A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 33/06 (2006.01)
Patent
CA 2581703
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.
La présente invention concerne un matériau particulaire et une forme de dose solide, notamment des tablettes comprenant un composé contenant du calcium de forme ordinaire comme un sel de calcium utilisé comme substance thérapeutiquement et/ou prophylactiquement active et un alcool de sucre répondant aux normes pharmaceutiques tels que, par exemple, du sorbitol et/ou un isomalt qui possède une microstructure telle que mise en évidence par SEM. Cette invention concerne aussi un processus de préparation de ce matériau particulaire et de cette forme de dose solide. Ce processus comprend l'agglomération du composé contenant du calcium et de l'alcool de sucre répondant aux normes pharmaceutiques au moyen d'un compactage par rouleau. Le matériau particulaire obtenu par compactage par rouleau convient pour être utilisé dans le traitement suivant du matériau particulaire dans des tablettes, par exemple telles que des tablettes de chewing-gum.
Bertelsen Poul Egon
Mathiesen Jacob
Nielsen Carsten Martini
Olsen Peder Mohr
Nycomed Pharma As
Sim & Mcburney
LandOfFree
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