US2010196455A1PendingUtilityA1

Compositions of Multicationic Drugs for Reducing Interactions with Polyanionic Biomolecules and Methods of Use Thereof

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Assignee: TRANSAVE INCPriority: May 4, 2007Filed: May 2, 2008Published: Aug 5, 2010
Est. expiryMay 4, 2027(~0.8 yrs left)· nominal 20-yr term from priority
Inventors:Vladimir Malinin
A61P 11/00A61K 31/7036A61K 9/5021A61K 9/127A61K 45/06
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Claims

Abstract

The present invention relates, in part, to a composition comprising a multicationic drug and an organic multianion. In some embodiments, the multicationic drug is enclosed within a carrier. In some embodiments, the carrier is a liposome. In some embodiments, the multicationic drug and organic multianion are enclosed within a carrier, while in other embodiments, the multicationic drug is enclosed within the carrier and the organic multianion is outside the carrier. The present invention also relates, in part, to a method of treating a subject for pulmonary distress comprising administering to a subject in need thereof the aforementioned composition.

Claims

exact text as granted — not AI-modified
1 . A composition comprising a multicationic drug and an organic multianion. 
     
     
         2 . The composition of  claim 1 , wherein the multicationic drug is enclosed within a carrier. 
     
     
         3 . The composition of  claim 1 , wherein the multicationic drug and organic multianion are enclosed within a carrier. 
     
     
         4 . The composition of  claim 1 , wherein the multicationic drug is enclosed within a carrier and the organic multianion is outside the carrier. 
     
     
         5 . The composition of  claim 2 , wherein the carrier is a liposome. 
     
     
         6 . The composition of  claim 1 , wherein the multicationic drug is an aminoglycoside. 
     
     
         7 . The composition of  claim 1 , wherein the multicationic drug is selected from the group consisting of amikacin, gentamicin, kanamycin, neomycin, vancomycin, netilmicin, paromomycin, streptomycin, tobramycin, and aparmycin. 
     
     
         8 . The composition of  claim 1 , wherein the organic multianion is selected from the group consisting of citrate, maleate, tartarate, glutarate, succinate, malonate, adipate, pimelate, suberate, azelate, sebacate, and terephthalate. 
     
     
         9 . The composition of  claim 1 , wherein the organic multianion is selected from the group consisting of citrate, maleate, tartarate, glutarate, succinate, malonate, adipate, pimelate, suberate, azelate, sebacate, and terephthalate, and the multicationic drug is selected from the group consisting of amikacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, tobramycin, and aparmycin. 
     
     
         10 . The composition of  claim 1 , wherein the multicationic drug is amikacin and the organic multianion is citrate. 
     
     
         11 . The composition of  claim 5 , wherein the liposome comprises a phospholipid. 
     
     
         12 . The composition of  claim 5 , wherein the liposome comprises a sterol. 
     
     
         13 . The composition of  claim 5 , wherein the liposome comprises a lipid selected from the group consisting of egg phosphatidyl choline (EPC), egg phosphatidylglycerol (EPG), egg phosphatidylinositol (EPI), egg phosphatidylserine (EPS), phosphatidylethanolamine (EPE), phosphatidic acid (EPA), soy phosphatidyl choline (SPC), soy phosphatidylglycerol (SPG), soy phosphatidylserine (SPS), soy phosphatidylinositol (SPI), soy phosphatidylethanolamine (SPE), soy phosphatidic acid (SPA), hydrogenated egg phosphatidyl choline (HEPC), hydrogenated egg phosphatidylglycerol (HEPG), hydrogenated egg phosphatidylinositol (HEPI), hydrogenated egg phosphatidylserine (HEPS), hydrogenated phosphatidylethanolamine (HEPE), hydrogenated phosphatidic acid (HEPA), hydrogenated soy phosphatidylcholine (HSPC), hydrogenated soy phosphatidylglycerol (HSPG), hydrogenated soy phosphatidylserine (HSPS), hydrogenated soy phosphatidylinositol (HSPI), hydrogenated soy phosphatidylethanolamine (HSPE), hydrogenated soy phosphatidic acid (HSPA), dipalmitoylphosphatidylcholine (DPPC), dimyristoylphosphatidylcholine (DMPC), dimyristoylphosphatidylglycerol (DMPG), dipalmitoylphosphatidylglycerol (DPPG), distearoylphosphatidylcholine (DSPC), distearoylphosphatidylglycerol (DSPG), dioleylphosphatidyl-ethanolamine (DOPE), palmitoylstearoylphosphatidyl-choline (PSPC), palmitoylstearolphosphatidylglycerol (PSPG), mono-oleoyl-phosphatidylethanolamine (MOPE), cholesterol, ergosterol, lanosterol, tocopherol, ammonium salts of fatty acids, ammonium salts of phospholipids, ammonium salts of glycerides, myristylamine, palmitylamine, laurylamine, stearylamine, dilauroyl ethylphosphocholine (DLEP), dimyristoyl ethylphosphocholine (DMEP), dipalmitoyl ethylphosphocholine (DPEP) and distearoyl ethylphosphocholine (DSEP), N-(2,3-di-(9-(Z)-octadecenyloxy)-prop-1-yl-N,N,N-trimethylammonium chloride (DOTMA), 1, 2-bis(oleoyloxy)-3-(trimethylammonio)propane (DOTAP), phosphatidyl-glycerols (PGs), phosphatidic acids (PAs), phosphatidylinositols (PIs), phosphatidyl serines (PSs), distearoylphosphatidylglycerol (DSPG), dimyristoylphosphatidylacid (DMPA), dipalmitoylphosphatidylacid (DPPA), distearoylphosphatidylacid (DSPA), dimyristoylphosphatidylinositol (DMPI), dipalmitoylphosphatidylinositol (DPPI), distearoylphospatidylinositol (DSPI), dimyristoylphosphatidylserine (DMPS), dipalmitoylphosphatidylserine (DPPS), distearoylphosphatidylserine (DSPS), and mixture thereof. 
     
     
         14 . The composition of  claim 5 , wherein the liposome comprises a phospholipid and a sterol. 
     
     
         15 . The composition of  claim 5 , wherein the liposome comprises DPPC and cholesterol. 
     
     
         16 . The composition of  claim 5 , wherein the multicationic drug is amikacin, the organic multianion is citrate, and the liposome comprises DPPC and cholesterol. 
     
     
         17 . The composition of  claim 1 , further comprising an inhalation device. 
     
     
         18 . The composition of  claim 1  in the form of a liquid. 
     
     
         19 . The composition of  claim 19 , wherein the liquid is an aqueous solution. 
     
     
         20 . The composition of  claim 1  in the form of a solid. 
     
     
         21 . The composition of  claim 20 , where in the solid is a powder, film, or paste. 
     
     
         22 . The composition of  claim 1 , wherein the concentration of anionic groups of the organic multianion is at least 10 mM. 
     
     
         23 . The composition of  claim 1 , wherein the concentration of anionic groups of the organic multianion is at least 30 mM. 
     
     
         24 . The composition of  claim 1 , wherein the concentration of anionic groups of the organic multianion is at least 100 mM. 
     
     
         25 . A method of treating a subject for pulmonary distress comprising administering to the subject in need thereof an effective amount of the composition of  claim 1 . 
     
     
         26 . The method of  claim 25 , wherein the pulmonary distress is cystic fibrosis or pneumonia. 
     
     
         27 . The method of  claim 25 , wherein the pulmonary distress is cystic fibrosis. 
     
     
         28 . The method of  claim 25 , wherein the subject is a mammal. 
     
     
         29 . The method of  claim 25 , wherein the subject is a human, primate, equine, bovine, porcine, canine, feline, or rodent. 
     
     
         30 . The method of  claim 25 , wherein the subject is a human. 
     
     
         31 . A kit comprising the composition of  claim 1 , an inhalation device, and directions for use thereof.

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