US2005107287A1PendingUtilityA1

Treatment of cancers by inhalation of stable platinum-containing formulations

59
Priority: Aug 20, 2001Filed: Sep 20, 2004Published: May 19, 2005
Est. expiryAug 20, 2021(expired)· nominal 20-yr term from priority
Inventors:Frank PilkiewiczJoel PortnoffLawrence BoniJin-Kwan Lee
A61K 9/1277A61K 31/555A61K 9/0075A61K 45/06A61K 9/008A61K 31/282A61K 9/127A61P 35/00A61K 38/40A61K 33/243
59
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Claims

Abstract

Disclosed are methods of treating cancers by inhalation of stable platinum-containing formulations.

Claims

exact text as granted — not AI-modified
1 - 49 . (canceled)  
     
     
         50 . A stable platinum-containing formulation comprising: 
 (a) a solid mixture of a platinum containing compound and a salt, or a platinum containing compound entrapped in salt crystals; and    (b) one or more lipid.    
     
     
         51 . The stable platinum-containing formulation of  claim 50 , wherein the salt is sodium chloride.  
     
     
         52 . The stable platinum-containing formulation of  claim 50 , wherein the platinum containing compound is selected from the following: cisplatin, carboplatin, oxaliplatin, iproplatin, tetraplatin, transplatin, JM118 (cis—amminedichloro(cyclohexylamine)platinum(II)), JM149 (cis-amminedichloro(cyclohexylamine)-trans-dihydroxoplatinum(IV)), JM216 (bis-acetato-cis-amminedichloro(cyclohexylamine)platinum(IV)), JM335 (trans-amminedichloro(cyclohexylamine)dihydroxoplatinum(IV)), or mixtures thereof.  
     
     
         53 . The stable platinum-containing formulation of  claim 50 , wherein the platinum containing compound is cisplatin.  
     
     
         54 . The stable platinum-containing formulation of  claim 52 , wherein the formulation further comprises transferrin.  
     
     
         55 . The stable platinum-containing formulation of  claim 52 , wherein the formulation further comprises a transferrin-cis-platinum complex.  
     
     
         56 . The stable platinum-containing formulation of  claim 53 , wherein the formulation further comprises transferrin.  
     
     
         57 . The stable platinum-containing formulation of  claim 53 , wherein the formulation further comprises a transferrin-cis-platinum complex.  
     
     
         58 . The stable platinum-containing formulation of  claim 50 , wherein the lipid is selected from the following: a synthetic lipid, a semi-synthetic lipid, a naturally-occurring lipid, a phospholipid, a tocopherol, a sterol, a fatty acid, a glycoprotein, albumin, a negatively-charged lipid, a cationic lipid, or mixtures thereof.  
     
     
         59 . The stable platinum-containing formulation of  claim 50 , wherein the lipid is a phospholipid.  
     
     
         60 . The stable platinum-containing formulation of  claim 50 , wherein the lipid is selected from the following: egg phosphatidylcholine (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 aicd (SPA), hydrogenated egg phosphatidylcholine (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 aicd (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 phospholids, 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 (Pls), phosphatidyl serines (PSs), distearoylphosphatidylglycerol (DSPG), dimyristoylphosphatidylacid (DMPA), dipalmitoylphosphatidylacid (DPPA), distearoylphosphatidylacid (DSPA), dimyristoylphosphatidylinositol (DMPI), dipalmitoylphosphatidylinositol (DPPI), distearoylphospatidylinositol (DSPI), dimyristoylphosphatidylserine (DMPS), dipalmitoylphosphatidylserine (DPPS), distearoylphosphatidylserine (DSPS), or mixtures thereof.  
     
     
         61 . The stable platinum-containing formulation of  claim 50 , wherein the lipid is selected from the following: DOPC, DOPE, DOPS, DOPG, or mixtures thereof.  
     
     
         62 . The stable platinum-containing formulation of  claim 50 , wherein the formulation comprises liposomes.  
     
     
         63 . The stable platinum-containing formulation of  claim 62 , wherein the liposomes have an average diameter of approximately 15 to 1000 nm.  
     
     
         64 . The stable platinum-containing formulation of  claim 63 , wherein the liposomes have an average diameter of approximately 25 to 100 nm.  
     
     
         65 . The stable platinum-containing formulation of  claim 62 , wherein the liposomes have an average diameter of greater than 1 micron.  
     
     
         66 . The stable platinum-containing formulation of  claim 65 , wherein the liposomes have an average diameter of 2 to 5 microns.  
     
     
         67 . The stable platinum-containing formulation of  claim 50 , wherein the formulation comprises one or more polymers.  
     
     
         68 . The stable platinum-containing formulation of  claim 50 , wherein the formulation comprises a carrier.  
     
     
         69 . The stable platinum-containing formulation of  claim 68 , wherein the carrier comprises one or more hydrofluorocarbons or fluorochlorocarbons.  
     
     
         70 . The stable platinum-containing formulation of  claim 69 , wherein the carrier comprises one or more of: 1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,2-tetrafluoroethane, dichlorodifluoromethane, trichlorofluoromethane, or 1,2-dichloro-1,1,2,2-tetrafluoroethane.  
     
     
         71 . The stable platinum-containing formulation of  claim 50 , wherein the stable platinum-containing formulation is a powder.  
     
     
         72 . The stable platinum-containing formulation of  claim 71 , wherein the formulation comprises one or more excipients.  
     
     
         73 . The stable platinum-containing formulation of  claim 72 , wherein the excipient comprises one or more sugars.  
     
     
         74 . The stable platinum-containing formulation of  claim 50 , wherein the formulation comprises a liquid.  
     
     
         75 . The stable platinum-containing formulation of  claim 74 , wherein the liquid includes ethanol.  
     
     
         76 . The stable platinum-containing formulation of  claim 75 , wherein the stable platinum-containing formulation comprises up to 2% by weight ethanol.  
     
     
         77 . A method of treating cancer comprising delivering via inhalation a cancer treating effective amount of a stable platinum-containing formulation to the respiratory tract of an individual in need of such treatment; wherein the stable platinum containing formulation comprises: 
 (a) a solid mixture of a platinum containing compound and a salt, or a platinum containing compound entrapped in salt crystals; and    (b) one or more lipid.    
     
     
         78 . The method of  claim 77 , wherein the salt is sodium chloride.  
     
     
         79 . The method of  claim 77 , wherein the platinum containing compound is selected from the following: cisplatin, carboplatin, oxaliplatin, iproplatin, tetraplatin, transplatin, JM118 (cis—amminedichloro(cyclohexylamine)platinum(II)), JM149 (cis-amminedichloro(cyclohexylamine)-trans-dihydroxoplatinum(IV)), JM216 (bis-acetato-cis-amminedichloro(cyclohexylamine)platinum(IV)), JM335 (trans-amminedichloro(cyclohexylamine)dihydroxoplatinum(IV)), or mixtures thereof.  
     
     
         80 . The method of  claim 77 , wherein the platinum containing compound is cisplatin.  
     
     
         81 . The method of  claim 79 , wherein the formulation further comprises transferrin.  
     
     
         82 . The method of  claim 79 , wherein the formulation further comprises a transferrin-cis-platinum complex.  
     
     
         83 . The method of  claim 80 , wherein the formulation further comprises transferrin.  
     
     
         84 . The method of  claim 80 , wherein the formulation further comprises a transferrin-cis-platinum complex.  
     
     
         85 . The method of  claim 77 , wherein the lipid is selected from the following: 
 a synthetic lipid, a semi-synthetic lipid, a naturally-occurring lipid, a phospholipid, a tocopherol, a sterol, a fatty acid, a glycoprotein, albumin, a negatively-charged lipid, a cationic lipid, or mixtures thereof.    
     
     
         86 . The method of  claim 77 , wherein the lipid is a phospholipid.  
     
     
         87 . The method of  claim 77 , wherein the lipid is selected from the following: 
 egg phosphatidylcholine (EPC), egg phosphatidylglycerol (EPG), egg phosphatidylinositol (EPI), egg phosphatidylserine (EPS), phosphatidylethanolamine (EPE), phosphatidic acid (EPA), soy phosphatidylcholine (SPC), soy phosphatidylglycerol (SPG), soy phosphatidylserine (SPS), soy phosphatidylinositol (SPI), soy phosphatidylethanolamine (SPE), soy phosphatidic aicd (SPA), hydrogenated egg phosphatidylcholine (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 aicd (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 phospholids, 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 (Pls), phosphatidyl serines (PSs), distearoylphosphatidylglycerol (DSPG), dimyristoylphosphatidylacid (DMPA), dipalmitoylphosphatidylacid (DPPA), distearoylphosphatidylacid (DSPA), dimyristoylphosphatidylinositol (DMPI), dipalmitoylphosphatidylinositol (DPPI), distearoylphospatidylinositol (DSPI), dimyristoylphosphatidylserine (DMPS), dipalmitoylphosphatidylserine (DPPS), distearoylphosphatidylserine (DSPS), or mixtures thereof.    
     
     
         88 . The method of  claim 77 , wherein the lipid is selected from the following: DOPC, DOPE, DOPS, DOPG, or mixtures thereof.  
     
     
         89 . The method of  claim 77 , wherein the formulation comprises liposomes.  
     
     
         90 . The method of  claim 89 , wherein the liposomes have an average diameter of approximately 15 to 1000 nm.  
     
     
         91 . The method of  claim 90 , wherein the liposomes have an average diameter of approximately 25 to 100 nm.  
     
     
         92 . The method of  claim 89 , wherein the liposomes have an average diameter of greater than 1 micron.  
     
     
         93 . The method of  claim 92 , wherein the liposomes have an average diameter of 2 to 5 microns.  
     
     
         94 . The method of  claim 77 , wherein the formulation comprises one or more polymers.  
     
     
         95 . The method of  claim 77 , wherein the formulation comprises a carrier.  
     
     
         96 . The method of  claim 95 , wherein the carrier comprises one or more hydrofluorocarbons or fluorochlorocarbons.  
     
     
         97 . The method of  claim 96 , wherein the carrier comprises one or more of: 1,1,2,3,3,3-heptafluoropropane, 1,1,1,2-tetrafluoroethane, dichlorodifluoromethane, trichlorofluoromethane, or 1,2-dichloro-1,1,2,2-tetrafluoroethane.  
     
     
         98 . The method of  claim 77 , wherein the stable platinum-containing formulation is a powder.  
     
     
         99 . The method of  claim 98 , wherein the formulation comprises one or more excipients.  
     
     
         100 . The method of  claim 99 , wherein the excipient comprises one or more sugars.  
     
     
         101 . The method of  claim 77 , wherein the formulation comprises a liquid.  
     
     
         102 . The method of  claim 101 , wherein the liquid includes ethanol.  
     
     
         103 . The method of  claim 102 , wherein the stable platinum-containing formulation comprises up to 2% by weight ethanol.

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