spacer
home > pmps > autumn 2009 > tried and tested
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Tried and Tested

 

Extractables and leachables are a very important part of OINDP development because of two factors. Firstly, the regulatory concerns associated with it (see Table 1), but also the analytical challenges associated with their testing.

Why are pressurised metered dose inhalers (pMDIs) the most challenging in terms of extractable and leachable testing? A pMDI is a pressurised canister containing liquefied volatile propellant with suspended active drugs, and may contain additional excipients to optimise drug delivery (see Figure 1). The major area for concern is the valve assembly.

In a pMDI, contact with polar propellant (HFa 134a or HFa 227) can result in extraction of chemical species from both polymeric and elastomeric materials. Consequently, extractables and leachables require extensive study. In addition to the valve and the can, other potential sources of extractables and leachables include secondary packaging and labels. For other orally inhaled and nasal drug products (OINDP) dosage forms, such as dry powder inhalers (DPIs) and aqueous nasal sprays that do not have the prolonged exposure to a polar solvent, leachable levels are typically lower. However, the same extractable testing of the critical components is required.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Andrew Feilden is a Senior Scientist within the Analytical Development of AstraZeneca. He has over 10 years of experience in the pharmaceutical industry, mainly in the use of hyphenated techniques and trace level analysis. He is responsible for the extractable and leachable testing, primarily of pMDIs. Andrew gained a degree and DPhil from York University. He is a member of both the IPAC-RS container closure group and the ELSIE group.
spacer
Andrew Feilden
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

MedPharm accelerates strategy to broaden service offering into commercial manufacturing

MedPharm Ltd, a leading contract provider of topical and transdermal product design and development services, has announced two new appointments to its Board to support plans to grow its commercial manufacturing services.
More info >>

White Papers
 
Industry Events

CPhI & P-MEC China

18-20 June 2019, SNIEC, Shanghai, China

CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement