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, it is important that analysts understand the importance of correctly setting up and sampling from the chosen apparatus.
In addition to use of dissolution testers, this two-day course will also cover equipment qualification, development and validation of dissolution procedures.
Why do we perform dissolution testing?
Dissolution theory, sink conditions and intrinsic dissolution rate
Dissolution and drug release testing apparatus
Dissolution equipment qualification
Dissolution method development
This 2 day course is designed for professionals new to dissolution testing and those with previous experience seeking to improve their skills and knowledge, working in the following areas
In addition to use of dissolution testers, this two-day course will also cover equipment qualification, development and validation of dissolution procedures.
Programme
Day 1Why 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
- Immediate release
- Extended release
- Delayed release
- Transdermal delivery systems
Dissolution equipment qualification
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
This 2 day course is designed for professionals new to dissolution testing and those with previous experience seeking to improve their skills and knowledge, working in the following areas
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
- Regulatory Affairs
- Pharmaceutical Development
