BIODEGRADABLE INJECTABLE DELIVERY SYSTEM FOR NALTREXONE

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 16813
Amount: $49,900.00
Phase: Phase I
Program: SBIR
Awards Year: 1991
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
1625 Sharp Point Dr, Box 20150, Fort Collins, CO, 80522
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Arthur Tipton
 (303) 482-5868
Business Contact
Phone: () -
Research Institution
N/A
Abstract
NALTREXONE IS AN EFFECTIVE NARCOTIC ANTAGONIST. HOWEVER, ITS EFFECTIVENESS IS LIMITED BY THE NEED FOR HIGH PATIENT COMPLIANCE, AS ORAL DOSAGES MUST BE TAKEN AT LEAST THREE TIMES WEEKLY. BY USING A PROPRIETARY DELIVERY SYSTEM, IT ISEXPECTED THAT NALTREXONE CAN BE DELIVERED AT A CONTROLLED RATE FOR ONE MONTH. THE DELIVERY SYSTEM TO STUDIED IS BIODEGRADABLE AND BIOCOMPATIBLE, AND HAS BEEN SHOWN TO CAUSENO ADVERSE TISSUE REACTIONS IN ANIMAL TESTING. IT HAS BEEN STUDIED IN VITRO FOR THE CONTROLLED RELEASE OF SEVERAL DRUGS AND IS CURRENTLY BEING STUDIED IN HUMANS UNDER A PHASEII IND. MOST IMPORTANTLY, IT CAN BE INJECTED USING STANDARDSYRINGES AND NEEDLES. NALTREXONE WILL BE INCORPORATED INTO THIS DELIVERY SYSTEM. THE EFFECT OF SEVERAL VARIABLES INCLUDING DRUG FORM AND POLYMER COMPOSITION, MOLECULAR WEIGHT AND CONCENTRATION, WILL BE STUDIED IN ORDER TO OBTAIN THE DESIRED RELEASE PROFILE OF 5 MG/DAY. THE MOST PROMISING FORMULATION WILL BETESTED IN RABBITS FOR TISSUE COMPATIBILITY. NALTREXONE IS AN EFFECTIVE NARCOTIC ANTAGONIST. HOWEVER, ITS EFFECTIVENESS IS LIMITED BY THE NEED FOR HIGH PATIENT COMPLIANCE, AS ORAL DOSAGES MUST BE TAKEN AT LEAST THREE TIMES WEEKLY. BY USING A PROPRIETARY DELIVERY SYSTEM, IT ISEXPECTED THAT NALTREXONE CAN BE DELIVERED AT A CONTROLLED RATE FOR ONE MONTH. THE DELIVERY SYSTEM TO STUDIED IS BIODEGRADABLE AND BIOCOMPATIBLE, AND HAS BEEN SHOWN TO CAUSENO ADVERSE TISSUE REACTIONS IN ANIMAL TESTING. IT HAS BEEN STUDIED IN VITRO FOR THE CONTROLLED RELEASE OF SEVERAL DRUGS AND IS CURRENTLY BEING STUDIED IN HUMANS UNDER A PHASEII IND. MOST IMPORTANTLY, IT CAN BE INJECTED USING STANDARDSYRINGES AND NEEDLES. NALTREXONE WILL BE INCORPORATED INTO THIS DELIVERY SYSTEM. THE EFFECT OF SEVERAL VARIABLES INCLUDING DRUG FORM AND POLYMER COMPOSITION, MOLECULAR WEIGHT AND CONCENTRATION, WILL BE STUDIED IN ORDER TO OBTAIN THE DESIRED RELEASE PROFILE OF 5 MG/DAY. THE MOST PROMISING FORMULATION WILL BETESTED IN RABBITS FOR TISSUE COMPATIBILITY.

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

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