CN1449288A - 沙美特罗和丙酸氟地松的药物制剂 - Google Patents
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Abstract
本发明涉及沙美特罗和丙酸氟地松的组合物用于治疗慢性阻塞性肺病的用途。
Description
本发明涉及沙美特罗和丙酸氟地松组合物在治疗慢性阻塞性肺病方面的用途。
β-2肾上腺素能拮抗剂沙美特罗或其生理学上可接受的盐和皮质类固醇丙酸氟地松的组合物在治疗气喘病和其它呼吸疾病方面的用途已记述于GB 2 235 627中。
由GB 2 088 877,已知丙酸氟地松本身具有抗炎活性,并且有用于治疗鼻、喉或肺的过敏性和炎性症状,如气喘病和鼻炎,包括干草热。然而,例如如Calverley和Barnes在American Journal ofRespiratory and Critical Medicine第161卷第341-344页(2000年)中的编者案中所述,吸入的皮质类固醇在治疗慢性阻塞性肺病方面的临床用途是不确定的。
沙美特罗由GB 2 140 800已知,并且在临床上以其xinafoate盐的形式用于治疗气喘病和慢性阻塞性肺病。
慢性阻塞性肺病(COPD)为包括慢性支气管炎、肺气肿和慢性阻塞性气道疾患在内的一般性术语。COPD是慢性的缓慢渐进的病症,其特征在于几个月期间无显著变化的气道障碍。不同于气喘病,由FEV1(强迫呼气体积)测量的COPD的气流限制可以再回复不到正常值。COPD的症状可随疾病的严重性而变化,包括带或不带痰的咳嗽和带或不带喘鸣的气绝(呼吸困难)。1990年至1992年间,在英国65岁以上人口中,81500例死亡是归因于COPD。目前仍存在着对可用于临床上控制COPD的进一步的治疗剂的需求。
在一个更为特别的方面,本发明涉及治疗和减轻与COPD相关的症状,尤其是治疗和减轻气绝,涉及健康状况的提高和降低病情恶化速度,包括需要用口服皮质类固醇治疗的那些。
我们现在提出的是,沙美特罗或其生理学上可接受的盐与丙酸氟地松的组合物的使用可以在治疗COPD方面相对于单独使用沙美特罗具有临床上的优点。
因此,本发明提供一种治疗哺乳动物比如人的COPD的方法,其包括使用有效量的沙美特罗或其生理学上可接受的盐比如xinafoate盐与丙酸氟地松的组合物。
在供选择的方案中,提供了沙美特罗或其生理学上可接受的盐比如xinafoate盐与丙酸氟地松的组合物在生产治疗COPD的药物方面的用途。
在此使用的术语“治疗”是指临床结果的改善,例如肺功能的改善和/或诸如带或不带喘鸣的气绝(呼吸困难)等症状的减轻,和/或健康状况的改善,和/或病情恶化速度的降低,包括需要用口服皮质类固醇治疗的那些。健康状况可以用《圣乔治呼吸调查表(St.George′sRespiratory Questionnaire)》(Jones PW,Quirk FH,BaveystockGM,和Littlejohns P.,A self-complete measure of healthstatus for chronic airflow limitation.The St George′sRespiratory Questionnaire,Am.Rev.Respir.Dis.,145卷,1321-7页,1992年)进行测量。
在本说明书和随后的权利要求中,除非内容另有所需,“包含”一词应被理解为意在包括所称的整数或步骤或整数组,但不排除任何其它整数或步骤或整数或步骤组。
应理解的是,沙美特罗和丙酸氟地松组合物的混合物可以在相同或不同的药物制剂中同时给药,或顺序给药。当顺序给药时,第二种或任何连续活性成分的延迟给药不应导致活性成分组合物失去有益的治疗作用。在本发明的一个优选方面中,沙美特罗或其生理学上可接受的盐与丙酸氟地松是以复合药物制剂的形式给药。根据本发明给药的沙美特罗与氟地松的重量/重量比优选范围为4∶1至1∶20。
获得治疗效果所需的沙美特罗或其生理学上可接受的盐比如xinafoate盐以及丙酸氟地松的量当然会随着特殊盐型、给药途经、治疗主体和所治疗的特殊病症或疾病而变化。本发明组合物通过吸入对成人的给药剂量可为丙酸氟地松每日50μg-2000μg,合适地为每日100μg/-1500μg,更合适地为每日500μg-1000μg,和沙美特罗为每日50μg-200μg,合适地为每日50μg-100μg。优选的组合物包含250μg或500μg的丙酸氟地松和50μg的沙美特罗。所述每日剂量可分为几个分剂量给药,例如每日两次。
虽然沙美特罗或其生理学上可接受的盐比如xinafoate盐和丙酸氟地松以生药形式给药是可能的,但优选其各自是以药物制剂的形式提供。
在下文中,术语“活性成分”是指沙美特罗或其生理学上可接受的盐比如xinafoate盐和/或丙酸氟地松。
合适的制剂包括适于口服、肠胃外(包括皮下、皮内、肌内、静脉内和关节内)、吸入(包括可通过各种不同类型的计量剂量加压气溶胶、喷雾器或吹入器产生的微粒粉剂或雾剂)、直肠和局部(包括皮肤、口腔、舌下和眼内)给药的那些制剂,而最合适的途经可取决于例如受药者的状况和病症。所述制剂可以方便地以单位剂量形式提供,并且可以通过药物领域任何众所周知的方法进行制备。所有方法均包括使活性成分与构成一种或多种辅助成分的载体缔和的步骤。一般而言,通过均匀且紧密地使活性成分与液体载体或细碎固体载体或其两者缔和而制备所述制剂,随后如果需要的话,使产品成形为所需的剂型。
优选地,根据本发明使用的药物制剂适于通过吸入方式给药。吸入型制剂可以是优选含有乳糖的粉剂组合物形式,或喷雾剂组合物形式,其可以例如以水溶液或悬浮液或以由加压包(pressurisedpacks)产生的气溶胶形式制剂,利用了合适的发生剂(propellant),例如二氯二氟甲烷、三氯氟甲烷、二氯四氟乙烷、1,1,1,2,3,3,3-七氟丙烷、1,1,1,2-四氟乙烷、二氧化碳或其它合适的气体。用于本发明的合适的气溶胶喷雾制剂组合物记述于WO 93/11743中。
优选的制剂是粉剂组合物,其含有沙美特罗或其生理学上可接受的盐比如xinafoate盐、丙酸氟地松和乳糖。
另一优选制剂是气溶胶制剂,其组成为沙美特罗或其生理学上可接受的盐比如xinafoate盐、丙酸氟地松和1,1,1,2,3,3,3-七氟丙烷和/或1,1,1,2-四氟乙烷作为发生剂。
可以配制形成用于吸入器或吹入器的例如明胶胶囊和药筒,或例如层压铝箔的泡(blisters),其含有本发明化合物的粉剂混合物和合适的粉末基体比如乳糖或淀粉。
用于通过喷雾吸入的溶液可以用含水赋形剂和附加的试剂比如酸或碱、缓冲盐、等渗调节剂或抗微生物剂来制剂。可通过过滤或在高压釜中加热而对其进行灭菌,或以非灭菌产品形式提供。
应理解的是,除了上述特别提到的成分外,本发明所使用的制剂还可以包含本领域常规的与所涉及的制剂类型相关的其它试剂,例如适于口服给药的那些制剂可以包含调味剂。另外,根据本发明所使用的沙美特罗或其生理学上可接受的盐比如xinafoate盐和丙酸氟地松的组合物可以与其它活性成分结合使用,例如与其它支气管扩张药,合适的是抗胆碱能药,比如药薯(ipratropium)、tiotropium或oxitropium,或甲基黄嘌呤比如1,3-二甲基黄嘌呤,另一种抗感染药比如色甘酸钠或萘多罗米钠,抗组胺剂或粘液溶解剂。
因此,根据本发明的另一方面,提供了一种用于治疗COPD的药物组合物,其含有沙美特罗或其生理学上可接受的盐比如xinafoate盐和丙酸氟地松,以及药学上可接受的载体或赋形剂,并任选地含有一种或多种其它的治疗剂。优选的是,所述药物制剂是以适于吸入的形式。
实施例
进行随机双盲对比组的六个月临床试验,以对比吸入的沙美特罗和丙酸氟地松组合物产品、吸入的沙美特罗、吸入的丙酸氟地松和空白对照剂对COPD患者的疗效。用沙美特罗/丙酸氟地松50μg/500μg(165患者)、或沙美特罗50μg(160患者)、或丙酸氟地松500μg(168患者)、或空白对照剂(181患者)治疗每组患者,均通过干粉吸入器(DISKUSTM,Glaxo Wellcome)每日给药两次。沙美特罗作为所述组合物产品的一部分和作为单一治疗剂,是以其xinafoate盐的形式给药。在本研究中所包括的71%的患者复合COPD的弱可逆标准,即ΔFEV1小于在吸入400μg沙丁胺醇(一种短效β-2拮抗剂)后所预测的10%。治疗第一天的预剂量FEV1与随后的治疗就诊时的预剂量FEV1之差的测量结果示于图1中。类似地测量了后剂量FEV1和PEFR,得到的结果分别示于图2和图3中。还测量了每次就诊时的过渡性呼吸困难记分(The Transitional Dyspnea Score,TIDI,参见MahlerDA,Weinberg DH,Wells CK,和Feinstein AR;Chest,(1984)85:751-8),结果示于表4中。
在另一空白对照剂对照的对COPD患者的12个月治疗期的临床试验中,吸入的沙美特罗xinafoate盐和丙酸氟地松的组合物产品的有规则使用迅速改进了肺功能,减少了气绝,并减少了减痛药物的使用。图5示出了参与试验的所有患者(意图治疗的人群)随时间的预剂量FEV1平均改进。图6示出了不需减痛药物(VentolinTM(沙丁胺醇),Glaxo Wellcome)时的平均%天数。此外,COPD恶化的危险和对口服皮质类固醇附加疗程的需要显著降低,如图7所示。同时健康状况也得到明显改善,如使用《圣乔治呼吸调查表(St.George′sRespiratory Questionnaire)》(Jones PW,Quirk FH,BaveystockGM,和Littlejohns P.,A self-complete measure of healthstatus for chronic airflow limitation.The St George′sRespiratory Questionnaire,Am.Rev.Respir.Dis.,145卷,1321-7页,1992年)所测量并示于图8中。
在图1-8中,所用的缩写如下:
Sa150:接受50μg沙美特罗的患者
FP500:接受500μg丙酸氟地松的患者
SFC50/500:接受沙美特罗/丙酸氟地松50μg/500μg的患者
FEV1:1秒钟内强迫呼吸量
PEFR:最大呼吸流量
EP:终点
PLA:空白对照剂
OCS:口服皮质类固醇
B/L:基线(试验开始前)
SGQR:圣乔治呼吸调查表
wks:进入试验的周数
Claims (11)
1.一种治疗哺乳动物比如人的COPD的方法,其包括使用有效量的沙美特罗或其生理学上可接受的盐和丙酸氟地松的组合物。
2.根据权利要求1的方法,其中,沙美特罗或其生理学上可接受的盐和丙酸氟地松是以复合药物制剂的形式给药。
3.根据权利要求1或2的方法,其中,沙美特罗或其生理学上可接受的盐和丙酸氟地松是通过吸入给药。
4.根据权利要求1-3中任一项的方法,其中,沙美特罗是以xinafoate盐的形式给药。
5.沙美特罗或其生理学上可接受的盐和丙酸氟地松的组合物用于生产治疗COPD的药物的用途。
6.权利要求5的用途,其中,所述药物是复合药物制剂。
7.权利要求5或6的用途,其中,所述药物适于吸入疗法。
8.权利要求5-7中任一项的用途,其中,沙美特罗是以xinafoate盐的形式。
9.一种用于治疗COPD的药物制剂,包含沙美特罗或其生理学上可接受的盐和丙酸氟地松,以及生理学上可接受的载体或赋形剂,并任选地包含一种或多种其它的治疗剂。
10.根据权利要求9的药物制剂,其是以适于吸入的形式。
11.根据权利要求9或10的药物制剂,其中,沙美特罗是以xinafoate盐的形式。
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US20070071689A1 (en) * | 2003-08-06 | 2007-03-29 | Galephar M/F | Advantageous combination for inhalation of nacystelyn and bronchodilators |
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TR201000681A2 (tr) * | 2010-01-29 | 2011-08-22 | B�Lg�� Mahmut | İnhalasyon yoluyla alınan kuru toz formülasyonları. |
US8834931B2 (en) | 2009-12-25 | 2014-09-16 | Mahmut Bilgic | Dry powder formulation containing tiotropium for inhalation |
US10105316B2 (en) | 2012-07-05 | 2018-10-23 | Arven llac Sanayi Ve Ticaret A.S. | Inhalation compositions comprising muscarinic receptor antagonist |
WO2014007772A2 (en) | 2012-07-05 | 2014-01-09 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Inhalation compositions comprising glucose anhydrous |
WO2014007781A2 (en) * | 2012-07-05 | 2014-01-09 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Inhalation compositions |
EP2991625A1 (en) * | 2013-04-29 | 2016-03-09 | Sanofi SA | Inhalable pharmaceutical compositions and the inhaler devices containing them |
MA41378A (fr) * | 2015-01-20 | 2017-11-28 | Teva Branded Pharmaceutical Prod R & D Inc | Inhalateur de poudre sèche comprenant du propionate de fluticasone et du xinafoate de salmétérol |
WO2024033624A1 (en) * | 2022-08-08 | 2024-02-15 | Verona Pharma Plc | Ensifentrine (rpl-554) for the treatment of moderate chronic obstructive pulmonary disease (copd) |
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IL104068A (en) * | 1991-12-12 | 1998-10-30 | Glaxo Group Ltd | Pharmaceutical preparations in a spray without surfactant containing 1, 1, 1, 2 tetrafluoroethane or 1,1,2,3,3 petafluor N propane as propellant |
GB9808802D0 (en) * | 1998-04-24 | 1998-06-24 | Glaxo Group Ltd | Pharmaceutical formulations |
GB9924992D0 (en) * | 1999-10-21 | 1999-12-22 | Glaxo Group Ltd | Pharmaceutical aerosol formulations |
AU2206801A (en) * | 1999-12-24 | 2001-07-09 | Alan Leslie Cripps | Pharmaceutical aerosol formulation of salmeterol and fluticasone propionate |
-
2001
- 2001-08-29 PE PE2001000867A patent/PE20020387A1/es not_active Application Discontinuation
- 2001-08-29 AR ARP010104122A patent/AR030516A1/es unknown
- 2001-08-31 MX MXPA03001752A patent/MXPA03001752A/es unknown
- 2001-08-31 CA CA002420532A patent/CA2420532A1/en not_active Abandoned
- 2001-08-31 SK SK230-2003A patent/SK2302003A3/sk unknown
- 2001-08-31 HU HU0303755A patent/HUP0303755A2/hu unknown
- 2001-08-31 CN CN01814708A patent/CN1449288A/zh active Pending
- 2001-08-31 EP EP01963205A patent/EP1313484A2/en not_active Withdrawn
- 2001-08-31 BR BR0113555-4A patent/BR0113555A/pt active Pending
- 2001-08-31 AU AU2001284236A patent/AU2001284236A1/en not_active Abandoned
- 2001-08-31 WO PCT/GB2001/003928 patent/WO2002017894A2/en not_active Application Discontinuation
- 2001-08-31 OA OA1200300054A patent/OA12370A/en unknown
- 2001-08-31 PL PL01365582A patent/PL365582A1/xx not_active Application Discontinuation
- 2001-08-31 KR KR10-2003-7002890A patent/KR20030031997A/ko not_active Application Discontinuation
- 2001-08-31 EA EA200300152A patent/EA200300152A1/ru unknown
- 2001-08-31 JP JP2002522868A patent/JP2004507494A/ja active Pending
- 2001-08-31 US US10/363,438 patent/US20040009963A1/en not_active Abandoned
- 2001-08-31 IL IL15440301A patent/IL154403A0/xx unknown
- 2001-08-31 AP APAP/P/2003/002753A patent/AP2003002753A0/en unknown
-
2003
- 2003-02-20 EC EC2003004487A patent/ECSP034487A/es unknown
- 2003-02-24 ZA ZA200301475A patent/ZA200301475B/en unknown
- 2003-02-26 NO NO20030899A patent/NO20030899L/no not_active Application Discontinuation
- 2003-02-27 MA MA27058A patent/MA25834A1/fr unknown
- 2003-02-27 BG BG107596A patent/BG107596A/bg unknown
Also Published As
Publication number | Publication date |
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BR0113555A (pt) | 2003-07-22 |
AP2003002753A0 (en) | 2003-06-30 |
AU2001284236A1 (en) | 2002-03-13 |
PE20020387A1 (es) | 2002-06-24 |
AR030516A1 (es) | 2003-08-20 |
SK2302003A3 (en) | 2003-08-05 |
ZA200301475B (en) | 2004-05-24 |
OA12370A (en) | 2004-03-19 |
EP1313484A2 (en) | 2003-05-28 |
PL365582A1 (en) | 2005-01-10 |
WO2002017894A3 (en) | 2002-08-08 |
HUP0303755A2 (hu) | 2004-04-28 |
IL154403A0 (en) | 2003-09-17 |
EA200300152A1 (ru) | 2003-08-28 |
NO20030899L (no) | 2003-04-28 |
US20040009963A1 (en) | 2004-01-15 |
JP2004507494A (ja) | 2004-03-11 |
KR20030031997A (ko) | 2003-04-23 |
CA2420532A1 (en) | 2002-03-07 |
BG107596A (bg) | 2004-01-30 |
WO2002017894A2 (en) | 2002-03-07 |
NO20030899D0 (no) | 2003-02-26 |
ECSP034487A (es) | 2003-03-31 |
MA25834A1 (fr) | 2003-07-01 |
MXPA03001752A (es) | 2003-06-04 |
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