It’s a challenge, certainly.

The customer has an important new generic drug for the market.  Ideally, a direct compression production process is preferred, since it is simple and highly efficient, and would speed the new product to market.  But for controlled-release products such as this drug, there also are risks:  poor flow properties, and a resulting lack of product content uniformity.

Ashland’s R&D laboratories in Brazil, supported by the Center of Excellence in the United States, were up for the assignment.  Working closely in partnership with the customer, the Ashland team quickly got the project rolling.  The product formulation and specifications for release and dissolution were in place quickly, saving the customer weeks, even months, in R&D.  But the problem of poor flow properties still had to be addressed.

The solution:  Benecel K 100DC, a new polymer developed by Ashland.

Divya Tewari, then global director of Pharmaceutical R&D for Ashland, summarized the answer that held the key to an effective, easily produced and profitable new generic controlled-release drug.

“When we developed Benecel K 100DC, we wanted to build a controlled-release polymer to provide not only the release profile but also the flowability necessary for direct compression at the tablet press, particularly for actives with poor flow properties,” he explained.

Better powder flow and improved content uniformity.  Reduced processing time and lower production costs.   Faster time to market.  And a better bottom line.

Another solution to a complex drug delivery challenge, from Ashland.