Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulations

May 01, 2010


(PHOTOALTO/ALIX MINDE/GETTY IMAGES)
Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.1–3 Dissolution testing provides comprehensive information about the dynamics of dissolution processes and is one of the first steps to facilitating the development of a new dosage form. It is also useful for assessing manufacturing reproducibility and can even be used to check the dissolution profile of generic formulations. The results of the test depend on both the chemical contents and the physical properties of the dosage, including particle size and binder composition.4,5

The recommended dissolution method in relevant pharmacopoeias results in an overall dissolution profile, where the absorbance is the sum of all soluble compounds present in a formulation. However, efforts are being made to obtain 'individual' profiles — i.e., profiles of all component parts of a formulation — with some strategies having already been developed.6–11 Individual profiles enhance the information that we have for a formulation and, as such, it is just as important to obtain an individual profile as it is to obtain a global profile, in vitro bioavailability or manufacturing controls.

Because of regulatory requirements, the pharmaceutical industry must perform a large number of dissolution profiles every day, which often requires many replicas of the same formulation. This article describes how automating the simultaneous recording of several replicas of the same formulation can facilitate dissolution testing. Additionally, we will examine the simultaneous recording replicas of global and individual dissolution profiles for active principles present in a pharmaceutical formulation.