Packaged film dosage unit containing a complexate

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/70 (2006.01) A61K 47/40 (2006.01) G06Q 90/00 (2006.01) G09F 3/00 (2006.01) G06Q 30/02 (2012.01) G06Q 50/26 (2012.01)

Patent

CA 2681077

The present invention relates to packaged orally consumable film dosage units for delivery of actives into the oral cavity. In particular, the packaged pharmaceutical product contains a complexate including a complexing agent and an active, an orally consumable film for delivery of the complexate and a package for containing the orally consumable filrn. The package includes indicia associated therewith, The indicia identifies the eomplexate as the active ingredient contained in the film, which is as a regulatory approvable chemical entity, The present invention aSso relates to methods of labeling, pricing, marketing and satisfying governmental regulations for such packaged pharmaceutical products.

La présente invention concerne des unités de dosage sous forme de film consommable par voie orale conditionné pour délivrer des principes actifs dans la cavité buccale. En particulier, le produit pharmaceutique conditionné contient un produit de la complexation comprenant un agent complexant et un principe actif, un film consommable par voie orale destiné à délivrer le produit de la complexation et un conditionnement destiné à contenir le film consommable par voie orale. Le conditionnement comprend des caractères associés à celui-ci, lesdits caractères identifiant le produit de la complexation comme le principe actif contenu dans le film, c'est-à-dire en tant qu'entité chimique admissible selon la réglementation. La présente invention concerne également des procédés d'étiquetage, de tarification, de commercialisation et de respect des réglementations gouvernementales pour de tels produits pharmaceutiques conditionnés.

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