Pharmaceutical compositions

Abstract

Methods of spray drying are described.

What is claimed is:  
     
         1 . A method of spray drying a drug, the method comprising forming or providing a mixture of the drug in a solvent system that comprises a solvent or combination of components where at least one solvent is a non-volatile solvent to form a mixture of the drug and solvent, and spray-drying the mixture to obtain amorphous drug product, with the proviso that the drug is other than N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide. 
     
     
         2 . The method of  claim 1 , wherein the mixture comprises a solution or a suspension. 
     
     
         3 . The method of  claim 1 , wherein the drug is a small molecule drug, for example a drug having a molecular weight of less than about 1000 daltons. 
     
     
         4 . The method of  claim 1 , wherein the drug is a poorly soluble drug. 
     
     
         5 . The method of  claim 1 , wherein the drug is selected from one of the following classifications: analgesics, anti-inflammatory agents, antihelminthics, anti-arrhythmic agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents, erectile dysfunction improvement agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anxiolytic agents, sedatives, hypnotics, neuroleptics, β-blockers, cardiac inotropic agents, corticosteroids, diuretics, anti-parkinsonian agents, gastro-intestinal agents, histamine receptor antagonists, keratolyptics, lipid regulating agents, anti-anginal agents, Cox-2 inhibitors, leukotriene inhibitors, macrolides, muscle relaxants, nutritional agents, opiod analgesics, protease inhibitors, sex hormones, stimulants, muscle relaxants, anti-osteoporosis agents, anti-obesity agents, cognition enhancers, anti-urinary incontinence agents, nutritional oils, anti-benign prostate hypertrophy agents, essential fatty acids, or non-essential fatty acids. 
     
     
         6 . The method of  claim 1 , wherein the drug comprises an anti-viral agent. 
     
     
         7 . The method of  claim 6 , wherein the anti-viral agent is used to treat Hepatitis C (HepC). 
     
     
         8 . The method of  claim 7 , wherein the anti-viral agent comprises a HepC protease inhibitor. 
     
     
         9 . The method of  claim 8 , wherein the HepC protease inhibitor comprises VX-950. 
     
     
         10 . The method of  claim 1 , wherein the solvent system comprises a combination of components comprising at least one non-volatile solvent. 
     
     
         11 . The method of  claim 10 , wherein the combination of components comprises a volatile solvent and a non-volatile solvent. 
     
     
         12 . The method of  claim 11 , wherein the volatile solvent comprises methylene chloride, acetone, chloroform, or THF. 
     
     
         13 . The method of  claim 11 , wherein the non-volatile solvent comprises glacial acetic acid, DMSO, DMF, or water. 
     
     
         14 . The method of  claim 11 , wherein the non-volatile solvent is present in an amount of from about 0.1% to about 20% by wt. 
     
     
         15 . The method of  claim 11 , wherein the solvent system comprises a combination of volatile solvents with a non-volatile solvent. 
     
     
         16 . The method of  claim 15 , wherein the volatile solvents comprise methylene chloride and acetone. 
     
     
         17 . The method of  claim 15 , wherein the non-volatile solvent comprises glacial acetic acid. 
     
     
         18 . The method of  claim 15 , wherein the solvent system comprises methylene chloride, acetone, and glacial acetic acid. 
     
     
         19 . The method of  claim 18 , wherein the solvent system comprises from about 40% to about 80% methylene chloride, from about 20% to about 35% acetone, and from about 0.1% to about 15% glacial acetic acid. 
     
     
         20 . The method of  claim 15 , wherein the non-volatile solvent comprises water. 
     
     
         21 . The method of  claim 15 , wherein the solvent system comprises methylene chloride, acetone, and water. 
     
     
         22 . The method of  claim 21 , wherein the solvent system comprises from about 40% to about 80% methylene chloride, from about 20% to about 35% acetone, and from about 0.1% to about 15% water. 
     
     
         23 . The method of  claim 1 , wherein the solvent system comprises glacial acetic acid. 
     
     
         24 . The method of  claim 1 , wherein the solvent system comprises water. 
     
     
         25 . The method of  claim 1 , wherein the mixture comprises a surfactant. 
     
     
         26 . The method of  claim 25 , wherein the surfactant comprises sodium lauryl sulfate (SLS) or Vitamin E or a derivative thereof.