Complete Solutions for Dissolution Testing – Monograph Methods for Tablets and Capsules
07 May 2015
Dissolution testing is an integral part of the drug development lifecycle. The goals of dissolution testing change as the drug moves through the different stages of development, and the effectiveness of different drug dosage forms relies on the drug dissolving in a predictable manner prior to absorption into the systemic circulation. It is also important to optimize the drug's bioavailability over time; deviations from expected dissolution profiles mean that treatment could be either ineffective or dangerous to the patient.
In this webinar, Dr. Patrik Appelblad, Application Team Manager, Instrumental Analytics, Merck KGaA, will use case studies to discuss:
- Dissolution testing of formulated small molecule drugs, following the current USP 37 - NF32 monographs, with compliance to USP38 - NF33 and the given suitability requirements
- The important role of filtration in relation to dissolution testing
- Solutions to improve separation methods and sample preparation for dissolution testing
- The possible changes that can be made to current monograph methods