USP Workshop Addresses Moisture Permeation Into Packages - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

USP Workshop Addresses Moisture Permeation Into Packages


The United States Pharmacopeial Convention (USP) and the Product Quality Research Institute (PQRI) are cosponsoring a workshop to address a proposed new USP method for measuring moisture vapor transmission rate. The workshop will be held May 20–21 at USP’s headquarters in Rockville, MD. Regulators and manufacturers use the moisture-permeation standards to determine the barrier protection afforded to medicines by their packaging.

 “The ability to accurately assess the degree to which packaging shields a product from moisture is an important USP testing requirement for packaging systems,” said Dr. V. Srini Srinivasan, executive VP and chief science officer of USP, in a press release. “New changes to these standards are being proposed and are expected to have high impact. At this workshop, we will seek input from stakeholders (manufacturers, packagers, repackagers, regulators, and others) on new methods for measuring moisture permeation as well as related issues that may result in far-reaching changes to the standard in the near future.”

Package moisture permeation is a critical quality attribute for solid oral-dosage forms, and moisture uptake is a common cause for product-package failure. Current permeation methods in USP General Chapter <671> Containers—Performance Testing were developed for pharmacists in the 1970’s and are not robust, but the chapter is being revised to include a new permeation method for pharmaceutical manufacturers that is more reproducible and may be better suited for modern applications.

The USP–PQRI workshop will also consider USP’s classification system for pharmaceutical packaging, which at present is based on the categories of “well-closed” and “tight” containers. Certain drug products require protection beyond “tight,” which is one of the reasons an open discussion on the topic is necessary, noted USP.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
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
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges

Click here