CN1088580C - 气溶胶药物制剂 - Google Patents

气溶胶药物制剂 Download PDF

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CN1088580C
CN1088580C CN95196953A CN95196953A CN1088580C CN 1088580 C CN1088580 C CN 1088580C CN 95196953 A CN95196953 A CN 95196953A CN 95196953 A CN95196953 A CN 95196953A CN 1088580 C CN1088580 C CN 1088580C
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CN1170356A (zh
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K·贝克斯特兰
M·德尔贝克
A·约翰森
G·卡尔斯特兰德
E·林奎维斯特
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

适用于加压计量式剂量吸入器的气溶胶制剂，其包含一种氢氟链烷烃推进剂、一种供吸入的药剂和一种表面活性剂，表面活性剂为C8～C16脂肪酸或其盐、胆汁盐、磷脂或烷基糖。

Description

气溶胶药物制剂
发明领域
本发明涉及适用于加压计量式剂量吸入器(pMDI＇s)的气溶胶制剂。更具体地，本发明涉及一种制剂，其包含一种氢氟链烷烃(HFA)推进剂和一种特别适宜的表面活性分散剂。
发明背景
治疗呼吸和嗅觉障碍的药剂通常是以气溶胶制剂通过口或鼻给药。一种广泛使用的分散这类气溶胶制剂的方法包括制备一种药物悬浮制剂，该药物以一种细分散粉末形式处于一种称为推进剂的液化气中。通常使用加压计量式剂量吸入器或(pMDI＇s)给病人施予这种制剂。通常加入表面活性试剂或表面活性剂，以有助于药剂在推进剂中的分散并防止微小药剂颗粒的凝聚，和改进对阀门的润滑。
直到最近，才接受含有氯氟碳的推进剂(CFC＇s)用于所有药用气溶胶制剂中。用于CFC制剂的一般表面活性剂分散剂为例如脱水山梨糖醇三油酸盐、油酸、卵磷脂和乙醇。因为CFC牵涉到破坏臭氧层，所以出现了新一代的推进剂，以代替CFC。
目前，氢氟链烷烃(HFA)推进剂如1，1，1，2-四氟乙烷(P134a)、1，1，1，2，3，3，3-七氟丙烷(P227)和1，1-二氟乙烷(P152a)，被认为是最有发展前景的新推进剂。其不仅环境上可以接受，而且毒性低，具有适用于气溶胶的蒸汽压。但通常与CFC制剂一同使用的表面活性剂不一定适用于新一代推进剂。已经提出了多种可以替代的表面活性剂。
例如WO92/00061公开了与氢氟碳推进剂一同使用的聚乙氧基化表面活性剂。WO91/11173公开了氟化表面活性剂。WO91/14422公开了与氢氟碳推进剂一同使用的过氟化羧酸推进剂。WO92/00107公开了使用1，1，1，2-四氟乙烷可溶性表面活性剂和1，1，1，2-四氟乙烷推进剂。
发明概述
现已发现，某些特殊种类的表面活性剂特别适用于新一代推进剂。
所以，本发明提供了一种药用气溶胶制剂，其包含一种氢氟链烷烃或一种氢氟链烷烃推进剂的混合物、一种供吸入的生理有效量的药剂和一种选自C8～C16脂肪酸或其盐、胆汁盐、磷脂或烷基糖的表面活性剂。
用于本发明中的表面活性剂在新推进剂中给予精细分散，并具有良好的稳定性。所以本发明的制剂可用于吸入式药剂施药。
在脂肪酸表面活性剂及其盐中，优选C8～C16脂肪酸盐。优选的脂肪酸盐的实例为辛酸盐(C8)、癸酸盐(C10)、月桂酸盐(C12)和肉豆蔻酸盐(C14)的钠盐、钾盐和赖氨酸盐。由于脂肪酸盐反离子的性质并不特别明显，所以其任何一种都可能有用。一种特别优选的脂肪酸盐为癸酸钠。
适用的胆汁盐可以是例如胆酸盐、鹅胆酸盐、甘氨胆酸盐、牛磺胆酸盐、甘氨鹅胆酸盐、牛磺鹅胆酸盐、脱氧胆酸盐、甘氨脱氧胆酸盐、牛磺脱氧胆酸盐、石胆酸盐和乌索脱氧胆酸盐。
胆汁盐中，优选三羟基胆汁盐。更优选胆酸盐、甘氨胆酸盐和牛磺胆酸盐，特别是其钠盐和钾盐。最优选的胆汁盐为牛磺胆酸钠。
适用的磷脂可以是例如单链磷脂，如溶血磷脂酰胆碱、溶血磷脂酰甘油、溶血磷脂酰乙醇胺、溶血磷脂酰肌醇和溶血磷脂酰丝氨酸，或双链磷脂，例如二酰基磷脂酰胆碱、二酰基磷脂酰甘油、二酰基磷脂酰乙醇胺、二酰基磷脂酰肌醇和二酰基磷脂酰丝氨酸。
磷脂中，优选二酰基磷脂酰甘油和二酰基磷脂酰胆碱，例如二辛酰基磷脂酰甘油和二辛酰基磷脂酰胆碱。
适用的烷基糖可以是例如烷基葡糖苷或烷基麦芽糖苷，例如癸基葡糖苷和十二烷基麦芽糖苷。
最优选的表面活性剂为胆汁盐。
推进剂可以包含例如一种或多种1，1，1，2-四氟乙烷(P134a)、1，1，1，2，3，3，3-七氟丙烷(P227)和1，1-二氟乙烷(P152a)，任选地与一种或多种其它的推进剂相混合。推进剂优选包含1，1，1，2-四氟乙烷(P134a)或1，1，1，2，3，3，3-七氟丙烷(P227)，或P134a和P227的混合物，例如一种P134a和P227密度相匹配的混合物。
除了药剂、推进剂和表面活性剂以外，本发明的制剂中还可包含少量的乙醇(一般最高达5％(重量)，但也可最高达20％(重量))。通常之所以将乙醇加入到气溶胶组合物中，是因为它能改善计量阀门的功能，并且在某些情况下还可提高分散体的稳定性。
适于加入本发明制剂中的药剂可以是通过吸入法输送的任何药物。适宜的吸入药剂可包括例如β2-肾上腺素能受体激动剂，如沙丁胺醇、叔丁喘宁、呱喘定、芬忒醇、茶丙喘定、肾上腺素、吡丁醇、异丙肾上腺素、异丙喘宁、双甲苯喘定、甲氧苯舒喘宁、福莫特罗、双氯喘安、异丙喹喘宁、broxaterol、picumeterol、TA-2005、马布特罗等，以及其药理上可接受的酯和盐；抗胆碱能支气管扩张剂，例如异丙托溴铵等；糖肾上腺皮质激素甾族化合物，如氯地米松、氟替卡松、布***、替波尼旦、***、β-米松、肤轻松、曲安奈德、莫米松等，以及其药理上可接受的酯和盐；抗过敏药剂，例如色氨酸钠和奈多罗米钠；祛痰药；粘液溶解剂；抗组织胺；环氧合酶抑制剂；白细胞三烯合成抑制剂；白细胞三烯拮抗药、磷脂酶-A2(PLA2)抑制剂、血小板凝聚因子(PAF)拮抗剂和气喘预防剂；抗心律失常药剂、安定药、强心甙、激素、抗高血压药剂、抗糖尿病-抗寄生物和抗癌药剂、镇静剂、止痛药剂、抗菌素、抗风湿药剂、免疫治疗药剂、抗真菌剂和抗低血压药剂、疫苗、抗病毒药剂、蛋白质、肽、维生素和其它药剂，例如细胞表面受体阻滞剂、抗氧剂、自由基消除剂和N，N′-二乙酰基胱氨酸的有机盐。
混合药剂也适用，例如一种福莫特罗和布***的混合物。
在适当的场合，药剂可以以盐或酯或溶剂化物(水合物)的形式使用。
若需要，其它成分也可加入本发明的制剂中。这类成分可以是，例如选自辅助剂、载体、香味剂、缓冲剂、抗氧剂、化学稳定剂的药用活性剂。
存在于本发明中的表面活性剂与药剂的比值优选为约1∶50～1∶0.2。本发明制剂中药剂的优选浓度为0.1毫克/毫升～25毫克/毫升。
＂吸入的药剂＂系指一种适于吸入的药剂，其主要由粒径适于在下呼吸道产生最大沉积的颗粒组成(即10微米以下)。所以，尽可能地优选药剂由粒径在10微米以下的颗粒组成，例如0.01～10微米或0.1～6微米，例如0.1～5微米。优选至少50％的药剂由粒径在所要求的范围内的颗粒组成。例如至少60％，优选至少70％，更优选至少80％，最优选至少90％的药剂由粒径在所要求范围内的颗粒组成。
所以为制备所需粒径的颗粒，用于本发明的药剂在加入制剂前必须进行加工。例如可以将药剂微粉化，例如用适当的研磨机，例如喷射研磨机。或者，例如用喷雾干燥或控制结晶的方法，例如用超临界流体结晶法来获得所要求粒径范围内的粒子。
优选用于本发明的表面活性剂也在所要求的粒径范围内。
本发明提供药用气溶胶制剂的方法，其包括下列步骤：将药剂和表面活性剂混合，并在低温下移到一容器中；加入推进剂和任选的乙醇；混合；并再加入推进剂和任选的乙醇。
当表面活性剂与药剂都要微粉化时，可将其干混合，然后一起微粉化，或者将其单独微粉化，然后混合。随后可加入推进剂和任选的乙醇。
另外，可将部分微粉化的表面活性剂和部分推进剂和任选的乙醇冷混合在一起，然后加入微粉化的药剂。混合加入药剂后，加入剩余的表面活性剂和推进剂和任选的乙醇，将悬浮体装入适当的容器中。
本发明的气溶胶制剂可用于对疾病进行局部或全身的治疗，并且可通过上下呼吸道给药，包括通过鼻腔给药。这样，本发明还提供了用于治疗的该气溶胶制剂；气溶胶制剂在制造通过呼吸道治疗疾病的药剂中的用途；以及一种处理需要治疗的病人的方法，包括给该患者施用治疗有效量的本发明气溶胶制剂。
拟用下述实施例来说明本发明，但不局限于下述实施例。
用P134a和/或P227与不同的表面活性剂制备了多种药物制剂，以评价所生成的悬浮体的质量。在下述实施例中，用＂可接受的＂或＂好的＂来评价悬浮体的质量。一种可接受的悬浮体的特征在于具有一种或多种下述现象：缓慢沉降或分离、易于重新分散、极少絮凝和不发生结晶或形态变化，这使得分散体足够稳定以释放出均匀剂量的药物。一种好的分散体甚至更加稳定。
实施例1
将微粉化的富马酸福莫特罗(1份)和微粉化的牛磺胆酸钠(2份)(总共5毫克)装入一只包覆有塑料的玻璃瓶内。将瓶子用二氧化碳冰和异丙醇的混合物冷却到约-40℃，加入10毫升冷P134a(约在-40℃)。用计量阀门密封好瓶子，并用超声波浴处理约10分钟。
一种好的悬浮体形成了。
实施例2
将微粉化的布***(10份)和微粉化的牛磺胆酸钠(2份)(总共5毫克)装入一只包覆有塑料的玻璃瓶内。将瓶子用二氧化碳冰和异丙醇的混合物冷却到约-40℃，加入10毫升冷P134a(约在-40℃)。用计量阀门密封好瓶子，并用超声波浴处理约10分钟。
一种好的悬浮体形成了。
实施例3
将微粉化的硫酸沙丁胺酯(10份)和微粉化的牛磺胆酸钠(2份)(总共5毫克)装入一只包覆有塑料的玻璃瓶内。将瓶子用二氧化碳冰和异丙醇的混合物冷却到约-40℃，加入10毫升冷P134a(约在-40℃)。用计量阀门密封好瓶子，并用超声波浴处理约10分钟。
一种好的悬浮体形成了。
实施例4
将微粉化的异丙托溴铵(1份)和微粉化的牛磺胆酸钠(2份)(总共5毫克)装入一只包覆有塑料的玻璃瓶内。将瓶子用二氧化碳冰和异丙醇的混合物冷却到约-40℃，加入10毫升冷P134a(约在-40℃)。用计量阀门密封好瓶子，并用超声波浴处理约10分钟。
一种好的悬浮体形成了。
实施例5～8
用推进剂P227代替P134a，重复实施例1～4。在全部实例中，均形成了好的悬浮体。
实施例9～16
用下述添加物重复实施例1～8：在用计量阀门密封前，将约650微升的乙醇加入到冷却的瓶子中。在全部实例中，均形成了好的悬浮体。

Claims (34)

1.一种药用气溶胶制剂，其包含一种HFA推进剂；一种供吸入的治疗或预防疾病有效量的药剂；和一种表面活性剂，该表面活性剂为C8～C16脂肪酸或其盐；胆汁盐；烷基糖；或一种基本上由单链磷脂组成的磷脂，其选自溶血磷脂酰胆碱、溶血磷脂酰甘油、溶血磷脂酰乙醇胺、溶血磷脂酰肌醇和溶血磷脂酰丝氨酸，或一种选自二酰基磷脂酰甘油、二酰基磷脂酰乙醇胺、二酰基磷脂酰肌醇和二酰基磷脂酰丝氨酸的双链磷脂。
2.一种如权利要求1所要求保护的药用气溶胶制剂，其中表面活性剂为C8～C16脂肪酸盐。
3.一种如权利要求2所要求保护的药用气溶胶制剂，其中脂肪酸盐选自辛酸盐、癸酸盐、月桂酸盐和肉豆蔻酸盐的钠盐、钾盐和赖氨酸盐。
4.一种如权利要求1所要求保护的药用气溶胶制剂，其中表面活性剂为一种三羟基胆汁盐。
5.一种如权利要求4所要求保护的药用气溶胶制剂，其中胆汁盐选自胆酸、甘氨胆酸和牛磺胆酸的盐。
6.一种如权利要求5所要求保护的药用气溶胶制剂，其中胆汁盐选自胆酸、甘氨胆酸和牛磺胆酸的钠盐和钾盐。
7.一种如权利要求6所要求保护的药用气溶胶制剂，其中胆汁盐为牛磺胆酸钠。
8.一种如权利要求1所要求保护的药用气溶胶制剂，其中表面活性剂选自烷基葡糖苷和烷基麦芽糖苷。
9.一种如权利要求8所要求保护的药用气溶胶制剂，其中表面活性剂选自癸基葡糖苷和十二烷基麦芽糖苷。
10.一种如权利要求1～9任何一项所要求保护的药用气溶胶制剂，其中推进剂包含1，1，1，2-四氟乙烷、1，1，1，2，3，3，3-七氟丙烷或1，1-二氟乙烷。
11.一种如权利要求10所要求保护的药用气溶胶制剂，其中推进剂包含1，1，1，2-四氟乙烷和1，1，1，2，3，3，3-七氟丙烷。
12.一种如权利要求10所要求保护的药用气溶胶制剂，其中推进剂包含一种1，1，1，2-四氟乙烷和1，1，1，2，3，3，3-七氟丙烷密度相匹配的混合物。
13.一种如权利要求1-9任何一项权利要求所要求保护的药用气溶胶制剂，其中药剂为β2-肾上腺素能受体激动剂、抗胆碱能支气管扩张剂或糖肾上腺皮质激素甾族化合物。
14.一种如权利要求13所要求保护的药用气溶胶制剂，其中药剂选自沙丁胺醇、叔丁喘宁、呱喘定、芬忒醇、茶丙喘定、肾上腺素、吡丁醇、异丙肾上腺素、异丙喘宁、双甲苯喘定、甲氧苯舒喘宁、福莫特罗、双氯喘安、异丙喹喘宁、溴噁特罗、匹库特罗、马布特罗、异丙托溴铵、氯地米松、氟替卡松、布***、潜泼尼旦、***、β-米松、肤轻松、曲安奈德、莫米松等，以及其药理上可接受的酯和盐。
15.一种如权利要求1～9、11和12任何一项所要求保护的药用气溶胶制剂，其中药剂选自抗过敏药物；祛痰药；粘液溶解剂；抗组织胺；环氧合酶抑制剂；白细胞三烯合成抑制剂；白细胞三烯拮抗药、磷脂酶-A2抑制剂、血小板凝聚因子拮抗药和气喘预防剂；抗心律失常药剂、安定药、强心甙、激素、抗高血压药剂、抗糖尿病-抗寄生物和抗癌药剂、镇静剂、止痛药剂、抗菌素、抗风湿药剂、免疫治疗药剂、抗真菌剂和抗低血压药剂、疫苗、抗病毒药剂、蛋白质、肽、维生素、细胞表面受体阻滞剂、抗氧剂、自由基消除剂和N，N＇-二乙酰基胱氨酸的有机盐。
16.一种如权利要求1～9、11和12任何一项所要求保护的药用气溶胶制剂，其所包含的乙醇的量最高达推进剂和表面活性剂的20％(重量)。
17.一种如权利要求1～9、11和12任何一项所要求保护的药用气溶胶制剂，其所包含的乙醇的量最高达推进剂和表面活性剂的5％(重量)。
18.一种如权利要求1～9、11和12任何一项所要求保护的药用气溶胶制剂，其包含其它的选自辅助剂、载体、香味剂、缓冲剂、抗氧剂、化学稳定剂的药用活性剂。
19.一种如权利要求1～9、11和12任何一项所要求保护的药用气溶胶制剂，其中表面活性剂以表面活性剂与药剂的比值为1∶50～1∶0.2的范围存在。
20.一种如权利要求1所要求保护的药用气溶胶制剂，其中药剂包括直径为0.01～10微米的颗粒。
21.一种如权利要求20所要求保护的药用气溶胶制剂，其中药剂包括直径为0.1～6微米的颗粒。
22.一种如权利要求21所要求保护的药用气溶胶制剂，其中药剂包括直径为0.1～5微米的颗粒。
23.一种如权利要求20～22中任何一项所要求保护的药用气溶胶制剂，其中至少有50％的药剂由所说粒径范围内的颗粒组成。
24.一种如权利要求20～22中任何一项所要求保护的药用气溶胶制剂，其中至少有60％的药剂由所说粒径范围内的颗粒组成。
25.一种如权利要求20～22中任何一项所要求保护的药用气溶胶制剂，其中至少有70％的药剂由所说粒径范围内的颗粒组成。
26.一种如权利要求20～22中任何一项所要求保护的药用气溶胶制剂，其中至少有80％的药剂由所说粒径范围内的颗粒组成。
27.一种如权利要求20～22中任何一项所要求保护的药用气溶胶制剂，其中至少有90％的药剂由所说粒径范围内的颗粒组成。
28.一种如权利要求1～9、11、12和20-22中任何一项所要求保护的药用气溶胶制剂，其中药剂的浓度为0.1毫克/毫升～25毫克/毫升制剂。
29.一种制造如权利要求1～28中任何一项所要求保护的药用气溶胶制剂的方法，其包括下列步骤：将药剂和表面活性剂混合，并在低温下移到一容器中；加入推进剂和任选的乙醇；混合；并再加入推进剂和任选的乙醇。
30.如权利要求1～28中任何一项所要求保护的药用气溶胶制剂的用途，其用于制造通过呼吸道治疗疾病的药剂。
31.一种如权利要求1所要求保护的药用气溶胶制剂，其中药剂选自富马酸福莫特罗和布***。
32.一种如权利要求1所要求保护的药用气溶胶制剂，其中药剂为富马酸福莫特罗和布***的组合。
33.权利要求30的用途，其中药剂选自富马酸福莫特罗和布***。
34.权利要求30的用途，其中药剂为富马酸福莫特罗和布***的组合。
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