Use of polymeric excipients for lyophilization or freezing of particles
AssigneeAbraxis BioScience, LLC
InventorsWillard FOSS, Rajesh SHINDE
Life of this patent
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Abstract
Provided herein are use of polymeric excipients, specifically polyvinyl alcohols, optionally in conjunction with sugars, as cryoprotectants to prevent aggregation of PEG-containing particles. Also provided are PEG-containing particles comprising such polymeric excipients.
Claims50
A method of preparing a lyophilized or frozen preparation of a composition comprising particles comprising a drug, wherein the particles are coated with PEG, the method comprising adding PVA to an aqueous composition comprising the particles and lyophilizing or freezing the aqueous composition;
- wherein the particles are liposomes or micelles.
A method of preventing particle aggregation and/or particle size increase upon lyophilization and resuspension or freezing and thawing of an aqueous composition comprising particles comprising a drug, wherein the particles are coated with PEG, the method comprising adding PVA to the aqueous particle composition prior to lyophilization or freezing;
- wherein the particles are liposomes or micelles.
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A pharmaceutical composition comprising particles comprising a drug, wherein the particles are coated with PEG, wherein the composition further comprises PVA, and wherein less than about 2% of the total PVA in the pharmaceutical composition is associated with the particles;
- wherein the particles are liposomes or micelles.
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46-47. (canceled)
Dependencies are inferred from the claim text.