Rapidly soluble film-shaped preparation

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/38 (2006.01) A61K 9/00 (2006.01) A61K 9/70 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2493881

A rapidly soluble film-shaped preparation containing a drug and an edible polymer, wherein the breaking strength of a film thereof is from 200 to 3, 000 g/.phi.7 mm, the tensile strength of the film is from 200 to 3, 000 g/15 mm, the water disintegration time Y[sec] is within 300 seconds (Y<=300), and when the reciprocal [mg/mm2] of the specific surface area [mm2/mg] of the film is taken as X(X>=0), the relationship of water disintegration time Y [sec] >=7500X2 is satisfied, and the rapidly soluble film-shaped preparation comprising one drug- containing layer, or having a support layer on one side or both sides of the drug-containing layer, wherein the edible polymer is hydroxypropyl cellulose and/or hydroxypropylmethyl cellulose, the compounding ratio of the drug is from 0.01 to 40% by weight based on the whole preparation, and that of the edible polymer is from 40 to 99. 99% by weight based on the whole preparation.

L'invention concerne une préparation de film rapidement soluble contenant un médicament et un polymère comestible, dans laquelle la résistance à la rupture du film oscille entre 200 et 3000 g/?7 mm, la résistance à la rupture par traction du film oscille entre 200 et 3000 g/15 mm et la durée de désintégration dans l'eau Y Ýsec¨ n'est pas supérieure à 300 sec (Y<=300). La préparation satisfait le rapport de durée de désintégration dans l'eau Y Ýsec¨>=7500X?2¿ (où X désigne le nombre réciproque Ýmg/mm?2¿¨ de la zone de surface spécifique du film (X>=0)). Dans cette préparation, le polymère comestible désigne une hydroxypropylcellulose et/ou une hydroxypropylméthylcellulose, la teneur du médicament étant comprise entre 0,01 et 40 % en poids de la préparation complète et la teneur en polymère comestible allant de 40 à 99,99 % en poids de la préparation complète. La préparation est constituée d'une seule couche contenant le médicament ou présente une (des) couche(s) de support sur une ou les deux faces de la couche contenant le médicament.

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