Cyclophosphamide film-coated tablets

Details Cyclophosphamide film-coated tablets Cyclophosphamide film-coated tablets

A - Human Necessities

61

K

A61K 31/675 (2006.01) A61J 3/10 (2006.01) A61K 9/28 (2006.01)

Patent

CA 2333682

The invention relates to coated tablets having cyclophosphamide as active substance, containing in the core cyclophosphamide, one or more fillers, one or several dry binding agents but no pre-swollen starches, flow regulation agents and lubricants. In a preferred embodiment of the invention, the core of the film tablet contains lactose monohydrate. D- mannite or CaHPO4 as fillers, non-pre-swollen corn starch or micro fine cellulose as dry binding agents, highly dispersed silicon oxide as flow regulation agents and magnesium stearate, stearic acid, glycerin palmitostearate, polyethylene glycol, talc or glycerin monobehenate as lubricants.

L'invention concerne des comprimés pourvus d'un film, contenant, comme principe actif, du cyclophosphamide. Ces comprimés contiennent, dans leur noyau, du cyclophosphamide, une ou plusieurs matières de charge, un ou plusieurs liants à sec, mais pas d'amidon prégonflé, des agents de régulation d'écoulement et des lubrifiants. Dans un mode préféré de réalisation, ledit noyau d'un tel comprimé contient: comme matière de charge, du monohydrate de lactose, du G-manitol ou du CaHPO4; comme liant à sec, de l'amidon de maïs non prégonflé ou de la cellulose microfine; comme agent de régulation d'écoulement, du dioxyde de silicium hautement dispersé; et comme lubrifiant, du stéarate de magnésium, de l'acide stéarique, du palmitostéarate de glycérine, du polyéthylèneglycol, du talc ou du monobéhénate de glycérine.

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