Active substance dissolution profile analysis is a critical stage in medicinal product development, used as a basic quality control tool. It is used: (1) to determine differences in the variability within a series and between different series; (2) to distinguish between the “bad” and “good” series of a medicinal product; as a basic method which facilitates (3) prediction of the behaviour of an in-vivo product and (4) assessment of “significant similarities” between a test and reference product in order to submit a registration application, as well as (5) assessment of “significant similarities” between products before and after introducing changes during their life cycle. Active substance dissolution profiles depend on a number of physiochemical characteristics of the medicinal product, thus various empirical / mathematical models are offered to describe dissolution of an active substance in in-vitro conditions and various acceptance criteria have been defined to assess similarities between profiles. The methods used to show similarities between dissolution profiles include graphical methods, analytical methods – model dependant and non-dependant, as well as methods based on variation analysis.
The aim of the training is to familiarise participants with guidelines and recommendations concerning the principles of developing dissolution methods, the scope of application of dissolution methods, acceptance criteria and statistical methods used to compare dissolution profiles for the purpose of registration, quality control and evaluation of changes introduced during the product life cycle. After the course the participants will be able to individually select the right profile comparison method, adjusted to the given case, to perform a comparative analysis of dissolution profiles and to prepare a report on the dissolution profile similarity assessment. Individual statistical issues will be discussed from a theoretical perspective and later developed through exercises.
Requirements: ability to work with a computer in the Windows environment
- What are the active substance dissolution mechanisms for different product forms
- How to select dissolution parameters (instrument, medium, timeline)
- What are the basic methods used to compare dissolution profiles
- What are the rules of using individual methods of dissolution profile comparison
- What changes require a dissolution profile comparison
- Example dissolution profile comparison report
- Graphical profile comparison methods
- Profile comparison model dependent methods
- Profile comparison model independent methods
- Dissolution profile comparison methods based on variation analysis