MINIMIZING AGGLOMERATION OF COATING MATERIAL OF DRUG PARTICLES DURING STORAGE TO STABILIZE DISINTEGRATION TIME OF PHARMACEUTICAL PRODUCTS Russian patent published in 2024 - IPC A61K9/10 A61K31/167 A61K31/192 A61K47/44 A61K47/02 A61K47/26 A61K47/42 

FIELD: medicine; pharmaceutics.

SUBSTANCE: group of inventions relates to a method for preparing a pharmaceutical composition, involving: coating active pharmaceutical ingredient (API) particles with a first coating material to form coated API particles, wherein first coating material contains one or more deformable components containing carnauba wax, candelilla wax or synthetic wax; applying mechanical stress to the coated API particles to deform one or more deformable components; applying a dry coating to the API particles coated with a second coating material comprising silicon dioxide to form a protective hydrophobic barrier layer for the first coating layer; applying mechanical stress to provide at least one of adhesion, partial inclusion or inclusion of silicon dioxide in the coated API particles; after applying mechanical stress to API particles coated with silicon dioxide, sieving the coated API particles to remove excess coating material, wherein excess coating material comprises coating material not associated with coated API particles; mixing coated API particles with matrix solution/suspension to form a pharmaceutical suspension, where the pharmaceutical suspension contains 5–60 wt./wt.% of particles of API with coating and 40–95 wt./wt.% of matrix solution/suspension and wherein the matrix solution/suspension contains a matrix-forming substance containing one or more of a water-soluble material, a water-dispersible material, a polypeptide, polysaccharide, polyvinyl alcohol, polyvinylpyrrolidone and gum arabic, and a structure-forming substance containing one or more of mannitol, dextrose, lactose, galactose and cyclodextrin; and dispensing the pharmaceutical suspension into a form, also relates to a pharmaceutical composition obtained by a method comprising the steps of: coating active pharmaceutical ingredient (API) particles with a first coating material to form coated API particles, wherein the first coating material contains one or more deformable components containing carnauba wax, candelilla wax or synthetic wax; applying mechanical stress to the coated API particles to deform one or more deformable components; applying a dry coating to the API particles coated with a second coating material comprising silicon dioxide to form a protective hydrophobic barrier layer for the first coating layer; applying mechanical stress to provide at least one of adhesion, partial inclusion or inclusion of silicon dioxide in the coated API particles; after applying mechanical stress to API particles coated with silicon dioxide, sieving the coated API particles to remove excess coating material, wherein excess coating material comprises coating material not associated with coated API particles; mixing the coated API particles with the matrix solution/suspension to form a pharmaceutical suspension, where the pharmaceutical suspension contains 5–60 wt./wt.% of particles of API with coating and 40–95 wt./wt.% of matrix solution/suspension and wherein the matrix solution/suspension contains a matrix-forming substance containing one or more of a water-soluble material, a water-dispersible material, a polypeptide, a polysaccharide, a polyvinyl alcohol, polyvinylpyrrolidone and gum arabic, and a structure-forming substance containing one or more of mannitol, dextrose, lactose, galactose and cyclodextrin; and dispensing the pharmaceutical suspension into the form.

EFFECT: group of inventions provides disintegration time and rate of dissolution of the pharmaceutical product, which remain relatively stable over time.

12 cl, 8 ex, 10 tbl, 22 dwg