Pharmaceutical Dissolution Testing

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, and the use of dissolution testing in the assessment of bioavailability and 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.

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

Dissolution and the assessment of bioavailability/bioequivalence