Pharmaceutical granulate containing cellulose product

A - Human Necessities – 61 – K

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167/169, 167/180

A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 1338553

A pharmaceutical composition in dosage-form is provided which contains or is prepared with a pharmaceutical granulate, which can uninterruptedly flow through a flow cup or- ifice not wider than 12 mm. A process for the preparation by wet granulation of the said granulate is provided, which process comprises the steps of (a) mixing a therapeutically useful sub- stance having a solubility in water of less than 10 wt%, 20 to 100 wt% of a cellulose product, which is microcrystalline cell- ulose or microfine cellulose or a mixture of both, and 0 to 0.5 wt% of a wet granulation binding substance, said percentages of the excipients being based on the therapeutically useful sub- stance, with an aqueous granulation liquid to form a wet mass; (b) processing said wet mass to form a granulate; (c) passing said wet mass through a first sieve; (d) drying the sieved granulate; (e) passing the dried granulate through a second sieve; and (f) collecting the resulting granulate.

591676

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