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 Applications

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM063291-01
Application #
6337837
Study Section
Special Emphasis Panel (ZRG1-SSS-8 (10))
Program Officer
Somers, Scott D
Project Start
2001-05-01
Project End
2002-04-30
Budget Start
2001-05-01
Budget End
2002-04-30
Support Year
1
Fiscal Year
2001
Total Cost
$100,000
Indirect Cost
Name
Poly-Med, Inc.
Department
Type
DUNS #
City
Anderson
State
SC
Country
United States
Zip Code
29625