Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. This course is designed to provide an overview of dissolution testing, showing how the elements included in a USP monograph can be applied to the development of a dissolution test for a wide variety of products, including those containing soluble and poorly soluble drugs, immediate, modified and extended release products and generic products. In addition, we will cover troubleshooting techniques designed to quickly and easily identify the root cause for unexpected or failing dissolution results. Finally, we’ll discuss the options available for qualification and calibration of the dissolution apparatus
- Understand regulatory and compendial drivers for dissolution methods
- Establishing expectations for a dissolution method
- Sources of information for existing dissolution methods
- Develop a dissolution method for a pharmaceutical dosage form, using the analytical target profile and drug substance solubility data, including selection of apparatus, medium, sampling times and analysis technique.
- Learn to address various situations, such as highly soluble drugs, poorly soluble drugs, delayed release products, extended release products, generic products and topical products.
- Approaches to validation of dissolution methods
- Identify the options for dissolution apparatus qualification and calibration.
- Troubleshoot unexpected or failing dissolution results
- Rationale and expectations (regulatory, compendial) for dissolution methods
- Review of USP monograph dissolution methods and FDA dissolution database
- General approach to dissolution development: medium, apparatus, speed, timepoints, analytical finish
- Discussion on some important details: Sinkers, deaeration, filtering, solution stability
- Addressing Soluble Drugs (BCS Class 1 and 3)
- Addressing Poorly Soluble Drugs (BCS Class 2 and 4)
- Dissolution Methods for Generic Products
- Dissolution Methods for Modified or Extended Release Products
- Troubleshooting Unexpected or Failing Dissolution Results
- Options for Dissolution Apparatus Qualification and Calibration
- Attendee challenges and questions
Who will Benefit:
- Supervisors and Managers in Pharmaceutical (Human or Veterinary)
- Generic, OTC or Contract Laboratories
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment