COURSE OVERVIEW
Who is this course for?
This course is for analysts at many levels – for those new to dissolution testing who require a good foundation in the subject, more experienced analysts who need greater understanding to improve troubleshooting or labs needing to develop or optimise dissolution methods
Previous Knowledge
Basic knowledge of chemistry is advantageous. Previous experience using dissolution equipment will be beneficial.
What you will learn
- Introduction - the human gastrointestinal tract and solid dose formulations
- Type 1 and Type 2 Dissolution apparatus
- Dissolution media
- Sampling
- System calibration and performance verification
- Calculation of results
- Method development
COURSE OUTLINE
Basics of Dissolution Testing
- Overview of the human GI tract
- Conventional oral solid dose formulations
- Apparatus 1 and 2 methods
- Typical system setup
Dissolution Media
- Role of the media
- Common additives
- Deaeration
Sampling Methods
- Correlation co-efficient
- Residuals
- Confidence Intervals
- Outliers
- Residual sum of squares
- Use of the origin
Sample Purity
- Manual and automated sampling
- Filtration
Calculation of Results
- Q and instant release
- Mass and volume correction
- Common causes of result failures
Equipment Verification
- Enhanced mechanical calibration
- Single and two-stage performance verification testing
Method Development
- The development process
- Key method parameters
- Setting limits