ZOOM Online: Pharmaceutical Dissolution Testing – a 2 day Webinar
After completing this course, trainees will be familiar with the different types of pharmaceutical dissolution testing equipment and understand the factors that must be considered when developing a test.
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
- Non-compendial approaches (including small-volume apparatus and peak vessels)
Day 2
Requirements for different dosage form types (including data interpretation)
- Immediate release
- Extended release
- Delayed release
- Transdermal delivery systems
Dissolution equipment qualification
Dissolution method development
- General requirements
- Selection of dissolution medium (including uses of biorelevant media)
- Apparatus and agitation rate
- Sampling (time points & filtration)
- Special requirements for gelatin capsules
- 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 3 day hands-on course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
‘
