Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

image description

PDI Blog

Formulation development combined with a unique manufacturing process resulted in a newly issued patent that provides barriers to competition for repurposed drugs

Friday, January 20, 2012

One of PharmaDirections' formulation development experts was named as a co-inventor on a recent patent entitled "Layered Pharmaceutical Formulations".  See the recent press release.

The product that is the subject of the patent employees two generic drugs, buproprion and naltrexone, in the same tablet.  The problems that needed to be solved were: 1) the potential that the drugs might interact in the dosage form over time, and 2) the different drugs needed to be delivered as controlled release, but with different dissolution profiles.   

To solve both problems at the same time prevent any interactions, each drug was in a different layer and these were separated by another inert layer.  The middle inert layer was designed to dissolve quickly.  This leaves the other drug layers to float away and release their drugs at their own individual rates. 

The key point is that a patent was issued that can become an additional barrier to competition. The final product that will be introduced to the market can have a very unique look that would be difficult to duplicate by generic manufacturers who would want to introduce their own products after the FDA’s mandatory data exclusivity period.

This is one of 19 issued or submitted patents where PharmaDirections helped develop intellectual property for their clients.  All patents developed by PharmaDirections are royalty free.

Comments
Post has no comments.
Post a Comment




Captcha Image

Trackback Link
http://www.pharmadirections.com/BlogRetrieve.aspx?BlogID=11578&PostID=390203&A=Trackback
Trackbacks
Post has no trackbacks.