MICRODROPLET BASED SUSTAINED DELIVERY OF NALTREXONE

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$46,575.00
Award Year:
1991
Program:
SBIR
Phase:
Phase I
Contract:
n/a
Agency Tracking Number:
16814
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Research Triangle Pharmctcls
4364 S Alston Ave, Durham, NC, 27713
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Indu Parikh
(919) 361-2286
Business Contact:
() -
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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