Pharmaceutical Dissolution Testing

Introduction

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)

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 3 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas: