METHOD FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING FINE PARTICLES OF POORLY SOLUBLE DRUG
The present invention provides a method for producing a pharmaceutical composition containing fine particles of a poorly soluble drug, comprising mixing a sugar or a sugar alcohol with a dispersion of nanoparticles of the poorly soluble drug and granulating the obtained mixture.
1 . A method for producing a pharmaceutical composition containing fine particles of a poorly soluble drug, comprising mixing a sugar or a sugar alcohol with a dispersion of nanoparticles of the poorly soluble drug and granulating the obtained mixture.
2 . The method according to claim 1 , wherein the sugar or the sugar alcohol is at least one selected from erythritol, xylitol, sorbitol and sucrose.
3 . The method according to claim 1 , wherein the sugar or the sugar alcohol is at least one selected from erythritol, xylitol and sucrose.
4 . The method according to claim 1 , wherein the nanoparticles of the poorly soluble drug are nanoparticles of the poorly soluble drug obtained by wet milling.
5 . The method according to claim 1 , wherein a particle size distribution (D50) of the nanoparticles is 2 μm or less.
6 . The method according to claim 1 , wherein granulating is performed by a wet granulation method.
7 . The method according to claim 1 , wherein the dispersion of the nanoparticles of the poorly soluble drug contains a surfactant and/or a polymer.
8 . The method according to claim 1 , wherein the mixing the sugar or the sugar alcohol is mixing an aqueous solution of the sugar or the sugar alcohol.
9 . A pharmaceutical composition containing fine particles of a poorly soluble drug, obtained by the method according to claim 1 .
10 . The pharmaceutical composition according to claim 9 , wherein the composition is in the form of a granule.
11 . An oral pharmaceutical composition comprising the pharmaceutical composition containing fine particles of a poorly soluble drug according to claim 9 , and an excipient.
12 . The oral pharmaceutical composition according to claim 11 , wherein the composition is in the form of a tablet, a capsule or a granule.