CN1927194A - 阿戈美拉汀与精神调节剂的新联合以及包含该联合的药物组合物 - Google Patents
阿戈美拉汀与精神调节剂的新联合以及包含该联合的药物组合物 Download PDFInfo
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Abstract
本发明涉及包含阿戈美拉汀或N－[2－(7－甲氧基－1－萘基)乙基]乙酰胺与精神调节剂的联合以及包含所述联合的药物。
Description
技术领域：
本发明涉及式(I)的阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节剂(thymoregulatory agent)的新联合，
用于获得用于治疗心境障碍、更特别是重症抑郁、循环性情绪障碍和情绪恶劣的药物组合物。
背景技术：
阿戈美拉汀，或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺，具有褪黑激素能系统受体激动剂和5-HT2C受体拮抗剂的双重特征。这些特征使得它在中枢神经系统中具有活性，更特别是在重症抑郁、季节性情感障碍、睡眠紊乱、心血管疾病、消化系统疾病、由时差导致的失眠和疲劳、食欲紊乱和肥胖症的治疗中有活性。
欧洲专利说明书EP 0447285中已经描述了阿戈美拉汀、其制备方法和在治疗中的用途。
发明内容：
现在，本申请人已经发现阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节剂的联合具有有价值的特性，该特性允许其用于治疗心境障碍、更特别是重症抑郁、循环性情绪障碍和情绪恶劣。
中枢神经系统紊乱，例如心境障碍，影响大量所有年龄段的人。它们被如此命名是因为牵连有持久的正性或负性作用，其强度足够严重以产生适应不良行为。
重症抑郁是一种急性和严重的心境障碍，其特征是悲伤、悲观、有自杀的想法、意想性动作迟缓以及各种身体不适。极端的障碍可导致所有的功能性或社会性活动停止。抑郁患者自身的患病累及家庭圈子。
循环性情绪障碍的特征是反复出现正(情绪膨胀)和负(情绪抑郁)情绪变化，其比双相性精神障碍的情绪变化轻，功能缺损较小；但是，存在诊断难度，并且一些因素导致人们相信循环性情绪障碍是双相性精神障碍的先兆。抗抑郁剂与精神调节剂的联合允许控制精神变化，并且阻止它们发展成为典型的双相性精神障碍。
最后，情绪恶劣是一种慢性和激烈的心境障碍，其特征是长期的烦躁不安情绪和功能缺损。正如对于职业极度疲劳综合征(professionalexhaustion syndrome)而言，情绪恶劣的其它症状可以包括以下情感：缺乏适应性、绝望、易怒或过分愤怒、内疚、缺乏兴趣或一般的乐趣、社交回避、慢性疲劳、活动或生产力降低以及注意力不集中。情绪恶劣是一种隐袭的精神障碍。与和诸如重症抑郁的疾病相关的丧失功能症状相反，罹患情绪恶劣的患者通常患有适当的社交和职业功能障碍。例如，尽管他们的一般人际交往功能通常存在障碍，情绪恶劣患者通常被看见勤勉工作并且维持正常的外表。
尽管在该领域中存在很多有效的分子(可更特别提及的是精神兴奋剂(thymoanaleptics)和精神调节剂)，但是无一能完全令人满意地治疗那些不同的病理状态，并且其中一些具有显著的副作用。因此，一直在研发新的可选治疗并且不断成为必需。
现在，申请人已经令人惊讶地发现阿戈美拉汀与精神调节剂的联合具有完全适于治疗心境障碍、更特别是重症抑郁、循环性情绪障碍和情绪恶劣的特性。精神调节剂(通常因为它们的抗躁狂性质而被述及，所述抗躁狂性质允许它们作用于躁狂状态的精神膨胀)目前用于治疗双相性精神障碍。现在，申请人已经发现那些精神调节剂在抑郁性心境障碍和躁狂障碍中均表现出增强阿戈美拉汀作用的特性。不可预知的作用允许在治疗心境障碍、更特别是在重症抑郁、循环性情绪障碍和情绪恶劣中考虑使用本发明的联合。
在本发明的精神调节剂中，可更特别且未加任何限制意义地提及的有锂、卡马西平、丙戊酸盐和拉莫三嗪，更优选为丙戊酸盐。
因此，本发明涉及阿戈美拉汀或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节化合物的联合在获得用于治疗心境障碍、更特别是重症抑郁、循环性情绪障碍和情绪恶劣的药物组合物中的用途。
本发明还涉及包含阿戈美拉汀或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节化合物的联合以及一种或多种可药用赋形剂的药物组合物。
在本发明的药物组合物中，可更特别提及的是适于经口服、胃肠道外或经鼻给药的那些，例如片剂或糖衣锭、舌下片、明胶胶囊、锭剂、栓剂、乳膏剂、软膏剂、皮肤凝胶等等。
除了阿戈美拉汀和精神调节化合物之外，本发明的药物组合物还包含一种或多种选自稀释剂、润滑剂、粘合剂、崩解剂、吸收剂、着色剂、甜味剂等等的赋形剂或载体。
以举例方式且无任何限制意义可被提及的有：
◆稀释剂：乳糖、葡萄糖、蔗糖、甘露醇、山梨醇、纤维素、甘油，
◆润滑剂：二氧化硅、滑石粉、硬脂酸及其镁盐和钙盐、聚乙二醇，
◆粘合剂：硅酸镁铝、淀粉、明胶、黄芪胶、甲基纤维素、羧甲基纤维素钠和聚乙烯吡咯烷酮，
◆崩解剂：琼脂、海藻酸及其钠盐、泡腾混合物。
有用剂量根据患者的性别、年龄及体重、给药途径、紊乱的性质以及任何所联合的治疗的不同而不同，为每24小时1mg至50mg阿戈美拉汀，更优选为每天25mg。精神调节剂的剂量将低于其单独给药时所用的剂量。
具体实施方式：
具体实施方式：
药物组合物：
制备1000片片剂的处方，每片包含25mg活性成分：
N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺.....................25g
乳糖一水合物..........................................62g
硬脂酸镁..............................................1.3g
聚维酮................................................9g
无水胶态二氧化硅......................................0.3g
纤维素羟乙酸钠........................................30g
硬脂酸................................................2.6g
临床研究
所进行的临床研究采用国际术语表，主要是DSM-IV，以及批准的测量工具，例如汉密尔顿抑郁量表(Hamilton Scale of Depression)、Young氏躁狂量表(Young’s mania scale)和总体临床印象量表(Global ClinicalImpression scale)，这些都是有效的指南所推荐的工具。在最佳方法学条件下比较阿戈美拉汀-丙戊酸盐联合和精神调节剂安慰剂，使我们得出如下结论：联合较优。
Claims (5)
1.阿戈美拉汀或N-[2-(7-甲氧基-1-萘基)乙基]乙酰胺或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节剂的联合。
2.权利要求1的联合，其中精神调节剂是丙戊酸盐。
3.药物组合物，包含作为活性成分的权利要求1或2的阿戈美拉汀或其水合物、晶体形式和可药用酸或碱的加成盐与精神调节剂的联合，单独或与一种或多种可药用赋形剂组合。
4.权利要求3的药物组合物，用于生产治疗心境障碍的药物。
5.权利要求1或2的联合在获得用于治疗心境障碍的药物组合物中的用途。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0509208A FR2890563B1 (fr) | 2005-09-09 | 2005-09-09 | Nouvelle association entre l'agomelatine et un agent thymoregulateur et les compositions pharmaceutiques qui la contiennent |
| FR0509208 | 2005-09-09 |
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| Publication Number | Publication Date |
|---|---|
| CN1927194A true CN1927194A (zh) | 2007-03-14 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2006101265895A Pending CN1927194A (zh) | 2005-09-09 | 2006-08-29 | 阿戈美拉汀与精神调节剂的新联合以及包含该联合的药物组合物 |
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| Country | Link |
|---|---|
| US (1) | US7902180B2 (zh) |
| EP (2) | EP1762238B1 (zh) |
| JP (1) | JP2007077149A (zh) |
| KR (2) | KR20070029607A (zh) |
| CN (1) | CN1927194A (zh) |
| AP (1) | AP3045A (zh) |
| AR (1) | AR055418A1 (zh) |
| AT (1) | ATE519482T1 (zh) |
| AU (1) | AU2006209371B2 (zh) |
| BR (1) | BRPI0603767A (zh) |
| CA (1) | CA2558764C (zh) |
| CY (1) | CY1112223T1 (zh) |
| DK (1) | DK1762238T3 (zh) |
| EA (1) | EA014381B1 (zh) |
| ES (1) | ES2371482T3 (zh) |
| FR (1) | FR2890563B1 (zh) |
| GE (1) | GEP20094741B (zh) |
| GT (1) | GT200600410A (zh) |
| HR (1) | HRP20110749T1 (zh) |
| JO (1) | JO2746B1 (zh) |
| MA (1) | MA28504B1 (zh) |
| ME (1) | ME01964B (zh) |
| MX (1) | MXPA06010234A (zh) |
| MY (1) | MY162318A (zh) |
| NO (1) | NO338079B1 (zh) |
| NZ (1) | NZ549727A (zh) |
| PE (1) | PE20070613A1 (zh) |
| PL (1) | PL1762238T3 (zh) |
| PT (1) | PT1762238E (zh) |
| RS (1) | RS52003B (zh) |
| SA (1) | SA110320045B1 (zh) |
| SG (1) | SG131029A1 (zh) |
| SI (1) | SI1762238T1 (zh) |
| TW (1) | TWI369980B (zh) |
| UA (1) | UA83541C2 (zh) |
| UY (1) | UY29776A1 (zh) |
| WO (1) | WO2007028903A1 (zh) |
| ZA (1) | ZA200607532B (zh) |
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| FR2658818B1 (fr) | 1990-02-27 | 1993-12-31 | Adir Cie | Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent. |
| KR20020008167A (ko) * | 1999-04-29 | 2002-01-29 | 플레믹 크리스티안 | 잠재적 항정신병제로서의 글리신 분해계 저해제 |
| YU37602A (sh) * | 1999-12-01 | 2005-07-19 | Ucb S.A. | Derivat pirolidinacetamida sam ili u kombinaciji za tretman poremećaja cns |
| AR047553A1 (es) * | 2003-07-04 | 2006-01-25 | Lundbeck & Co As H | La combinacion de un inhibidor de reabsorcion de serotonina y agomelatina |
| FR2884714B1 (fr) * | 2005-04-20 | 2011-05-06 | Servier Lab | Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires |
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- 2006-09-08 MX MXPA06010234A patent/MXPA06010234A/es active IP Right Grant
- 2006-09-08 PT PT06291423T patent/PT1762238E/pt unknown
- 2006-09-08 RS RS20110407A patent/RS52003B/sr unknown
- 2006-09-11 KR KR1020060087623A patent/KR20070029607A/ko not_active Ceased
- 2006-09-11 JP JP2006245011A patent/JP2007077149A/ja active Pending
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2009
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2011
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