In addition to use of dissolution testers, this three-day course will also cover equipment qualification, development and validation of dissolution procedures, and the use of dissolution testing in the assessment of bioavailability and bioequivalence. Delegates will have the opportunity to set up and run dissolution tests using a USP I/II dissolution tester during the course.
Programme
Day 1
Why do we perform dissolution testing?
Dissolution theory, sink conditions and intrinsic dissolution rate
Dissolution and drug release testing apparatus
· Rotating basket (USP Apparatus 1)
Day 2
Requirements for different dosage form types (including data interpretation)
Practical session: delegates will perform a dissolution test on an immediate release drug product
Day 3
Dissolution method development
Who should attend?
This 3 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
Programme
Day 1
Why do we perform dissolution testing?
Dissolution theory, sink conditions and intrinsic dissolution rate
Dissolution and drug release testing apparatus
· Rotating basket (USP Apparatus 1)
- Rotating paddle (USP Apparatus 2)
- Reciprocating cylinder (USP Apparatus 3)
- Flow-through cell (USP Apparatus 4)
- Paddle over disc (USP Apparatus 5)
- Rotating cylinder (USP Apparatus 6)
- Reciprocating holder (USP Apparatus 7)
- Franz cell
Day 2
Requirements for different dosage form types (including data interpretation)
- Immediate release
- Extended release
- Delayed release
- Transdermal delivery systems
Practical session: delegates will perform a dissolution test on an immediate release drug product
Day 3
Dissolution method development
- General requirements
- Selection of dissolution medium
- Apparatus and agitation
- Sampling (time points & filtration)
- Assay requirements
- Setting acceptance criteria with reference to drug product specifications
- Specificity
- Linearity/range
- Accuracy/recovery
- Precision
- Robustness
- Solution stability
Who should attend?
This 3 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
