Stable pharmaceutical composition and method for its production

DETAILED DESCRIPTION It is an object of the present invention to provide a stable pharmaceutical composition wherein the absorbability of a lipophilic drug which is insoluble or practically insoluble in water or another drug, such as a bioactive peptide, upon oral, administration has been improved to such extent that a high blood concentration level thereof can be obtained.
It is another object of the present invention to provide a method for producing such a stable pharmaceutical composition.
With the aim of improving the absorbability of lipophilic drugs which are insoluble or practically insoluble in water or drugs such as bioactive peptides in oral administration, the inventors made investigations and found that the absorbability of these drugs can be improved by administering an emulsion with high emulsification stability containing a lipophilic drug which is insoluble or practically insoluble in water or a bioactive peptide, obtained by fractionally purifying oil-in-water emulsion grains prepared using a fat globule membrane for mammalian milk such as bovine milk fat globule membrane as an emulsifier, or a preparation prepared from said emulsion.
The inventors made further investigations based on this finding, and developed the present invention.
Accordingly, the present invention essentially relates to a stable pharmaceutical composition which contains a drug emulsified with a fat globule membrane of mammalian milk wherein the emulsified drug is obtained from a grain size fraction containing a high density of lipid microspheres with high emulsification stability.
The present invention also relates to a method for producing a stable pharmaceutical composition wherein a drug is emulsified with a fat globule membrane of mammalian milk and then centrifuged under at least two different sets of conditions to fractionally purify the desired grain size fraction.