British Pharmacopoeia testing and Quality Control Flashcards
What is quality control?
- 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
What is the impact of poor-quality medicines?
- 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
What are the common reasons for a drug recall?
- Hazardous nature of drug
- Contaminated ingredients
- Defects in manufacturing
- Errors in labelling
Describe the physical tests for tablets.
- Hardness (non-official)
- Friability (non-official)
- General appearance (non-official)
- Disintegration
- Uniformity of mass
Describe the chemical tests for tablets.
- Uniformity of content
- Dissolution
- Assay of active ingredients
What are the physical test for capsules?
- General appearance (non-official)
- Disintegration
- Uniformity of mass (weight)
What are the chemical tests for capsules?
- Uniformity of content
- Dissolution
- Assay of active ingredients
Quality control for tablets - general appearance
- Size
- Shape
- Colour
- Odour
- Surface texture
What are the common tablet defects?
- Capping
- Lamination
What is meant by capping?
Upper and lower segments of the tablet separates horizontally
What are the formulation causes of capping?
- Low moisture content
- Insufficient binder and lubricant
What is meant by lamination?
Separation of the tablet in two or more distinct horizontal layers
What are the formulation causes of lamination?
Oily or waxy excipients
High content of hydrophobic lubricant
What are the common capsule defects?
- Body dent
- Cap dent
- Pinhole
- Cracking
What are the possible causes of body dent and cap dent?
- 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)
What are the possible causes of pinhole?
- Excessive closing length setting during the encapsulation
- Excessive closing pressure
- Overfilling of capsules
- Improper storage conditions
What are the possible causes of cracking?
- Improper storage conditions that favour the transfer of moisture from the capsule shell to encapsulated components
- Misalignment of the upper and lower capsule segments
Why should tablets not be too hard or too soft?
- A very hard tablet could decrease dissolution rate
What is friability?
The percentage of weight loss of powder from the surface of tablets due to mechanical action
Why is the friability test performed?
To measure the weight loss during transportation.
What are the causes of weak tablet?
- Poor tablet design
- Low moisture content
- Insufficient binder and over-lubrication
Define friability
Inadequate bonding of the tablet mix
What is the cause of friability of a tablet?
Too much or too little compression pressure
What is the remedy for friability of a tablet?
- Increase binder level
- Add or increase Sancel
- Adjust pressure for acceptable compression pressure friability
What is sancel?
Mixture of microcrystalline cellulose and colloidal silicon dioxide
What are the factors affecting disintegration of tablets?
- 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
Define dissolution.
The amount of drug substance that goes into solution per unit time under standardised conditions of liquid/solid interface, temperature, solvent composition.
What type of process is dissolution?
Kinetic
How does particle size of drug substance affect dissolution?
Small particle size = greater area = fast dissolution
What is sink conditions during dissolution testing?
Its the ability of the dissolution media to dissolve at least 3 times the amount of drug that is in the dosage form.
How does having sink conditions help the dissolution?
Means it has more robustness and is more biologically relevant.
The composition of the medium chosen is based on what?
The physicochemical characteristics of the drug and excipients
For poorly aqueous-soluble drug what is recommended? (dissolution media)
The use of a surfactant
What should be avoided in the dissolution media?
Organic solvents.
