DEVELOPMENT OF A LIPOSOME BASED INTRAMUSCULAR SUSTAINED RELE

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 2937
Amount: $500,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1986
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Liposome Technology, Inc.
1050 Hamilton Court, Menlo Park, CA, 94025
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Hans Schreier
 Principal Investigator
 (415) 323-9011
Business Contact
Phone: () -
Research Institution
N/A
Abstract
A LIPOSOME BASED SUSTAINED RELEASE DELIVERY SYSTEM FOR I.M. INJECTION OF WATER SOLUBLE DRUGS WAS DEVELOPED USING GENTAMICIN (I) AS A MODEL DRUG. THE PHARMACOKINETIC PROFILE OF (I) IN MICE, BIODEGRADATION OF THE CARRIER AT THE SITE OF INJECTION, AND HISTOLOGICAL EFFECTS WERE INVESTIGATED. THREE TYPES OF LIPOSOMAL CARRIERS WITH DIFFERENT RELEASE CHARACTERISTICS WERE TESTED. PEAK PLASMA CONCENTRATIONS OF COMPARABLE DOSES OF (I), IN LIPOSOMES OR AS SOLUTION, WERE REDUCED 2.575 TIMES WHEN GIVEN ENCAPSULATED. PROLONGED PLASMA LEVELS OVER AT LEAST 4 HOURS WERE ACHIEVED WITH ENCAPSULATED (I), WHEREAS A COMPARABLE DOSE OF (I) IN SOLUTION WAS ELIMINATED FROM PLASMA WITHIN 2 HOURS. THE CARRIER WAS SLOWLY DEGRADED IN MUSCLE OVER SEVERAL DAYS. BOTH DRUG INPUT AND DEGRADATION RATE WERE A FUNCTION OF LIPOSOME COMPOSITION. THE CARRIER WAS FOUND NO MORE IRRITATING TO MUSCLE TISSUE THAN SALINE. NO ADVERSE HISTOLOGICAL REACTION WAS FOUND OVER 14 DAYS. PHARMACOKINETIC MODELING INDICATED THAT DRUG INPUT CAN BE TAILORED OVER A WIDE RANGE. CLINICALLY, DOSAGE FREQUENCY MAY BE REDUCED TO ONE DAILY INJECTION AND LESS FLUCTUATION OF PLASMA LEVELS, REDUCTION OF SIDE EFFECTS, AND IMPROVED PATIENT COMPLIANCE MAY BE EXPECTED. IN PHASE II, EFFICACY AND TOXICITY STUDIES IN ANIMALS AND PRODUCTION OF PILOT BATCHES TO SUPPORT PRECLINICAL AND CLINICAL STUDIES

* information listed above is at the time of submission.

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