Making dosage units using low shear granulation

Details Making dosage units using low shear granulation Making dosage units using low shear granulation

A - Human Necessities

61

K

A61K 31/565 (2006.01) A61J 3/00 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2265211

Disclosed is a process for the preparation of pharmaceutical dosage units containing as an active substance of from 0.005 to 1.0 % by weight of micronised Org 30659, comprising (a) a mixing step comprising bringing into association the active substance and a suitable carrier to form a mixture, and (b) a granulating step in which the mixture is granulated to form agglomerates or granules by wetting the mixture with a binder liquid, the wetting being conducted under agitation, characterised in that the granulation step (b) is conducted so as to exert on the granules a shear force which does not exceed the tensile strength of the agglomerates or granules. The process leads to granules and tablets having an excellent content-uniformity.

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