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CONTROLLED RELEASE BIOPOLYMER SYSTEMS FOR TUBERCULOSIS

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 18975
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 1992
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
195 Common Street
Belmont, MA 02178
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Debra J Trantolo
 (617) 424-6626
Business Contact
Phone: () -
Research Institution
N/A
Abstract

IN SPITE OF THE AVAILABILITY OF SEVERAL POWERFUL DRUGS WHICH COULD ACHIEVE A COMPLETE CURE, OPPORTUNISTIC INFECTIONS SUCH A TUBERCULOSIS ARE A SERIOUS GLOBAL PROBLEM. THE MAIN HURDLE IN ACHIEVING SUCCESS OF CHEMOTHERAPY IN NON-COMPLIANCE IN TAKING THE DRUGS. IN ORDER TO SOLVE THIS PROBLEM, WE HAVE INVESTIGATED IF WE COULD DELIVER THE ANTIMYCOBACTERIAL CHEMOTHERAPY IN ONE OR FEW DOSES. IN EARLY WORK, WE FOUND THAT A SINGLE DAILY ORAL DOSE OF ISONIAZID, GIVEN IN AN IMPLANT OF A POLYLACTIC-CO-GLYCOLIC ACID (PLGA) CO POLYMER, WAS ABLE TO RELEASE SUSTAINED AND THERAPEUTICALLY ACTIVE LEVELS FOR 6-8 WEEKS. IN THE CURRENT STUDIES, WE ARE ADAPTING THE TRADITIONAL SOLVENT-BASED PLGA FORMULATION TECHNOLGY, WHICH WAS USED IN THE AFOREMENTIONED FEASIBILITY STUDIES, TO OUR PROPRIETARY, NON-SOLVENT CHEMOTHERAPY REGIMES FOR TUBERCULOSIS. A NON-SOLVENT FORMULATION WILL GREATLY FACILITATE SAMPLE PREPARATION UNDER GOOD MANUFACTURING PRACTICES (GMP'S) AND ALSO FIND MORE READY ACCEPTANCE BY THE FDA WHEN PLANNING CLINICAL TRIALS. VARIOUS TECHNOLOGICAL ASPECTS OF FORMULATION AND CHARACTERIZING SUCH POLYMER PREPARATIONS FOR ISONIAZID DELIVERY IN THE CURRENT STUDY.

* Information listed above is at the time of submission. *

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