A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01) A61J 3/06 (2006.01) A61J 3/07 (2006.01) A61K 9/00 (2006.01) A61K 9/48 (2006.01) A61K 31/415 (2006.01)
Patent
CA 2232152
The present invention is concerned with bioadhesive pharmaceutical compositions comprising a pharmaceutically effective amount of an active ingredient, from 80 % to 98.8 % (w/w) pre-gelatinized starch, and from 1 % to 10 % (w/w) of a hydrophilic matrix forming polymer characterized in that the composition further comprises from 0.2 % to 5 % (w/w) alkali C16-22alkyl fumarate as a lubricant; solid dosage forms such as tablets which are suitable for oral, nasal, rectal and vaginal administration; processes of preparing the compositions and solid dosage forms.
L'invention concerne des compositions pharmaceutiques bioadhésives, contenant une quantité suffisante d'un ingrédient actif pour avoir un effet pharmaceutique, de 80 % à 98,8 % (poids/poids) d'amidon pré-gélatinisé et de 1 % à 10 % (poids/poids) d'un polymère constituant une matrice polymère hydrophile. La composition de l'invention contient, en outre, de 0,2 % à 5 % (poids/poids) de C16-22alkyl-fumarate de métal alcalin comme lubrifiant. L'invention concerne également des formes galéniques solides, telles que des comprimés, convenant à une administration par voie orale, nasale, rectale et vaginale. L'invention concerne également des procédés de préparation de ces compositions et de ces formes galéniques solides.
Gowling Lafleur Henderson Llp
Janssen Pharmaceutica N.v.
Tibotec Pharmaceuticals Ltd.
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