MICRODROPLET BASED SUSTAINED DELIVERY OF NALTREXONE

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 16814
Amount: $46,575.00
Phase: Phase I
Program: SBIR
Awards Year: 1991
Solitcitation Year: N/A
Solitcitation Topic Code: N/A
Solitcitation Number: N/A
Small Business Information
Research Triangle Pharmctcls
4364 S Alston Ave, Durham, NC, 27713
Duns: N/A
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Indu Parikh
 (919) 361-2286
Business Contact
Phone: () -
Research Institution
N/A
Abstract
MICRODROPLET TECHNOLOGY IS A NOVEL MEANS OF IMPROVING TISSUECOMPATIBILITY AND PROVIDING SUSTAINED RELEASE OF A WATER INSOLUBLE DRUG BY DISSOLVING IT INTO MICROSPHERES, (O, LU DIAMETER) OF AN OIL PHASE AND ENCAPSULATING THEM WITHA LAYER OF PHOSPHOLIPID. A RAT MODEL WILL BE USED TO TEST TTHE MICRODROPLET TECHNOLOGY-BASED SUSTAINED DELIVERY OF A NARCOTIC ANTAGONIST, NALTREXONE. NALTREXONE IS THE DRUG OF CHOICE FOR TREATMENT OF HEROIN ADDICTION BECAUSE IT IS ESSENTIALLY A PURE NARCOTIC ANTAGONIST AND DEVOID OF ANALGESIC EFFECTS. A SERIES OF MICRODROPLET FORMATIONS CONTAINING DIFFERENT CONCENTRATIONS OF NALTREXONE WILL BE PREPARED IN AT LEAST THREE TISSUE-COMPATIBLE AND FDA APPROVED SYNTHETIC OILS. THE DRUG RELEASE KINETICS OF THE NALTREXONE-CONTAINING MICRODROPLETS WILL BE TESTED IN A IN VITRO MODEL AS WELL AS BY SUBCUTANEOUS AND INTRAMUSCULAR INJECTIONS INTO RATS. A FORMULATION WHICH PROVIDES ACCEPTABLE (ZERO ORDER) RELEASE KINETICS OVER A PERIOD OF 3-4 WEEKS WILL BE IDENTIFIED FOR FURTHER DEVELOPMENT IN A PHASE II SBIR FOR ITS POTENTIAL INDICATION FOR THE TREATMENT OF HEROIN ADDICTS. MICRODROPLET TECHNOLOGY IS A NOVEL MEANS OF IMPROVING TISSUECOMPATIBILITY AND PROVIDING SUSTAINED RELEASE OF A WATER INSOLUBLE DRUG BY DISSOLVING IT INTO MICROSPHERES, (O, LU DIAMETER) OF AN OIL PHASE AND ENCAPSULATING THEM WITHA LAYER OF PHOSPHOLIPID. A RAT MODEL WILL BE USED TO TEST TTHE MICRODROPLET TECHNOLOGY-BASED SUSTAINED DELIVERY OF A NARCOTIC ANTAGONIST, NALTREXONE. NALTREXONE IS THE DRUG OF CHOICE FOR TREATMENT OF HEROIN ADDICTION BECAUSE IT IS ESSENTIALLY A PURE NARCOTIC ANTAGONIST AND DEVOID OF ANALGESIC EFFECTS. A SERIES OF MICRODROPLET FORMATIONS CONTAINING DIFFERENT CONCENTRATIONS OF NALTREXONE WILL BE PREPARED IN AT LEAST THREE TISSUE-COMPATIBLE AND FDA APPROVED SYNTHETIC OILS. THE DRUG RELEASE KINETICS OF THE NALTREXONE-CONTAINING MICRODROPLETS WILL BE TESTED IN A IN VITRO MODEL AS WELL AS BY SUBCUTANEOUS AND INTRAMUSCULAR INJECTIONS INTO RATS. A FORMULATION WHICH PROVIDES ACCEPTABLE (ZERO ORDER) RELEASE KINETICS OVER A PERIOD OF 3-4 WEEKS WILL BE IDENTIFIED FOR FURTHER DEVELOPMENT IN A PHASE II SBIR FOR ITS POTENTIAL INDICATION FOR THE TREATMENT OF HEROIN ADDICTS.

* information listed above is at the time of submission.

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