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AssigneeNycomed Pharma AS
InventorsJacob Mathiesen, Carsten M. Nielsen, Peder M. Olsen, Poul E. Bertelsen
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The present invention relates to a particulate material and a solid dosage form notably tablets comprising a regularly shaped calcium-containing compound such as a calcium salt as a therapeutically and/or prophylactically active substance and a pharmaceutically acceptable sugar alcohol such as, e.g., sorbitol and/or isomalt that has a micro structure as evidenced by SEM. The invention also relates to a process for the preparation of the particulate material and solid dosage form. The process involves agglomeration of the calcium-containing compound and the pharmaceutically acceptable sugar alcohol by means of roller compaction. The particulate material obtained by roller compaction is suitable for use in the further processing of the particulate material into e.g. tablets such as chewing tablets.
1-75. (canceled)
A particulate material comprising one or more regularly shaped calcium-containing compounds as an active substance and one or more pharmaceutically acceptable sugar alcohols having a micro structure, wherein the one or more sugar alcohols have a mean particle size of at the most about 150 μm.
A process according to claim 48, wherein the pharmaceutically acceptable sugar alcohol—when compressed into tablets containing 100% w/w of the sugar alcohol—has a slope of correlation between crushing strength (measured in N) and compression pressure (measured in N) of 7×10−3 or more.
Dependencies are inferred from the claim text.