Pharmaceutical compositions for lipophilic drugs

Abstract

Stable solutions of lipophilic drugs, such as cyclosporin, forming a polar lipid self-emulsifying drug delivery system. The solutions can include lipophilic drugs, such as cyclosporin, dissolved in a polar lipid, such as having a C 6 -C 12 fatty acid monoglyceride content of at least about 50%, surfactants and triglycerides. The composition forms a fine emulsion on exposure to water. The encapsulated dosage form of this composition needs neither a hydrophilic component nor air-tight blister packaging, and is particularly suitable for oral administration.

1 - 19 . (canceled) 
     
     
         20 . A composition for oral administration comprising:
 a cyclosporin and   a carrier medium;   wherein the carrier medium is selected to cause the composition, on contact with an aqueous phase, to spontaneously form a clear, fine emulsion of mean particle size of less than about 50 nm,   wherein the composition does not contain a hydrophilic phase, and wherein the composition comprises a polyoxyethylated natural vegetable oil, a polyoxyethylated hydrogenated vegetable oil, or a mixture thereof.   
     
     
         21 . The composition of  claim 20 , wherein the composition comprises PEG castor oil. 
     
     
         22 . The composition of  claim 20 , further comprising a monoglyceride, a diglyceride, a medium-chain triglyceride, or a combination thereof. 
     
     
         23 . The composition of  claim 20 , further comprising a monoglyceride, a diglyceride, or a combination thereof. 
     
     
         24 . The composition of  claim 20 , wherein the composition comprises polysorbate 80. 
     
     
         25 . The composition of  claim 20 , wherein the composition comprises polysorbate 20. 
     
     
         26 . The composition of  claim 20 , wherein the composition comprises polyglycolyzed glycerides. 
     
     
         27 . A composition for oral administration comprising:
 a cyclosporin and   a carrier medium comprising a combination of two or more surfactants;   wherein the combination of surfactants are selected to cause the composition, on contact with an aqueous phase, to spontaneously form a clear, fine emulsion, and   wherein the composition does not contain a hydrophilic phase, and   wherein the composition comprises a polyoxyethylated natural vegetable oil, a polyoxyethylated hydrogenated vegetable oil, or a mixture thereof.