Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

TOPICAL PRODUCT DEVELOPMENT SHOULD INCLUDE IN VITRO RELEASE TESTING

This article was originally published in The Tan Sheet

Executive Summary

TOPICAL PRODUCT DEVELOPMENT SHOULD INCLUDE IN VITRO RELEASE TESTING where meaningful test standards can be developed and applied, according to a consensus reached at a May 24-26 workshop on the scale-up of liquid and semi-solid disperse systems co- sponsored by the American Association of Pharmaceutical Scientists (AAPS), FDA and the U.S. Pharmacopeia. Schering-Plough Pharmaceutical Sciences VP Allan Kaplan voiced the general meeting consensus that both manufacturers and FDA would benefit from establishing in vitro release test standards for the products. "Ideally," Kaplan said, "this in vitro test should relate to an in vivo parameter." The development and use of meaningful in vitro release test methods for evaluating and regulating liquids and semi-solid products was a focal point of the three-day conference. Kaplan, who chaired a working group on quality assurance/quality control testing, emphasized the "benefit during the development either of a new product or a generic drug, of somehow including this as part of your formulation program." In reaching a consensus from the workshop discussion on release rate testing of topical/liquid products, Kaplan cautioned that his working committee was "very careful" to recognize that "we are in the infant stage. We are probably where dissolution was in the 1960s." Incorporating workable in vitro or in situ release testing methods into the development program on the products, he maintained, "will provide information to the agency, but also information for [the industry(BRACKET). We will get more degrees of freedom" and gain "a chance to make [scale-up] changes that we feel are logical" without having to do, "perhaps, a clinical study." FDA Office of Generic Drugs Director Roger Williams described the search for valid surrogates for clinical tests for the topicals/liquids as "the heart" of the conference. "I don't think anybody here would be enthusiastic about doing clinical trials to document scale-up or a site change or a formulation change or a minor change in process or equipment," Williams said. The generic office head added that "even in the instance when we do look at clinical trials to document bioavailability and bioequivalence, I have a lot of problems with them. I don't think they are validated. I think they lack sensitivity. They are very expensive. They are very cumbersome. They are difficult for the generic industry."

You may also be interested in...



People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

UsernamePublicRestriction

Register

PS081559

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel