CN103251598A - 氟班色林在治疗绝经前性欲障碍中的用途 - Google Patents
氟班色林在治疗绝经前性欲障碍中的用途 Download PDFInfo
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Abstract
本发明涉及氟班色林在制备用于治疗绝经前性欲障碍的药物中的用途。
Description
本申请是申请日为2006年11月6日、申请号为200680041697.0、发明名称为“氟班色林在治疗绝经前性欲障碍中的用途”的发明专利申请的分案申请。
本发明涉及氟班色林(flibanserin)在制备用于治疗绝经前性欲障碍的药物中的用途。
发明描述
化合物1-[2-(4-(3-三氟甲基-苯基)哌嗪-1-基)乙基]-2,3-二氢-1H-苯并咪唑-2-酮(氟班色林)以其氢氯酸盐形式公开于欧洲专利申请EP-A-526434中，且具有以下化学结构：
氟班色林显示出对5-HT1A及5-HT2-受体的亲和力。因此，其为一种有前景的用于治疗多种疾病(例如抑郁、精神分裂症，以及焦虑)的治疗剂。
一般性术语“性功能障碍”包括：性欲障碍、性唤起障碍、性高潮障碍、性交痛障碍、一般医学状况所致性功能障碍(Sexual Dysfunction due to a General Medical Condition)、物质引起的性功能障碍(Substance-Induced Sexual Dysfunction)，以及未指明的性功能障碍(Diagnostic and Statistical Manual of Mental Disorders,第4版,Text Revision.Washington DC,American Psychiatric Association,2000)。
在对患有性功能障碍的绝经前女性患者的研究中发现，氟班色林，任选 以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，显示出性欲增强特性。因此，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗绝经前妇女性欲障碍的药物中的用途。
本发明中术语“治疗绝经前机能减退的性欲障碍”等具有“治疗绝经前妇女中机能减退的性欲障碍”的含义。
无论性欲障碍是终生存在的还是获得的、是“泛发性型的”或“情境型的”以及不依赖病原学起因的(器质性的-两种情况：身体上及药物造成的-、心理引发(由心理因素引发)、由器质性的-两种情况：身体上及药物造成的-与心理引发(由组合因素引发)的组合，或未知的)，皆可观察到氟班色林的有益效果。术语“终生性(lifelong)”指本发明中性欲障碍是自从性机能初始即一直存在的。术语“获得性(acquired)”指本发明中性疾病是仅在正常的性功能一段时期后发生的。“泛发性型(generalized type)”指本发明中性疾病并不限于刺激、情境、或伴侣的特定类型。“情境型(situational type)”指本发明中性疾病局限于刺激、情境、或伴侣的特定类型。由“心理因素”引发的亚型适用于当心理因素在性疾病的发病、严重度、恶化或维持中的判断扮演重要角色，且一般医学状况和物质对该性疾病的病因并无作用的情况。由“组合因素”引发的亚型适用于当1)心理因素在该性疾病的发病、严重度、恶化或维持中的判断扮演重要角色，且2)一般医学状况或物质使用经判断亦促进但不足以诱发性疾病的情况(Diagnostic and Statistical Manual of Mental Disorders，第4版，Text Revision.Washington DC，American Psychiatric Association，2000)。
因此，举例而言，术语“终生性绝经前机能减退的性欲障碍”指自从性功能初始一直存在的绝经前妇女机能减退的性欲障碍，及术语“获得性绝经前机能减退的性欲障碍”指在正常的性功能一定时期后发生的绝经前妇女机能减退的性欲障碍。
因此，在优选实施方式中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：绝经前机能减退的性欲障碍(HSDD)、绝经前性厌恶障碍、绝经前性欲缺失(pre-menopausal loss of sexual desire)、绝经前性欲缺乏(pre-menopausal lack of sexual desire)、绝经前性欲降 低(pre-menopausal decreased sexual desire)、绝经前性欲抑制(pre-menopausal inhibited sexual desire)、绝经前性冲动缺失(pre-menopausal loss of libido)、绝经前性冲动紊乱(pre-menopausal libido disturbance)，以及绝经前性冷淡(pre-menopausal frigidity)。
本发明特别优选的是氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：绝经前机能减退的性欲障碍、绝经前性厌恶障碍、绝经前性欲缺失、绝经前性欲缺乏、绝经前性欲降低，以及绝经前性欲抑制。
在优选的实施方案中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：绝经前机能减退的性欲障碍、绝经前性欲缺失、绝经前性欲降低，以及绝经前性欲抑制。
在另一优选实施方案中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：终生性绝经前机能减退的性欲障碍、终生性绝经前性厌恶障碍、终生性绝经前性欲缺失、终生性绝经前性欲缺乏、终生性绝经前性欲降低、终生性绝经前性欲抑制、终生性绝经前性冲动缺失、终生性绝经前性冲动紊乱，以及终生性绝经前性冷淡。
本发明特别优选的是氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：终生性绝经前机能减退的性欲障碍、终生性绝经前性厌恶障碍、终生性绝经前性欲缺失、终生性绝经前性欲缺乏、终生性绝经前性欲降低，以及终生性绝经前性欲抑制。
在特别优选的实施方案中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：终生性绝经前机能减退的性欲障碍、终生性绝经前性欲缺失、终生性绝经前性欲降低，以及终生性绝经前性欲抑制。
在另一优选的实施方案中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列的疾病的药物中的用途：获得性绝经前机能减退的性 欲障碍、获得性绝经前性厌恶障碍、获得性绝经前性欲缺失、获得性绝经前性欲缺乏、获得性绝经前性欲降低、获得性绝经前性欲抑制、获得性绝经前性冲动缺失、获得性绝经前性冲动紊乱，以及获得性绝经前性冷淡。
本发明特别优选的是氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于治疗选自下列疾病的药物中的用途：获得性绝经前机能减退的性欲障碍、获得性绝经前性厌恶障碍、获得性绝经前性欲缺失、获得性绝经前性欲缺乏、获得性绝经前性欲降低、获得性绝经前性欲抑制。
在特别优选的实施方案中，本发明涉及氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式，在制备用于下列疾病的药物中的用途：获得性绝经前机能减退的性欲障碍、获得性绝经前性欲缺失、获得性绝经前性欲降低，以及获得性绝经前性欲抑制。
此外，本发明涉及任何上文提及的病症的泛发性的或情境的亚型和/或涉及由器质因素、心理因素引发或由组合因素引发的此类病症。
氟班色林可任选以其游离碱形式、以其可药用的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式使用。合适的酸加成盐包括例如选自下列酸形成的酸加成盐：琥珀酸、氢溴酸、乙酸、富马酸、马来酸、甲磺酸、乳酸、磷酸、氢氯酸、硫酸、酒石酸和柠檬酸。也可使用上文提及的酸加成盐的混合物。在前面提及的酸加成盐中，优选氢氯酸盐(hydrochloride)及氢溴酸盐(hydrobromide)、特别优选氢氯酸盐。若氟班色林以游离碱形式使用，优选以WO 03/014079中所公开的氟班色林多晶形A的形式使用。
任选以其游离碱形式、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式使用的氟班色林可以以固体、液体或喷雾剂形式混入常规的药物制剂中。举例而言，该组合物可以以适于口服、直肠、肠胃外给药或适于鼻吸入的形式存在：优选的形式包括例如胶囊、片剂、包衣片剂、安瓿剂、栓剂及鼻腔喷雾剂。
可将该活性成份混入药物组合物中常规使用的赋形剂或载体中，例如：滑石粉、阿拉伯胶、乳糖、明胶、硬脂酸镁、玉米淀粉、水性或非水性溶媒(vehicle)、聚乙烯吡咯烷酮、半合成脂肪酸甘油酯、苯扎氯铵、磷酸钠、EDTA、聚山梨醇酯80。该组合物可方便地以剂量单元进行配制，各剂量单元经调整以供应单个剂量的活性成分。每天适用的剂量范围介于0.1至400毫克之 间，优选介于1.0至300毫克之间，更优选介于2至200毫克之间。各剂量单元可合宜地包含0.01毫克至100毫克、优选0.1至50毫克。
向患者每日1、2、3或4次给药该剂量单元。本发明化合物优选在一段时间内连续地以每天三次或更少次，更优选一次或两次来给药。
优选地，该剂量在一段时间内连续地在早晨和晚上给药患者，更优选是在早晨给药一次(25或50毫克氟班色林)和晚上给药一次(25或50毫克氟班色林)，最优选地仅在晚上给药一次(50或100毫克氟班色林)。
因此，诸如镇静等副作用较不显著。
合适的片剂可通过(例如)将活性物质与已知赋形剂混合而获得，此赋形剂可是例如惰性稀释剂，例如碳酸钙、磷酸钙或乳糖；崩解剂，例如玉米淀粉或海藻酸；粘结剂，例如淀粉或明胶；润滑剂，例如硬脂酸镁或滑石粉；和/或延迟释放剂，例如羧甲基纤维素、醋酸邻苯二甲酸纤维素或聚乙酸乙烯酯。片剂亦可包括若干层。
包衣片剂亦可相应地通过使用通常用于片剂包衣的物质，例如可力酮或虫胶、阿拉伯胶、滑石粉、二氧化钛或糖，以类似于片剂的方式生产的对内核进行包衣而制备。为达成延迟释放或防止不相容性，内核亦可由许多层组成。类似地，该片剂包衣可由许多层组成以达成延迟释放，其可使用上述用于片剂的赋形剂。
包含本发明活性物质或其组合的糖浆或酏剂可另外包含增甜剂，例如糖精、甜精、甘油或蔗糖，和口味改良剂，例如调味品，如香草醛或橙提取物。其也可包含悬浮液助剂或增稠剂，例如羧甲基纤维素钠；湿润剂，例如脂肪醇与环氧乙烷的缩合产物；或防腐剂，例如对羟基苯甲酸酯。
注射溶液以常规方式制备，例如，添加防腐剂如对羟基苯甲酸酯，或稳定剂如乙二胺四乙酸的碱金属盐，并转移至注射小瓶或安瓿中。
含有一种或多种活性物质或活性物质组合的胶囊可通过如将该活性物质与惰性载体如乳糖或山梨醇混合，并将其封装至明胶胶囊内而制得。
适合的栓剂可通过例如与提供用于此目的的载体如中性脂肪或聚乙二醇或其衍生物混合而制得。
实施方式
下面实施例对本发明进行说明而非限制其范围：
药物制剂的实施例
将精细研磨的活性物质、乳糖及一些玉米淀粉混合在一起。对混合物进行过筛，然后用聚乙烯吡咯烷酮溶于水的溶液润湿、进行揉捏、湿法制粒并干燥。对此颗粒、剩余的玉米淀粉及硬脂酸镁进行筛分并混合在一起。对将该混合物压制以制备适宜形状及大小的片剂。
将精细研磨的活性物质、一些玉米淀粉、乳糖、微晶纤维素及聚乙烯吡咯烷酮混合在一起，对该混合物进行过筛，并用剩余的玉米淀粉及水进行处理以形成颗粒，其经过干燥和筛分。添加羧甲基淀粉钠及硬脂酸镁，并将其混合，对该混合物进行压制以形成适宜大小的片剂。
将活性物质、玉米淀粉、乳糖及聚乙烯吡咯烷酮完全混合并用水润湿。将该湿团块穿过1毫米网目大小的筛，在约45℃下干燥，然后将该颗粒穿过相同的筛。将硬脂酸镁混合后，在片剂制造机中压制直径6毫米的凸面片剂核心。以已知方法用基本上由糖和滑石粉组成的涂层对由此制造的片剂核心进行包衣。用蜡对精制的糖衣片剂磨光。
将物质及玉米淀粉混合并用水弄湿。对湿团块进行过筛及干燥。对干燥颗粒进行过筛并与硬脂酸镁混合。将精制的混合物封装至1号硬明胶胶囊中。
E)安瓿溶液
氟班色林 50毫克
氯化钠 50毫克
注射用水 5毫升
将该活性物质以其自身的pH值或任选以5.5至6.5的pH值溶解于水中，并添加氯化钠使其等渗。对所得溶液进行过滤使其不含致热原，并在无菌条件下将滤液转移至安瓿中，然后对安瓿实施灭菌并通过熔融法加以密封。
将硬质脂肪熔化。在40℃下使经研磨活性物质均匀地分散。将其冷却至38℃并倾倒至轻微冷冻的栓剂模中。
临床试验结果
在下文中，提供证明氟班色林在治疗绝经前妇女性疾病中的效果的临床试验的实验数据。
为在绝经前女性HSDD患者中比较氟班色林(最大日总剂量：100毫克一天2次)与安慰剂的效果，将此试验设计为前瞻性、多中心、十二周、随机、双盲、安慰剂对照、概念验证(proof of concept)、平行组的试验。对于各治疗组，随机分配七十五名患者。
设计此概念验证试验以用来评价在健康的女性HSDD患者中是否十二周的氟班色林治疗产生临床上有意义的治疗响应(如由DSM-IV标准所确定)。与平行的安慰剂组相比较，评价氟班色林的效力。
在大约二十八天的筛选期(无治疗)后，将符合条件的患者随机划分至该试验的十二周、双盲的部分中，在此试验期间，其在早晨和在相隔约12小时的晚上服用研究药物。
根据DSM-IV标准，患者必须是18至45岁的绝经前女性且经初步诊断为患有获得型的HSDD。截止到基线访问，最近发作必须持续至少24周。
基线严重度标准来自亚利桑那性经验量表(Arizona Sexual Experiences Scale)，在性冲动项目上需要5或6的评分(非常弱的或无性冲动)。(McGahuey CA.等人,Psychiatric Annals 1999;29(1):39-45;McGahuey CA.等人,J.Sex Marital Therapy2000;26:25-44)。
剂量分配为简单的随机分配，在第8周可实施一倍加量给药(one-time up titration)。开始剂量为早晨一片片剂和晚上一片片剂。
指导患者尽可能地接近于每十二小时一次服用不知情的研究药物。建议不要以小于十小时的间隔服药。若漏服了一次剂量，则按照计划服用下一规定剂量。不服用双倍剂量。建议患者用150毫升(五盎司)水服用各剂量的研究药物。
若患者在第56天(第8周)未显示研究者认为有意义的进展且无严重的或不能忍受的负面事件，则将每天片剂数目自早晨和晚上各一片片剂加倍，将氟班色林的剂量自50毫克一天2次增加至100毫克一天2次，或将对照剂组中患者的安慰片剂数目自每天两片加倍至每天四片。
作为一个证明氟班色林在治疗绝经前妇女HSDD中的效力的效力变量，将交互式语音响应-女性性行为问卷(interactive Voice Response-Female Sexual Behavior Question,IVR-FSBQ)设计为使用电话完成的简单自填问卷以量测性欲相关的情感及事件。为促进其应用的灵活性，在此试验中于每周基础上通过由Healthcare Technology Systems公司开发及管理的IVR系统使用FSBQ。
下面显示IVR-FSBQ(性欲相关)。
1.上周你陷于性念想(例如念及做爱或性幻想)的频率如何
如果一点都没有，请按0
如果有一天，请按1
如果有两天，请按2
如果有三天但不是每天，请按3
如果每天都有，请按4
如果每天大于1次，请按5
在FAS(完全分析数据集)上进行终点分析。除非另外指明，否则使用数据评价的LOCF法(末次观察向前归入)。
为符合机能减退的性欲障碍的DSM-IV标准，性欲缺乏的严重度要求为“永久性或反复性缺乏(或缺少)性幻想及性活动欲望”。因此，IVR-FSBQ问题1“上周你陷于性念想(例如念及做爱或性幻想)的频率如何”对于证明氟班色林是否可治疗性欲障碍是不可缺少的。此临床试验的一个主要结果是介于用氟班色林及用安慰剂治疗的患者之间在此问题(即，对基线的每月平均变化)上的差别。图1中显示的为对于性念想频率，相对于基线评分的IVR-FSBQ每月平均变化(LOCF；柱形线=标准误差)，该图清楚地证明了氟班色林在治疗绝经前妇女性欲障碍中的效力。
Claims (17)
1.氟班色林，任选以其游离碱、药理学上可接受的酸加成盐形式和/或任选以其水合物和/或溶剂合物形式在制备用于治疗妇女绝经前性欲障碍的药物中的用途。
2.如权利要求1的用途，其特征在于所述绝经前性欲障碍选自绝经前机能减退的性欲障碍、绝经前性厌恶障碍、绝经前性欲缺失、绝经前性欲缺乏、绝经前性欲降低、绝经前性欲抑制、绝经前性冲动缺失、绝经前性冲动紊乱，以及绝经前性冷淡。
3.如权利要求1或2的用途，其特征在于所述绝经前性欲障碍选自绝经前机能减退的性欲障碍、绝经前性厌恶障碍、绝经前性欲缺失、绝经前性欲缺乏、绝经前性欲降低、绝经前性欲抑制。
4.如权利要求1、2或3的用途，其特征在于所述绝经前性欲障碍为终生性型。
5.如权利要求1、2或3的用途，其特征在于所述绝经前性欲障碍为获得性型。
6.如前述权利要求中一项或多项的用途，其特征在于所述绝经前性欲障碍为泛发性亚型。
7.如前述权利要求中一项或多项的用途，其特征在于所述绝经前性欲障碍为情境性亚型。
8.如前述权利要求中一项或多项的用途，其特征在于所述绝经前性欲障碍是由心理因素引发。
9.如前述权利要求中一项或多项的用途，其特征在于所述绝经前性欲障碍是由器质因素引发。
10.如前述权利要求中一项或多项的用途，其特征在于所述绝经前性欲障碍是由组合因素引发。
11.如前述权利要求中一项或多项的用途，其特征在于氟班色林是以选自由下列酸形成的可药用的酸加成盐的形式施用：琥珀酸、氢溴酸、乙酸、富马酸、马来酸、甲磺酸、乳酸、磷酸、氢氯酸、硫酸、酒石酸、柠檬酸，及其混合物。
12.如前述权利要求中一项或多项的用途，其特征在于氟班色林是以其游离碱形式施用。
13.如权利要求12的用途，其特征在于氟班色林是以游离碱多晶形A形式施用，其当使用DSC测量时具有约161℃的熔点。
14.如前述权利要求中一项或多项的用途，其特征在于氟班色林是以介于0.1至400毫克/天之间的剂量范围施用。
15.如前述权利要求中一项或多项的用途，其特征在于氟班色林在一段时间内连续地每天一次或两次施用。
16.如前述权利要求中一项或多项的用途，其特征在于氟班色林是在早晨及晚上施用，更优选是早晨一次25或50毫克氟班色林及晚上一次25或50毫克氟班色林。
17.如前述权利要求中一项或多项的用途，其特征在于氟班色林在一段时间内连续地仅在晚上施用一次50或100毫克氟班色林。
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| KR20090042967A (ko) * | 2006-08-14 | 2009-05-04 | 베링거 인겔하임 인터내셔날 게엠베하 | 플리반세린 제형 및 이의 제조방법 |
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