CN1674910A - 氮 斯汀和甾族化合物的组合 - Google Patents
氮 斯汀和甾族化合物的组合 Download PDFInfo
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Abstract
本发明涉及一种药物产品或制剂,其包含氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,优选该产品或制剂为适于鼻内或眼内给药的形式。
Description
本发明涉及药物产品和制剂。更具体地说,本发明涉及用于预防变态反应或使之最小化的药物产品和制剂。更具体但不唯一地,本发明涉及鼻用和眼用药物产品和制剂。
这种变态反应一般包括与变态反应有关和与血管舒缩有关的症状以及与鼻病毒有关的症状。
已知将抗组胺药用于鼻喷雾剂和滴眼剂以治疗与变态反应有关的症状。因此,例如,已知将抗组胺药氮斯汀(通常以盐酸盐的形式)用作抗季节性或常年性变应性鼻炎的鼻喷雾剂,或者用作抗季节性和常年性变应性结膜炎的滴眼剂。
还已知用抑制鼻和眼炎症的皮质甾类治疗这些症状。已知的鼻用皮质甾类例如有倍氯米松、莫米松、氟替卡松、布地奈德和cyclosenide。已知用于眼抗炎用途的皮质甾类包括例如倍他米松钠、地塞米松钠和醋酸强地松龙。
但是,非常期望提供一种在药学可接受的制剂中联合抗组胺药治疗和甾族化合物治疗的效果的治疗剂,所述治疗剂原位耐受,不显著破坏组成药物的效力。
我们现已非常令人惊奇地发现,氮斯汀(4-[(4-氯苯基)甲基]-2-(六氢-1-甲基-1H-吖庚因-4-基)-1(2H)-酞嗪酮)或其药学可接受的盐、溶剂化物或生理功能性衍生物,优选盐形式,更优选盐酸盐形式,可以有利地与甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物组合,以提供稳定、非常有效的组合产品或制剂,优选用于鼻或眼治疗。所述组合可以在一次给药或服药方案中提供氮斯汀的抗组胺性质和甾族化合物的抗炎(和/或其它)性质,而没有两者之间的任何明显干扰,或者原位不良反应。
在一方面,本发明提供一种药物产品,其包含氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及甾族化合物,优选皮质甾类,或其药学可接受的盐、溶剂化物或生理功能性衍生物,该制剂优选为适于鼻内或眼内给药的形式。
本文所用的术语“生理功能性衍生物”指本文所述的任何具体治疗剂的化学衍生物,其具有与游离碱治疗剂相同或类似的生理功能,并且例如可以在体内转化成游离碱。根据本发明,生理功能性衍生物的实例包括酯。
本发明的制剂的优选形式为滴鼻剂、滴眼剂、鼻喷雾剂、鼻吸入溶液或气雾剂或吹入粉末。
本发明的优选实施方案可以包含氮斯汀或一种或多种其盐以及可以为倍氯米松、莫米松、氟替卡松、布地奈德或cyclosenide的甾族化合物的稳定水溶液,其可以吸入溶液、加压气雾剂、滴眼剂或滴鼻剂的形式使用;在特别优选的实施方案中,以喷雾剂(优选鼻喷雾剂)的形式使用。例如,该喷雾剂可以通过使用常规喷雾挤压瓶或泵汽化器来形成。此外,还可以使用压缩气体气雾剂。在优选的实施方案中,每一次开动应该释放0.03-3mg氮斯汀碱和0.05-0.15mg甾族化合物。
该制剂优选含有防腐剂和/或稳定剂。这些包括,例如:乙二胺四乙酸(依地酸)及其碱金属盐(例如二碱金属盐如二钠盐、钙盐、钙-钠盐)、对羟基苯甲酸低级烷基酯、氯己定(例如为乙酸盐或葡糖酸盐的形式)和硼酸苯汞。其它适宜的防腐剂为:药用季铵化合物,例如十六烷基氯化吡啶鎓、一般称为“cetrimide”的十四烷基三甲基溴化铵、一般称为“苄索氯铵”的苄基二甲基-[2-[2-[p-(1,1,3,3-四甲基-丁基)苯氧基]乙氧基]氯化铵和肉豆蔻基氯化甲基吡啶鎓。这些化合物中的每一种可以0.002-0.05%,例如0.02%(重量/液体制剂体积,否则为重量/重量)的浓度使用。但是,季铵化合物中优选的防腐剂为烷基苄基二甲基氯化铵及其混合物,例如一般称为“苯扎氯铵”的化合物。
该制剂(溶液剂、软膏剂等)中防腐剂的总量优选为0.001-0.10g,优选为0.01g/100ml溶液/悬浮液或100g制剂。
在防腐剂的情况下,例如可以使用以下量的各物质:乙基汞硫代水杨酸钠0.002-0.02%;苯扎氯铵0.002-0.02%(与乙基汞硫代水杨酸钠组合,例如乙基汞硫代水杨酸钠的量=0.002-0.005%);醋酸氯己定或葡糖酸氯己定0.01-0.02%;硝酸苯汞、硼酸苯汞、醋酸苯汞0.002-0.004%;对羟基苯甲酸酯(例如甲酯和丙酯的7∶3比率的混合物):优选0.05-0.15,更优选0.1%。
所用的防腐剂优选为依地酸(例如以二钠盐的形式)和苯扎氯铵的组合。在此组合中,依地酸优选以0.05-0.1%的浓度使用,苯扎氯铵优选以0.005-0.05%,更优选0.01%的浓度使用。
在溶液剂/混悬剂的情况下,百分比总是指重量/体积百分比,在固体或半固体制剂的情况下,百分比总是指重量/制剂重量百分比。
其它例如可用于本发明的制剂的辅助物质为:聚乙烯吡咯烷酮、失水山梨糖醇脂肪酸酯如失水山梨糖醇三油酸酯、聚乙氧基化失水山梨糖醇脂肪酸酯(例如聚乙氧基化失水山梨糖醇三油酸酯)、山梨聚乙二醇(sorbimacrogol)油酸酯、合成amphotensides(tritons)、辛基酚醛缩合产物的环氧乙烷醚、磷脂如卵磷脂、聚乙氧基化脂肪、聚乙氧基化甘油三酸酯和聚乙氧基化脂肪醇。在此上下文中,聚乙氧基化意指相关的物质含有聚乙烯链,其聚合度一般为2-40,特别是10-20。这些物质优选用于改善氮斯汀组分的溶解度。
任选可以使用附加的等渗剂。例如可以使用的等渗剂有:蔗糖、葡萄糖、甘油、山梨糖醇、1,2-丙二醇和NaCl。
等渗剂将制剂的渗透压调至与鼻分泌物相同的渗透压。为此目的,在每种情况下这些物质的用量使得,例如在溶液剂的情况下,与纯水相比冰点降低0.50-0.56℃。
在实施例1中,例如可以代替NaCl/100ml溶液使用:葡萄糖1H2O3.81g;蔗糖6.35g;甘油2.2g;1,2-丙二醇1.617g;山梨糖醇3.84g(在这些物质的混合物的情况下可以任选相应地使用较少量)。
而且,可以将增稠剂加入根据本发明的溶液剂中以防止溶液从鼻内太快流出,并给溶液提供约1.5-3,优选2mPa的粘度。
例如这些增稠剂可以为:纤维素衍生物(例如纤维素醚),其中纤维素-羟基用低级不饱和脂族醇和/或低级不饱和脂族氧化醇(oxyalcohols)(例如甲基纤维素、羧甲基纤维素、羟丙基甲基纤维素)、明胶、聚乙烯吡咯烷酮、黄蓍胶、ethoxose(基于乙基纤维素的水溶性粘合和增稠剂)、海藻酸、聚乙烯醇、聚丙烯酸、果胶和等同试剂部分醚化。如果这些物质含有酸基团,则还可以使用相应的生理学可接受的盐。
在使用羟丙基纤维素的情况下,例如用于此目的的用量可以为制剂的0.1重量%。
在使用Avicel RC 591或CLII的情况下,例如用于此目的的用量可以为制剂的0.65-3.0重量%。
还可以向该制剂中加入缓冲物质,如柠檬酸/钠硫酸氢盐硼酸盐缓冲剂、磷酸盐(正磷酸氢钠、磷酸氢二钠)、氨丁三醇或等同的常规缓冲剂,例如用于将该制剂的pH值调节为3-7,优选4.5-6.5。
例如柠檬酸的用量为0.01-0.14g,优选0.04-0.05g,磷酸氢二钠的用量为0.1-0.5g,优选0.2-0.3g/100ml溶液。所给出的重量在每种情况下涉及无水物质。
在溶液剂和混悬剂的情况下,活性试剂和缓冲剂的最大总浓度优选小于5%,特别是小于2%(重量/体积)。
对于鼻内施用,优选可以使用这样的溶液剂或混悬剂,它们以气雾剂的形式施用,即它们是在空气或另一种常规载气中的精细分散体,例如通过常规泵汽化器形成的精细分散体的形式。
但是,以剂量气雾剂的形式的施用也是可能的。剂量气雾剂定义为在所谓的抛射剂中含有氮斯汀或其盐与甾族化合物的溶液或悬浮液形式的加压包装。抛射剂可以是加压的液体氯化、氟化烃或不同氯化、氟化烃的混合物,以及丙烷、丁烷、异丁烯或它们自身的混合物或它们与氯化、氟化烃的混合物,它们在大气压和室温下为气体。也可以使用氢碳氟化合物(hydrofluorocarbon,HFC),如HFC 134a和HFC 227a,并由于环境原因而优选。加压包装具有剂量或计量阀,其在开动时释放确定量的药物溶液或悬浮液。抛射剂的随后非常快速的汽化将氮斯汀的溶液或悬浮液分裂成可以喷在鼻内或者可以用于吸入鼻内的最细微滴或者微小颗粒。某些塑料施用器可以用于开动阀门并将雾化悬浮液转运至鼻内。
在以气雾剂的形式施用的情况下,还可以使用常规的转接器。
本发明的特别优选的实施方案在下文中描述,它当然可以这样理解:对适宜成分和制剂特征的任何先前描述也可以应用于本发明提供的以下产品和制剂。
因此,可以认识到,本发明还提供一种药物产品,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,其优选与通常适于MDI递送的抛射剂一起以气雾剂制剂提供,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,其优选与通常适于MDI递送的抛射剂一起以气雾剂制剂提供,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
本发明还提供一种气雾剂制剂,优选其适于MDI递送,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,和(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及抛射剂。
从上述还可以认识到,该组合制剂的各治疗剂可以在相同或不同的药物制剂中同时或者单独或者连续给药。如果是单独或连续给药,则还可以认识到,应在一定时间范围内给予随后给予的治疗剂以实现,或者更特别地优化作为存在于根据本发明的药物产品中的组合制剂的上述有利的协同治疗效果。
用于本发明提供的药物产品或制剂中的适宜的抛射剂包括1,1,1,2-四氟乙烷(HFA 134a)或1,1,1,2,3,3,3-七氟丙烷(HFA 227)或这二者的组合,或者一氟三氯甲烷和二氯二氟甲烷,特别是1,1,1,2-四氟乙烷(HFA 134a)或1,1,1,2,3,3,3-七氟丙烷(HFA 227),优选HFA134a。
根据本发明的药物气雾剂制剂还优选包括极性助溶剂,如C2-6脂族醇和多元醇,例如乙醇、异丙醇和丙二醇,一般优选乙醇。优选该助溶剂的浓度为总制剂的约2-10重量%,通常达约5重量%。
根据本发明的药物气雾剂制剂还可以包含一种或多种表面活性剂。可以包含这种表面活性剂以稳定制剂并润滑阀门系统。气雾剂制剂中的某些最常用的表面活性剂为来自天然来源的油,如玉米油、橄榄油、棉子油和向日葵籽油,以及磷脂。适宜的表面活性剂可以包括卵磷脂、油酸或失水山梨糖醇油酸酯。
本发明的进一步优选的实施方案可以是,当以可吹入粉末的形式提供制剂或产品时,优选该物质的最大粒径适宜地不超过10μm。可以将氮斯汀或其盐和甾族化合物与惰性载体物质混合,或者吸于惰性载体物质上。例如可以使用的载体物质为:糖,如葡萄糖、蔗糖、乳糖和果糖。还有淀粉或淀粉衍生物、寡糖如糊精、环糊精和它们的衍生物、聚乙烯吡咯烷酮、海藻酸、纤基乙酸钠、硅酸、纤维素、纤维素衍生物(例如纤维素醚)、糖醇如甘露糖醇或山梨糖醇、碳酸钙、磷酸钙等。
在一个实施方案中,所用的治疗剂的粒径小于约10μm,优选小于5μm。
吹入粉末的使用可以代表本发明的优选实施方案,而且本发明提供一种药物产品,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,其以吹入粉末的形式提供,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,其以吹入粉末的形式提供,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
从上述可以认识到,该组合制剂的各治疗剂可以在相同或不同的吹入粉末制剂中同时或者单独或者连续给药。如果是以上讨论的单独或连续给药,则还可以认识到,应在一定时间范围内给予随后给予的治疗剂以实现,或者更特别地优化作为存在于根据本发明的药物产品中的组合制剂的上述有利的协同治疗效果。
本发明还提供一种吹入粉末制剂,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物和(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及药学可接受的载体或赋形剂。
本发明提供的干燥吹入粉末制剂在要求根据本发明使用的治疗剂保持在鼻腔内时可能有益,并可以最小化或消除全身性副作用。而且,用于本发明的吹入粉末制剂的有益之处可能在于改善氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物在鼻粘膜内的保留,并明显降低与液体抗组胺制剂有关的苦余味,同时还表现出与本发明提供的氮斯汀/甾族化合物组合有关的协同治疗效果。通过提供平均粒径为约10μm的氮斯汀和甾族化合物的干燥吹入粉末制剂,可以将该治疗剂主要限制在目标靶器官鼻粘膜。
根据本发明的干燥粉末吹入制剂可以通过可以产生干燥粉末的精细分散烟雾的吹入器给药。该吹入器优选具有确保给予基本上预定量的本发明提供的制剂或产品的工具。该粉末可以直接用具有粉末的瓶或容器的吹入器使用,或者可以将该粉末填入胶囊或药筒,如明胶胶囊,或者其它适于给药的一次剂量装置中。该吹入器优选具有打开胶囊和其它剂量装置的工具。
用于根据本发明的药物产品和制剂(特别是上述的鼻喷雾剂或滴剂、气雾剂或吹入产品和制剂)的优选治疗剂组合包括任何一种以下组合。
因此,本发明进一步提供一种药物产品,其包含(i)氮斯汀或其药学可接受的盐,以及(ii)至少一种选自倍氯米松、氟替卡松、莫米松及其药学可接受的酯的甾族化合物,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。适宜的酯可以选自倍氯米松二丙酸酯、氟替卡松丙酸酯、氟替卡松戊酸酯、莫米松糠酸酯和莫米松糠酸酯一水合物。
本发明还提供一种药物制剂,其包含(i)氮斯汀或其药学可接受的盐,和(ii)至少一种选自倍氯米松、氟替卡松、莫米松及其药学可接受的酯的甾族化合物,以及药学可接受的载体或赋形剂。适宜的酯可以选自倍氯米松二丙酸酯、氟替卡松丙酸酯、氟替卡松戊酸酯、莫米松糠酸酯和莫米松糠酸酯一水合物。
在鼻喷雾剂的情况下,本发明提供的特别优选的制剂是包含氮斯汀或其药学可接受的盐(优选盐酸氮斯汀),以及游离碱或酯形式,优选莫米松糠酸酯形式的莫米松的鼻喷雾剂。
用于根据本发明的药物产品和制剂的治疗剂的特定组合包括任何一种以下组合:
盐酸氮斯汀和倍氯米松二丙酸酯;
盐酸氮斯汀和氟替卡松丙酸酯;
盐酸氮斯汀和氟替卡松戊酸酯;
盐酸氮斯汀和莫米松糠酸酯;和
盐酸氮斯汀和莫米松糠酸酯一水合物。
本发明还提供一种在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的方法,所述方法包括给予治疗有效量的基本上如前文所述的药物产品,所述药物产品作为组合制剂用于在这种症状的治疗中同时、单独或顺续使用。
本发明还提供一种在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的方法,所述方法包括给予治疗有效量的基本上如前文所述的药物制剂。
本发明还提供一种药物产品在制备用于在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的药物中的用途,所述药物产品作为组合制剂用于在这种症状的治疗中同时、单独或顺续使用。
因此,本发明进一步提供一种基本上如前文所述的药物产品的制备方法,所述方法包括提供以下物质,作为用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用的组合制剂:(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物。
本发明还提供一种基本上如前文所述的药物制剂的制备方法,所述方法包括将药学可接受的载体或赋形剂与以下物质混合:(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物。优选根据本发明的药物制剂可以包括基本上如前文所述的吹入粉末制剂、鼻喷雾剂、鼻吸入溶液或气雾剂。
现在通过以下实施例例示本发明,这些实施例不以任何方式限制本发明的范围。在仅列出根据本发明的制剂的成分的实施例中,这些制剂通过本领域中已知的技术制备。
实施例1
含有0.1%盐酸氮斯汀作为活性成分和甾族化合物0.1%的鼻喷雾剂或滴鼻剂
序号 | 成分 | 量%w/v |
1. | 盐酸氮斯汀 | 0.1% |
2. | 甾族化合物 | 0.1% |
3. | 依地酸二钠 | 0.005% |
4. | 氯化钠 | 0.9% |
5. | 苯扎氯铵 | 0.001% |
6. | Avicel RC 591 | 1.2% |
7. | 柠檬酸一水合物 | 0.2% |
8. | 磷酸氢二钠十二水合物 | 0.1% |
9. | 纯化水 |
实施例2
每次冲击放出0.5mg盐酸氮斯汀和50微克倍氯米松二丙酸酯氟利昂溶剂化物的剂量气雾剂
在适宜的冷却容器中将约8.0kg 70重量份的二氟二氯甲烷和30重量份的1,2二氯四氟乙烷的混合物冷却至约-55℃。在-55℃下将0.086kg预冷却的失水山梨糖醇三油酸酯和0.8600kg预冷却的三氯氟甲烷的混合物在搅拌下溶解于该混合物中,然后在充分搅拌下将0.0688kg微粉化盐酸氮斯汀、0.00688kg倍氯米松二丙酸酯氟利昂溶剂化物和0.0688kg微粉化乳糖分批加入由此得到的溶液中。通过加入更多的冷却至约-55℃的70重量份的二氟二氯甲烷和30重量份的1,2-二氯四氟乙烷的混合物使由此得到的悬浮液的总重达到9.547kg。
在关闭冷却容器之后,在充分搅拌下将悬浮液再次冷却至约-55℃。然后准备将其装填。
实施例3
含氮斯汀和甾族化合物的鼻喷雾剂或滴鼻剂*
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀 | 0.10 | |
氟替卡松丙酸酯 | 0.0357 | |
甘油 | 2.60 | |
Avicel RC 591 | 1.35 | |
聚山梨酸酯80 | 0.025 | |
苯扎氯铵 | 0.01 | |
苯基乙基醇 | 0.25 | |
纯化水 | 足量 |
*每个喷雾剂递送盐酸氮斯汀(140mcg)和氟替卡松丙酸酯(50mcg)
实施例4
含氮斯汀和甾族化合物的鼻喷雾剂或滴鼻剂*
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀 | 0.10 | |
氟替卡松戊酸酯 | 0.0357 | |
甘油 | 2.60 | |
Avicel RC 591 | 1.20 | |
聚山梨酸酯80 | 0.030 | |
苯扎氯铵 | 0.01 | |
苯基乙基醇 | 0.25 | |
纯水 | 足量 |
*每个喷雾剂递送盐酸氮斯汀(140mcg)和氟替卡松戊酸酯(50mcg)
实施例5
含氮斯汀和甾族化合物的鼻喷雾剂或滴鼻剂*
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀 | 0.10 | |
氟替卡松丙酸酯 | 0.0714 | |
甘油 | 2.60 | |
Avicel RC 581 | 1.35 |
聚山梨酸酯80 | 0.025 | |
苯扎氯铵 | 0.01 | |
苯基乙基醇 | 0.25 | |
纯化水 | 足量 |
*每个喷雾剂递送盐酸氮斯汀(140mcg)和氟替卡松丙酸酯(50mcg)
实施例6
含氮斯汀和甾族化合物的鼻喷雾剂或滴鼻剂
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀 | 0.10 | |
莫米松糠酸酯 | 0.05173 | |
甘油 | 2.30 | |
依地酸二钠 | 0.005 | |
聚山梨酸酯80 | 0.0125 | |
Avicel RC 581 | 1.35 | |
苯扎氯铵 | 0.01 | |
柠檬酸一水合物 | 0.20 | |
磷酸氢二钠十二水合物 | 0.10 | |
纯化水 | 足量 |
实施例7
含氮斯汀和甾族化合物的鼻喷雾剂或滴鼻剂*
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀 | 0.10 | |
莫米松糠酸酯一水合物 | 0.05173 | |
甘油 | 2.60 | |
Avicel CL 611 | 2.295 | |
聚山梨酸酯80 | 0.0125 | |
苯扎氯铵 | 0.01 | |
苯基乙基醇 | 0.25 | |
纯化水 | 足量 |
*每个喷雾剂递送盐酸氮斯汀(140mcg)和莫米松糠酸酯(50mcg)
实施例8
含氮斯汀和甾族化合物的鼻用MDI
序号 | 成分 | 以mcg为单位的量 |
盐酸氮斯汀 | 140 | |
莫米松糠酸酯一水合物 | 50 | |
HFA 134a | 足量 | |
卵磷脂 | 0.1% | |
醇 | (达5%) |
实施例9
含氮斯汀和甾族化合物的鼻用MDI
序号 | 成分 | 以mcg为单位的量 |
盐酸氮斯汀 | 140 | |
氟替卡松丙酸酯 | 50 | |
HFA 134a | 足量 | |
失水山梨糖醇三油酸酯 | 0.1% | |
醇 | (达5%) |
实施例10
含氮斯汀和甾族化合物的鼻用MDI
序号 | 成分 | 以mcg为单位的量 |
盐酸氮斯汀 | 140 | |
氟替卡松丙酸酯 | 100 | |
HFA 134a | 足量 | |
油酸 | 0.1% |
实施例11
含氮斯汀和甾族化合物的鼻用MDI
序号 | 成分 | 以mcg为单位的量 |
盐酸氮斯汀 | 140 | |
氟替卡松戊酸酯 | 50 | |
HFA 134a | 足量 | |
醇 | (达5%) |
含有氮斯汀和甾族化合物的可吹入粉末:
实施例12
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀(微粉化) | 140mcg | |
氟替卡松丙酸酯 | 50mcg | |
乳糖 | 足量(达25mcg) |
实施例13
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀(微粉化) | 140mcg | |
氟替卡松丙酸酯 | 100mcg | |
甘露醇 | 足量(达30mcg) |
实施例14
序号 | 成分 | 量(%w/w) |
盐酸氮斯汀(微粉化) | 140mcg | |
氟替卡松丙酸酯 | 250mcg | |
乳糖 | 足量(达30mcg) |
Claims (50)
1.一种药物制剂,其包含氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,优选该制剂为适于鼻内或眼内给药的形式。
2.根据权利要求1的药物制剂,其中所述氮斯汀以盐酸氮斯汀的形式存在。
3.根据权利要求1或2的制剂,其中该甾族化合物为倍氯米松或其药学可接受的酯、莫米松或其药学可接受的酯、氟替卡松或其药学可接受的酯、布地奈德或cyclosenide,其为任何手性形式或混合物。
4.根据权利要求3的制剂,其中该甾族化合物为倍氯米松丙酸酯、莫米松糠酸酯、莫米松糠酸酯一水合物、氟替卡松丙酸酯或氟替卡松戊酸酯。
5.根据权利要求1-4之任一项的制剂,其中每毫升制剂含有约50微克至约5mg的甾族化合物。
6.根据权利要求1-5之任一项的制剂,其中该制剂的粒径小于约10μm,优选小于5μm。
7.根据权利要求1-6之任一项的制剂,其为含有0.0005-2%(重量/制剂重量)的氮斯汀或氮斯汀的药学可接受的盐,以及0.5-1.5%(重量/制剂重量)的所述甾族化合物的混悬剂。
8.根据权利要求7的制剂,其含有0.001-1%(重量/制剂重量)的氮斯汀或其盐,以及0.5%-1.5%(重量/制剂重量)的甾族化合物。
9.根据权利要求1-8之任一项的制剂,其还含有表面活性剂。
10.根据权利要求9的制剂,其中该表面活性剂包含聚山梨酸酯或泊洛沙姆表面活性剂。
11.根据权利要求9或10的制剂,其中每毫升制剂含有约50微克至约1毫克表面活性剂。
12.根据权利要求1-11之任一项的制剂,其还含有等渗剂。
13.根据权利要求12的制剂,其中该等渗剂包含氯化钠、蔗糖、葡萄糖、甘油、山梨糖醇或1,2-丙二醇。
14.根据权利要求1-13之任一项的制剂,其还含有至少一种缓冲剂、防腐剂和助悬或增稠剂。
15.根据权利要求14的制剂,其中所述防腐剂选自依地酸及其碱金属盐、对羟基苯甲酸低级烷基酯、氯己定、硼酸苯汞或者苯甲酸或盐、季铵化合物或者山梨酸或其盐。
16.根据权利要求14或15的制剂,其中该助悬剂或增稠剂选自纤维素衍生物、明胶、聚乙烯吡咯烷酮、黄蓍胶、ethoxose(基于乙基纤维素的水溶性粘合和增稠剂)、海藻酸、聚乙烯醇、聚丙烯酸或果胶。
17.根据权利要求14、15或16之任一项的制剂,其中该缓冲剂包含柠檬酸-柠檬酸盐缓冲剂。
18.根据权利要求14、15、16或17之任一项的制剂,其中该缓冲剂将水相的pH保持在3-7,优选4.5至约6.5。
19.根据权利要求1-18之任一项的制剂,其为含水悬浮液或溶液。
20.根据权利要求19的制剂,其为气雾剂、软膏剂、滴眼剂、滴鼻剂、鼻喷雾剂或吸入溶液的形式。
21.根据权利要求20的制剂,其为滴鼻剂或鼻喷雾剂的形式。
22.根据权利要求20的制剂,其为气雾剂的形式。
23.具有剂量或计量阀的加压包装,其含有根据权利要求22的制剂。
24.一种MDI,其包含根据权利要求23的加压包装。
25.根据权利要求1-19之任一项的制剂,其为吹入粉末的形式。
26.一种药物产品,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,其优选与通常适于MDI递送的抛射剂一起以气雾剂制剂提供,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,其优选与通常适于MDI递送的抛射剂一起以气雾剂制剂提供,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
27.一种气雾剂制剂,其优选适于MDI递送,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及一种抛射剂。
28.一种药物产品,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,其以吹入粉末的形式提供,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,其以吹入粉末的形式提供,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
29.一种吹入粉末制剂,其包含(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,和(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及药学可接受的载体或赋形剂。
30.一种药物产品,其包含(i)氮斯汀或其药学可接受的盐,以及(ii)至少一种选自倍氯米松、氟替卡松、莫米松及其药学可接受的酯的甾族化合物,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
31.一种药物制剂,其包含(i)氮斯汀或其药学可接受的盐,和(ii)至少一种选自倍氯米松、氟替卡松、莫米松及其药学可接受的酯的甾族化合物,以及药学可接受的载体或赋形剂。
32.一种鼻喷雾剂,其包含氮斯汀或其药学可接受的盐,和作为莫米松游离碱或作为莫米松糠酸酯的莫米松,以及药学可接受的载体或赋形剂。
33.一种药物产品,其包含盐酸氮斯汀和倍氯米松二丙酸酯,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
34.一种药物制剂,其包含盐酸氮斯汀和倍氯米松二丙酸酯,以及药学可接受的载体或赋形剂。
35.一种药物产品,其包含盐酸氮斯汀和氟替卡松丙酸酯,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
36.一种药物制剂,其包含盐酸氮斯汀和氟替卡松丙酸酯,以及药学可接受的载体或赋形剂。
37.一种药物产品,其包含盐酸氮斯汀和氟替卡松戊酸酯,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
38.一种药物制剂,其包含盐酸氮斯汀和氟替卡松戊酸酯,以及药学可接受的载体或赋形剂。
39.一种药物产品,其包含盐酸氮斯汀和莫米松糠酸酯,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
40.一种药物制剂,其包含盐酸氮斯汀和莫米松糠酸酯,以及药学可接受的载体或赋形剂。
41.一种药物产品,其包含盐酸氮斯汀和莫米松糠酸酯一水合物,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
42.一种药物制剂,其包含盐酸氮斯汀和莫米松糠酸酯一水合物,以及药学可接受的载体或赋形剂。
43.一种基本上如本文任何实施例中所述的药物制剂。
44.根据权利要求26、28、30、33、35、37、39或41之任一项的药物产品的制备方法,所述方法包括提供(i)氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物,以及(ii)至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物,所述药物产品作为组合制剂用于在给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的治疗中同时、单独或顺续使用。
45.根据权利要求1-22、27、29、31、32、34、36、38、40、42或43之任一项的药物制剂的制备方法,所述方法包括将药学可接受的载体或赋形剂与氮斯汀或其药学可接受的盐、溶剂化物或生理功能性衍生物和至少一种甾族化合物或其药学可接受的盐、溶剂化物或生理功能性衍生物混合。
46.一种在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的方法,所述方法包括给予治疗有效量的根据权利要求26、28、30、33、35、37、39或41之任一项的药物产品,所述药物产品作为组合制剂用于在这种症状的治疗中同时、单独或顺续使用。
47.一种在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的方法,所述方法包括给予治疗有效量的根据权利要求1-22、27、29、31、32、34、36、38、40、42或43之任一项的药物制剂。
48.根据权利要求26、28、30、33、35、37、39或41之任一项的药物产品在制备用于在哺乳动物,如人中预防或治疗给予一种或多种抗组胺药和/或一种或多种甾族化合物所适用的病症的药物中的用途,所述药物产品作为组合制剂用于在这种症状的治疗中同时、单独或顺续使用。
49.一种治疗鼻或眼的刺激或疾病的方法,其包括适宜地将根据权利要求26、28、30、33、35、37、39或41之任一项的药物产品或者根据权利要求1-22、27、29、31、32、34、36、38、40、42或43之任一项的药物制剂直接施用于鼻组织或施用于眼结膜囊。
50.一种治疗气道疾病的方法,其包括通过向气道表面进行喷雾而给予治疗有效量的如前述权利要求定义的产品或制剂。
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CN103784462A (zh) * | 2014-02-25 | 2014-05-14 | 宋俊智 | 包含比拉斯汀及甾族化合物的药物制剂 |
CN104173286A (zh) * | 2014-09-10 | 2014-12-03 | 贵州云峰药业有限公司 | 氮卓斯汀组合物和用途 |
CN107737105A (zh) * | 2017-11-28 | 2018-02-27 | 贵州云峰药业有限公司 | 一种鼻腔用盐酸氮卓斯汀组合物喷雾剂及生产工艺 |
CN107929738A (zh) * | 2017-11-28 | 2018-04-20 | 贵州云峰药业有限公司 | 一种含盐酸氮卓斯汀的组合物 |
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