Improved method for manufacturing freeze dried dosages in a...

A - Human Necessities – 61 – J

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A61J 1/03 (2006.01) A61K 9/20 (2006.01) B65D 75/34 (2006.01) B65D 75/36 (2006.01)

Patent

CA 2129254

An improved method for manufacturing freeze dried pharmaceutical tablets in blister packs is disclosed. Liquid dosages are introduced into a multilayer laminated buster sheet having an impermeable intermediate layer (14) that is positioned between first and second outer layers (16, 18) each of which has substantially the same coefficient of thermal expansion. The properties of the outer layers of the blister sheet are such that there are no inter-layer stresses that will cause curvature of the buster sheet when it is subjected to temperature changes during the freezing and freeze drying sips. Following the introduction of the dosages into the depressions (10) of the blister sheet, the dosages are frozen and freeze dried. A lidding sheet (32) is then attached to the blister sheet to seal the solid dosages into the buster pack.

On décrit un procédé perfectionné de fabrication de comprimés pharmaceutiques lyophilisés dans des emballages alvéolaire. On introduit les doses liquides dans une feuille multi-couche stratifiée alvéolaire possédant une couche intermédiaire (14) imperméable placée entre une première et une deuxième couche extérieure (16, 18), chacune de ces couches possédant sensiblement le même coefficient de dilatation thermique. Les propriétés des couches extérieures sont telles qu'aucune tension entre les couches ne provoque de déformation de la feuille alvéolaire lorsqu'on la soumet à des variations de température durant les étapes de congélation et de lyophilisation. Après introduction des doses dans les cavités (10) de la feuille alvéolaire, on procéde à leur congélation et à leur lyophilisation. On fixe ensuite un film de couverture (32) sur la feuille alvéolaire afin d'enfermer de façon étanche les doses solides dans l'emballage alvéolaire.

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