Biodegradable polymer formulations for extended efficacy of botulinum toxin
AssigneeSK Joint Ventures II, LLC
InventorsKinam Park, Yeonhee Yun, Sarah Michelle Skidmore, Byung Kook Lee, John Solomon Garner
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AssigneeSK Joint Ventures II, LLC
InventorsKinam Park, Yeonhee Yun, Sarah Michelle Skidmore, Byung Kook Lee, John Solomon Garner
Estimating the term…
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.
A method of treating or preventing one or more symptoms of a diseases, disorder or cosmetic defects in a subject comprising administering to the subject an effective amount of a pharmaceutical composition comprising a plurality of polymer particles having uniformly dispersed therein between about 100 units and about 50,000 units of botulinum toxin complexed with a protein bulking agent and precipitated by a precipitating agent selected from the group consisting of L-histidine methyl ester, L-cysteine ethyl ester, Nα-(tert-butoxycarbonyl)-L-asparagine, L-proline benzyl ester, N-acetyl-L-tryptophan, gentisic acid, pentetic acid, octanoic acid, zinc chloride, and combinations thereof,
Dependencies are inferred from the claim text.