Pharmaceutical Dissolution Testing – a 2 day course
This course is available to be run inhouse
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.
This course has been approved by the Royal Society of Chemistry for Continuing Professional Development (CPD)
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
Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)
Mark is a Fellow of the Royal Society of Chemistry with over thirty years' experience as a senior analytical chemist. He taught pharmaceutical analysis at the Liverpool John Moores University School of Pharmacy and Chemistry from 1997 to 2003 and was also active in research.
In 2003, he joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible
for analytical development. Since 2010, as Quay"s Scientific Manager, Mark was involved more generally with drug development programmes and also established collaborations with a number of UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences.
In 2013 Mark set up his own consultancy company and has since worked
for clients all over the world on both early-stage and late-stage drug
development projects. He has particular expertise in dissolution method development and chromatography, and is in demand as a trainer in topics ranging from pharmaceutical analysis to data integrity and technical report writing.
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
xxxxx
