The document, part of a Type V Drug Master File (DMF), contains absorption, distribution, metabolism, and excretion (ADME) data that support the use of “high-doses” of hypromellose acetate succinate (HPMCAS) in oral delivery applications.
The HPMCAS file was originally submitted to the Food and Drug Administration (FDA) in 2005 as part of an exclusive, 23-year drug delivery collaboration between Bend and US drug giant Pfizer.
However, since the dissolution of that exclusive relationship in October last year, Bend has been making its formulation technologies available to other customers, with the expanded DMF being the latest stage in the process.
The new data updates on the 2005 submission as well as a DMF filed by Japan’s Shin-Etsu Chemical and, according to Bend, provides additional support for use of the excipient in techniques that improve oral drug bioavailability.
Bend CEO Rod Ray said the new data will accelerate the regulatory process for his firm’s customers and said that its availability “adds significant value to the formulation work we perform for our clients.”
Technologies that improve bioavailability are always in demand in the pharmaceutical industry, with HPMCAS being one of leading excipients the drugmakers use to address the problem.
The compound’s position at the head of the pack is supported by research published by Pfizer scientis William Curatolo and his team in the journal Pharmaceutical Research in June this year.
The paper, entitled “Utility of Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS) for Initiation and Maintenance of Drug Supersaturation in the GI Milieu” compared materials for their ability to inhibit drug precipitation in solutions.
The team used the various excipients to create spray-dried dispersions (SDDs) of drug and polymer and tested them for drug form and homogeneity and, in vitro, for their ability to achieve and maintain drug supersaturation.
Of the 41 compounds tested HPMCAS proved to be the most effective at maintaining supersaturation and creating homogenous bioavalable formulations.
The paper can be obtained here.