Drug dose-form and method of manufacture

B - Operations – Transporting – 65 – B

Patent

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Details

B65B 9/04 (2006.01) A61K 9/00 (2006.01) A61K 9/70 (2006.01) B65B 63/08 (2006.01)

Patent

CA 2476250

Disclosed is a novel solid dosage unit, preferably in the form of a film or thin troche, containing at least one pharmaceutical agent, and its method of manufacture, which involves introduction of a fluid containing at least one non-volatile material, such as a polymeric film forming substance, a volatile carrier and at least one pharmaceutical agent into a depression or cavity comprising the major element of the packaging film for the finished dosage unit (s), and removing the volatile carrier from the cavity by exposure to radiant energy, whereby the remaining non-volatile residue comprises the desired dosage unit. The packaging film can be subsequently lidded by conventional sealing methods to produce packaged dosage units which are suitable for sublingual and other oral applications.

La présente invention se rapporte à une nouvelle forme posologique solide, se présentant de préférence sous la forme d'un film ou d'un trochisque mince, contenant au moins un agent pharmaceutique, ainsi qu'à son procédé de fabrication. Ledit procédé consiste à introduire un fluide contenant au moins une matière non volatile, telle qu'une substance susceptible de former un film polymère, un excipient volatil et au moins un agent pharmaceutique à l'intérieur d'un creux ou d'une cavité comprenant l'élément principal du film de conditionnement destiné à la forme posologique ou aux formes posologiques finie(s), et à extraire l'excipient volatil de la cavité par exposition à une énergie rayonnante, le résidu non volatil restant comportant la forme posologique souhaitée. Le film de conditionnement peut être ultérieurement doté d'une couverture au moyen de procédés de scellement classique permettant de produire des formes posologiques conditionnées qui sont adaptées à une administration sublinguale ainsi qu'à d'autres administrations orales.

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