Compositions comprising biodegradable copolymers for prolonged local release of an antibiotic
AssigneeDexcel Pharma Technologies Ltd.
InventorsAbraham J. Domb, Michael Grishko, Ezra Hanuka, Ron Schlinger, Tal Hagigit
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Abstract
A depot system containing at least one antibiotic and a biodegradable poly(ester-anhydride) of ricinoleic acid (RA) and sebacic acid (SA) having alternating or semi-alternating ester and anhydride bonds is provided. The system provides prolonged local release of the antibiotic at the site of injection while maintaining the systemic antibiotic levels at sub-therapeutic concentrations.
Claims21
A parenteral pharmaceutical composition comprising a biodegradable poly(ester-anhydride) copolymer of ricinoleic acid (RA) and sebacic acid (SA) having alternating or semi-alternating ester and anhydride bonds and an antibiotic, the composition being a sustained release depot system which releases a local therapeutically effective amount of the antibiotic over a period of about 1 day to about 20 weeks, wherein 24 hours after a single parenteral administration and throughout said period, the systemic level of the antibiotic or a metabolite thereof is about 10 μg/ml or less.
A parenteral pharmaceutical composition comprising a biodegradable poly(ester-anhydride) copolymer of ricinoleic acid (RA) and sebacic acid (SA) having alternating or semi-alternating ester and anhydride bonds and a therapeutically effective amount of gentamicin or a pharmaceutically acceptable salt thereof, the composition provides an in-vitro release of not more than about 20% of gentamicin in 25 days in 1 ml of 0.1M phosphate buffer at pH 7.4, 100 rpm and 37° C.
Dependencies are inferred from the claim text.