TWI389689B - 氟利本西林（ｆｌｉｂａｎｓｅｒｉｎ）於治療停經前性慾疾病之用途 - Google Patents
氟利本西林（ｆｌｉｂａｎｓｅｒｉｎ）於治療停經前性慾疾病之用途 Download PDFInfo
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- TWI389689B TWI389689B TW095141075A TW95141075A TWI389689B TW I389689 B TWI389689 B TW I389689B TW 095141075 A TW095141075 A TW 095141075A TW 95141075 A TW95141075 A TW 95141075A TW I389689 B TWI389689 B TW I389689B
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
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Description
本發明係關於氟利本西林於製備用於治療停經前性慾疾病之藥物中之用途。
化合物1－[2－(4－(3－三氟甲基－苯基)哌嗪－1－基)乙基]－2,3－二氫－1H－苯并咪唑－2－酮(氟利本西林)以其鹽酸鹽形式揭示於歐洲專利申請案第EP－A－526434號中，且具有以下化學結構：
氟利本西林可顯示對5－HT1 A
及5－HT2
－受體的親和力。因此，其為一種有前景的用於治療多種疾病(例如抑鬱、精神分裂症、及焦慮)的治療藥劑。
一般性術語「性疾病」包括：性慾疾病、性喚起疾病、性高潮疾病、性疼痛疾病、由一般醫療條件引起的性功能障礙、物質誘發的性功能障礙、及未有特殊說明的性功能障礙(Diagnostic and Statistical Manual of Mental Disorders，第4版，Text Revision.Washington DC,美國精神病學協會，2000)。
在對患有性功能障礙的停經前女性患者的研究中發現，9氟利本西林(視情況以游離鹼、藥理學上可接受之酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)可展示性慾增強特性。因此，本發明係關於氟利本西林(視情況呈游離鹼、藥理學上可接受之酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備一用於治療停經前婦女性慾疾病之藥物中之用途。
本發明中術語「治療停經前性慾減退疾病」等具有「治療停經前婦女性慾減退疾病」之含義。
無論性慾疾病是終生存在的還是後天獲得的、是「一般型的」或「情境型的」及不依賴病原學起因的(器質性的－兩種情況：身體上及藥物造成者－、心理引發者(由心理因素引發)、器質性的－兩種情況：身體上及藥物造成者－及心理引發者(由組合因素引發)之組合，或未知者)，皆可觀察到氟利本西林的有益效應。術語「終生性」指本發明中性慾疾病係自從性機能初始即一直存在的。術語「後天獲得性」指本發明中性疾病係僅在正常的性機能時期後發生的。「一般型」指本發明中性疾病並不限於刺激、情境、或伴侶的特定類型。「情境型」指本發明中性疾病侷限於刺激、情境、或伴侶的特定類型。由「心理因素」引發的亞型適用於當心理因素在性疾病之發病、嚴重度、惡化、或維持中之判斷扮演重要角色，且一般醫療條件及物質對該性疾病之病因並無作用。由「組合因素」引發的亞型適用於當1)心理因素在該性疾病之發病、嚴重度、惡化、或維持中之判斷扮演重要角色，且2)一般醫療條件或物質使用經判斷亦促進但不足以誘發一性疾病時(Diagnostic and Statistical Manual of Mental Disorders，第4版，Text Revision.Washington DC，American Psychiatric Association，2000)。
因此，舉例而言，術語「終生性停經前性慾減退疾病」指自從性機能初始一直存在的停經前婦女活性減退的性慾疾病，及術語「後天獲得性停經前性慾減退疾病」指在正常的性機能時期後發生的停經前婦女性慾減退疾病。
因此，在一較佳實施例中，本發明係關於氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由下列組成之群之疾病的藥物中之用途：停經前性慾減退疾病(HSDD)、停經前性厭惡疾病、停經前性慾缺失、停經前性慾缺乏、停經前性慾降低、停經前性慾抑制、停經前性衝動缺失、停經前性衝動紊亂、及停經前性冷淡。
本發明尤佳者係氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由下列組成之群之疾病的藥物中之用途：停經前性慾減退疾病、停經前性厭惡疾病、停經前性慾缺失、停經前性慾缺乏、停經前性慾降低、及停經前性慾抑制。
在一尤佳實施例中，本發明係關於氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由停經前性慾減退疾病、停經前性慾缺失、停經前性慾降低、及停經前性慾抑制組成之群之疾病的藥物中之用途。
在另一較佳實施例中本發明係關於氟利本西林(視情況呈游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由下列組成之群之疾病的藥物中之用途：終生性停經前性慾減退疾病、終生性停經前性厭惡疾病、終生性停經前性慾缺失、終生性停經前性慾缺乏、終生性停經前性慾降低、終生性停經前性慾抑制、終生性停經前性衝動缺失、終生性停經前性衝動紊亂、及終生性停經前性冷淡。
本發明尤佳者係氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由下列組成之群之疾病的藥物中之用途：終生性停經前性慾減退疾病、終生性停經前性厭惡疾病、終生性停經前性慾缺失、終生性停經前性慾缺乏、終生性停經前性慾降低、及終生性停經前性慾抑制。
在一尤佳實施例中，本發明係關於氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由終生性停經前性慾減退疾病、終生性停經前性慾缺失、終生性停經前性慾降低、及終生性停經前性慾抑制組成之群之疾病的藥物中之用途。
在另一較佳實施例中本發明係關於氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由下列組成之群之疾病的藥物中之用途：後天獲得性停經前性慾減退疾病、後天獲得性停經前性厭惡疾病、後天獲得性停經前性慾缺失、後天獲得性停經前性慾缺乏、後天獲得性停經前性慾降低、後天獲得性停經前性慾抑制、後天獲得性停經前性衝動缺失、後天獲得性停經前性衝動紊亂、及後天獲得性停經前性冷淡。
本發明進一步較者係氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式於製備用於治療選自由下列組成之群之疾病的藥物中之用途：後天獲得性停經前性慾減退疾病、後天獲得性停經前性厭惡疾病、後天獲得性停經前性慾缺失、後天獲得性停經前性慾缺乏、後天獲得性停經前性慾降低、後天獲得性停經前性慾抑制。
在一尤佳實施例中，本發明係關於氟利本西林(視情況以游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式)於製備用於治療選自由後天獲得性停經前性慾減退疾病、後天獲得性停經前性慾缺失、後天獲得性停經前性慾降低、及後天獲得性停經前性慾抑制組成之群之疾病的藥物中之用途。
此外，本發明係關於任何上文提及之病況之一般的或情境的亞類及/或係關於該等由器質因素、心理因素引發或由組合因素引發者。
氟利本西林可視情況以游離鹼形式、以其醫藥上可接受的酸加成鹽形式及/或視情況以其水合物及/或溶劑合物形式使用。適合的酸加成鹽包括(例如)選自琥珀酸、氫溴酸、乙酸、富馬酸、馬來酸、甲磺酸、乳酸、磷酸、氫氯酸、硫酸、酒石酸及檸檬酸之酸之彼等。亦可使用上文提及之酸加成鹽的混合物。在前面提及之酸加成鹽中，氫氯酸化物及氫溴化物、尤其氫氯酸化物較佳。若氟利本西林以游離鹼形式使用，較佳以WO 03/014079中揭示的氟利本西林多晶物A之形式使用。
視情況以游離鹼形式、藥理學上可接受的酸加成鹽及/或視情況以其水合物及/或溶劑合物形式使用的氟利本西林可納入呈固體、液體或噴霧劑形式的習用醫藥製劑中。舉例而言，該組合物可以一適合經口、經直腸、非經腸給藥或適合鼻吸入的形式存在：較佳形式包括(例如)膠囊、錠劑、糖衣片劑、安瓿劑、栓劑及鼻腔噴霧劑。
該活性成份可納入在醫藥組合物中習用的賦形劑或載劑中，例如：滑石粉、阿拉伯膠、乳糖、明膠、硬脂酸鎂、玉米澱粉、水性或非水性媒劑、聚乙烯吡咯烷酮、半合成脂肪酸甘油酯、氯苄烷銨、磷酸鈉、EDTA、聚山梨醇酯80。該等組合物可方便地以劑量單元進行調配，各劑量單元經調整以供應一單次劑量的活性成分。每天適用的劑量範圍介於0.1至400之間，較佳介於1.0至300之間，更佳介於2至200毫克之間。各劑量單元可合宜地包含自0.01毫克至100毫克、較佳自0.1至50毫克。
該等劑量單元係每日1、2、3、或4次投與患者。本發明化合物較佳係經一段時間連續地以每天三次或更少次、更佳係一次或兩次來投與。
該劑量較佳係經一段時間連續地在早晨及晚上投與患者，更佳係在早晨投與一次(25或50毫克氟利本西林)及晚上投與一次(25或50毫克氟利本西林)，最佳係僅在晚上投與一次(50或100毫克氟利本西林)。
因此，諸如鎮靜等副作用較不顯著。
適合的錠劑可藉由(例如)將活性物質與已知賦形劑混合而獲得，該等賦形劑可係例如惰性稀釋劑，例如碳酸鈣、磷酸鈣或乳糖；崩解劑，例如玉米澱粉或海藻酸；黏結劑，例如澱粉或明膠；潤滑劑，例如硬脂酸鎂或滑石粉；及/或延遲釋放劑，例如羧甲基纖維素、乙酸鄰苯二甲酸纖維素、或聚乙酸乙烯基酯。錠劑亦可包括若干層。
包衣錠劑亦可相應地藉由使用通常用於錠劑塗層之物質(例如可力酮或蟲膠、阿拉伯樹膠、滑石粉、鈦白或醣)對以類似於錠劑之方式生產的內核進行塗覆而製備。為達成延遲釋放或防止不相容，內核亦可由許多層組成。同樣地，該錠劑塗層可由許多層組成以達成延遲釋放，可使用上述用於錠劑之賦形劑。
包含本發明活性物質或其組合之糖漿或酏劑可額外包含一增甜劑(例如糖精、甜精、甘油或醣)及一口味改良劑(例如一調味品，如香草醛或柑桔提取物)。其亦可包含懸浮液佐劑或增稠劑，例如羧甲基纖維素鈉；濕潤劑，例如脂肪醇與環氧乙烷之縮合產物；或保存劑，例如對羥基苯甲酸酯。
注射溶液係以一通常方式製備，例如，添加保存劑(例如對羥基苯甲酸酯)、或穩定劑(例如乙二胺四乙酸的鹼金屬鹽)，並轉移至注射小瓶或安瓿中。
包含一或多種活性物質或活性物質組合之膠囊可藉由(例如)將該等活性物質與惰性載劑(例如乳糖或山梨醇)混合並將其封裝至明膠膠囊內而製備。
適合的栓劑可藉由(例如)與提供用於此目的之載劑(例如中性脂肪或聚乙二醇或其衍生物)混合而製得。
隨附實例對本發明進行說明而非限制其範圍：
將精細研磨的活性物質、乳糖及一些玉米澱粉混合在一起。對混合物進行篩分，然後用聚乙烯吡咯烷酮溶於水之溶液弄濕、進行揉捏、濕法製粒並實施乾燥。對該等粒料、剩餘的玉米澱粉及硬脂酸鎂實施篩分並混合在一起。對該混合物實施壓製以產生適合形狀及大小的錠劑。
將精細研磨的活性物質、一些玉米澱粉、乳糖、微晶纖維素及聚乙烯吡咯烷酮混合在一起，對該混合物實施篩分，並用剩餘的玉米澱粉及水進行處理以形成經乾燥及篩分的顆粒。添加羧甲基澱粉鈉及硬脂酸鎂並使其混入，對該混合物實施壓製以形成適宜大小之錠劑。
將活性物質、玉米澱粉、乳糖及聚乙烯吡咯烷酮完全混合並用水弄濕。推動該濕團塊穿過一具有1毫米網目大小的篩，在約45℃下實施乾燥，然後使粒料穿過相同的篩。將硬脂酸鎂混入後，在錠劑製造機中壓製直徑6毫米的凸面錠劑核心。以熟知方法用主要由醣及滑石粉組成的塗層對如此製造的錠劑核心實施塗覆。用蠟對精製的糖衣片劑實施磨光。
將物質及玉米澱粉混合並用水弄濕。對濕團塊實施篩分及乾燥。對乾燥粒料實施篩分並與硬脂酸鎂混合。將精製的混合物封裝至1號硬明膠膠囊中。
E)安瓿劑溶液
氟利本西林 50毫克氯化鈉 50毫克注射用水 5毫升
將該活性物質以其自身的pH值或視情況以5.5至6.5的pH值溶解於水中，並添加氯化鈉以使其等滲。對所得溶液實施過濾使其不含致熱原，並在無菌條件下將濾液轉移至安瓿中，然後對安瓿實施滅菌並藉由熔融法加以密封。
將硬質脂肪熔化。在40℃下使經研磨活性物質均勻地分散。將其冷卻至38℃並傾倒至輕微冷凍的栓劑模中。
在下文中，提供一證明氟利本西林在治療停經前婦女性疾病中之效果之臨床試驗的實驗數據。
此試驗經設計為一比較氟利本西林(最大日總劑量：100毫克b.i.d.)與安慰劑在停經前去性HSDD患者中之效果的預期的、多中心、十二週、隨機、雙盲、安慰劑對照、概念驗證、平行組的試驗。對於各治療組，七十五名患者係隨機化的。
此概念驗證試驗經設計以評價在健康的女性HSDD患者中(如由DSM－IV標準所確定)是否十二週的氟利本西林治療產生一在臨床上有意義的治療響應。與一平行的安慰劑組相比較，對氟利本西林之效力進行評價。
在一大約二十八天的篩選期(無治療)後，將適宜患者隨機劃分至該試驗之十二週、雙盲的部分中，在此試驗期間，其在早晨及在相隔約12小時的晚上服用研究藥物。
根據DSM－IV標準，患者必須是18至45歲的停經前女性且經初步診斷為患有後天獲得類的HSDD。截止到基線訪問，最近發作必須持續至少24週。基線嚴重度尺度係來自亞利桑那性經驗量表(Arizona Sexual Experiences Scale)，在性衝動項目上需要5或6的評分(非常弱的或無性衝動)。(McGahuey CA.等人，Psychiatric Annals 1999；29(1)：39－45；McGahuey CA.等人，J.Sex Marital Therapy 2000；26：25－44)。
該劑量分配為一簡單的隨機分配，在第8週可實施一次起床滴定。開始劑量為早晨一片錠劑及晚上一片錠劑。
指導患者盡可能地接近於每十二小時一次服用不知情的研究藥物。建議不要以小於十小時之間隔服藥。若漏服了一次劑量，則按照計劃服用下一規定劑量。不服用雙倍劑量。建議患者用150毫升(五盎司)水服用各劑量的研究藥物。
若患者在第56天(第8週)未顯示研究者認為有意義的進展且無嚴重的或不能忍受的負面事件，則將每天錠劑數目自早晨及晚上各一片錠劑加倍，將氟利本西林的劑量自50毫克b.i.d.增加至100毫克b.i.d.，或將對照劑組中患者的安慰錠劑數目自每天兩片加倍至每天每天四片。
作為一個證明氟利本西林在治療停經前婦女HSDD中之效力的效力變量，將交互式語音響應－去性性行為問卷(IVR－FSBQ)設計為一使用電話完成的簡單自填問卷以量測性慾相關的情感及事件。為促進其應用的依從性，在此試驗中於每週基礎上經由一由Healthcare Technology Systems公司開發及管理的IVR系統使用FSBQ。
下面顯示IVR－FSBQ(與性慾相關)。
1. How often did you engage in sexual thoughts such as thinking about having sex or sexual fantasies,this past week？If not at all in the past week－Press 0 If on one day in the past week－Press 1 If on two days in the past week－Press 2 If on three days or more but not every day in the past week－Press 3 If everyday this past week－Press 4 If more than once per day in the past week－Press 5
終點分析在FAS(完全分析數據集)上實施。除非另外指明，否則使用數據評價的LOCF法(末次觀察向前歸入)。
為符合性慾減退疾病之DSM－IV標準，性慾缺乏的嚴重度要求為「persistently or recurrently deficient(or absent)sexual fantasies and desire for sexual activity(永久性或反覆性缺乏(或缺少)性幻想及性活動欲望)」。因此，IVR－FSBQ問題1「How often did you engage in sexual thoughts such as thinking about having sex or sexual fantasies,this past week(你陷於性念想(例如念及做愛或性幻想)的頻率如何)？」對於證明氟利本西林是否可治療性慾疾病係不可缺少的。此臨床試驗之一主要結果係介於用氟利本西林及用安慰劑治療的患者之間的此問題(即，對基線的每月平均變化)上的差別。圖1中展示一針對性念想頻率的IVR－FSBQ對基線評分每月平均變化圖，該圖清晰地說明瞭氟利本西林在治療停經前婦女性慾疾病中的效力。
圖1是治療後IVR－FSBQ性念想頻率對基線的每月總平均變化(LOCF；柱形線＝標準誤差)。
Claims (14)
- 一種視情況呈游離鹼、藥理學上可接受的酸加成鹽形式及/或視情況呈其水合物及/或溶劑合物形式的氟利本西林的用途，其係用於製備用於治療婦女停經前性慾疾病之藥物，其中該藥物係經一段時間連續地每天施用一次。
- 如請求項1之用途，其特徵在於該停經前性慾疾病係選自由停經前性慾減退疾病、停經前性厭惡疾病、停經前性慾缺失、停經前性慾缺乏、停經前性慾降低、停經前性慾抑制、停經前性衝動缺失、停經前性衝動紊亂、及停經前性冷淡組成之群。
- 如請求項1之用途，其特徵在於該停經前性慾疾病係停經前性慾減退疾病。
- 2或3之用途，其特徵在於該停經前性慾疾病係為一終生性型。
- 2或3之用途，其特徵在於該停經前性慾疾病係為後天獲得性型。
- 2或3之用途，其特徵在於該停經前性慾疾病係為一般性亞型。
- 2或3之用途，其特徵在於該停經前性慾疾病係為情境性亞型。
- 2或3之用途，其特徵在於該停經前性慾疾病係由心理因素引發。
- 2或3之用途，其特徵在於該停經前性慾疾病係由器質因素引發。
- 2或3之用途，其特徵在於該停經前性慾疾病係由組合因素引發。
- 2或3之用途，其特徵在於氟利本西林係以選自由選自琥珀酸、氫溴酸、乙酸、富馬酸、馬來酸、甲磺酸、乳酸、磷酸、氫氯酸、硫酸、酒石酸、檸檬酸、及其混合物之酸形成之鹽的醫藥上可接受之酸加成鹽的形式施用。
- 2或3之用途，其特徵在於氟利本西林係以其游離鹼形式施用。
- 如請求項12之用途，其特徵在於氟利本西林係以當使用DSC量測時具有一約161℃之熔點的游離鹼多晶物A形式施用。
- 2或3之用途，其特徵在於氟利本西林係經一段時間連續地僅在晚上施用一次(50或100毫克氟利本西林)。
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| CA2626134C (en) * | 2005-10-29 | 2013-12-24 | Boehringer Ingelheim International Gmbh | Benzimidazolone derivatives for the treatment of premenstrual and other female sexual disorders |
| US20070123540A1 (en) * | 2005-10-29 | 2007-05-31 | Angelo Ceci | Sexual desire enhancing medicaments comprising benzimidazolone derivatives |
| WO2007093624A2 (en) * | 2006-02-18 | 2007-08-23 | Boehringer Ingelheim International Gmbh | Pharmaceutical compositions for the treatment of attention deficit hyperactivity disorder comprising flibanserin |
| JP2009527525A (ja) * | 2006-02-20 | 2009-07-30 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 尿失禁治療用のベンゾイミダゾロン誘導体 |
| JP2009528322A (ja) * | 2006-02-28 | 2009-08-06 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | フリバンセリンによる弁膜性心疾患の治療又は予防 |
| ATE456369T1 (de) * | 2006-06-30 | 2010-02-15 | Boehringer Ingelheim Int | Flibanserin zur behandlung von harninkontinenz und assoziierten erkrankungen |
| US20090318469A1 (en) * | 2006-07-14 | 2009-12-24 | Boehringer Ingelheim International Gmbh | Use of Flibanserin for the Treatment of Sexual Disorders in Females |
| WO2008006839A2 (en) * | 2006-07-14 | 2008-01-17 | Boehringer Ingelheim International Gmbh | Combinations of flibanserin with caffeine, process for their preparation and use thereof as medicaments |
| EA200900264A1 (ru) * | 2006-08-14 | 2009-08-28 | Бёрингер Ингельхайм Интернациональ Гмбх | Композиции флибансерина и способ их приготовления |
| CL2007002214A1 (es) * | 2006-08-14 | 2008-03-07 | Boehringer Ingelheim Int | Composicion farmaceutica en la forma de comprimido, donde al menos la longitud del comprimido en el estado anterior de la aplicacion es al menos 7/12 del diametro pilorico del paciente y despues de ingerirlo en estado alimentado, la longitud del comp |
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