A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01) A61K 9/00 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2419290
The present invention relates to a quick-disintegrating tablet in the buccal cavity comprising a drug, a diluent, and a saccharide with a relatively lower melting point than the drug and the diluent, which is obtained by uniformly mixing the saccharide with a low melting point in the tablet so that a bridge will be formed between said drug and/or said diluent particles by the product of melting and then solidification of this saccharide with a low melting point. Moreover, the present invention relates to a method of manufacturing a quick- disintegrating tablet in the buccal cavity comprising a drug, a diluent and a saccharide with a relatively lower melting point than the drug and the diluent, which comprises (a) the process whereby tablet starting materials including a drug, a diluent, and a saccharide with a relatively lower melting point than the drug and the diluent are molded under the low pressure necessary for retaining the shape of a tablet, (b) the process whereby the molded product obtained in process (a) is heated to at least the temperature at which this saccharide with a low melting point will melt, and (c) the process whereby the molded product obtained in process (b) is cooled to at least the temperature at which the molten saccharide with a low melting point solidifies. The present invention presents a quick-disintegrating tablet in the buccal cavity that can be used for practical purposes in that it has almost the same properties as conventional oral pharmaceutical tablets, that is, it has sufficient tablet strength that it can be used with automatic unit dosing machines, and it is produced by conventional tableting machines, and a manufacturing method thereof. Moreover, the present invention presents a quick-disintegrating tablet in the buccal cavity which, in comparison to conventional quick-disintegrating tablets in the buccal cavity, has increased tablet strength and an improved friability without prolonging the disintegration time in the buccal cavity, and a manufacturing method thereof.
Comprimés à désintégration rapide dans la cavité orale, qui contiennent un médicament, un diluant et un saccharide ayant un point de fusion inférieur aux points de fusion du médicament et du diluant. Le saccharide à point de fusion bas est uniformément dispersé dans les comprimés et la réticulation dudit saccharide, qui a d'abord été fondu et solidifié, est effectuée parmi les particules du médicament et / ou du diluant. En comparaison aux comprimés classiques qui se désintègrent rapidement dans la cavité orale, les comprimés selon la présente invention possèdent une solidité améliorée et une résistance améliorée à l'abrasion, sans prolongation de la durée de désintégration dans la cavité orale.
Masuda Yoshinori
Mizumoto Takao
Takaishi Yuuki
Astellas Pharma Inc.
Dennison Associates
Yamanouchi Pharmaceutical Co. Ltd.
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