Bend Research makes available Type V DMF for HPMCAS concerning FDA regulatory filings

Bend Research Inc. announced today that its clients may now reference a key safety file for HPMCAS, an excipient used in technologies developed by the firm to enhance the oral bioavailability of clients' low-solubility drugs.

Bend Research clients may now reference a Type V Drug Master File (DMF) for HPMCAS for regulatory filings with the FDA, Bend Research officials said.

"We're excited about this new development and know it will assist our clients in accelerating the regulatory process for new therapeutic products," Bend Research CEO Rod Ray explained.

HPMCAS-hypromellose acetate succinate-is a polymeric excipient with a demonstrated safety record for use in humans. The polymer is used in Bend Research drug-delivery technologies such as spray-dried dispersions (SDDs), which have successfully enhanced the oral bioavailability for scores of low-solubility drugs.

The Type V DMF for HPMCAS was filed with the FDA in 2005 by Pfizer Inc., the sponsor of Bend Research's work investigating the use of HPMCAS to improve drug solubility. This Type V DMF contains supplemental nonclinical safety data-including absorption, distribution, metabolism, and excretion (ADME) data-to support chronic and high-dosage use of HPMCAS as an excipient for human oral delivery.

The Type V DMF supplements the DMF filed by Shin-Etsu Chemical Co. and provides additional data to support the use of HPMCAS in SDDs for improving oral drug bioavailability.

Bend Research clients may obtain a letter of authorization that allows the FDA to reference the Type V DMF for regulatory reviews such as Investigational New Drug (IND), New Drug Application (NDA), or Abbreviated New Drug Application (ANDA) reviews. (Contact: Dana Settell, 541-382-4100)

"The availability of the Type V DMF for HPMCAS adds significant value to the formulation work we perform for our clients," Ray said. "It provides additional safety data our clients can reference during the FDA approval process for the new therapeutics we develop with them."