Process for making gel films

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 9/48 (2006.01)

Patent

CA 2522297

The present invention is directed to a process for making homogeneous, thermoreversible gel films comprising the steps of: (i) heating, hydrating, mixing, solubilizing, and, optionally, de-aerating a high solids, low moisture film forming composition in an apparatus providing sufficient shear, temperature and residence time to form a homogeneous molten composition, wherein the temperature is at or above the solubilizing temperature of said composition; (ii) feeding the molten composition into at least one of a mixer, pump or devolatilizer; and (iii) cooling the homogeneous molten composition at or below its gelling temperature to form said gel films. The present invention is also directed to various products made from such films, such as the gel films themselves, soft capsules, solid dosage forms and delivery systems.

La présente invention porte sur un procédé de fabrication de films de gel thermoréversibles et homogènes consistant à : (i) chauffer, hydrater, mélanger, solubiliser et éventuellement désaérer une composition de formation de films à faible humidité et très solide dans un appareil assurant un cisaillement, une température et une durée de résidence suffisants pour former une composition fondue homogène, la température étant de ou dépassant la température de solubilisation de ladite composition ; (ii) acheminer la composition fondue dans au moins un mixeur, une pompe ou un dévolatiliseur ; et (iii) refroidir ladite composition à une température de gélification au moins afin d'obtenir lesdits films de gel. La présente invention porte également sur différents produits obtenus à partir de tels films, notamment les films de gel à proprement parlé, des capsules molles, des posologies solides et des systèmes d'administration.

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