Navigation Links
Bend Research Clients May Now Reference Key Safety Document for Important Solubility Excipient
Date:12/15/2009

BEND, Oregon, December 15 /PRNewswire/ -- 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.

    Contact:

    Dana Settell
    Bend Research Inc.
    64550 Research Road
    Bend, OR 97701
    Phone: +1-541-382-4100
    Fax: +1-541-382-2713
    E-mail: settell@bendres.com


SOURCE Bend Research Inc.


'/>"/>
SOURCE Bend Research Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. New Market Research Report from BioTrends Provides Insight on How Rheumatologists are Utilizing Biologic Agents in the Treatment of Rheumatoid Arthritis
2. US Oncology Research Network Participates in Seven Oral Clinical Studies Presentations and 15 Posters at 2009 San Antonio Breast Cancer Symposium
3. AVAC Says MDP 301 Microbicide Trial Results Disappointing, but Researchers and 9,400 Trial Volunteers Deserve Praise for Successful Trial
4. Arrayit Diagnostics Announces Sponsored Research Agreement With Wayne State University and Arrayit Corporation
5. ULURU Inc. Invited to Present Altrazeal(TM) Research at 10th Annual Wound Healing Science and Industry Conference
6. Shanghai ChemPartner Is Pleased to be Part of Agios Groundbreaking Cancer Research
7. Seven New Biopharmaceutical Research Companies Join PhRMAs Mission to Advance Medical Innovation
8. The Epilepsy Research Foundation and Milken Family Foundation Announce Prestigious Translational Research Grants for Two Pioneering Epilepsy Therapies
9. New Research Shows a Vitamin/Nutriceutical Formulation Improves Memory and Cognitive Performance in Community-Dwelling Adults
10. Leading Primary Research Firm Guidepoint Global Announces Launch of Sleep Apnea Tracker
11. Alzheimers Research May Lead to Preventing the Debilitating Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
Breaking Medicine News(10 mins):