Quick-disintegrating tablet in the buccal cavity and manufacturing method thereof
    10.
    发明公开
    Quick-disintegrating tablet in the buccal cavity and manufacturing method thereof 审中-公开
    在德国Mundhöhlerasch zerfallende Tablette和Verfahren deren Herstellung

    公开(公告)号:EP1374858A2

    公开(公告)日:2004-01-02

    申请号:EP03076769.3

    申请日:2002-05-08

    IPC分类号: A61K9/20

    CPC分类号: A61K9/0056 A61K9/2018

    摘要: 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.

    摘要翻译: 本发明涉及颊腔中的快速崩解片剂,其包含药物,稀释剂和具有比药物和稀释剂相对较低的熔点的糖,其通过将糖均匀混合到低熔点 在片剂中使得在所述药物和/或所述稀释剂颗粒之间将由低熔点的这种糖的熔化然后凝固的产物形成桥。 此外,本发明涉及在口腔中制造快速崩解片剂的方法,其包括药物,稀释剂和具有比药物和稀释剂更低的熔点的糖类,其包括(a) 包含药物,稀释剂和具有比药物和稀释剂相对较低熔点的糖类的片剂起始材料在保持片状形状所需的低压下成型,(b)所得成型品 在加工过程(a)中被加热到至少具有低熔点的糖的熔融温度,和(c)将方法(b)中得到的模塑产物冷却至至少在 具有低熔点的熔融糖固化。 本发明提供了一种颊腔中的快速崩解片,其可用于实际目的,因为其具有与常规口服药物片剂几乎相同的性质,即其具有足够的片剂强度,其可以是 与自动单位计量机一起使用,并且由常规压片机生产,及其制造方法。 此外,本发明在口腔中提供了快速崩解片剂,其与口腔中的常规快速崩解片剂相比具有增加的片剂强度和改善的脆性,而不延长颊腔内的崩解时间,并且 其制造方法。