Film-coated tablet with cyclophosphamide, process for its manufacture and method for manufacturing of tablet cores

Film-coated tablet with cyclophosphamide as active compound comprises in the core cyclophosphamide, one or more fillers selected from the group consisting of lactose monohydrate, D-mannitol and CaHPO4, one or more dry binders selected from the group consisting of not pre-swollen corn starch and micr...

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Hauptverfasser: SAUERBIER DIETER, WICHERT BURKHARD, RAWERT JURGEN, ENGEL JURGEN
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creator SAUERBIER DIETER
WICHERT BURKHARD
RAWERT JURGEN
ENGEL JURGEN
description Film-coated tablet with cyclophosphamide as active compound comprises in the core cyclophosphamide, one or more fillers selected from the group consisting of lactose monohydrate, D-mannitol and CaHPO4, one or more dry binders selected from the group consisting of not pre-swollen corn starch and microcrystalline cellulose, highly disperse silica as flow regulator, and a lubricant selected from the group consisting of magnesium stearate, stearic acid, glycerol palmitostearate, polyethylene glycol, talcum and glycerol monobehenate, wherein the core can comprise the auxiliaries either individually or alternatively in any desired mixture. The invention also relates to a process for manufacturing of tablet cores and film-coated tablets by spraying tablet cores with a suspension. Obalená tableta s cyklofosfamidom ako účinnou zlúčeninou obsahuje v jadre cyklofosfamid, jedno alebo viac plnív zvolených zo skupiny pozostávajúcej zmonohydrátu laktózy, D-manitolu a hydrogenfosforečnanu vápenatého, jedno alebo viac suchých spojív zvolených zo skupiny pozostávajúcej z vopred nenapučaného kukuričného škrobu a mikrokryštalickej celulózy, vysokodispergovaný oxid kremičitý ako regulátor tečenia a mazadlo zvolené zo skupiny pozostávajúcej zo stearanu horečnatého, kyseliny stearovej, palmitoylstearoylglycerolu, polyetylénglycerolu,mastenca a monobehenoylglycerolu, pričom jadro obsahuje tieto pomocné prostriedky buď jednotlivo, alebo alternatívne v ľubovoľnej požadovanej zmesi. Opísaný je tiež spôsob výroby jadier takýchto tabliet a spôsob výroby obalených tabliet nastrekovaním obalovej suspenzie na jadrá tabliet.
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The invention also relates to a process for manufacturing of tablet cores and film-coated tablets by spraying tablet cores with a suspension. Obalená tableta s cyklofosfamidom ako účinnou zlúčeninou obsahuje v jadre cyklofosfamid, jedno alebo viac plnív zvolených zo skupiny pozostávajúcej zmonohydrátu laktózy, D-manitolu a hydrogenfosforečnanu vápenatého, jedno alebo viac suchých spojív zvolených zo skupiny pozostávajúcej z vopred nenapučaného kukuričného škrobu a mikrokryštalickej celulózy, vysokodispergovaný oxid kremičitý ako regulátor tečenia a mazadlo zvolené zo skupiny pozostávajúcej zo stearanu horečnatého, kyseliny stearovej, palmitoylstearoylglycerolu, polyetylénglycerolu,mastenca a monobehenoylglycerolu, pričom jadro obsahuje tieto pomocné prostriedky buď jednotlivo, alebo alternatívne v ľubovoľnej požadovanej zmesi. 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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
title Film-coated tablet with cyclophosphamide, process for its manufacture and method for manufacturing of tablet cores
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