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 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.
Who should attend?
This course is aimed at those new to dissolution testing and analysts with previous experience seeking to improve their skills and knowledge.
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
Practical session: setting up a dissolution tester with basket and paddle apparatus
Day 2
Requirements for different dosage form types (including data interpretation)
* Immediate release
* Extended release
* Delayed release
* Transdermal delivery systems
Dissolution equipment qualification
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
Dissolution method validation
* 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
Who should attend?
This course is aimed at those new to dissolution testing and analysts with previous experience seeking to improve their skills and knowledge.
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
Practical session: setting up a dissolution tester with basket and paddle apparatus
Day 2
Requirements for different dosage form types (including data interpretation)
* Immediate release
* Extended release
* Delayed release
* Transdermal delivery systems
Dissolution equipment qualification
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
Dissolution method validation
* 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
