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1. 发明授权

US07670619B2 Controlled-release formulations containing tryptophan or its metabolites 有权
标题翻译：含有色氨酸或其代谢物的控制释放制剂
公开(公告)号：US07670619B2
公开(公告)日：2010-03-02
申请号：US11201070
申请日：2005-08-09
申请人： Bojidar Mihaylov
发明人： Bojidar Mihaylov
IPC分类号： A61K9/20 , A61K31/05
CPC分类号： A61K9/209 , A61K31/405
摘要： New controlled-release formulations containing tryptophan and/or its metabolites are described, as well as the process to obtain them in tablet forms suitable for oral administration in the treatment of pathologies or conditions related to serotonin deficiency in the Nervous System. The formulations are comprised in double-layer tablets, one layer containing 5-hyrohytryptophan released rapidly (phase “fast), the other layer containing tryptophan or 5-hydroxytryptophan, progressively released (“retarded”). The finished product is characterized by optimal differential release profile under physiological conditions. In all cases the release kinetics obtained is accurately time- and concentration-controlled, therefore avoiding fortuitous release of the active ingredients, and in clinical setting is free of undesirable side effects.
摘要翻译：描述了含有色氨酸和/或其代谢物的新的控制释放制剂，以及以适于口服给药的片剂形式获得它们以治疗与神经系统中的5-羟色胺缺乏有关的病症或病症的方法。制剂包含在双层片剂中，一层含有快速释放的5-羟色氨酸（相“快”），另一层含有色氨酸或5-羟色氨酸，逐渐释放（“延迟”）。成品的特征在于生理条件下的最佳差速释放曲线。在所有情况下，获得的释放动力学是精确时间和浓度控制的，因此避免了活性成分的偶然释放，并且在临床设置中没有不期望的副作用。

2. 发明申请

US20130122092A1 THREE-PHASE CONTROLLED-RELEASE TABLET COMPRISING MELATONIN AND PROCESS OF PREPARATION 审中-公开
标题翻译：包含MELATONIN的三相控制释放片和制备方法
公开(公告)号：US20130122092A1
公开(公告)日：2013-05-16
申请号：US13810061
申请日：2011-07-22
申请人： Bojidar Mihaylov Stankov
发明人： Bojidar Mihaylov Stankov
IPC分类号： A61K9/24 , A61K31/404 , A61J3/00
CPC分类号： A61K9/209 , A61J3/005 , A61K9/2077 , A61K31/404 , A61K31/4045
摘要： The invention relates, in one aspect, to a tablet having an internal core and external coating, both comprising melatonin and separated by an internal coating which does not comprise melatonin. The tablet is useful as a medicinal product, dietetic or food supplements for the treatment or as adjunctive therapy in sleep disorders.
摘要翻译：本发明在一个方面涉及具有内部核心和外部涂层的片剂，其均包含褪黑激素并由不包含褪黑素的内部涂层分离。该片剂可用作药物产品，饮食或食物补充剂用于治疗或作为睡眠障碍的辅助治疗。

3. 发明授权

US07858656B2 Controlled release formulations containing an active ingredient, preferably melatonin and the method of preparation 有权
标题翻译：含有活性成分，优选褪黑素的控制释放制剂及其制备方法
公开(公告)号：US07858656B2
公开(公告)日：2010-12-28
申请号：US11983958
申请日：2007-11-13
申请人： Bojidar M. Stankov
发明人： Bojidar M. Stankov
IPC分类号： A61K31/405 , A61K9/24 , A61K9/36 , A61K47/00 , A61P5/00
CPC分类号： A61K31/4045 , A61K9/2077 , A61K9/209 , Y10S514/96 , Y10S514/961 , Y10S514/964
摘要： A controlled release melatonin tablet having a slow release nucleus of melatonin, hydroxypropyl methylcellulose, a lubricant, a volume excipient and a glidant, wherein 95% of the melatonin is released within 5 hours in an oscillating tray containing gastric/intestinal juice at 37° C. and a fast release cortex coating on said nucleus of melatonin, hydroxypropyl methylcellulose and a volume excipient, wherein at least 95% of the melatonin is released within 10 minutes in an oscillating tray containing gastric/intestinal juice at 37° C.
摘要翻译：具有褪黑激素释放缓释核，羟丙基甲基纤维素，润滑剂，体积赋形剂和助流剂的控释褪黑激素片剂，其中95％的褪黑素在5℃内在含有胃液/肠液的摆动盘中在37℃下释放和在褪黑素，羟丙基甲基纤维素和体积赋形剂的所述细胞核上的快速释放皮质涂层，其中至少95％的褪黑激素在10分钟内在含有胃液/肠液的摆动盘中在37℃下释放。

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