Dissolution and drug release tests are directly relevant to the safety and efficacy of many common pharmaceutical dosage forms. To achieve reliable and reproducible results, analysts must understand the importance of correct equipment set-up, sample introduction and sampling.
In addition to use of dissolution testers, this 3.5 day course will also cover equipment
qualification, data evaluation and development and validation of dissolution procedures.
An optional half day will deal with 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 and the course will include case studies and individual/group exercises.
Programme
Day 1
Why do we perform dissolution testing?
Dissolution theory, sink conditions and intrinsic dissolution rate
Dissolution and drug release testing apparatus
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
Dissolution and the assessment of bioavailability/bioequivalence
This 3.5 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
In addition to use of dissolution testers, this 3.5 day course will also cover equipment
qualification, data evaluation and development and validation of dissolution procedures.
An optional half day will deal with 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 and the course will include case studies and individual/group exercises.
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
- Non-compendial approaches (including small-volume apparatus and peak vessels)
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 (including uses of biorelevant media)
- Apparatus and agitation rate
- Sampling (time points & filtration)
- Special requirements for gelatin capsules
- Assay requirements
- Setting acceptance criteria with reference to drug product specifications
- Specificity
- Linearity/range
- Accuracy/recovery
- Precision
- Robustness
- Solution stability
Dissolution and the assessment of bioavailability/bioequivalence
- Bioavailability and bioequivalence—definitions and in vivo evaluation
- In vitro biowaivers
- In vitro-in vivo correlation
This 3.5 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
