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Gel-forming Systems for Adhesion Prevention

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2001 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
51 Technology Drive ANDERSON, SC 29625-6826
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Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No
Phase 1
Fiscal Year: 2001
Title: Gel-forming Systems for Adhesion Prevention
Agency: HHS
Contract: N/A
Award Amount: $100,000.00


DESCRIPTION (Verbatim from the Applicant's Abstract): Adhesion formation after abdominal surgery is a significant cause of post-operative morbidity. In gynecological surgery, adhesions can lead to infertility, chronic pain, and obstructive disorder. Numerous adhesion prevention adjuvant have been investigated, most of which are based on a pharmacological agents or protective barriers. However, no systematic studies have been conducted to determine the combined effect of a transient barrier and pharmacological agent using a local, controlled release system. This provided an incentive to conduct comparative studies on controlled release systems based on unique transient barriers containing previously tested pharmacological agents or potentially effective ones. Phase I objective is to determine the feasibility of using gel-forming, hyaluronic acid/calcium acetate aqueous solution and no aqueous absorbable liquid co polyester as transient barrier matrices to control release of pharmacologically active agents for preventing post-surgical adhesion. Phase I plans entail (1) identifying and synthesizing fast absorbing liquid gel-forming co-polyesters; (2) preparing and conducting comparative rheological studies on hyaluronic acid Ca acetate (HA/CaAc) and liquid copolyesters as candidate matrices for controlled drug release, (3) formulating, the selected (HA/CaAc) and liquid copolyesters with selected pharmacological agents; (4) validating, and conducting a pilot study on three rat models for evaluation of three types of post-surgical adhesion, (5) conducting' the main study and using the results to identify two promising formulations for a Phase II study This will entail (1) completing a comprehensive in vivo studies using three animal species; (2) selecting one final system and completing pertinent development and scale-up studies; and (3) initiating the safety study. PROPOSED COMMERCIAL APPLICATION: Successful completion of Phase I study will provide the bases for pursuing a Phase II study and eventual development and marketing of a unique, highly effective system for managing key post-surgical complications associated with several procedures. This will not only benefit patients, but also reduce the cost of healthcare.

Principal Investigator:

Shalaby W. Shalaby

Business Contact:

Small Business Information at Submission:

6309 HWY 187 ANDERSON, SC 29625

EIN/Tax ID: 570981494
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No