Pharmaceutical Dissolution Testing

Introduction

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.

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

Requirements for different dosage form types (including data interpretation)

Immediate release
Extended release
Delayed release
Transdermal delivery systems

Day 2
Dissolution equipment qualification
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

Who should attend?
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