Process for the preparation of solid pharmaceutical products

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/46 (2006.01) A61K 9/54 (2006.01)

Patent

CA 1220421

- 17 - O.Z. 0050/36388 Abstract of the Disclosure: A process for the preparation of solid pharmaceuti- cal products, wherein, in a first step, spherical single crystals of a pharmaceutical active compound or assistant are prepared by agitating a saturated aqueous, organic or organic-aqueous solution in high speed stirred crystal- lizers or draft-tube crystallizers at 50 - 500 revolutions per minute and seeding the solution with finely ground seed crystals of particle size less than 100 µm, while ensuring that at the time of addition of the seed crystals and during the growth thereof the solution is at all times only minimally supersaturated, this being achieved by slow- cooling at a rate of not more than 50 K/h or corresponding slow evaporation of the solution, and in a second step the resulting spherical single crystals with diameters of 0.1 - 3 mm, preferably 0.5 - 2 mm, are separated from the solution, dried at 40 - 200°C, compounded, where appro- priate; with suitable pharmaceutical assistants or, if the single crystals serve as assistants, with suitable pharma- ceutical active compounds, and then converted to solid pharmaceutical products by coating, tableting or filling into hard gelatin capsules.

447819

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