TSRL awarded a Phase I Small Business Innovation Research (SBIR) grant

Therapeutic Systems Research Laboratories, Inc. (TSRL) a biopharmaceutical research firm, has been awarded a Phase I Small Business Innovation Research  (SBIR) grant from the National Institutes of Health for the development of  oral alendronate formulation with increased bioavailability for the treatment of osteoporosis. Bisphosphonates are effective treatments for various diseases of excessive bone resorption, including Paget's disease of bone, myeloma, bone metastases, and osteoporosis. However, the bisphosphonates are associated with two major problems, poor oral bioavailability (<1% in humans) and a high rate of gastrointestinal mucosal damage that limit effectiveness and long-term tolerability. At TSRL, we have developed carrier molecules, termed Bile Acid Conjugates (BAC) which enhance the oral bioavailability of poorly absorbed, charged molecules. The goal of the current project is to use the BAC technology to improve the oral bioavailability of alendronate (Fosamax), which will allow for prevention of bone loss at a greatly reduced dose and may also play an important role in reducing the incidence of gastrointestinal damage. TSRL will collaborate with researchers at the University of Michigan on this project. The grant, providing over $250,000 in research funding, is part of the federal government’s National Institute of Arthritis and Musculoskeletal and Skin diseases (NIAMS).

Therapeutic Systems Research Laboratories (TSRL), Inc. is a privately held oral drug delivery specialty firm focused on R&D efforts to enhance the oral absorption of investigational and marketed compounds currently not suitable for this most convenient route of drug administration. TSRL has developed an oral drug delivery technology portfolio which addresses the three most common barriers to adequate systemic exposure of drug candidates when given orally: low aqueous solubility, poor intestinal permeability and high presystemic metabolism. More detailed information about TSRL is available at the company website www.tsrlinc.com or from Dr. Elke Lipka, Vice President for Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

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