DEVELOPMENT OF A NEW DOSAGE FORM FOR LONG-TERM STUDIES OF ^9-THC

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$252,000.00
Award Year:
1988
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
5362
Agency Tracking Number:
5362
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
1215 1/2 Jackson Avenue, Oxford, MS, 38655
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
M A Elsohly
Principal Investigator
(601) 236-2609
Business Contact:
() -
Research Institution:
n/a
Abstract
STUDIES IN THIS PROPOSAL WILL BE AIMED AT THE PREPARATION OFA SUPPOSITORY FORMULATION OF A PRO-DRUG OF DELTA-9-TETRA- HYDROCANNABINOL (^9-THC) AND STUDY THE BIOAVAILABILITY OF THC FROM THIS FORMULATION AS COMPARED TO I.V. ADMINISTRATIONOF BOTH THC AND ITS PRODRUG. BIOAVAILABILITY STUDIES WILL BE CONDUCTED IN MONKEYS, AND BLOOD SAMPLES WILL BE COLLECTEDAT 0, 15, 30, 60, 90, 120, 180, 240, AND 480 MINUTES AND THEN AT 24 HOURS FROM EACH TEST ANIMAL. ANALYSIS OF THE ^9-THC IN PLASMA WILL BE CARRIED OUT BOTH BY RIA AND GC/MS. INADDITION, PLASMA WILL BE ANALYZED BY GC/MS FOR 11-OH-^9-THC AND 11-NOR-^9-THC-9-COOH; THE LATTER COULD ALSO BE ASSAYED BY RIA. COMPARISON WILL BE MADE BETWEEN DATA OBTAINED FROM ^9-THC I.V. ANIMALS AND ANIMALS ADMINISTERED WITH THE NEW FORMULATION. THE AREA UNDER THE CURVE (CONCENTRATION OF ^9-THC VS TIME) CORRECTED FOR DOSE ADMINISTERED WILL BE TAKEN AS A DIRECT MEASURE OF THE BIOAVAILABILITY OF THC FROM THE NEW FORULATION. IN ADDITION, PRELIMINARY DATA WILL BE COLLECTED RELATIVE TO THE STABILITY OF THE FORMULATION. THE PROPOSED WORK COULD RESULT IN OVERCOMING THE ABSORPTION PROBLEMS ASSOCIATED WITH ORAL ADMINISTRATION OF THC AND POSSIBLE APPLICATION OF THIS CONCEPT TO OTHER HIGHLY LIPOPHYLIC DRUGS.

* information listed above is at the time of submission.

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