US2017304203A1PendingUtilityA1

Pharmaceutical Formulations of PEGylated Liposomes and Blood Coagulation Factors

37
Assignee: CANTAB BIOPHARMACEUTICALS PATENTS LTDPriority: Oct 6, 2014Filed: Oct 6, 2015Published: Oct 26, 2017
Est. expiryOct 6, 2034(~8.2 yrs left)· nominal 20-yr term from priority
Inventors:William Henry
A61P 7/04A61K 9/1278A61K 38/4846A61K 9/0019A61K 38/36A61K 9/1271A61K 38/4833A61P 17/02A61K 38/4866A61K 38/37A61K 9/127A61K 38/17
37
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Claims

Abstract

The present invention provides a pharmaceutical composition for subcutaneous administration comprising a blood factor and a colloidal particle comprising about 0.5 to 20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer, wherein the blood factor is not encapsulated in said colloidal particle.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition for subcutaneous administration comprising a blood factor and a colloidal particle comprising about 0.5 to 20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer, wherein the blood factor is not encapsulated in said colloidal particle. 
     
     
         2 . The pharmaceutical composition of  claim 1  wherein the colloidal particles are substantially neutral and the polymer carries substantially no net charge. 
     
     
         3 . The pharmaceutical composition of  claim 1  wherein the colloidal particle has a mean particle diameter of between about 0.03 to about 0.4 microns (μm). 
     
     
         4 . The pharmaceutical composition of  claim 3  wherein the colloidal particle has a mean particle diameter of approximately 0.1 microns (μm). 
     
     
         5 . The pharmaceutical composition of  claim 1  wherein said amphipathic lipid is a phospholipid from natural or synthetic sources. 
     
     
         6 . The pharmaceutical composition of  claim 5  wherein said amphipathic lipid is phosphatidylethanolamine (PE). 
     
     
         7 . The pharmaceutical composition of  claim 1  wherein said amphipathic lipid is a carbamate-linked uncharged lipopolymer. 
     
     
         8 . The pharmaceutical composition of  claim 7  wherein said amphipathic lipid is aminopropanediol distearoyl (DS). 
     
     
         9 . The pharmaceutical composition of  claim 1  wherein said colloidal particles further comprise a second amphipathic lipid obtained from either natural or synthetic sources. 
     
     
         10 . (canceled) 
     
     
         11 . The pharmaceutical composition of  claim 9  wherein the colloidal particle comprises palmitoyl-oleoyl phosphatidyl choline (POPC) and 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine (DSPE) in a ratio (POPC:DSPE) of from 85 to 99:15 to 1. 
     
     
         12 . The pharmaceutical composition of  claim 11  wherein the ratio of POPC:DPSE is from 90 to 99:10 to 1. 
     
     
         13 . The pharmaceutical composition of  claim 12  wherein the ratio of POPC:DPSE is 97:3. 
     
     
         14 . The pharmaceutical composition of  claim 9  wherein cholesterol is supplemented to the composition. 
     
     
         15 . The pharmaceutical composition of  claim 1  wherein said biocompatible hydrophilic polymer is selected from the group consisting of polyalkylethers, polylactic acids and polyglycolic acids. 
     
     
         16 . The pharmaceutical composition of  claim 15  wherein said biocompatible hydrophilic polymer is polyethylene glycol. 
     
     
         17 . The pharmaceutical composition of  claim 16  wherein the polyethylene glycol has a molecular weight of between about 500 to about 5000 Daltons. 
     
     
         18 . The pharmaceutical composition of  claim 17  wherein the polyethylene glycol has a molecular weight of approximately 2000 Daltons. 
     
     
         19 . The pharmaceutical composition of  claim 16  wherein the derivatized amphipathic lipid is 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine-N-[poly-(ethyleneglycol)]. 
     
     
         20 . The pharmaceutical composition of  claim 16  wherein the derivatized amphipathic lipid is 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine-N-[poly-(ethyleneglycol)-2000] (DSPE-PEG 2000). 
     
     
         21 . The pharmaceutical composition of  claim 1  wherein the blood factor protein or polypeptide is selected from the group consisting of Factor VIII, Factor VIIa, Factor VII, Factor IX, Factor X, Factor Xa, Factor XI, Factor V, Factor XII, Factor XIII, von Willebrand's Factor (vWF), prothrombin or Protein C and/or a fragment thereof. 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . (canceled)

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