Granulation

Question 1

Granulation

Answer 1

Powder to granules, to form oral granules tablets and capsules

Question 2

Four granulating steps

Answer 2

• Fluidised bed granulators
• High speed shear granulators
• Spray driers
• Extrnsion spheronisation

Question 3

Disadvantages of High speed sheer graulators

Answer 3

• Optimisation
• Check up on size
• Sensitive to raw particle materal

Question 4

Advantages of High speed sheer granulated

Answer 4

• One step process (Massing/granulator/drying)
• Short processing time
• Less binder than FBG
• Works on highly cohesive granules

Question 5

Advantages of FBG

Answer 5

• One step process
• Homogenous particles made
• Free flowing particles

Question 6

Disadvantages of FBG

Answer 6

• Expensive

- Optimisation

Question 7

Spray driers

Answer 7

• All components are dried into a liquid and go through a hot chamber

Question 8

Advantages of spray driers

Answer 8

• Rapid process
• One step process
• Heat sensitive process

Question 9

Disadvantages of spray driers

Answer 9

• Size

- Low thermal efficiency

Question 10

Exrension spheronisation advantages

Answer 10

• High coperation of drug

- Used for immediate and controlled release dugs

Question 11

Exrension spheronisation disadvantages

Answer 11

• Labour extensive

Question 12

Exrension spheronisation - how it works

Answer 12

1) wet mass
2) wet pass compressed via dye
3) Material gets extruded on the other side
4) Puts into the drum and rotation size breaks material down and makes it spherical

Question 13

Fluidised bed granulator (FBD) - how it works

Answer 13

Spraying granules with binder on the fluidised bed

Question 14

High speed granulator (HSG) - how it works

Answer 14

Chopper - Breaks down particles

Impeller - Shear and compression

Question 15

Wet excipients

Answer 15

• Binder

- Lubricant

Question 16

Dry excipients

Answer 16

• API
• Disintegrant
• Filler

Question 17

Wet granulation advantages

Answer 17

• Low pressure and energy required
• Less dust and contamination
• Dissolution rate increased for hydrophobic drugs

Question 18

Wet granulation disadvantages

Answer 18

• Loss of material
• Time consuming
• Requires more material than dry granulator
• Stability of heat and moisture API

Question 19

Drying problems

Answer 19

Solute migration

Hydrates

Question 20

Solute migration

Answer 20

Water evaporates stays at the top can affect uniformity and loss off API
-Intergranular migration of colour and binder

Question 21

Hydartes

Answer 21

Water evaporates from solid , causes crystallisation of solid and in affect causes polymorphism

Question 22

Drying techniques

Answer 22

1) Convection ( tray drier/ fludized bed(dynamic)
2) Conduction (vacuum oven / vacuum tumbling
3) Radiation (infa /microwave)

Question 23

Dry granulation advantages

Answer 23

• Ideal for moisture and heat soluble material
• Ideal for heat sensitive material
• Ideal for improved disintegration (no binder)

Question 24

Dry granulation disadvantages

Answer 24

• Specialised heavy duty machine
• Poor colour and distribution and uniformity
• Creates more dust and increases the potential of contamination
• Can cause polymorphism due to high temperature and pressure
• No binder easier to disintegrate

Question 25

Point to consider when drying

Answer 25

- Heat sensitivity - Physical character of the material - Nature of the liquid to be remove d - The scale of the operation - Available heat sources

Question 26

Two methods for dry granulation compression

Answer 26

1) Large tablet slug via a heavy duty tabletting press (slugging) 2) Powder is squeezed between two counter rotating rollers to produce a continuous sheet or ribbon of materials

Question 27

Factors affecting slugging

Answer 27

``` Compressibility or cohesiveness of the material Compression ratio of the powder Destiny of the powder Machine type Punch and die size Slug thickness Speed of compression Pressure used to produce slug ```