A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/48 (2006.01) A61J 3/07 (2006.01) B29C 47/00 (2006.01)
Patent
CA 2530619
A film-forming composition comprising a hydrocolloid, a plasticizer, and water is described. A process and apparatus for producing a non-gelatin film comprising a hydrocolloid, a plasticizer, and water is also disclosed. The process includes combining at least one non-gelatin hydrocolloid, water, and at least one plasticizer into a substantially homogeneous film-forming composition comprising at least about 40 percent water by weight. A substantial portion of the water is then extracted from the film-forming composition to form a dried portion having a water content of less than or equal to about 25 percent by weight. The dried portion of the film-forming composition is formed into a film. A film produced according to the process preferably has a tensile strength at rupture of at least about 5 N, and a percent elongation of at least about 50 percent at rupture at room temperature. An apparatus for performing the process is also described, as well oral dosage forms encapsulated or enrobed in the produced film.
L'invention concerne une composition de formation de film contenant un hydrocolloïde, un plastifiant et de l'eau. L'invention concerne également un procédé et un appareil de production d'un film non gélatineux contenant un hydrocolloïde, un plastifiant et de l'eau. Le procédé selon l'invention consiste à associer au moins un hydrocolloïde non gélatineux, de l'eau et au moins un plastifiant dans une composition de formation de film sensiblement homogène contenant au moins environ 40 % en poids d'eau. Une partie importante de l'eau est ensuite extraite de ladite composition, de sorte à former une partie séchée présentant une teneur en eau inférieure ou égale à environ 25 % en poids. La partie séchée de la composition de formation de film est ensuite préparée sous forme de film. L'invention concerne encore un film ainsi produit, présentant de préférence une résistance en traction à la rupture d'au moins environ 5 N, et un pourcentage d'allongement d'au moins environ 50 % à la rupture, à température ambiante. L'invention concerne enfin un appareil servant à mettre en oeuvre ledit procédé, ainsi que des formes dosifiées orales encapsulées ou enrobées dans le film ainsi produit.
Archibald Don A.
Dietel Gregory L.
Fang Qi
Fonkwe Linus G.
Banner Pharmacaps Inc.
Ridout & Maybee Llp
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