Pharmaceutical compositions of amorphous dispersions of drugs and lipophilic microphase-forming materials

Abstract

A pharmaceutical composition comprises a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer and a lipophilic microphase-forming material. Alternatively, a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer is co-administered with a lipophilic microphase-forming material to an in vivo use environment.

1 - 22 . (canceled) 
     
     
         23 . A composition in the form of a dosage form, comprising:
 a) a solid amorphous dispersion comprising an active pharmaceutical ingredient and a polymer; and   b) an amphiphilic material dispersed in a solid excipient;   wherein the amphiphilic material is selected from sulfonated hydrocarbons and their salts, poloxamers, polyoxyethylene alkyl ethers, polyoxyethylene sorbitan fatty acid esters, short-chain glyceryl mono-alkylates, polyglycolized glycerides, mono- and di-alkylate esters of polyols, polyethylene (40 or 60) hydrogenated castor oil, polyoxyethylene (35) castor oil, alpha tocopheryl polyethylene glycol 1000 succinate, glyceryl PEG 8 caprylate/caprate, PEG 32 glyceryl laurate, polyoxyethylene fatty acid esters, and polyoxyethylene fatty acid ethers.   
     
     
         24 . The composition of  claim 23 , wherein the amphiphilic material is alpha tocopheryl polyethylene glycol 1000 succinate. 
     
     
         25 . The composition of  claim 23 , wherein the amphiphilic material is a poloxamer. 
     
     
         26 . The composition of  claim 23 , wherein the amphiphilic material is a polyoxyethylene sorbitan fatty acid ester. 
     
     
         27 . The composition of  claim 23 , wherein the amphiphilic material is polyoxyethylene 20 sorbitan monolaurate or polyoxyethylene 80 sorbitan monooleate. 
     
     
         28 . The composition of  claim 23 , wherein the amphiphilic material is polyethylene (40 or 60) hydrogenated castor oil or polyoxyethylene (35) castor oil. 
     
     
         29 . The composition of  claim 23 , wherein the amphiphilic material is a polyoxyethylene fatty acid ester or a polyoxyethylene fatty acid ether. 
     
     
         30 . The composition of  claim 23 , wherein the amphiphilic material is a polyglycolized glyceride. 
     
     
         31 . The composition of  claim 23 , wherein the amphiphilic material is a sulfonated hydrocarbon or a salt thereof. 
     
     
         32 . The composition of  claim 23 , wherein the amphiphilic material is sodium lauryl sulfate. 
     
     
         33 . The composition of  claim 23 , wherein the solid excipient is a polymer. 
     
     
         34 . The composition of  claim 23 , wherein the solid excipient is selected from microcrystalline cellulose, silica, dibasic calcium phosphate, calcium silicate, clays, hydrated aluminum silicate, bentonite, hectorite, Na-, Al-, and Fe-montmorillonite, silicon dioxide, magnesium trisilicate, aluminum hydroxide, magnesium hydroxide, magnesium oxide, and talc.