Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Subscribe to Newsletter

Understanding excipient functionality in a formulation

Pharmaceutical Excipient Characterization

Abstract

The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product.

Introduction

The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.

With reference to the excipient, guidance from the FDA and USP encourages identification of the CQAs for excipients and the setting of associated quality controls [1]. Changes in the physical characteristics of an excipient may impact its interaction with other formulation components and thereby have a major impact on the QTPP.

Analytical strategies

The analysis of formulation blends using microscope images is widely employed during the initial stages of product development in order to understand how the physical properties of the excipient correlate with product performance.

Once the CQAs associated with the excipient have been identified, a routine quality control strategy is developed and validated using techniques such as laser diffraction for particle size analysis.

Read the full article now

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE!

Login
Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register