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INTERMITTENT HORMONE DELIVERY SYSTEM

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 13843
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: 1990
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
195 Common St
Belmont, MA 02178
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Joseph D Gresser
 (617) 484-3184
Business Contact
Phone: () -
Research Institution
N/A
Abstract

TO REDUCE STRESS IN LABORATORY ANIMALS, AND ULTIMATELY ALSO IN CLINICAL SETTINGS, CAMBRIDGE SCIENTIFIC, INC., PROPOSES TO REPLACE HORMONE DELIVERY PUMPS WITH IMPLANTABLE CAPSULES THAT RUPTURE AT PREDETERMINED TIMES, I.E., "PULSED" RELEASE. EXPERIMENTAL RESULTS TO DATE USING BIODEGRADABLE POLYMERS HAVE DEMONSTRATED THIS "BURST" PHENOMENON. FEASIBILITY WILL BE DEMONSTRATED IF, IN PHASE I, A POLYLACTIC/GLYCOLIC ACID POLYMER FORMULATION IS PREPARED WITH MECHANICAL PROPERTIES FAVORING PREDICTABLE BURSTS, AND A METHOD FOR PRODUCING IMPLANTS OF PRECISE SIZE AND POLYMER COATING THICKNESS IS DEMONSTRATED. PHASE I RESEARCH INCLUDES: (1) MEASURING YOUNG'S MODULUS, TENSILE STRENGTH, AND DIALYSIS PERMEABILITY OF POLYMER FORMULATIONS; (2) USINGTHE VALUES OF (1) TO DETERMINE OPTIMUM SIZE AND COATING THICKNESSES; (3) PRODUCING MODEL IMPLANTS; (4) SORTING IMPLANTS INTO PRECISE SIZE CATEGORIES; (5) PREPARING IMPLANTS WITH POLYMER; AND (6) MEASURING BURSTING TIMES OF CAPSULES WITH A SERIES OF COATING THICKNESSES. PHASE II WILL BE AIMED AT TESTING SELECTED HORMONES FOR INTERMITTENT RELEASE USING BOTH IN VITRO AND IN VIVO METHODSAND IN VIVO EVALUATIONS OF STRESS EFFECTS (I.E., HORMONAL ALTERATIONS) WITH THE MICROSPHERE-BASED PUMP ALTERNATIVE. THE OVERALL GOAL WILL BE THE VALIDATION OF IMPLANTABLE BURSTING CAPSULES AS A NOVEL PULSATILE HORMONE DELIVERY SYSTEM FOR RESEARCH AND CLINICAL APPLICATIONS; VALIDITY WILLBE MEASURED BY BOTH DELIVERY EFFICACY AND STRESS MODULATION.

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

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