Pharmaceutical Dissolution Testing

Pharmaceutical dissolution testing helps to ensure the safety and efficacy of a variety of different formulated drug products. This three-day course covers the theory behind drug solubility and dissolution rate, regulatory expectations, experimental technique, interpretation of test results, investigating anomalous data, setting suitable dissolution specifications and the development and validation of dissolution tests. It also includes details of the USP and US FDA approaches for equipment qualification as well as the use of in vitro dissolution testing to establish bioequivalence. The establishment and uses of in vitro-in vivo correlations (IVIVC) will also be discussed.

The focus of the course will be on solid oral dosage forms, but apparatus and techniques for other types of drug product will also be presented, including transdermal drugs and dosage forms designed for release over a period of weeks or months. The course consists of lectures and exercises/workshops designed to reinforce the taught component.

By the end of the course, you will understand the science underpinning dissolution/drug release testing, and have the knowledge required to:
Avoid practical errors in the dissolution/release testing of drug products
Select appropriate test conditions (dissolution medium, apparatus, agitation rate, time points)
Validate dissolution methods in accordance with regulatory expectations
Reduce dissolution result variability
Troubleshoot anomalous results
Set scientifically-sound acceptance criteria
Implement a compliant dissolution equipment qualification strategy
Use in vitro data to establish bioequivalence
Understand the potential for establishing an in vitro-in vivo correlation (IVIVC) and the regulatory application of different IVIVC classes
Learning Objectives:
Reasons for dissolution testing
Factors affecting drug solubility and dissolution rate
Apparatus for the dissolution/release testing of different dosage forms
Instrument qualification approaches
Dissolution tests for immediate-release and modified-release drug products
Release testing of transdermal products
Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
Calculation and interpretation of test results
Dissolution method development
Options for the analytical finish
Dissolution method validation
Troubleshooting anomalous data
The role of dissolution testing in establishing bioequivalence (biowaivers)
In vitro-in vivo correlation
Who will Benefit:
Laboratory staff responsible for developing dissolution methods
Personnel responsible for equipment qualification
Quality control analysts
Regulatory affairs professionals
Quality management