Bend, OR – 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.”
About Bend Research Inc.
Bend Research has more than 30 years of experience in helping clients solve their most difficult scientific and technical problems. The firm has a long, established track record of matching the right technologies with the customers’ needs to provide a rapid, straightforward solution. As CEO Rod Ray states, “Our goal at Bend Research is to be the leading drug formulation problem-solving company in the world in terms of the best performance, speed, and cost—which all boils down to client value.”
Bend Research provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical trial quantities of drug candidates in its cGMP facility, and advances promising drug candidates from conception through to commercialization.
The company’s flexible, client-focused business model and collaborative approach to working with its customers result in long-term partnerships focused on value creation.
Bend Research has more than 140 employees based in three state-of-the-art facilities in Bend, Oregon, USA.
