PHARMACEUTICAL COMPOSITIONS OF AMORPHOUS DISPERSIONS OF DRUGS AND LIPOPHILIC MICROPHASE-FORMING MATERIALS
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.