
size, shape and density)

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Dust free formulations.
(Decrease dust generation and reduce
employee exposure to drug product)

To eliminate poor content uniformity.

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 Methods of granulation

DRY GRANULATION

 DIRECT COMPRESSION

 COMPRESSION GRANULATION

WET GRANULATION
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When To Choose DRY method?

Drug dose is too high.

Do not compress well after wet granulation.

Heat sensitive drugs.

Moisture sensitive drugs.

e.g. Aspirin , Vitamins

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 Steps in Dry Granulation

Compaction of powder

Milling

Screening

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 Contd…

How can
we do it………?

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 Contd…
By two ways

ROLLER
SLUGGING COMPACTION

Large tablet produced Powder is squeezed

in heavy duty tablet between two rollers to
press. produce sheet of material
e.g. Chilsonator
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 Contd…
Equipments

Has two parts,

Machine for compressing dry powder to
form compacts.

Mill for breaking these intermediates to

granule.

e.g. CHILSONATER
HAMMER MILL
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 COMPRESSION granulation

It mainly involves three steps -

 Milling of drug and excipients

Mixing of drug and

excipients

Tablet compression

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 Contd…

CAPPING
LAMINATION

EQUIPMENTS
ARE
EXPENSIVE
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 wet granulation

In this, powdered medicament and

other excipients are moistened with
granulating agent.

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 Contd…
Steps in wet granulation
• Mixing of the drug(s) and excipients
1
• Mixing of binder solution with powder mix. to form
2 wet mass

• Coarse screening of wet mass using a suitable sieve .

3 (6-12 # screens)

4 • Drying of moist granules.

• Screening of dry granules through a suitable sieve

5 (14-20 # screen).

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 Contd…

Granulating Binding
liquid agent-

Natural Polymers:
-Volatile
Starch,
-Non-toxic Pregelatinized
Starch

e.g. synthetic binders:

PVP, MC, HPMC,
Water, Ethanol ,
Isopropanol Maltrodextrins
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 Contd…
TIME

LABOR EQUIPMENTS

Limitation
of wet
granulation
LOSS OF
ENERGY MATERIAL

SPACE

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 Methods
Contd…
Single pot granulation

High shear mixture granulation

Fluid bed granulation

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Single pot granulation
The granulation is done in a normal
high shear processor and dried in same
equipment.

e.g. Single Pot Processor /

One-Pot Processor

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 Single pot granulator

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 High shear mixture granulation
Dry Powder mixing (Approx 2-5 mins)

Liquid binder addition (Approx 1-2 mins)

Wet massing

Wet sieving of granules

Drying

Dry sieving of granules

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 Rapid mixer granulator

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 Contd..

ADVANTAGES DISADVANTAGES

Increase in
Short processing time. temperature may cause
chemical degradation of
Lesser amount of liquid thermolabile material.
binders required compared
with FBG. Over wetting of
granules can lead to large
Highly cohesive material size lumps formation.
can be granulated.

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 Fluid bed granulation

Fluidization is the operation by which fine

solids are transformed into a fluid like state
through contact with a air/gas.

Granulating and drying can be completed in one step

inside the machine.

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 Contd…

-Homogeneous granules.

---Gentle product handling.

--Uniform spraying of all

particles in the fluid bed.

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 Contd…

Advantages Disadvantages

[Link] reduces dust 1. The Fluid Bed cleaning is

formation during labor-intensive and time
processing consuming.

2. It reduces product loss

2. Difficulty of assuring
3. It improves worker reproducibility.
safety.

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  BLENDING

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 BLENDING EQIPMENTS

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Advanced Granulation Techniques
Steam Granulation
Melt Granulation
Moisture Activated Dry Granulation (MADG)

Moist Granulation Technique (MGT)

Thermal Adhesion Granulation Process (TAGP)
Foam Granulation
Pneumatic Dry Granulation (PDG)

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 Contd…

Freeze granulation Technology

Steam Granulation

Melt Extrusion Technology

Liquisolid Technique

TOPO Technology

Continuous Flow Technology

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 QUESTIONS :

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