British Pharmacopoeia testing and Quality Control

Question 1

What is quality control?

Answer 1

• Small part of quality assurance
• Concerned with sampling, specifications and testing, documentation and release procedures
• Essential operation in the stage of formulation development, manufacturing and post-manufacturing

Question 2

What is the impact of poor-quality medicines?

Answer 2

• Increased mortality and morbidity
• Engendering of drug resistance and loss of medicine efficacy
• Loss of confidence in health systems and health workers
• Economic loss for patients, health systems and the producers
• Adverse effects
• Increased burden for health workers, medicine regulatory authorities, customs officials and police officers

Question 3

What are the common reasons for a drug recall?

Answer 3

1. Hazardous nature of drug
2. Contaminated ingredients
3. Defects in manufacturing
4. Errors in labelling

Question 4

Describe the physical tests for tablets.

Answer 4

• Hardness (non-official)
• Friability (non-official)
• General appearance (non-official)
• Disintegration
• Uniformity of mass

Question 5

Describe the chemical tests for tablets.

Answer 5

• Uniformity of content
• Dissolution
• Assay of active ingredients

Question 6

What are the physical test for capsules?

Answer 6

• General appearance (non-official)
• Disintegration
• Uniformity of mass (weight)

Question 7

What are the chemical tests for capsules?

Answer 7

• Uniformity of content
• Dissolution
• Assay of active ingredients

Question 8

Quality control for tablets - general appearance

Answer 8

• Size
• Shape
• Colour
• Odour
• Surface texture

Question 9

What are the common tablet defects?

Answer 9

• Capping
• Lamination

Question 10

What is meant by capping?

Answer 10

Upper and lower segments of the tablet separates horizontally

Question 11

What are the formulation causes of capping?

Answer 11

• Low moisture content
• Insufficient binder and lubricant

Question 12

What is meant by lamination?

Answer 12

Separation of the tablet in two or more distinct horizontal layers

Question 13

What are the formulation causes of lamination?

Answer 13

Oily or waxy excipients
High content of hydrophobic lubricant

Question 14

What are the common capsule defects?

Answer 14

• Body dent
• Cap dent
• Pinhole
• Cracking

Question 15

What are the possible causes of body dent and cap dent?

Answer 15

• Excessive closing length setting during the encapsulation
• Excessive lock length
• Excessive closing pressure
• Over-filling of capsules
• Incorrect pin size or pin configuration
• Improper storage conditions (moisture)

Question 16

What are the possible causes of pinhole?

Answer 16

• Excessive closing length setting during the encapsulation
• Excessive closing pressure
• Overfilling of capsules
• Improper storage conditions

Question 17

What are the possible causes of cracking?

Answer 17

• Improper storage conditions that favour the transfer of moisture from the capsule shell to encapsulated components
• Misalignment of the upper and lower capsule segments

Question 18

Why should tablets not be too hard or too soft?

Answer 18

• A very hard tablet could decrease dissolution rate

Question 19

What is friability?

Answer 19

The percentage of weight loss of powder from the surface of tablets due to mechanical action

Question 20

Why is the friability test performed?

Answer 20

To measure the weight loss during transportation.

Question 21

What are the causes of weak tablet?

Answer 21

• Poor tablet design
• Low moisture content
• Insufficient binder and over-lubrication

Question 22

Define friability

Answer 22

Inadequate bonding of the tablet mix

Question 23

What is the cause of friability of a tablet?

Answer 23

Too much or too little compression pressure

Question 24

What is the remedy for friability of a tablet?

Answer 24

• Increase binder level
• Add or increase Sancel
• Adjust pressure for acceptable compression pressure friability

Question 25

What is sancel?

Answer 25

Mixture of microcrystalline cellulose and colloidal silicon dioxide

Question 26

What are the factors affecting disintegration of tablets?

Answer 26

• Medium used
• Temperature
• Nature of the drug
• The diluent used in the formulation
• The type and concentration of binder used
• Type and amount of disintegrant used + method of incorporation
• The presence of excessive lubricants and overly mixed lubricants
• Compressional force used

Question 27

Define dissolution.

Answer 27

The amount of drug substance that goes into solution per unit time under standardised conditions of liquid/solid interface, temperature, solvent composition.

Question 28

What type of process is dissolution?

Answer 28

Kinetic

Question 29

How does particle size of drug substance affect dissolution?

Answer 29

Small particle size = greater area = fast dissolution

Question 30

What is sink conditions during dissolution testing?

Answer 30

Its the ability of the dissolution media to dissolve at least 3 times the amount of drug that is in the dosage form.

Question 31

How does having sink conditions help the dissolution?

Answer 31

Means it has more robustness and is more biologically relevant.

Question 32

The composition of the medium chosen is based on what?

Answer 32

The physicochemical characteristics of the drug and excipients

Question 33

For poorly aqueous-soluble drug what is recommended? (dissolution media)

Answer 33

The use of a surfactant

Question 34

What should be avoided in the dissolution media?

Answer 34

Organic solvents.