Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulations - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulations

Pharmaceutical Technology Europe
Volume 22, Issue 5

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology Europe,
Click here