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ORODISPERSIBLE TABLETS OBTAINED BY COMPRESSION MOULDING
专利权人:
ETHYPHARM
发明人:
DECORTE, ISABELLE,DECORTE, Isabelle,GENDROT, EDOUARD,GENDROT, Edouard,PREVOST, YANN,PREVOST, Yann
申请号:
FRFR2013/053113
公开号:
WO2014/096669A1
申请日:
2013.12.17
申请国别(地区):
FR
年份:
2014
代理人:
摘要:
The subject matter of the present invention is an orodispersible tablet having a hardness of 30 to 80 N, and preferably 40 to 75 N, a brittleness less than 1% and preferably less than 0.5%, disintegrating in the mouth within 60 seconds and preferably within 40 seconds, comprising an active ingredient in the form of coated microcrystals or microgranules and a mixture of excipients chosen from a group comprising a diluent, a disintegrant, a sweetener, a binder, a levelling agent, a humectant or wetting agent, a lubricant, a flavouring agent, a dye, and mixtures thereof, said mixture of excipients preferably coming in the form of grains, characterised in that said tablet is obtained by a method of compression moulding comprising the following steps; preparing the mixture of recipients by humidification, preferably in the form of grains, having a residual humidity or water level from 0.5% to 7%, preferably from 1% to 5%, and more preferably from 2% to 4%, preparing coated microcrystals or microgranules of the active ingredient, mixing the coated microcrystals or microgranules of the active ingredient and the wet mixture of excipients as prepared above, said mixture of excipients preferably being in the form of grains, potentially adding to the wet mixture for compression, as prepared above, excipients chosen from the group comprising a levelling agent, a lubricant, a flavouring agent, a sweetener, a dye, and mixtures thereof, compressing the mixture for compression prepared above in order to obtain a tablet, potentially drying the tablet thereby contained.La présente invention a pour objet un comprimé orodispersible présentant une dureté allant de 30 à 80 N, et de préférence de 40 à 75 N, une friabilité inférieure à 1 % et de préférence inférieure à 0,5 %, une désintégration en bouche inférieure à 60 secondes et de préférence inférieure à 40 secondes, comprenant un principe actif sous forme de microcristaux ou de micro granules enrobés et un mélange d'excipients choisis
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