It’s certainly important for a pharmaceutical company to measure and keep a complete record of API release while the process and lifecycle of drug development. In vitro release testing indeed keeps a great relevance for certain semi-solid formulations. It is, in fact, considered to be the most useful tool for determining releasing rate and also API diffusion in those of topical products.
When it comes to dissolution testing, it is something that keeps great importance on the course of different phases of the process and lifecycle of drug development for all types of solid oral dosages. The test is capable of identifying API changes. IVRT testing is also necessary to be done for those of non-oral dosage forms for determining different characteristics of drug release characteristics.
Apart from this, IVRT also possesses the capability of determining drug releasing rate with the use of Franz diffusion and also synthetic membrane, which should be non-interactive. It is appropriate to be used for developing various methods when it comes to observing various ranges of those of semi-solid dosage forms. Some of these are;
- Hydrogels
- Creams
- Topical Aerosols
- Suspensions
- Ointments
- Lotion
Use and Guidance of IVRT
FDA first issued its IVRT guidance in May 1997 for pharmaceutical industries. These are related to the following.
- Levels of change
- Conduct of CMC tests for supporting different levels of changes
- Create documentation for keeping in view to support changes
- In vitro release test for supporting different level of changes
Apart from this, FDA also issued various other specific guidelines with the main purpose to get rid of different barriers for the development of different generics and also to enhance patient care. These guidelines are issued to help the industry that works with the compliance of in-vitro release.
