Sk Joint Ventures Ii, LLC

Akina, Inc.

The United States Government As Represented by the Department of Veterans Affairs

John Solomon Garner

Kinam Park

Haesun Park

Yeonhee Yun

Byung Kook Lee

Sarah Michelle Skidmore

Yourong Fu

Clark Tobias Barco

Methods for the formulation of biodegradable microparticles for delivery of protein drugs, such astoxin, have been developed. The methods include the steps of precipitating and washing proteins with organic solvent to remove water prior to dispersing in polymer-dissolved organic solvent to prevent exposure to water/solvent interfaces and maintain bioactivity of the protein drugs and fabrication of microparticles by either template or emulsion method. Biodegradable microparticles, formed of one or more biodegradable polymers having entrapped in the polymer one or more protein agents, such astoxin, are also provided. Precipitatedtoxin andtoxin-loaded microparticles can also be formulated into thermogels or crosslinked hydrogels. The stability of the protein within these microparticles, as well as the controlled release of the entrapped agents, provides for sustained efficacy of the agents.

Biodegradable polymer formulations for extended efficacy of botulinum toxin

A solid crosslinked polyester composition is disclosed wherein the crosslinked polyester is environmentally degradable in less than about 180 days. The crosslinked polyester is the polyesterification reaction product between one or more multi-hydroxylic alcohols, one or more hydroxy acids, and one or more multi-carboxylic acid compounds. Alternately, the crosslinked polyester is the polyesterification reaction product between one or more multi-hydroxylic alcohols, one or more hydroxy acids, one or more multi-carboxylic acid compounds, and a cyclic ester.

Synthesis of environmentally degradable alkyl polyesters

Methods for the formulation of biodegradable microparticles for delivery of protein drugs, such as botulinum toxin, have been developed. The methods include the steps of precipitating and washing proteins with organic solvent to remove water prior to dispersing in polymer-dissolved organic solvent to prevent exposure to water/solvent interfaces and maintain bioactivity of the protein drugs and fabrication of microparticles by either template or emulsion method. Biodegradable microparticles, formed of one or more biodegradable polymers having entrapped in the polymer one or more protein agents, such as botulinum toxin, are also provided. Precipitated botulinum toxin and botulinum toxin-loaded microparticles can also be formulated into thermogels or crosslinked hydrogels. The stability of the protein within these microparticles, as well as the controlled release of the entrapped agents, provides for sustained efficacy of the agents.

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New York, NY, United States of America

John Solomon Garner