High dose orally dissolvable/disintegrable lyophilized...

A - Human Necessities – 61 – K

Patent

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A61K 9/00 (2006.01) A61K 9/16 (2006.01)

Patent

CA 2658109

The present invention provides an orally dissolvable/disintegrable, lyophilized dosage form including a protected granulate comprising an active ingredient and a protective granulation binder, which substantially protects the form and/or attributes of a granulate and/or active ingredient, and participates in masking bad tasting active ingredients, such as sulfur-containing materials, and a matrix, and a method for making same. There is also provided a method of treating a patient using any orally dissolvable/disintegrable lyophilized dosage form comprising the steps of placing the dosage form in the mouth of a patient in need of treatment, allowing the dosage form to disintegrate/dissolve sufficiently to allow it, and in particular, the protected granulate, to be swallowed as a solution, suspension or slurry, and swallowing the at least partially disintegrated/dissolved dosage form.

L'invention concerne une forme posologique lyophilisée à dissolution/désintégration orale qui contient un granulé protégé comprenant un ingrédient actif et un liant de granulation protecteur qui protège sensiblement la forme et/ou les attributs d'un granulé et/ou d'un ingrédient actif et contribue à masquer des ingrédients actifs ayant mauvais goût, tels que les substances contenant du soufre, ainsi qu'une matrice. L'invention concerne également un procédé de fabrication de cette forme posologique, ainsi qu'une méthode de traitement d'un patient au moyen de n'importe quelle forme posologique lyophilisée à dissolution/désintégration orale, cette méthode consistant à placer ladite forme posologique dans la bouche d'un patient nécessitant un traitement, à laisser la forme posologique se désintégrer/dissoudre suffisamment pour que celle-ci, et en particulier le granulé protégé, puisse être avalée comme une solution, suspension ou bouillie, puis à avaler la forme posologique au moins partiellement désintégrée/dissoute.

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