abstract |
The present invention relates to a pharmaceutical composition comprising N-(2-piridyl)-2-methyl-4-hydroxy-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide as active ingredient and a process for preparing the same. The composition is composed of 1 part by weight of N-(2-piridyl)-2-methyl-4-hydroxy-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide as active ingredient which at least in 90% by mass has a particle size of at most 30 /um, preferably 10 /um, if desired, 0.1 to 5.0 parts by mass, preferably 1 part by mass, of mannitol optionally of the same particle size, if desired, 0.005 to 0.15 parts by mass, preferably 0.06 to 0.1 parts by mass of silica optionally of the same particle size, 5 to 25 parts by mass, preferably 8 to 18 parts by mass, of spray-dried lactose which at least in 80% by mass has a particle size of 80 to 200 /um, if desired, 0.5 to 6.0 parts by mass, preferably 1.5 to 4.0 parts by mass, of a disintegrant, preferably corn starch, if desired, 0.005 to 0.05 parts by mass, preferably 0.01 to 0.02 parts by mass, of a surface active agent, preferably sodium lauryl sulfate, and if desired, 0.05 to 0.5 parts by mass, preferably 0.1 to 0.2 parts by mass of a lubricant, preferably magnesium stearate. |