SDF

Question 1

A good tablet must have?

Answer 1

• Accurate dosing
• Stability of the active drug
• Uniformity
• Consistent performance
• Appropriate disintegration & dissolution
• Withstand packaging, transport & handling without breaking
• Mask taste and odour
• Pharmaceutically elegant

Question 2

Types of tablets?

Answer 2

• Compressed (uncoated) - Advil
• Filmed coated - erythromycin
• Enteric coated - aspirin
• Effervescent - paracetamol
• Sublingual/buccal-buprenorphine/hydrocortisone

Question 3

What are the types of excipients in a tablet?

Answer 3

• Dilutants
• Lubricants
• Glidants
• Disintegrants
• Binders

Question 4

Function and example of Dilutants?

Answer 4

Function:
It is a bulking agent, compression and flow aid

Example:
- lactose BP
- microcrystalline cellulose

Question 5

Function & example of lubricants?

Answer 5

Function:
- Prevent adherence of granules/powders to punch die/faces
- hydrophobic

Example:
Magnesium stearate

Question 6

What happens if there is a lack of lubricant?

Answer 6

Sticking problems

Question 7

What happens if there is too much lubricant?

Answer 7

Affects tablet hardness & dissolution

Question 8

Function & example of Glidants?

Answer 8

Function:
Aids flow

Example:
Colloidal SiO2

Question 9

Function & example of Disintegrants?

Answer 9

Function:
Causes rapid break up of tablet upon exposure of moisture

Example:
Sodium starch glycolate

Question 10

Function & example of Binders?

Answer 10

Function:
Act as an adhesive to bind powders/granules

Example:
PVP (polyvinyl pyrrolidone)

Question 11

How does a tablet disintegrate?

Answer 11

Saliva causes the disintegration agent to swell - creating channels for the saliva

Fast dissolving granules dissolve and the tablet disintegrates

Question 12

Which route is used for heat & moisture sensitive drugs?

Answer 12

Dry granulation or slugging

Question 13

Advantages of Dry Granulation?

Answer 13

• Less equipment & space
• No need for binder solution, heavy mixing equipment
• No need for costly and time-consuming drying step (needed for wet granulation)

Slugging is good for:
- Moisture sensitive material
- Heat sensitive material
- Improved disintegration, as powder particles are not bonded together by binder

Question 14

Disadvantages of Dry Granulation

Answer 14

• Heavy duty tablet press is required to form slug
• Lack of uniform colour distribution
• Press creates more dust than wet granulation, causing contamination

Question 15

What is the role of Binders in wet granulation?

Answer 15

• Good binder distribution
• Chemical affinity between binder and host

For good binding characteristics: similarity of surface free energy (surface tension) between host and binder

Question 16

What are the mechanisms involved in Wet granulation?

Answer 16

Pendular state - granules contain 0-14% liquid in pores

Funicular state - granules contain 14-100% liquid in pores

Capillary state - granules may contain 100% liquid in pores

Droplet state- granules contain >100% liquid in pores

Question 17

Disadvantages of Wet granulation?

Answer 17

• expensive process
• requires a lot of labour, time, equipment, energy and space
• loss of material
• stability concern (for moisture sensitive drugs)
• complex (multiple steps)

Question 18

Methods for testing the End point of wet granulation?

Answer 18

• hand test
• power consumption
• Mixer Torque Rhinometry

Question 19

What is the End Point of the MTQR

Answer 19

Funicular/capillary stage

Question 20

Young’s Modulus?

Answer 20

Reflects how resistant a material is to elongation. The higher the YM, the more force needed to deform the material

Question 21

What is elastic deformation?

Answer 21

Applying force will cause deformation, removing force will return it to its original state

Question 22

What is plastic (ductile) deformation?

Answer 22

When force applied it soo high, the material will deform

Question 23

Tablet formulations required?

Answer 23

Elasticity - low-medium
Plasticity - medium
Brittleness - medium

Question 24

Steps for roller compression method - dry granulation?

Answer 24

1. Feed the material into the hopper of the machine, it if further moved along to the roller system.
2. At the roller system, 2 rollers are used to compress the material in a ribbons
3. The ribbons will be of a specific size/shape. There is a sieve which only allow the granules to pass through.

Any granules let behind will, the machine will recirculate them back to step 1 and 2.