Published on December 15, 2009 at 6:41 AM
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."
SOURCE Bend Research Inc.