spacer
home > > autumn 2009 > accelerating device specific formulation
PUBLICATIONS


Accelerating Device Specific Formulation

In June 2008, the UK Court of Appeal decided that a ‘second medical use’ claim can be patentable, even if the sole distinguishing feature of the claim is the new dosing regime or new dosage form. This brings the UK into line with common practice at the European Patent Office (EPO) and provides a fresh incentive to explore different delivery devices.

Although over 70 per cent of drugs are administered in tablet form, there is increasing interest in the inhaled route. The respiratory tract is an attractive delivery route as it does not subject drugs to the harsh conditions of the gastrointestinal tract; it is also non-invasive and convenient for the patient.

There are a number of delivery devices available including the nebuliser, pressurised metered dose inhaler (pMDI), dry powder inhaler (DPI), nasal spray and other novel delivery systems. For each of these, a different formulation of the drug is required to ensure that best performance is achieved, and this can also vary according to the device manufacturer as there are few ‘standard’ components in this industry.

With the new clarification, we anticipate an increase in companies looking at reformulating patented drugs for inhaled devices. However, whether it is a new chemical entity or an existing drug, a battery of tests are required to improve understanding of what will make the most stable and effective formulation. This early stage analysis falls into two broad categories: pre-formulation studies and accelerated feasibility testing.


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
David Ward has a BSc in Chemistry as well as in IT and Computing. He has over 10 years’ experience in the pharmaceutical and drug delivery industries. Project responsibilities have included managing accelerated feasibility and research studies for customers on a wide variety of projects, including formulation and evaluation of pMDIs, nasal sprays, nebulisers, DPIs or novel delivery devices, analytical method development and experimental design. Before joining Melbourn Scientific, David worked at Bespak Europe Ltd. His current role at Melbourn Scientific involves leading their new formulation service.
spacer
David Ward
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals welcomes Keensight Capital as majority shareholder


More info >>

White Papers
 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement