CN111587243A - 用于增溶5-氨基-2,3-二氢-1,4-酞嗪二酮的方法 - Google Patents
用于增溶5-氨基-2,3-二氢-1,4-酞嗪二酮的方法 Download PDFInfo
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- CN111587243A CN111587243A CN201980008025.7A CN201980008025A CN111587243A CN 111587243 A CN111587243 A CN 111587243A CN 201980008025 A CN201980008025 A CN 201980008025A CN 111587243 A CN111587243 A CN 111587243A
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- dihydro
- amino
- phthalazinedione
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D237/00—Heterocyclic compounds containing 1,2-diazine or hydrogenated 1,2-diazine rings
- C07D237/26—Heterocyclic compounds containing 1,2-diazine or hydrogenated 1,2-diazine rings condensed with carbocyclic rings or ring systems
- C07D237/30—Phthalazines
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Abstract
本发明涉及一种用于增溶5‑氨基‑2,3‑二氢‑1,4‑酞嗪二酮或其盐的方法,涉及通过该方法生产的增溶物及其在药物剂型中的各个用途。公开了基于磷脂酰胆碱的增溶方法。
Description
技术领域
本发明涉及一种用于增溶5-氨基-2,3-二氢-1,4-酞嗪二酮或其盐的方法,涉及通过该方法生产的增溶物、其用途和含有所述增溶物的药物组合物。
背景技术
几十年来,犯罪现场调查人员使用5-氨基-2,3-二氢-1,4-酞嗪二酮(鲁米诺(luminol))来检测血液痕迹,即使有人极力清洗或去除血液(参见Barni等人,Talanta2007,72,896-913)。由血红蛋白中的铁催化氧化产生的强发光使鲁米诺成为灵敏的感测器(sensor)。除了其在司法鉴定中的应用之外,自从有关鲁米诺合成的第一份报告问世以来(A.J.Schmitz,das Hydrazid derund derHeidelberg,1902),已经建立了从环境到医学的许多其它应用。例如,鲁米诺用于生物分析化学中的重金属检测或生物传感(参见Klopf和Nieman,Anal.Chem.1983,55,1080-1083)。
随着鲁米诺的钠盐已因其药物活性而重新受到关注,鲁米诺的碱性盐直到最近才在结构上有所表征(Guzei等人,J.Coord.Chem.2013,66,3722-3739)。鲁米诺钠盐在炎症和自身免疫性疾病的免疫调节治疗中显示出巨大潜力,此外,鲁米诺钠盐显示丰富的多态性,具有迄今表征的三种脱水晶体结构(参见WO 2011/107295 A1;WO 2016/96143 A1)。同样,对于鲁米诺本身,已经公开了两种晶型(Paradies,Ber.Bunsen-Ges.Phys.Chem 1992,96,1027-1031;WO 2017/140430 A1)。Skripnikova等人(2017;J Mol Struct 1154:59-63)已公开了水溶液中鲁米诺的同分异构体形式的一般理化性质。这些鲁米诺钠盐或鲁米诺晶型的特殊治疗用途已经在WO 2017/202496 A1中描述。
已知化合物的晶型可显示出不同的物理特性,例如溶解度、溶解速率和稳定性(参见Haleblian und McCrone(1969):Journal of Pharmaceutical Sciences,58:911-929)。这些特性可影响化合物的药物加工以及其生物利用度和药代动力学,因此影响其生物功效(参见Griesser(2006)标题为:Polymorphisms in the PharmaceuticalIndustry.Hilfiker(编辑.)211-234)。在WO 2013/108254 A1中公开了一种通过向溶液中加入至少一种胡椒碱来提高药物的口服生物利用度的配方。
迄今为止所描述的鲁米诺盐易溶于水,而鲁米诺本身的水溶性差。此外,少量可溶解的鲁米诺在几天后趋于沉淀。同样,也已经描述对光、高温和金属阳离子的敏感性。这严重妨碍了鲁米诺水溶液的使用。可以通过使用碱性溶液、或通过使用如乙醇或DMSO等稀释剂来解决此问题。然而,这些稀释剂不适用于多种药物应用。
就在水性环境中的溶解度而言,鲁米诺钠盐的使用是有利的。然而,对于在胃肠道中吸收、经皮递送用局部施用或对于跨血脑屏障的运输,如果可以施用游离酸以提高鲁米诺的生物利用度,这将是优选的。因此,可以达到足够高的血浆和细胞内浓度,以最大化鲁米诺的治疗潜力。因此,需要找到一种使鲁米诺在水性介质中增溶的方法。
有多种方法用于改善亲脂性药剂的溶解度,在许多情况下,还通过使用增溶技术来改善其生物利用度。本文通过添加第三物质来增加药物在介质中的溶解度。这些第三物质是指增溶剂(增溶试剂),即可以例如与待增溶的物质形成复合物的物质。这类螯合剂的实例是苯甲酸钠和水杨酸钠。增溶剂的另一作用机理是例如通过干扰水的团簇结构来提高溶剂的溶解能力。此类结构破坏剂的实例是甘油(glycerol,glycerin)和聚乙二醇(macrogol,polyethylene glycol,PEG)。
第三种增溶机理是胶束和脂质体的应用技术。它们在过去的几十年中受到了广泛的关注。本文待递送的物质被包封在表面活性剂分子的球形聚集体中。这些分子的特征在于极性头基团和长的非极性链(“尾”)。当接触水性介质时,这些分子倾向于通过将极性头基团朝向周围的介质并将非极性链朝向球体内部取向而聚集为球形结构来缔合。当这些球体仅由一层此类两亲分子组成时,它们被称为胶束。根据两亲分子的性质和反应条件,也可以形成具有一层以上的球体。这里在球体的外层内部形成第二层,该第二层的非极性基团朝向外层的非极性基团取向,并且极性头基团朝向该球体的内部取向。这种聚集体被称为脂质体。在它们的结构中,它们类似于细胞膜的脂双层。还存在多层脂质体,其中至少两个脂质体球体彼此同心地形成,从而形成多级球形聚集体(multispherical aggregate)。当在亲脂性介质中时,这些物质趋于形成颠倒的球形结构,其中亲脂性链朝向溶液介质取向且其他层相应排列。
在本领域中已经描述了这种负载球体的不同用途,其中它们用作用于施用亲脂性物质和/或用于提高被包封物质的生物利用度的剂型。在胶束中,被包封的非极性物质集中在两亲分子的非极性链所朝向的球体内部空间中。然而,在脂质体中,在脂质体中,球体的内部空间是水性的,各自为亲水性介质。其可用于包装亲水性分子。然而,各自水溶性差的亲脂性分子主要聚集在脂质体层的亲脂性结构之间。
例如在WO 03/007907 A1或WO2014/094921 A1中已经公开了基于胶束的增溶技术。其中使用的HLB(亲水-亲脂平衡)值分别为9-16或13-18的乳化剂。经常使用聚山梨酯(Tween)20或80。显然,该技术的实施仅限于口香糖的生产。
另一种方法是将葡萄糖醛酸化抑制剂与药物组合物混合。例如泊洛沙姆(poloxamers)或聚山梨酯20、聚山梨酯60、聚山梨酯80等表面活性剂被广泛使用。另一种常见的葡萄糖醛酸化抑制剂是胡椒素(bioperine)。然而,葡萄糖醛酸化抑制剂也抑制正常代谢并因此消除其他药物或内源性物质。因此,它们的使用是一把双刃剑,并且应取决于每个患者的药物治疗。因此,这种组合物对于长期药物治疗、特别是在多重病症患者中带来问题。
从经验的药代动力学测定得知,生物体可以通过肠绒毛吸收胃肠道中的胶束和脂质体。然而,它们的吸收程度似乎变化很大,因此这些方法在增加包封化合物的生物利用度方面成败参半。每种物质在细胞膜上的迁移率或吸收速率是每种物质的固有特性,这取决于多种因素,例如分子大小、亲脂性程度以及细胞膜内部合适的转运蛋白分子的存在。对于许多化合物,这些参数是未知的,必须在找到适合该特定化合物的包装之前首先确定。
脂质体的应用已在医学和药理学中被广泛讨论,并且已经为特定的活性剂开发了一些复杂的解决方案。然而,它们的使用不是很常见。一个原因是相对高的生产成本,另一个原因是可能的不利副作用。EP 3290026 A1中公开了用于水溶性差的膳食补充剂和药物活性剂的基于脂质体的自乳化方法。具体地,当肠胃外施用时,脂质体具有在肝脏、脾脏和/或骨髓中积累的风险。因此,人们常以怀疑的目光看待脂质体制剂。
在WO 2013/108254中公开了用于增加药物生物利用度的基于纳米脂球的配制方法。尽管此方法相对于现有技术提供了一些进步,但也存在一些固有的缺点。这些固体脂质纳米颗粒的生产需要高压均质机。然而,已经描述了某些药物或膳食补充剂的高压诱导的药物降解。发生脂质结晶、胶凝现象和几种胶体物质的共存。迄今为止,诸如吞噬作用后的细胞毒性效果、有机残留物的毒性效果以及难以工业化扩展等的进一步的限制性因素限制了它们的使用(Mehnert和Adv Drug Deliv Res 2001,47,165-196;Dudala等人,Int J Pharm Investg 2014,4,149-155)。此外,它们的载药量相对小并且显示出低粘度。这使得它们对于局部或经皮施用形式不是很有吸引力(Mukherjee等人,Indian J PharmSci 2009,71,349-358)。此外,在WO 2013/108254中需要使用两亲性溶剂,例如乳酸或N-甲基吡咯烷酮的低级烷基酯。N-甲基吡咯烷酮在潜在的致癌性和生殖毒性方面被列为备受关注的物质,乳酸甲酯通常在水性环境中被水解为乳酸和甲醇。乳酸乙酯等具有良好的耐受性。然而,由于相对高的生产成本,它不是非常有吸引力的溶剂。
在WO 03/007907 A1中描述了借助于含甘油三酯的轻油的泛醌(ubichinon)Q10用增溶技术。
另一种增溶技术是使待增溶的物质与诸如α-、β-或γ-环糊精等环糊精类或例如2-羟丙基-β-环糊精、甲基-β-环糊精或三甲基-β-环糊精等环糊精衍生物形成包合物。通常,环糊精由6至8个形成大环的1,4-连接的α-D-吡喃葡萄糖苷组成。因此,产生了能够在其内部容纳疏水性物质的水溶性环面(圆锥形或桶形)结构。内部空间的亲水性大大低于接触水性环境的外部的亲水性。通过酶处理由淀粉生产环糊精。它们负载有待通过分散而增溶的化合物。然后,取决于具体组成,可以通过使这些复合物与水接触、通过pH或温度变化来释放待增溶的化合物。然而,环糊精的开发显然不容易并且相对昂贵。到目前为止,这限制了它们的使用。另一个问题是环糊精与例如对羟基苯甲酸酯等防腐剂相互作用。
因此,所有这些技术都有其优点,但也有一些缺点。
聚山梨酯广泛用于这些增溶技术中。然而,关于聚山梨酯对健康的有害影响一直存在争议。讨论了聚山梨酯-20被未反应的1,4-二噁烷和环氧乙烷(至少来自某些供应商)污染。这些是已知的可透过皮肤的致癌性物质(参见,截至2017年3月22日的http://www.fda.gov/ohrms/dockets/98fr/060199a.txt)。最近发现,聚山梨酯80对鼠肠道微生物群具有有害影响,由此促进肥胖和炎症性肠病(Chassaing等人,Dietary emulsifiersimpact the mouse gut microbiota promoting colitis and metabolic syndrome,Nature,2015,519,92-96)。这对于患有例如克罗恩氏病(Crohn’s disease)等慢性炎症性肠病(IBD)的患者尤为重要(Roberts等人,Translocation of Crohn's diseaseEscherichia coli across M-cells:contrasting effects of soluble plant fibresand emulsifiers,Gut,2010,59,p.1331–1339)。IBD是5-氨基-2,3-二氢-1,4-酞嗪二酮的治疗用途的目标适应症。例如Tween 80等聚山梨酯的另一个问题是,它们通过结合广泛使用的例如对羟基苯甲酸酯等防腐剂而降低它们的功效(参见Blanchard等人,Effect ofsorbitol on interaction of phenolic preservatives with polysorbate 80,1977,JPharm Sci 66,p.1470-1473)。然而,由于其雌激素的潜力,不应相应增加对羟基苯甲酸酯的浓度(参见Okubo等人;ER-dependent estrogenic activity of parabens assessed byproliferation of human breast cancer MCF-7cells and expression of ERalpha andPR;2001,Food Chem Toxicol 39,p.1225-1232)。聚山梨酯(特别是聚山梨酯80)的其他众所周知的问题是患者的超敏反应(参见Steele等人,Hypersensitivity reactions to thepolysorbate contained in recombinant erythropoietin and darbepoietin,Nephrology,2005,10,p.317-320;Norris等人,Polysorbate 80hypersensitivityreactions:a renewed call to action,Commun Oncol,2010,7,425-428)。聚山梨酯80还与胺碘酮制剂中的系统性低血压有关,甚至可能导致人员伤亡(参见Cushing等人,PM 101:A cyclodextrin-based intravenous formulation of amiodarone devoid of adversehemodynamic effects,Eur J Pharmacol,2009,607,p.167-172)。
发明内容
5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶方法应满足以下标准:
·易于操作
·无需花费很长的开发时间来寻找合适的组合物
·无需昂贵的设备
·廉价的材料和生产成本
·无需添加聚山梨酯(Tween)增溶剂。
令人惊讶的是,发现根据本发明的方法能够解决该任务。
本文中,通过根据本发明的方法增溶5-氨基-2,3-二氢-1,4-酞嗪二酮,所述方法包括以下步骤:
a)在室温和0.2bar至1bar的压力下,提供总范围为0.1重量%至25重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮;
b)以任意顺序添加以下的增溶剂:总范围为20重量%至80重量%的至少一种磷脂酰胆碱、
总范围为10重量%至70重量%的至少一种中链甘油三酯、
总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱、
总范围为1重量%至20重量%的至少一种C2至C4醇、和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯和/或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂均为药学上可接受的赋形剂;
c)通过在20–60分钟的时间内以0.5℃/分钟至3℃/分钟的连续温度增量连续升高温度而小心地加热所得混合物;
d)一旦达到澄清溶液就在30℃至125℃的温度范围内停止升温;和
e)使所得增溶物冷却至室温。
在优选实施方案中,通过根据本发明的方法增溶5-氨基-2,3-二氢-1,4-酞嗪二酮,所述方法包括以下步骤:
a)在室温和0.2bar至1bar的压力下,提供总范围为0.5重量%至10重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮;
b)以任意顺序添加以下的增溶剂:总范围为20重量%至80重量%的至少一种磷脂酰胆碱、
总范围为10重量%至70重量%的至少一种中链甘油三酯、
总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱、
总范围为1重量%至20重量%的至少一种C2至C4醇、和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯和/或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂均为药学上可接受的赋形剂;
c)通过在20–60分钟的时间内以0.5℃/分钟至3℃/分钟的连续温度增量连续升高温度来小心地加热所得混合物;
d)一旦达到澄清溶液就在30℃至125℃的温度范围内停止升温;和
e)使所得的增溶物冷却至室温。
本发明的另一方面为,根据本发明的方法不需要聚山梨酯作为增溶剂和/或乳化剂。因此,可通过根据本发明的方法增溶5-氨基-2,3-二氢-1,4-酞嗪二酮,所述方法包括以下步骤:
a)在室温和0.2bar至1bar的压力下,提供总范围为0.1重量%至25重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮;
b)以任意顺序添加以下的增溶剂:总范围为20重量%至80重量%的至少一种磷脂酰胆碱、
总范围为10重量%至70重量%的至少一种中链甘油三酯、
总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱、
总范围为1重量%至20重量%的至少一种C2至C4醇、和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯和/或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂均为药学上可接受的赋形剂;
c)通过在20–60分钟的时间内以0.5℃/分钟至3℃/分钟的连续温度增量连续升高温度来小心地加热所得混合物;
d)一旦达到澄清溶液就在30℃至125℃的温度范围内停止升温;和
e)使所得增溶物冷却至室温,
其特征在于所得增溶物不含聚山梨酯。
在另外的实施方案中,根据本发明的增溶物也可以由5-氨基-2,3-二氢-1,4-酞嗪二酮的盐生产。已经描述了钠盐、钾盐和锂盐用于治疗应用(参见WO 2010/082858)。Guzei等人(2013,Journal of Coordination Chemistry 66,3722-3739;还可参见WO 2011/107295 A1;WO 2016/96143 A1)中描述了锂盐、钠盐、钾盐、铷盐和铯盐的晶体结构。通常,这些盐是水溶性的,因此不需要将其增溶用于水溶液。然而,当在治疗上使用时,根据本发明的增溶物易于延长液体剂型的保存期限。在用于口服给药的液体剂型中,它们可以覆盖对许多患者而言没有吸引力的5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐溶液的味道。此外,它们在数量和时间方面改善了这些5-氨基-2,3-二氢-1,4-酞嗪二酮的盐在胃肠道中的再吸收。因此,可以改善生物利用度,这可以导致有利的药代动力学特性。然而,较大的离子浓度妨碍了多层囊泡的形成,这被认为对于将本发明的增溶物溶解在水溶液中是必不可少的。因此,5-氨基-2,3-二氢-1,4-酞嗪二酮的盐的最大相对量低于游离碱的最大相对量。
发现根据本发明的方法可溶解多至2重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮的盐。
因此,通过根据本发明的方法增溶5-氨基-2,3-二氢-1,4-酞嗪二酮的盐,所述方法包括以下步骤:
a)在室温和0.2bar至1bar的压力下,提供总范围为0.1重量%至2重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮的盐,
其中所述盐是钠盐、钾盐或锂盐或它们的混合物;
b)以任意顺序添加以下的增溶剂:总范围为20重量%至80重量%的至少一种磷脂酰胆碱、
总范围为10重量%至70重量%的至少一种中链甘油三酯、
总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱、
总范围为1重量%至20重量%的至少一种C2至C4醇、和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯和/或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂均为药学上可接受的赋形剂;
c)通过在20–60分钟的时间内以0.5℃/分钟至3℃/分钟的连续温度增量连续升高温度来小心加热所得混合物;
d)一旦达到澄清溶液就在30℃至125℃的温度范围内停止升温;和
e)使所得增溶物冷却至室温。
在优选的实施方案中,这些5-氨基-2,3-二氢-1,4-酞嗪二酮的盐的实施方案的特征还在于所得增溶物不含聚山梨酯。
具体实施方式
应理解,以下描述和实施方案同样是指对于游离碱而言的所述5-氨基-2,3-二氢-1,4-酞嗪二酮的盐。
在本领域中可以找到令人困惑甚至矛盾的定义。为了避免任何歧义,将根据本发明的增溶物定义如下:
增溶物是5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的组合物以及根据本发明所定义的增溶剂。该术语不应包括进一步添加溶剂或稀释剂。首先通过根据本发明的增溶方法来生产根据本发明的增溶物,然后将特定的药物组合物与所述增溶物一起生产,最后将所述药物组合物包装至用于各个剂型的合适的药学上可接受的容器中。
根据本发明的增溶物的特征在于基本上完全溶解的5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物,因此是近乎完美的溶液,其中分子在溶液中基本上表现为独立实体,并且基本上经历布朗运动的分布和热力学规则。因此,增溶物是含有高浓度5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的澄清溶液。通常,增溶物不意味着没有稀释地给药,或者没有以药学上可接受的剂型配制地给药。在大多数情况下,一部分增溶物占几毫升的体积。
在本专利申请的范围内,术语“增溶聚集体”或“增溶本质”应与“增溶物”同义使用。
必须将根据本发明的增溶物与悬浮液(胶体悬浮液)区分开。该术语定义了包含固体颗粒的异质混合物,该固体颗粒迟早会沉降。它也不同于乳液(通常不互溶的两种液体的混合物)。
为了增加物质的生物利用度,高度优选完全溶解。
根据本发明使用的术语增溶物必须与药物组合物区分开。通过在优选的水溶液中稀释根据本发明的增溶物以制备液体剂型,或通过将增溶物混合至局部剂型、胶囊或栓剂中来生成根据本发明的药物组合物。
在本申请的范围内的稀释剂是稀释试剂(稀释剂(dilutant,thinner))。它不是根据本发明的增溶物的一部分。
在本申请的范围内,术语“增溶剂(solubilizing agent)”是指添加至5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物中以使其增溶、使得5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物随即在水溶液中溶解的任何化学物质。术语“增溶剂(solubilizer)”应同义使用。
在本申请的范围内,术语“医学”应包含人类医学和兽医学。
这种增溶物的一大优势在于其体积小。因此,可以很容易地将其分配给患者友好的设备,或者可以以低成本运输相对大量的增溶物质。为了制备剂型,该制备可以由医务人员或患者容易地进行。
还必须将根据本发明的增溶物与浓缩物区分开。浓缩物是一种化合物,或者是无稀释剂的多种化合物的组合物。当将浓缩物释放至稀释剂中时,浓缩物自身完全溶解在稀释剂中或与稀释剂形成悬浮液或乳液。浓缩物不需要与增溶剂相互作用,因为其本质上可溶于水或水溶液中。
在根据本发明的方法的优选实施方案中,提供总范围为2重量%至15重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮,在更优选的实施方案中,提供总范围为2重量%至10重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮。
磷脂酰胆碱是一类与胆碱连接的磷脂。它们是细胞膜的主要成分,并且例如从蛋黄、牛肝、海洋动物、磷虾油或大豆中获得。实际上,这表明磷脂酰胆碱的来源对它们的生物学和化学作用有很大影响。根据本发明,至少一种磷脂酰胆碱(PC)可以选自包含以下的组:1-棕榈酰-2-油酰-sn-甘油-3-磷酸胆碱(POPC)、天然的(非氢化的)或氢化的大豆PC、天然或氢化的卵PC、二棕榈酰磷脂酰胆碱(DPPC)、二硬脂酰磷脂酰胆碱(DMPC)或1,2-二油烯基-SN-甘油-3-磷酸胆碱(DOPC)、1-油酰基-棕榈酰磷脂酰胆碱(OPPC)、二硬脂酰磷脂酰胆碱(DSPC)、单硬脂酰磷脂酰胆碱(MSPC)、二花生四酰基磷脂酰胆碱(DAPC)及其混合物。优选的磷脂酰胆碱是非氢化的大豆PC、DMPC、POPC和DOPC。也优选非氢化的磷脂酰胆碱。特别优选的是非氢化大豆PC。
对于根据本发明的增溶物的局部剂型,特别优选非氢化的磷脂酰胆碱。
卵磷脂通常用作磷脂酰胆碱的同义词。它是磷脂酰胆碱和其它化合物的混合物。
根据本发明的方法,以总范围为20重量%至80重量%,优选总范围为40重量%至70重量%,更优选总范围为50重量%至65重量%,最优选总范围为60重量%使用磷脂酰胆碱。
中链甘油三酯(MCT)是指脂肪酸具有碳数为6-12的脂肪族尾的甘油三酯,MCT中引入的脂肪酸称为中链脂肪酸(MCFA)。在甘油三酯中,在甘油三酯中,三个脂肪酸分子结合至甘油主链。根据定义,在MCT中,这三种脂肪酸中的至少两种必须是MCFA。根据本发明,MCFA可以彼此独立地选自包含以下的组:己酸、庚酸、辛酸、壬酸、癸酸、十一碳酸、月桂酸、它们的不饱和衍生物及其混合物。优选的MCFA是己酸、辛酸、癸酸和月桂酸。
在本发明的一些实施方案中,使用含有1-3个肉豆蔻酸和/或棕榈酸残基的甘油三酯代替MCFA可以是有利的。因此,这两种脂肪酸也应归入根据本发明的术语MCT之下。
MCT油或MCT脂肪是主要包含所述MCT的油或脂肪。这些术语是指可包含多种MCFA的不同MCT的各自的混合物。根据本发明,这些术语应涵盖任何合理的混合比。MCT脂肪通常从特定的植物脂肪(plant fat)中提取,而MCT油并非天然存在。MCT油和MCT脂肪分别作为健康的膳食补充剂、作为营养中长链脂肪的替代品而广泛销售。
根据本发明的方法,以总范围为10重量%至70重量%,优选总范围为20重量%至40重量%,更优选总范围为25重量%至35重量%,最优选总范围为30重量%使用MCT。
溶血磷脂酰胆碱(LPC,lysoPC,也称为:溶血卵磷脂)是一类磷脂酰胆碱的衍生物,是磷脂酰胆碱部分水解的结果,其中去除了脂肪酸基团之一。在生物体中,这种水解受到酶磷脂酶A2影响。根据本发明,至少一种溶血磷脂酰胆碱可以彼此独立地选自包含以上列出的磷脂酰胆碱的所有水解化合物、1-溶血磷脂酰胆碱(2-酰基-sn-甘油-3-磷酸胆碱)、2-溶血磷脂酰胆碱、L-α-溶血磷脂酰胆碱及其混合物的组。
根据本发明的方法,以总范围为1重量%至15重量%,优选总范围为3重量%至8重量%,更优选总范围为5重量%至7重量%,最优选总范围为6重量%使用溶血磷脂酰胆碱。
在本申请的范围内,所述溶血磷脂酰胆碱不仅仅是磷脂酰胆碱的变体或替代物,而是发挥独立的作用。令人惊讶地,发现如果以不均匀的比例使用两种化学结构相似但不相同的增溶剂,可以显著改善增溶效果。根据本发明,磷脂酰胆碱与溶血磷脂酰胆碱之比为80:1至1.33:1,优选40:1至3:1,更优选25:1至5:1,并且最优选20:1至8:1。
根据本发明,至少一种C2至C4醇(低级醇)可以选自包含以下的组:乙醇、丙醇、异丙醇、丁烷-1-醇、丁烷-2-醇、异丁醇(2-甲基-1-丙醇)、乙二醇(乙烷-1,2-二醇)、α-丙二醇(丙烷-1,2-二醇)、β-丙二醇(丙烷-1-3-二醇)、1,2-丁二醇(丁烷-1,2-二醇)、1,3-丁二醇(丁烷-1,3-二醇)、1,4-丁二醇(丁烷-1,4-二醇)和二甘醇。优选乙醇。
根据本发明的方法,以总范围为1重量%至20重量%,优选总范围为2重量%至10重量%,更优选总范围为3重量%至8重量%,最优选总范围为5重量%使用C2至C4醇。
硬脂酸甘油酯(甘油单硬脂酸酯,GMS)是一种乳化剂。片状粉末也具有吸湿性。GMS用作增稠、乳化、防结块、防老化和防腐剂。
根据本发明,可以使用至少一种饱和或不饱和的C14至C20脂肪酸代替硬脂酸甘油酯或与硬脂酸甘油酯组合使用。其可以选自包含以下的组:肉豆蔻酸(14:0)、十五烷酸(15:0)、棕榈酸(16:0)、十七酸(17:0)、硬脂酸(18:0)、十九烷酸(19:0)、花生酸(20:0)、肉豆蔻烯酸(14:1,顺式-Δ9)、棕榈油酸(16:1,顺式-Δ9)、十六碳烯酸(sapienic acid)(16:1,顺式-Δ6)、十六碳三烯酸(16:3,(n-3)、油酸(18:1,顺式-Δ9)、反油酸(18:1,反式-Δ9)、反式十八碳烯酸(vaccenicacid)(18:1,反式-Δ11)、亚油酸(18:2;顺式,顺式-Δ9,Δ12)、反式,反式十八碳二烯酸(linoleadic acid)(18:2,反式,反式-Δ9,Δ12)、α-亚麻酸(18:3,顺式,顺式,顺式-Δ9,Δ12,,Δ15)、γ-亚麻酸(18:3,(ω-3))、十八碳三烯酸(8E,10E,12Z-十八碳三烯酸)、十八碳四烯酸(18:4(n-3))、双高(dihomo)-γ-亚麻酸(20:3;(ω-6))、二十碳二烯酸(20:2,(n-6))、二十碳三烯酸(20:3,(n-3))、二十碳四烯酸(20:4,(n-3))、花生四烯酸(20:4,顺式,顺式,顺式,顺式-Δ5,Δ8,Δ11,Δ14)、二十碳五烯酸(20:5,顺式,顺式,顺式,顺式,顺式-Δ5,Δ8,Δ11,Δ14,Δ17)。优选的是偶数的C14至C20脂肪酸。特别优选的是油酸。
根据本发明的方法,以总范围为0.5重量%至10重量%,优选总范围为1重量%至8重量%,更优选总范围为2重量%至6重量%,最优选总范围为3重量%使用硬脂酸甘油酯和/或饱和或不饱和的C14至C20脂肪酸。
根据本发明的方法通常在室温下开始。然而,在替代实施方案中,也可以预热5-氨基-2,3-二氢-1,4-酞嗪二酮和/或在本发明方法的步骤b)中加入的任何增溶剂,条件是预热温度不超过28℃。
根据本发明的方法可以在0.2bar至1bar的压力下进行。然而,优选在1bar(大气压)下进行该方法。对于某些应用,可以优选使用轻真空。应用、维持和控制这种轻真空的技术设备在本领域中是众所周知的。
根据本发明的方法,在步骤c)中通过在20-60分钟的时间内连续升高温度而小心地加热所得混合物。在优选的实施方案中,该时间为25–40分钟,并且最优选30–35分钟。
根据本发明的方法的必要特征是温度控制(相对于时间和加热持续时间的温度增量)。尽管增溶剂的相对量存在变化,但是受控的温度升高是必不可少的。显然,取决于所用增溶剂的混合物,每种要增溶的物质都有一个最佳窗口。确切的值很难预测,必须凭经验找出。
连续温度增量(升温幅度(steepness of the temperature ramp))可以在0.5℃/分钟至3℃/分钟之间变化,优选1℃/分钟至2℃/分钟,最优选2℃/分钟。
根据步骤d),一旦达到澄清溶液,在30℃至125℃的温度范围内停止升温。这一时刻在很大程度上取决于所选的增溶剂和反应条件。显然,不可能根据要使用的特定组分来预测该“增溶温度”。这些组分的每种组成显示出必须通过实验发现的特定特征。因此,实验者要找出这些参数的最佳组合。
应理解,可以以这样的方式改变根据本发明的方法,即可以首先提供步骤b)的任意增溶剂,然后可以以任意顺序添加5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物以及其他增溶剂。也可以首先提供步骤b)的增溶剂的混合物,然后添加5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物。发现该变化对根据本发明的方法的结果是中性的。
在一个优选的实施方案中,将步骤b)的增溶剂和5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的所述混合物以两室体系提供。这可以促进根据本发明的增溶过程,并且每个隔室可以分开销售。这对于根据本发明的剂型的稳定性以及由此的保存期限是有利的。
由实验者观察确定所得的增溶物变成澄清溶液的时刻。通常,这个时刻是在溶液看起来透明并且没有显示任何沉降、沉淀、污点(slur)、污迹或条纹(斑马效应)时达到的。
在替代实施方案中,如前所述已经确定的根据本发明的升温的参数可以在自动或半自动设备设置中实现。例如,在高档工业应用中,这可以是有利的。
根据本发明的方法生产的增溶物在冷却时保持这种透明度,并且在储存时保持透明和稳定。含有所述增溶物的药物剂型的可获得的储存时间(大致对应于产品的保存期限)明显不受限制。在初步稳定性分析中,最短储存时间不得少于6个月。
然而,为了延长这些5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的增溶物的保存期限,可以将至少一种抗氧化剂添加至增溶物中。在优选的实施方案中,该至少一种抗氧化剂是药学上可接受的赋形剂。合适的抗氧化剂可以选自包含以下的组:乳酸、抗坏血酸、抗坏血酸钠、抗坏血酸钙、抗坏血酸钾、抗坏血酸的脂肪酸酯、抗坏血酸棕榈酸酯、抗坏血酸硬脂酸酯、生育酚、α-生育酚、β-生育酚、γ-生育酚、δ-生育酚、α-生育三烯酚、β-生育三烯酚、γ-生育三烯酚、δ-生育三烯酚、没食子酸丙酯、没食子酸辛酯、没食子酸月桂酯、没食子酸乙酯、愈创树脂、异抗坏血酸(erythorbic acid)、异抗坏血酸钠(sodium erythorbate)、异抗坏血酸(erythorbin acid)、异抗坏血酸钠(sodiumerythorbin)、叔丁基氢醌、丁基羟基茴香醚、丁基羟基甲苯,磷酸二氢钠、磷酸氢二钠、磷酸钠、磷酸二氢钾、磷酸氢二钾、磷酸钾、阿诺克索默(anoxomer)、乙氧基喹啉、乳酸钾、氯化亚锡、硫代硫酸钠、4-己基间苯二酚、葡萄糖氧化酶。优选的是抗坏血酸棕榈酸酯和α-生育酚、β-生育酚、γ-生育酚、δ-生育酚。特别优选的是抗坏血酸棕榈酸酯与α-生育酚、β-生育酚、γ-生育酚、δ-生育酚中的至少一种的组合。
术语生育酚是指任何上述生育酚或其混合物。
根据本发明的方法,该至少一种抗氧化剂可任选以总范围为0.01重量%至10重量%、优选总范围为0.1重量%至5重量%、更优选总范围为0.2重量%至1重量%且最优选总范围为0.3重量%至0.5重量%添加至所述增溶物或其优选实施方案中。
因此,本申请还涉及由根据本发明的增溶方法得到的增溶物:
一种增溶物,其包含总范围为0.5重量%至10重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮和以下增溶剂:
a)总范围为20重量%至80重量%的至少一种磷脂酰胆碱;
b)总范围为10重量%至70重量%的至少一种中链甘油三酯;
c)总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱;
d)总范围为1重量%至20重量%的至少一种C2至C4醇,和
e)和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂彼此独立地为药学上可接受的赋形剂。
在一个优选的实施方案中,根据本发明的增溶物包含总范围为1重量%至8重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮,和
a)总范围为40重量%至70重量%的至少一种磷脂酰胆碱;
b)总范围为20重量%至40重量%的至少一种中链甘油三酯;
c)总范围为3重量%至8重量%的至少一种溶血磷脂酰胆碱;
d)总范围为2重量%至10重量%的至少一种C2至C4醇,和
e)和总范围分别为0.5重量%至5重量%的至少一种硬脂酸甘油酯或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂彼此独立地为药学上可接受的赋形剂。
在另一个优选的实施方案中,根据本发明的增溶物包含总范围为2重量%至5重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮,和
a)总范围为40重量%至60重量%的至少一种磷脂酰胆碱;
b)总范围为25重量%至35重量%的至少一种中链甘油三酯;
c)总范围为5重量%至7重量%的至少一种溶血磷脂酰胆碱;
d)总范围为4重量%至7重量%的至少一种C2至C4醇,和
e)和总范围分别为0.5重量%至5重量%的至少一种硬脂酸甘油酯或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂彼此独立地为药学上可接受的赋形剂。
在替代实施方案中,根据本发明的方法还涉及:
一种增溶物,其包含总范围为0.1重量%至2重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮的盐和以下增溶剂,
其中所述盐是钠盐、钾盐或锂盐或它们的混合物,
a)总范围为20重量%至80重量%的至少一种磷脂酰胆碱;
b)总范围为10重量%至70重量%的至少一种中链甘油三酯;
c)总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱;
d)总范围为1重量%至20重量%的至少一种C2至C4醇,和
e)和总范围分别为0.5重量%至10重量%的至少一种硬脂酸甘油酯或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比总计为100%,并且所有增溶剂彼此独立地为药学上可接受的赋形剂。
根据本发明,所述增溶物或其优选的实施方案可以额外包含如上文所列出的抗氧化剂,其总范围为0.01重量%至10重量%,优选总范围为0.1重量%至5重量%,更优选总范围为0.2重量%至1重量%,最优选总范围为0.3重量%至0.5重量%。
在这种增溶物的特别优选的实施方案中,所述至少一种饱和或不饱和的C14至C20脂肪酸是油酸。
在这种增溶物的特别优选的实施方案中,所述至少一种C2至C4醇是乙醇。
在优选的实施方案中,在根据本发明的增溶物中额外包含总范围为0.01-10重量%的至少一种抗氧化剂,其中所述至少一种抗氧化剂是药学上可接受的赋形剂。
在特别优选的实施方案中,所述至少一种抗氧化剂是抗坏血酸棕榈酸酯和/或至少一种生育酚。
本申请的另一方面是根据本发明的增溶物在医学中的预防或治疗用途以及所述增溶物在医学中的预防或治疗用途。
在本申请的范围内,术语“医学”应指人类医学以及兽医学。
具体地,本申请涉及根据本发明的增溶物用作免疫调节剂的预防或治疗用途。
本申请还涉及根据本发明的增溶物在治疗具有过度免疫反应的病况或具有免疫缺陷背景的病况中的用途。
本申请还涉及用于治疗医学病况的药物组合物,其包含根据本发明的5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的增溶物。
在本文中,术语渗透性是指药物在人中穿过肠壁的吸收程度。根据确定的定义,如果90%以上的口服剂量在胃肠道中吸收,则该药物被归类为高渗透性。相应地,吸收率小于90%的药物被归类为低渗透性。
因此,溶解度和渗透性是固有的物质特性。然而,吸收和生物利用度描述了可通过适当措施改善的药物参数。吸收是指从胃肠道吸收的口服物质量中的一部分,物质的生物利用度不仅取决于吸收,还取决于血液中与物种特异性蛋白结合以及例如首过代谢等的药代动力学参数。
因此,本发明的另一方面是根据本发明的增溶物的用于增强5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的吸收和/或生物利用度的预防或治疗用途。
因此,本申请还涉及根据本发明的增溶物在药物剂型中的用途。
此外,本申请还涉及根据本发明的增溶物在药物剂型中的医学用途。
在大多数情况下,5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的增溶物还不是药物剂型。为了准备以液体剂型摄入,必须将所述增溶物溶解在稀释剂中。用于液体剂型的优选稀释剂是水。因此,将根据本发明的增溶物添加至合适容器中的水溶液中。容器可以选自包含但不限于以下的组:瓶、小瓶、长颈细口瓶、玻璃杯、杯子、注射器、广口瓶、罐、分配器、盒子、管、盖、小袋和定制的两室或多室容器。优选的容器是瓶、小瓶和广口瓶。
优选将含有水溶液和溶解于其中的增溶物的容器搅拌或搅动数次,以确保增溶物在水溶液中的均匀分布。
因此,本申请还涉及药物剂型,其中根据本发明的增溶物溶解在水溶液中。
在本发明的另一个优选实施方案中,将根据本发明的增溶物包括在软明胶胶囊(SGC)中。SGC在其通过胃肠道时溶解。它们主要由富含各种量的诸如甘油或脱水山梨糖醇等的增塑剂的明胶组成。释放速率取决于SGC载体材料的具体配方。它们也适合于活性剂的持续释放。SGC对于水溶性差的活性剂的给药特别有用。它们非常适合将5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶物容纳在腔中。
在本发明的另一个实施方案中,将根据本发明的增溶物提供于硬明胶胶囊中。它们由明胶、水和通常的着色剂组成,但不含增塑剂。在生产过程中可以包括根据本发明的增溶物。增溶物在硬明胶胶囊溶解时释放。
在本发明的另一个优选实施方案中,将根据本发明的增溶物包括在可咀嚼的片剂或硬焦糖中。本文中,将根据本发明的增溶物整合至片剂或焦糖的基质中。
在本发明的另一个实施方案中,将根据本发明的增溶物包括在栓剂中。在典型的生产方法中,首先将具有低熔点的蜡以及例如可可脂等脂肪酸甘油酯的混合物熔融。然后将活性剂,本文中为5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物的增溶物,在搅拌或其他混合方法下均匀分散。然后将熔融的均质混合物转移至合适的模具中,并冷却直至固化。
还在本发明的另一个实施方案中,提供根据本发明的增溶物作为局部施用形式,例如乳膏剂、乳剂、洗剂、凝胶剂、水凝胶剂、糊剂、粉剂、软膏剂、擦剂、薄膜、脂质体、皮肤贴剂、经皮贴剂、透皮喷雾剂或混悬剂。
在另一方面,本申请还涉及包含以如上定义的剂型配制的5-氨基-2,3-二氢-1,4-酞嗪二酮或者其盐之一或它们的混合物、和至少一种药学上可接受的赋形剂的药物组合物。
术语“药物赋形剂”是指与药物活性剂一起添加至药物制剂中的天然或合成化合物。它们可以帮助增加制剂的体积,以增强期望的药代动力学特性或制剂的稳定性,并且在制造过程中是有益的。根据本发明的赋形剂的有利类别包括载体、粘合剂、润滑剂、助流剂、崩解剂、着色剂、缓冲剂、防腐剂、乳化剂、渗透促进剂、抗氧化剂、稀释剂、pH调节剂、加脂剂(fatiquors)、溶剂、稠度增强剂、水溶助剂(hydrotopes)、甜味剂、酸化剂、增稠剂、抗粘剂、填料、调味剂、甜味剂、遮光剂、矫味物质(flavoring substances)和芳香物质。
将一种或多种药学上可接受的载体添加至药学活性剂中是有利的,或者是强制性的。合格的是本领域已知的所有载体及其组合。在固体剂型中,它们可以是例如植物和动物脂肪、蜡、石蜡、淀粉、黄蓍胶、纤维素衍生物、聚乙二醇、硅酮、膨润土、二氧化硅、滑石、氧化锌。对于液体剂型和乳液,合适的载体是例如溶剂、增溶剂、乳化剂,例如水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苯甲醇、苯甲酸苄酯、丙二醇、1,3-丁二醇、棉籽油、花生油、橄榄油、蓖麻油,芝麻油、甘油脂肪酸酯、聚乙二醇、脱水山梨糖醇的脂肪酸酯。根据本发明的混悬剂可以使用本领域已知的载体,例如稀释剂(例如水、乙醇或丙二醇)、乙氧基化的异硬脂醇、聚氧乙烯和聚氧乙烯脱水山梨糖醇酯、微晶纤维素、膨润土、琼脂、黄蓍胶。
术语粘合剂是指粘合粉末或将它们胶合、通过颗粒形成使其具有粘性的物质。它们充当制剂的“胶水”。粘合剂增加所提供的稀释剂或填料的内聚强度。
合适的粘合剂是例如来自小麦、玉米、大米或马铃薯的淀粉,明胶,天然存在的糖例如葡萄糖、蔗糖或β-乳糖,来自玉米的甜味剂,天然和合成树胶例如阿拉伯胶、黄蓍胶或海藻酸钙铵,海藻酸钠、羧甲基纤维素、羧甲基纤维素钠、羟丙基羧甲基纤维素、聚乙二醇、聚乙烯吡咯烷酮、硅酸铝镁、蜡等。粘合剂在组合物中的百分比范围可以为1-30重量%,优选2-20重量%,更优选3-10重量%,最优选3-6重量%。
着色剂是赋予饮料成分或剂型色彩的赋形剂。这些赋形剂可以是食品着色剂。它们可以被吸附在例如粘土或氧化铝等合适的吸附手段上。着色剂的量可以在药物组合物的0.01重量%至10重量%、优选在0.05重量%至6重量%、更优选在0.1重量%至4重量%、最优选在0.1重量%至1重量%之间变化。
合适的药物着色剂是例如姜黄素、核黄素、核黄素-5'-磷酸盐、酒石黄、紫草素(alkannin)、喹啉酮黄WS、坚牢黄(Fast Yellow)AB、核黄素-5'-磷酸钠、黄2G、日落黄FCF、橙色GGN、胭脂红、胭脂红酸、柑红2、淡红、紫红、朱红4R、朱红SX、朱红6R、赤藓红、红色2G、鲜红AC、还原蓝RS、专利蓝V、靛蓝胭脂红、亮蓝FCF、叶绿素和叶绿酸、叶绿素和叶绿酸的铜配合物、绿S、坚牢绿FCF、普通焦糖、苛性亚硫酸焦糖、氨化焦糖、亚硫酸氨焦糖、黑PN、炭黑、植物炭、棕FK、棕HT、α-胡萝卜素、β-胡萝卜素、γ-胡萝卜素、胭脂树橙、胭脂树素、降胭脂树素、辣椒油树脂、辣椒红素、辣椒玉红素、番茄红素、β-apo-8'-胡萝卜素、β-apo-8'-胡萝卜酸乙酯、毛莨黄素、叶黄素、隐黄素、玉红黄素、紫黄素、紫杉紫素、角黄素、玉米黄素、柠檬黄素、虾青素、甜菜碱、花青素、藏红花、碳酸钙、二氧化钛、铁氧化物、铁氢氧化物、铝、银、金、颜料红、单宁、地衣红、葡萄糖酸亚铁、乳酸亚铁。
此外,缓冲溶液优选用于液体制剂,特别是用于药物液体制剂。术语缓冲剂、缓冲剂体系和缓冲剂溶液,特别是水溶液,是指该体系通过添加酸或碱或通过用溶剂稀释来抵抗pH变化的能力。优选的缓冲剂体系可以选自包含以下的组:甲酸盐、乳酸、苯甲酸、草酸盐、富马酸盐、苯胺、乙酸盐缓冲液、柠檬酸盐缓冲液、谷氨酸盐缓冲液、磷酸盐缓冲液、琥珀酸盐、吡啶、邻苯二甲酸盐、组氨酸、MES(2-(N-吗啉代)乙磺酸、马来酸、二甲胂酸盐(砷酸二甲酯)、碳酸、ADA(N-(2-乙酰氨基)亚氨基二乙酸)、PIPES(4-哌嗪-双乙磺酸)、BIS-TRIS丙烷(1,3-双[三(羟甲基)甲基氨基]丙烷)、乙二胺、ACES(2-[(氨基-2-氧乙基)氨基]乙磺酸)、咪唑、MOPS(3-(N-吗啉基)丙烷磺酸、二乙基丙二酸、TES(2-[三(羟甲基)甲基]氨基乙磺酸、HEPES(N-2-羟乙基哌嗪-N'-2-乙磺酸)以及pKa在3.8至7.7之间的其他缓冲剂。
优选的是例如乙酸盐缓冲剂等碳酸缓冲剂和例如富马酸盐、酒石酸盐和邻苯二甲酸盐等二羧酸缓冲剂,以及例如柠檬酸盐等三羧酸缓冲剂。
另一组优选的缓冲剂是无机缓冲剂,例如硫酸盐氢氧化物、硼酸盐氢氧化物、碳酸盐氢氧化物、草酸盐氢氧化物、氢氧化钙和磷酸盐缓冲剂等。另一组优选的缓冲剂是含氮的膨化剂,例如咪唑、二亚乙基二胺和哌嗪等。进一步优选的是磺酸缓冲剂,例如TES、HEPES、ACES、PIPES、[((2-羟基-1,1-双(羟甲基)乙基)氨基]-1-丙烷磺酸(TAPS)、4-(2-羟乙基)哌嗪-1-丙磺酸(EEPS)、4-吗啉代丙磺酸(MOPS)和N,N-双-(2-羟乙基)-2-氨基乙磺酸(BES)等。另一组优选的缓冲剂是甘氨酸、甘氨酰-甘氨酸、甘氨酰-甘氨酰-甘氨酸、N,N-双(2-羟乙基)甘氨酸和N-[2-羟基-1,1-双(羟甲基)乙基]甘氨酸(Tricine)。还优选氨基酸缓冲剂,例如甘氨酸、丙氨酸、缬氨酸、亮氨酸、异亮氨酸、丝氨酸、苏氨酸、苯丙氨酸、酪氨酸、色氨酸、赖氨酸、精氨酸、组氨酸、天冬氨酸、谷氨酸、天冬酰胺、谷氨酰胺、半胱氨酸、蛋氨酸、脯氨酸、4-羟基脯氨酸、N,N,N-三甲基赖氨酸、3-甲基组氨酸、5-羟基赖氨酸、邻磷酸丝氨酸、γ-羧基谷氨酸、[ε]-N-乙酰赖氨酸、[ω]-N-甲基精氨酸、瓜氨酸、鸟氨酸及其衍生物等。
液体剂型或补充剂的防腐剂可按需使用。它们可以选自包含但不限于以下的组:山梨酸、山梨酸钾、山梨酸钠、山梨酸钙、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸甲乙酯、对羟基苯甲酸丙酯、苯甲酸、苯甲酸钠、苯甲酸钾、苯甲酸钙、对羟基苯甲酸庚酯、对羟基苯甲酸甲酯钠、对羟基苯甲酸乙酯钠、对羟基苯甲酸丙酯钠、苄醇、苯扎氯铵、苯乙醇、甲酚、氯化十六烷基吡啶、氯丁醇、硫柳汞(2-(乙基汞硫代)苯甲酸钠)、二氧化硫、亚硫酸钠、亚硫酸氢钠、偏亚硫酸氢钠、偏亚硫酸氢钾、亚硫酸钾、亚硫酸钙、亚硫酸氢钙、亚硫酸氢钾、联苯、邻苯酚、邻苯酚钠、噻苯达唑(thiabendazole)、乳链菌肽(nisin)、游霉素、甲酸、甲酸钠、甲酸钙、六胺、甲醛、二碳酸二甲酯、亚硝酸钾、亚硝酸钠、硝酸钠、硝酸钾、乙酸、乙酸钾、乙酸钠、二乙酸钠、乙酸钙、乙酸铵、脱氢乙酸、脱氢乙酸钠、乳酸、丙酸、丙酸钠、丙酸钙、丙酸钾、硼酸、四硼酸钠、二氧化碳、苹果酸、富马酸、溶菌酶、硫酸铜(II)、氯、二氧化氯和本领域技术人员已知的其他合适的物质或组合物。
附加乳化剂可以选自例如以下的阴离子和非离子乳化剂:阴离子乳化剂蜡、鲸蜡醇、鲸蜡硬脂醇、硬脂酸、油酸、聚氧乙烯聚氧丙烯嵌段聚合物、2至60mol环氧乙烷与蓖麻油和/或硬化的蓖麻油的加合产物、羊毛蜡油(羊毛脂)、脱水山梨糖醇酯、聚氧乙烯烷基酯、聚氧乙烯脱水山梨糖醇脂肪酸酯、聚氧乙烯脱水山梨糖醇单月桂酸酯、聚氧乙烯脱水山梨糖醇单油酸酯、聚氧乙烯脱水山梨糖醇单棕榈酸酯、聚氧乙烯脱水山梨糖醇单硬脂酸酯、聚氧乙烯脱水山梨糖醇三硬脂酸酯、聚氧乙烯硬脂酸酯、聚乙烯醇、偏酒石酸、酒石酸钙、海藻酸、海藻酸钠、海藻酸钾、海藻酸铵、海藻酸钙、丙烷-1,2-二醇海藻酸酯、角叉菜胶、加工的麒麟菜海藻、刺槐豆胶、黄蓍胶、阿拉伯胶、卡拉亚胶(karaya gum)、结冷胶(gellan gum)、印度树胶(gum ghatti)、葡甘露聚糖、果胶、酰胺化果胶、磷脂酸铵(ammoniumphosphatide)、溴化植物油、乙酸异丁酸蔗糖酯、木松香的甘油酯、磷酸二钠、二磷酸三钠、二磷酸四钠、二磷酸二钙、二磷酸二氢钙、三磷酸钠、三磷酸五钾、多磷酸钠、多磷酸钠钙、多磷酸钙、多磷酸铵、β-环糊精、粉状纤维素、甲基纤维素、乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、乙基甲基纤维素、羧甲基纤维素、羧甲基纤维素钠、乙基羟乙基纤维素、交联羧甲基纤维素、酶水解的羧甲基纤维素、脂肪酸的甘油单酯和甘油二酯、单硬脂酸甘油酯、二硬脂酸甘油酯、脂肪酸的甘油单酯和甘油二酯的乙酸酯、脂肪酸的甘油单酯和甘油二酯的乳酸酯、脂肪酸的甘油单酯和甘油二酯的柠檬酸酯、脂肪酸的甘油单酯和甘油二酯的单乙酰和二乙酰酒石酸酯、脂肪酸的甘油单酯和甘油二酯的混合乙酸和酒石酸酯、琥珀酰化单甘油酯、脂肪酸的蔗糖酯、蔗糖甘油酯、脂肪酸的聚甘油酯、聚甘油聚蓖麻醇酸酯、脂肪酸的丙烷-1,2-二醇酯、脂肪酸的丙二醇酯、甘油和丙烷-1的乳酸化脂肪酸酯、与脂肪酸甘油单酯和甘油二酯相互作用的热氧化的大豆油、磺基琥珀酸二辛酯钠、硬脂酰-2-乳酸钠、硬脂酰-2-乳酸钙、酒石酸硬脂酯、柠檬酸硬脂酯、硬脂酰富马酸钠、硬脂酰富马酸钙、酒石酸硬脂酯、柠檬酸硬脂酯、硬脂酰富马酸钠、硬脂酰富马酸钙、十二烷基硫酸钠、乙氧基化甘油单酯和甘油二酯、甲基葡萄糖苷-椰子油酯、脱水山梨糖醇单硬脂酸酯、脱水山梨糖醇三硬脂酸酯,脱水山梨糖醇单月桂酸酯、脱水山梨糖醇单油酸酯、脱水山梨糖醇单棕榈酸酯、脱水山梨糖醇三油酸酯、聚磷酸钙钠、聚磷酸钙、聚磷酸铵、胆酸、胆碱盐、二淀粉甘油、淀粉辛烯基琥珀酸钠、乙酰化氧化淀粉。
优选的是甘油单油酸酯和硬脂酸。
稳定剂是可以添加以防止不必要的变化的物质。尽管稳定剂不是真正的乳化剂,但它们也有助于乳剂或者增溶物的稳定性。稳定剂的合适实例是羟基硬脂精、黄原胶、琼脂、燕麦胶、瓜尔豆胶(guar gum)、他拉胶(tara gum)、聚氧乙烯硬脂酸酯、乙酰舒泛-阿司帕坦盐(aspartame-acesulfame salt)、淀粉酶、蛋白酶、木瓜蛋白酶、菠萝蛋白酶、无花果蛋白酶、转化酶、聚葡萄糖、聚乙烯吡咯烷酮、聚乙烯聚吡咯烷酮、柠檬酸三乙酯、麦芽糖醇、麦芽糖醇糖浆。
适用作附加表面活性增溶剂(增溶剂)的为例如二甘醇单乙酯、聚乙基丙二醇共聚物、例如α-和β-环糊精等环糊精、例如Solutol HS 15(来自BASF的聚乙二醇-15-羟基硬脂酸酯,PEG 660-15-羟基硬脂酸酯)等单硬脂酸甘油酯,脱水山梨糖醇酯、聚氧乙烯二醇、聚氧乙烯脱水山梨糖醇酸酯、聚氧乙烯脱水山梨糖醇单油酸酯、聚氧乙烯氧硬脂酸甘油三酯、聚乙烯醇、十二烷基硫酸钠、(阴离子)单油酸甘油酯等。
合适的附加溶剂可以选自包含但不限于以下的组:水、碳酸水、注射用水、具有等渗剂的水、盐水、等渗盐水、醇,特别是乙醇和正丁醇、二醇、油酸和亚油酸甘油三酯、辛酸和癸酸甘油单酯、甘油二酯和甘油三酯、聚氧乙烯辛酸和癸酸甘油酯、丙二醇脂肪酸酯、低级烷基脂肪酸酯、大豆油、月桂酸丙二醇酯、聚氧乙烯(35)蓖麻油、聚氧乙烯甘油三油酸酯、丁酸乙酯、辛酸乙酯、油酸乙酯及其混合物。
合适的等渗剂为例如药学上可接受的盐,特别是氯化钠和氯化钾、例如葡萄糖或乳糖等糖、例如甘露醇和山梨糖醇等糖醇、柠檬酸盐、磷酸盐、硼酸盐及其混合物。
合适的增稠剂可以选自包含但不限于以下的组:聚乙烯吡咯烷酮、甲基纤维素、羟丙基甲基纤维素、羟丙基纤维素、糊精、聚右旋糖、改性淀粉、碱性改性淀粉、漂白淀粉、氧化淀粉、酶处理淀粉、单淀粉磷酸酯、用三偏磷酸钠或氯氧化磷酯化的二淀粉磷酸酯、磷酸二淀粉磷酸酯、乙酰化二淀粉磷酸酯、用乙酸酐酯化的乙酸淀粉、用醋酸乙烯酯酯化的乙酸淀粉、乙酰化二淀粉己二酸酯、乙酰化二淀粉甘油、二淀粉甘油、羟丙基淀粉、羟丙基二淀粉甘油、羟丙基二淀粉磷酸酯、羟丙基二淀粉甘油、辛烯基琥珀酸淀粉钠、乙酰化氧化淀粉、羟乙基纤维素。
稀释剂或填料是添加至药物中以处理最少量的活性剂的非活性物质。它们在增溶过程中是有用的。合适的稀释剂的实例是水、甘露醇、预糊化淀粉、淀粉、微晶纤维素、粉状纤维素、硅化微晶纤维素、磷酸氢钙二水合物、磷酸钙、碳酸钙、羟丙基纤维素、羟乙基纤维素、羟丙基甲基纤维素、聚乙二醇、黄多糖胶(xanthum gum)、阿拉伯胶或其任何组合。
渗透促进剂通常用于局部用剂型。合适的渗透促进剂包括本领域已知的所有药学上可接受的渗透促进剂,例如但不限于,例如月桂氮卓酮、1-十二烷基氮杂环庚-2-酮(1-dodecylazacycloheptan-2-one)等氮酮;例如二甲基亚砜、DMAC、DMF等亚砜;例如2-吡咯烷酮、N-甲基-2-吡咯烷酮等吡咯烷酮;例如乙醇、1,2-丙二醇或癸醇等醇;例如丙二醇、二甘醇、四甘醇等二醇;例如油酸、月桂酸、十二烷基硫酸钠、肉豆蔻酸、异丙基肉豆蔻酸、癸酸等脂肪酸;例如聚氧乙烯-2-油基醚、聚氧乙烯-2-硬脂基醚等非离子表面活性剂;萜烯;萜类化合物;噁唑烷酮类;尿素;神经酰胺类似物、氮酮(azone)类似物、薄荷醇衍生物、醚化衍生物、酯化衍生物、转卡巴姆(transkarbams)、氨基甲酸酯盐、TXA衍生物、DDAIP(2-(二甲基氨基)十二烷基丙酸酯)、DDAK、天然精油(所有这些均在Chen等人.(2014)AsianJ.Pharm.Sc.9,51-64中列出);例如柠檬酸三乙酯等柠檬酸酯;疏水蛋白多肽;α-红没药醇;二甲基异山梨醇(DMI);乙氧基二甘醇。优选的是1,2-丙二醇。
适用于局部应用的防腐剂的典型实例为例如苯甲酸苄酯,苯甲酸,苄醇,苯扎氯铵,N-鲸蜡基-N-N-三甲基溴化铵(Cetrimid,Merck),氯己定,氯丁醇,氯甲酚,咪唑烷脲,对羟基苯甲酸酯类例如甲基、乙基、丙基或丁基对羟基苯甲酸酯,对羟基苯甲酸甲酯钠,对羟基苯甲酸丙酯钠,山梨酸钾,苯甲酸钠,丙酸钠,苯酚,苯氧乙醇,苯乙醇,苯汞乙酸酯,苯汞硼酸酯,苯汞硝酸酯,山梨酸或硫柳汞(甲汞硫水杨酸钠)。优选的是对羟基苯甲酸甲酯、对羟基苯甲酸丙酯以及对羟基苯甲酸甲酯钠和对羟基苯甲酸丙酯钠。
在局部剂型中,特别优选添加足够量的抗氧化剂。抗氧化剂的合适实例包括焦亚硫酸钠、α-生育酚、抗坏血酸、马来酸、抗坏血酸钠、棕榈酸抗坏血酸酯、丁基化羟基茴香醚、丁基化羟基甲苯、富马酸或没食子酸丙酯。优选使用焦亚硫酸钠。
用于局部剂型的合适的pH调节剂是例如,氢氧化钠、盐酸、例如磷酸二氢钠或磷酸氢二钠等的缓冲物质。
乳膏制剂还可以包含其他赋形剂和添加剂,例如加脂剂、溶剂、稠度增强剂或水溶助剂,以改善流动特性。本文中,混合物中可以存在来自同一组添加剂或赋形剂的单一或几种物质。
合适的加脂剂为例如,油酸癸基酯、水合蓖麻油、轻质矿物油、矿物油,聚乙二醇、十二烷基硫酸钠。
合适的溶剂是玉米油、棉籽油、花生油、芝麻油、大豆油、油酸乙酯、甘油、肉豆蔻酸异丙酯、棕榈酸异丙酯、聚乙二醇或聚丙二醇。
稠度增强剂为例如,鲸蜡醇、鲸蜡酯蜡、水合蓖麻油、微晶蜡、非离子乳化剂蜡、蜂蜡、石蜡或硬脂醇。
合适的水溶助剂是醇,例如乙醇、异丙醇或例如甘油等多元醇。
根据本发明,只要不破坏创造性地使用增溶物,不发生毒性作用或违反法律,所有上述赋形剂和赋形剂类别可以不受限制地单独使用或以其任何可能的组合形式使用。
因此,本申请还涉及根据本发明的药物组合物在医学中的用途。
本申请还涉及用于口服、肠胃外或局部给药根据本发明的药物组合物。
过度免疫反应的病况为例如但不限于移植后的移植排斥、活动性自身免疫疾病、或者具有自身免疫性成分的疾病,特别是活动性类风湿性关节炎、复发-缓解型多发性硬化症、类肝炎、结节性多发性动脉炎、克罗恩病(Crohn’s disease)、溃疡性结肠炎、贝氏病(disease)、贝氏葡萄膜炎(uveitis)、特发性血小板减少性紫癜、重症肌无力、兰伯特-伊顿综合征(Lambert-Eaton syndrome)、多发性肌炎、牛皮癣、牛皮癣关节炎、强直性脊柱炎、阵发性夜间血红蛋白尿、自身免疫性甲状腺炎疾病,例如桥本氏甲状腺炎(Hashimoto’s thyroiditis)、奥德甲状腺炎(Ord’s thyroiditis)或格雷夫斯病(Graves‘disease)、红斑狼疮、白癜风、自身免疫性脑脊髓炎、特发性视神经炎、交感性眼炎、前葡萄膜炎、视网膜变性、周围溃疡性角膜炎、大疱性天疱疮、慢性荨麻疹、疱疹样皮炎、后天性大疱性表皮松解症、斑秃、自身免疫性肠病、例如APECED(自身免疫性多内分泌病-念珠菌病-外胚层营养不良)、施密特综合征(Schmidt’s syndrome)和XPID(X连锁多发性内分泌病免疫缺陷和腹泻综合征)等自身免疫性多内分泌综合症、慢性胃炎、皮肌炎、糖尿病1型、糖尿病2型、格雷夫斯氏眼病(Graves‘ophthalmopathy)、肾小球肾炎、肺出血肾炎综合征、肉芽肿合并多血管炎、格林巴里综合征(Guillain-Barré syndrome)、硬化性苔藓、红色黏液性苔藓、线状IgA皮肤病、显微镜下多发性肾炎、粘液性脑脊髓炎、嗜睡症、PANS(小儿急性发作性神经精神综合征)如PANDAS(与链球菌感染相关的儿童自身免疫性神经精神疾病)、叶状天疱疮、脂溢性天疱疮、寻常天疱疮、多软骨炎、风湿性多肌痛、风湿热、萨福综合征(SAPHOsyndrome)(滑膜炎、痤疮、脓疱病、骨质增生、骨炎)、结节病、干燥综合征、硬皮病、僵人综合征、过敏性紫癜、乳糜泻、急性播散性脑脊髓炎、抗磷脂综合征、自身免疫性心肌病、自身免疫性溶血性贫血、自身免疫性内耳疾病、自身免疫性淋巴增生综合征、自身免疫性胰腺炎、自身免疫性多内分泌综合征、自身免疫性黄体酮皮炎、查加斯病(Chagas disease)、慢性炎性脱髓鞘性多发性神经病、慢性复发性多发性骨髓炎、COPD(慢性阻塞性肺疾病)、楚格·史特劳斯综合征(Churg Strauss syndrome)、冷凝集素疾病、多洛马氏脂肪瘤(Lipomatosisdolorosa)、子宫内膜异位症、嗜酸性筋膜炎、桥本脑病(Hashimoto’s encephalopathy)、痤疮逆、间质性膀胱炎、川崎病(Kawasaki disease)、夏普综合征(Sharp‘s syndrome)、神经性肌强直、眼阵挛肌阵挛综合征、原发性胆汁性肝硬化、雷诺现象(Raynaud’sphenomenon)、不宁腿综合征、横贯性脊髓炎和血管炎、再生障碍性贫血、天疱疮、类天疱疮、内源性葡萄膜炎;肾病综合征和特应性皮炎;以及感染性病况,例如由革兰氏阴性或革兰氏阳性细菌如MRSA(耐甲氧西林金黄色葡萄球菌(Staphylococcus aureus))或真菌病原体感染引起的病况,以及由其他因素(例如免疫或化学因素)引起的全身炎症反应综合征(SIRS)。
具有免疫缺陷背景的病况包括但不限于,频繁的流感样感染;气道反复感染;泌尿系统反复感染;疲劳;恶病质;来历不明的注意力障碍;再康复(reconvalescence);慢性病毒感染,特别是例如HIV-1和HIV-2等人类免疫缺陷病毒、乙型肝炎、丙型肝炎、脑炎、带状疱疹、单纯疱疹、内耳感染、水痘、麻疹、细胞增生、爱泼斯坦-巴尔(Epstein-Barr)、腺病毒、人乳头瘤病毒和细小病毒,例如变形病毒、博卡病毒、依赖病毒、红细胞病毒和细小病毒种类、几种肿瘤疾病,尤其是毛细胞白血病、髓样白血病、多发性骨髓瘤、滤泡性淋巴瘤、卡波西肉瘤、皮肤T细胞淋巴瘤、鼻咽癌、类癌、肾癌、膀胱癌、基底细胞癌、转移性癌和恶性黑色素瘤;化脓性肉芽肿,中性粒细胞减少症;生殖器疣;角化病;自身免疫性疾病,尤其是非活动阶段,例如复发之间的复发缓解型多发性硬化症;放射源性结肠炎,憩室炎;过敏,特别是花粉症、多形性日光疹、湿疹、神经性皮炎;肠炎;结肠炎;以及化疗和放疗之前、期间和之后。
综上所述,本发明方法生产的5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶物特别适合于治疗显示出促炎细胞因子,特别是IL-6和TNF-α的释放显著增加的所有炎性疾病。除了上述示例,在伤口愈合期间,例如在外科手术、外伤或烧伤后,在例如干燥性角膜炎等的独立的免疫过程或诸如腱炎或骨关节炎等的未知来源的急性或慢性炎症中也是如此。
通过本发明的方法生产的5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶物也可以与至少一种其他已知的药物活性剂和/或标准疗法联合施用。
因此,本申请还涉及根据本发明的增溶物与至少一种药物活性剂的组合。
本申请同样涉及根据本发明的增溶物和至少一种药物活性剂的组合用于预防和/或治疗具有过度免疫反应的疾病或具有免疫缺陷背景的疾病的用途。
适用于这种组合的药物活性剂可以选自包含以下的组:甾体类和非甾体类抗炎剂、免疫调节剂、免疫刺激剂、免疫抑制剂、抗感染剂、抗生素、抗病毒剂、抗真菌剂、抗原生动物剂、驱虫药、镇痛药、局部麻醉药、抗凝剂、抗血小板药、肌肉松弛剂、补剂和同化剂(anabolic agents)。这种药物活性剂的组合可以用于有需要的人的预防和/或治疗应用。
甾体类抗炎剂的合适实例包含以下:皮质类固醇、糖皮质激素、可的松、醋酸可的松、氢化可的松、醋酸氢化可的松、地塞米松、倍他米松(betamethasone)、泼尼松(prednisone)、泼尼松龙(prednisolone)、甲基泼尼松龙(methylprednisolone)、地他松(deltasone)、曲安西龙(triamcinolone)、替考索尔新戊酸酯(tixocortol pivalate)、莫米松(mometasone)、安西奈德(amcinonide)、布地奈德(budesonide)、地索奈德(desonide)、氟西诺尼(fluociconide)、氟轻松(fluocinolone)、哈西奈德(halcinonide)、氟可龙(fluocortolone)、氢化可的松17-戊酸酯(hydrocortisone-17-valerate)、卤米松(halometasone)、阿氯米松双丙酸酯(alclometasone dipropionate)、倍他米松戊酸酯(betamethasone valerate)、倍他米松二丙酸酯(betamethasone dipropionate)、泼尼卡酯(prednicarbate)、氯倍他酮17-丁酸(clobetasone-17-′butyrate)、氯倍他索17-丙酸(clobetasol-17-propionate)、氟可龙己酸酯(fluocortolone caproate)、氟可隆新戊酸酯(fluocortolone pivalate)、醋酸氟泼尼定(fluprednidene acetate)、氢化可的松17-丁酸酯(hydrocortisone-17-butyrate)、氢化可的松-17-醋丙酸酯(hydrocortisone-17-aceponate)、氢化可的松-17-丁丙酸酯(hydrocortisone-17-buteprate)、环索奈德(ciclesonide)、氟尼缩松(flunisolide)、糠酸氟替卡松(fluticasone furoate)、丙酸氟替卡松(fluticasone propionate)、曲安奈德(triamcinolone acetonide)、二丙酸倍氯米松(beclomethasone dipropionate)。
非甾体类抗炎剂(NSAID)的合适实例包含以下:乙酰水杨酸、水杨酸和水杨酸酯、对乙酰氨基酚(醋氨酚)、水杨酰水杨酸、二氟尼柳(diflunisal)、布洛芬(ibuprofen)、右旋布洛芬(dexibuprofen)、萘普生(naproxen)、非诺洛芬(fenoprofen)、酮洛芬(ketoprofen)、右旋酮洛芬(dexketoprofen)、氟比洛芬(flurbiprofen)、奥沙普秦(oxaprozin)、洛索洛芬(loxoprofen)、吲哚美辛(indomethacin)、托麦汀(tolmetin)、舒林酸(sulindac)、依托度酸(etodolac)、酮咯酸(ketorolac)、双氯芬酸(diclofenac)、醋氯芬酸(aceclofenac)、萘丁美酮(nabumetone)、吡罗昔康(piroxicam)、美洛昔康(meloxicam)、替诺昔康(tenoxicam)、屈昔康(droxicam)、氯诺昔康(lornoxicam)、伊索西康(isoxicam)、保泰松(phenylbutazone)、甲芬那酸(mefenamic acid)、甲氯芬那酸(meclofenamicacid)、氟灭酸(flufenamic acid)、托灭酸(tolfenamic acid)、塞来昔布(celexoxib)、罗非昔布(rofecoxib)、伐地昔布(valdecoxib)、帕瑞昔布(parecoxib)、鲁米昔布(lumiracoxib)、依托昔布(etoricoxib)、非罗考昔(firocoxib)、尼美舒利(nimesulide)、氯尼辛(clonixin)、利克飞龙(licofelone)、H-哈帕苷(H-harpagide)、氟尼辛(flunixin)、噻洛芬酸(tiaprofenic acid)。
免疫调节剂的合适实例包含沙利度胺(thalidomide)、来那度胺(lenalidomide)、泊马度胺(pomalidomide)和阿普斯特(apremilast)。
免疫刺激剂的合适实例包含干扰素(α-、β-、γ-、tau-干扰素)、白介素、CSF、PDGF、EGF、IGF、THF、左旋咪唑、二甲氨丙醇(dimepranol)、肌苷。
免疫抑制剂的合适实例包括例如如上所述的糖皮质激素的组;细胞抑制剂例如烷基化剂(例如环磷酰胺),抗代谢药例如甲氨蝶呤、硫唑嘌呤、巯基嘌呤、氟尿嘧啶、来氟米特(leflunomide)、蛋白质合成抑制剂和例如放线菌素、蒽环类、丝裂霉素C、博来霉素(bleomycin)和光神霉素(mithramycin)等特定的抗生素,嵌入剂例如米托蒽醌(mitoxantrone);抗体例如莫罗单抗(muromonab)-CD3、利妥昔单抗(rituximab)、乌司奴单抗(ustekinumab)、阿仑单抗(alemtuzumab)、那他珠单抗(natalizumab)、巴利昔单抗(basiliximab)和达利珠单抗(daclizumab)等;作用于免疫亲和素的药剂例如环孢菌素、他克莫司(tacrolimus)和西罗莫司(sirolimus);和未分类的免疫抑制剂例如β-干扰素、γ-干扰素、阿片类药物,例如英夫利昔单抗(infliximab)、依那西普(etanercept)、阿达木单抗(adalimumab)等的TNF结合蛋白;或姜黄素、儿茶素、麦考酚酸、芬戈莫德(fingolimod)、多球壳菌素(myriocin)和富马酸二甲酯。
抗感染剂是可用于治疗细菌、病毒、真菌、原生动物和蠕虫感染的化合物的总称,包括抗生素、抗病毒剂、抗真菌剂、抗原生动物剂、驱虫药和其他抗寄生虫药。
抗生素的合适实例包括亚胺培南(imipenem)、美罗培南(meropenem),厄他培南(ertapenem)、头孢菌素、氨曲南(aztreonam)、青霉素如青霉素G和青霉素V、哌拉西林(piperacillin)、美洛西林(mezlocillin)、氨苄青霉素、阿莫西林、氟氯西林(flucloxacillin)、甲氧西林(methicillin)、奥沙西林(oxacillin)、克拉维酸(clavulanic acid)、舒巴坦(sulbactam)、他唑巴坦(tazobactam)、舒他西林(sultamicillin)、磷霉素、替考拉宁(teicoplanin)、万古霉素、杆菌肽(bacitracin)、粘菌素(colistin)、短菌杆肽(gramicidin)、多粘菌素B、短杆菌素(tyrothricin)、泰斯巴汀(teixobactin)、磷胺霉素、阿米卡星(amikacin)、庆大霉素、卡那霉素、新霉素、奈替霉素(netilmicin)、链霉素、妥布霉素(tobramycin)、氯霉素(chloramphenicol)、夫西地酸(fusidic acid)、塞红霉素(cethromycin)、那波霉素(narbomycin)、泰利霉素(telithromycin)、克林霉素(clindamycin)、林可霉素(lincomycin)、达托霉素(daptomycin)、达福普汀(dalfopristin)、奎奴普丁(quinupristin)、阿奇霉素(azithromycin)、克拉霉素(clarithromycin)、红霉素(erythromycin)、罗红霉素(roxithromycin)、利奈唑胺(linezolid)、多西环素(doxycyclin)、米诺环素(minocyclin)、四环素、土霉素、替加环素(tigecyclin)、诺氟沙星(norfloxacin)、依诺沙星(enoxacin)、环丙沙星(ciprofloxacin)、氧氟沙星(ofloxacin)、左氧氟沙星(levofloxacin)、莫西沙星(moxifloxacin),甲硝唑(metronidazol)、替硝唑(tinidazol)、氨基香豆素(aminocoumarin)、磺胺嘧啶(sulfadiazine)、磺胺多辛(sulfadoxine)、磺胺甲噁唑(sulfamethoxazole)、柳氮磺吡啶(sulfasalazine)、乙胺嘧啶(pyrimethamine)、甲氧苄啶(trimethoprim)、利福平(rifampicin)。
抗病毒剂的适当实例包括安立维罗(ancriviroc)、阿普维罗(aplaviroc)、森昔维罗(cenicriviroc)、恩夫韦肽(enfuvirtide)、马拉维罗(maraviroc)、维立维罗(vicriviroc)、金刚烷胺(amantadine)、金刚乙胺(rimantadine)、普雷康那利(pleconaril)、碘苷(idoxuridine)、阿昔洛韦(aciclovir)、溴呋啶(brivudine)、泛昔洛韦(famciclovir)、喷昔洛韦(penciclovir)、索瑞夫定(sorivudine)、伐昔洛韦(valaciclovir)、西多福韦(cidofovir)、更昔洛韦(ganciclovir)、缬更昔洛韦(valganciclovir)、索福布韦(sofosbusvir)、膦甲酸钠(foscarnet)、利巴韦林(ribavirine)、他巴韦林(taribavirine)、非利布韦(filibuvir)、奈斯布韦(nesbuvir)、替戈布韦(tegobuvir)、福斯德韦(fosdevirine)、法匹拉韦(favipiravir)、美利美波地布(merimepodib)、阿那匹韦(asunaprevir)、巴拉皮拉韦(balapiravir)、波普瑞韦(boceprevir)、西普列韦(ciluprevir)、丹诺普韦(danoprevir)、达卡他韦(daclatasvir)、纳拉普列韦(narlaprevir)、特拉匹韦(telaprevir)、西普列韦(simeprevi)、万尼普列韦(vaniprevir)、芦平曲韦(rupintrivir)、福米韦森(fomivirsen)、阿蒙那韦(amenamevir)、阿利斯波里韦(alisporivir)、贝维利马(bevirimat)、莱特莫韦(letermovir)、拉尼米韦(laninamivir)、奥司他韦(oseltamivir)、佩拉米韦(peramivir)、扎那米韦(zanamivir)。
抗真菌剂的合适实例包括阿巴芬净(abafungin)、两性霉素B、坎迪西汀(candicidin)、菲利平(filipin)、哈霉素(hamycin)、纳他霉素(natamycin)、制霉菌素(nystatin)、龟裂霉素(rimocidin)、联苯苄唑(bifonazole)、布康唑(butoconazole)、克霉唑(clotrimazole)、益康唑(econazole)、芬替康唑(fenticonazole)、异康唑(isoconazole)、酮康唑(ketoconazole)、卢利康唑(luliconazole)、咪康唑(miconazole)、奥莫康唑(omoconazole)、奥昔康唑(oxiconazole)、舍他康唑(sertaconazole)、硫康唑(sulconazole)、噻康唑(tioconazole)、阿巴康唑(albaconazole)、艾氟康唑(efinaconazole)、氟环唑(epoxiconazole)、氟康唑(fluconazole)、伊莎康唑(isavuconazole)、伊曲康唑(itraconazole)、泊沙康唑(posaconazole)、丙环唑(propiconazole)、雷夫康唑(ravuconazole)、特康唑(terconazole)、伏立康唑(voriconazole)、阿莫洛芬(amorolfine)、布替萘芬(butenafine)、萘非替芬(nafitifine)、特比萘芬(terbinafine)、阿尼芬净(anidulafungin)、卡泊芬净(caspofungin)、米卡芬净(micafungin)、苯甲酸、环吡酮(ciclopirox)、氟胞嘧啶(flucytosine)、灰黄霉素(griseofulvin)、卤普罗近(haloprogin)、托萘酯(tolnaftate)、十一酸(undecylic acid)、结晶紫(crystal violet)、秘鲁香脂(balsam of Peru)。
抗原生动物剂的合适实例包括甲硝唑(metronidazole)、替硝唑(tinidazole)、奥硝唑(ornidazole)、阿托伐醌(atovaquone)、氯碘羟喹(clioquinol)、氯喹那多(chlorquinaldol)、依美丁(emetine)、喷他脒羟乙磺酸盐(pentamidine isethionate)、依氟鸟氨酸(eflornithine)、呋喃西林(nitrofural)、常山酮(halofuginone)、米替福新(miltefosine)、氯喹(chloroquine)、羟氯喹(hydroxychloroquine)、美帕卡林(mepacrine)、伯氨喹(primaquine)、阿莫地喹(amodiaquine)、帕马喹(pamaquine)、哌喹(piperaquine)、氯胍(proguanil)、恩波环氯胍(cycloguanil embonate)、奎宁、甲氟喹(mefloquine)、乙胺嘧啶(pyrimethamine)、蒿甲醚(artemether)、青蒿素(artemisinin)、青蒿琥酯(artesunate)、双氢青蒿素(dihydroartemisinin)、卤泛群(halofantrine)、苯芴醇(lumefantrine)、磺胺多辛(sulfadoxine)。
驱虫药的合适实例包括甲苯达唑(mebendazole)、吡喹酮(praziquantel)、阿苯达唑(albendazole)、乙胺嗪(diethylcarbamazine)、氟苯达唑(flubendazole)、伊维菌素(ivermectin)、左旋咪唑(levamisole)、美曲磷酯(metrifonate)、氯硝柳胺(niclosamide)、羟氯扎胺(oxyclozanide)、奥沙尼喹(oxamniquine)、奥克太尔(oxantel)、哌嗪(piperazine)、噻吩嘧啶(pyrantel)、双羟萘酸噻嘧啶(pyrantel pamoate)、单潘特(monopantel)、得曲恩特(derquantel)、硫酸球果碱(pelletierin sulfate)、扑蛲灵(pyrvinium)、噻苯哒唑(thiabendazole)、芬苯达唑(fenbendazole)、三氯苯达唑(triclabendazole)、阿维菌素(abamectin)、苏拉明(suramine)、艾默德斯(emodepside)、恩波维铵(pyrvinium embonate)、氨基乙腈(aminoacetonitril)。
其他抗寄生虫药的合适实例包括葡甲胺锑酸盐、苄硝唑,葡萄糖酸锑钠、烟曲霉素(fumagillin)、卤泛群(halofantrine)、美拉胂醇(melarsoprol)、硝呋替莫(nifurtimox)、硝唑尼特(nitazoxanide)、氯菊酯(permethrin)、林丹(lindane)、马拉硫磷(malathion)、西维因(carbaryl)、除虫菊(pyrethrum)、苯醚菊酯(phenothrin)、生物烯丙菊酯(bio-allethrin)、吡虫啉(imidacloprid)、莫西地汀(moxidectin)、烯啶虫胺(nitenpyram)、氟虫腈(fipronil)、pyriprol、塞拉菌素(selamectin)、二嗪农(dimpylate)、多杀菌素(spinosad)、茚虫威(indoxacarb)、甲氧普林(methoprene)、吡丙醚(pyriproxyfen)、氟丙氧脲(lufenuron)、苦楝油(neem oil)、香茅油(citronella oil)、丁香油(clove oil)、薄荷油(peppermint oil)、桉树油(eucalyptus oil)。
镇痛剂的合适实例包括上文所列的NSAID;阿片类镇痛剂,例如吗啡、芬太尼(fentanyl)、美沙酮(methadone)、羟考酮(methadone)、卡芬太尼(carfentanyl)、二氢埃托啡(dihydroetorphine)、欧姆芬太尼(ohmefentanyl)、埃托啡(etorphine)、舒芬太尼(sufentanil)、瑞芬太尼(remifentanil)、阿芬太尼(alfentanil)、丁丙诺啡(buprenorphine)、氢吗啡酮(hydromorphone)、左美沙酮(levomethadone)、氢可酮(hydrocodone)、品曲胺(pintramide)、纳布芬(nalbuphine)、他喷他多(tapentadol)、喷他佐辛(pentazocine)、二氢可待因(dihydrocodeine)、可待因(codeine)、哌替啶(pethidine)、曲马多(tramadol)、替利定(tilidine)、美普他酚(meptazinol)、纳洛酮(naloxone)、纳曲酮(naltrexone)、二丙诺啡(diprenorphine)、洛哌丁胺(loperamide)、阿扑吗啡(apomorphine);地棘蛙素(epibatidine);东莨菪碱(scopolamine);齐康诺肽(ziconitide);大麻素(cannabinoids),例如四氢大麻酚(tetrahydrocannabinol)、大麻二酚(cannabidiol)、屈大麻酚(marinol);氟吡汀(flupirtine);氯胺酮(ketamine)和上述局部麻醉剂。
局部麻醉剂的合适实例包括利多卡因(lidocaine)、利诺卡因(lignocaine)、薄荷脑(menthol)、阿替卡因(articaine)、丁哌卡因(bupivacaine)、罗哌卡因(ropivacaine)、苯佐卡因(benzocaine)、氯普鲁卡因(chloroprocaine)、可卡因、环美卡因(cyclomethycaine)、二甲卡因(dimethocain)、拉罗卡因(larocaine)、哌罗卡因(piperocaine)、丙氧卡因(propoxycaine)、普鲁卡因(procaine)、奴佛卡因(novocaine)、丙美卡因(proparacaine)、丁卡因(tetracain)、阿美索卡因(amethocaine)、辛可卡因(cinchocaine)、地布卡因(dibucaine)、依替卡因(etidocaine)、左布比卡因(levobupivacaine)、甲普拉卡因(meplavacaine)、丙胺卡因(prilocaine)、三美卡因(trimecaine)、石房蛤毒素(saxitoxin)、新石房蛤毒素(neosaxitoxin)、河豚毒素、丁香酚。
抗凝剂的合适实例包括肝素、香豆素如苯丙香豆素(马库玛)和华法林(warfarin)、阿哌沙班(apixaban)、利伐沙班(rivaroxaban)、伊多沙班(edoxaban)、达比加群(dabigatran)、希美加群(ximelagatran)、水蛭素、重组水蛭素、比伐卢定(bivalirudin)、柠檬酸盐、EDTA、磺达肝素(fondaparinux)、阿加曲班(argatroban)、奥米沙班(otamixaban)。
抗血小板药物的合适实例包括阿昔单抗(abciximab)、乙酰水杨酸、潘生丁(dipyridamole)、氯吡格雷(clopidogrel)、依替巴肽(eptifibatide)、伊洛美丁(ilomedine)、前列环素(prostacyclin)、普拉格雷(prasugrel)、替卡格雷(ticagrelor)、噻氯匹定(ticlopidine)、替罗非班(tirofiban)。
肌肉松弛剂的合适实例包括地屈溴铵(tercuronium)、1-乙基氨基甲酰基-3-(3-三氟甲基苯基)吡咯烷、美他沙酮(metaxalone)、美索巴莫(methocarbamol)、甲丙氨酯(meprobamate)、巴氯芬(baclofen)、卡立普多(carisoprodol)、氯唑沙宗(chlorzoxazone)、环苯扎林(cyclobenzaprine)、丹曲林(dantrolene)、地西泮(diazepam)、邻甲苯海明(orphenadrine)、奎宁、罗库溴铵(rocuronium)、琥珀胆碱(succinylcholine)、癸烷双胺(decamethonium)、泮库溴铵(pancuronium)、维库溴铵(veruronium)、瑞库溴铵(rapacuronium)、达库溴铵(dacuronium)、杜阿多(duador)、马洛易亭(malouetine)、dipyrandium、哌库溴铵(pipercuronium)、chandonium、HS-342、阿曲库铵(atracurium)、米伐库溴铵(mivacurium)、多卡库铵(doxacurium)、d-筒箭毒碱(d-tubocurarine)、二甲筒箭毒碱(dimethyl tubocurarine)、加拉碘铵(gallamine)、阿库曲铵(alcuronium)、anatruxonium、diadonium、法扎溴铵(fazadinium)、特罗培尼(tropeinium)、西沙曲库铵(cisatrucurium)。
补剂是增强身体、增加紧张度或重建其生理功能的药物的通用术语。它们可以是草本或动物来源的。
同化剂可以促进合成代谢和细胞胶原支架的增强。然而,影响深远的滥用在体育和健美运动中被称为兴奋剂。因此,仅在相应的国家法律所容许的情况下推荐使用与本发明的增溶物组合。
本领域技术人员将容易从现有技术中确定上述药物活性剂的标准疗法。优选的是,药物活性剂的上述组合的各自的给药方式和剂量使自身针对已经建立的用于组合的活性剂的标准疗法。
实施例
在随后的实施例中,增溶剂的相对量可以在根据本发明的方法中为每种组分指示的幅度(margins)内改变。油酸甘油酯和/或抗氧化剂的添加是任选的。
可以根据要溶解在增溶物中的所需绝对量,扩大或缩减指示的量。可以根据需要向有此需要的患者施用的试剂的期望的最终量来分配增溶物。
通常,根据本发明的方法生产的所得增溶物的比重为0.92–0.94kN/m3。
在各实施例中,出于说明性目的描述了根据本发明的增溶物的剂型的生产。应理解,根据本发明的增溶物也可以以本领域已知的任何相应剂型,例如Remington:TheScience and Practice of Pharmacy,第22版,Pharmaceutical Press,2013中所列出的来使用,该文献通过引用并入本文。
标准化学品购自德国达姆施塔特的Sigma-Aldrich。
实施例1:5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶–实施方案1
以下指示是指混合物的重量百分比。生成约100ml的增溶物。提供5-氨基-2,3-二氢-1,4-酞嗪二酮,然后在室温(20±5℃)和大气压下搅拌5分钟将增溶剂一一混合。
然后在连续搅拌下以约1℃/分钟的温度增量小心地加热组合物。在约20分钟(约40℃)后,组合物开始变成透明溶液。该增溶过程持续约16分钟以上。因此,在约56℃下、在约36分钟后获得根据本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。在最低6个月的观察期内,增溶物保持透明和稳定。
实施例2:5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶–实施方案2
以下指示是指混合物的重量百分比。生成约100ml的增溶物。提供5-氨基-2,3-二氢-1,4-酞嗪二酮,然后在室温(20±5℃)和大气压下搅拌5分钟将增溶剂一一混合。
然后在连续搅拌下以约1.5℃/分钟的温度增量小心地加热组合物。在约23分钟(约55℃)后,组合物开始变成透明溶液。该增溶过程持续约10分钟以上。因此,在约70℃下、在约33分钟后获得根据本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。在最低6个月的观察期内,增溶物保持透明和稳定。
实施例3:5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的增溶
以下指示是指混合物的重量百分比。生成约100ml的增溶物。提供5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐(以如WO 2011/107295 A1中所述的I型多晶型物形式),然后在室温(20±5℃)和大气压下搅拌5分钟将增溶剂一一混合。
然后在连续搅拌下以约1℃/分钟的温度增量小心地加热组合物。在约32分钟(约52℃)后,组合物开始变成透明溶液。该增溶过程持续约8分钟以上。因此,在约60℃下、在约40分钟后获得根据本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。在最低2个月的观察期内,增溶物保持透明和稳定。
实施例4:口服施用的液体剂型的制备
在45ml液体载体中具有以下组成(以重量%计)
溶解5ml的实施例1的增溶物。可以将该溶液(50ml)填充至本领域已知的合适的滴瓶中。
该制剂不需要额外的例如聚山梨酯等的乳化剂。
实施例5:肠胃外施用的液体剂型的制备
在245ml液体载体中具有以下组成(以重量%计)
溶解5ml的实施例1的增溶物。可以将该肠胃外溶液(250ml)填充到本领域已知的合适的输液袋中。
该制剂不需要额外的例如聚山梨酯等的乳化剂。
实施例6:软明胶胶囊形式的固体剂型的制备
软明胶胶囊壳的组成(以重量%计):
根据Mahato和Narang,Pharmaceutical Dosage Forms and Drug Delivery,第2版,第18.3.5章中所列的标准方法生产含有5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶物的明胶软胶囊。在此,将1.25ml的实施例1的增溶物注入所提供的软明胶胶囊的模腔中,然后将其密封。
实施例7:硬明胶胶囊形式的固体剂型的制备
硬明胶胶囊壳的组成(以重量%计):
通过本领域已知的标准方法生产硬明胶胶囊(尺寸“000”,体积为1.4ml)。分别将1.25ml的实施例1中生产的增溶物填充至胶囊中。然后将两片硬明胶胶囊组装。
实施例8:乳膏形式的局部剂型的制备
使用以下成分(以重量%计):
在第一制剂中,将5-氨基-2,3-二氢-1,4-酞嗪二酮的增溶物、鲸蜡硬脂醇、硬脂酸甘油酯、鲸蜡硬脂酸聚醚20、鲸蜡硬脂酸聚醚12、油酸癸酯和鲸蜡硬脂基硫酸钠混合并加热至70℃。在第二制剂中,将尿囊素、甘油和水混合并加热至70℃。然后将第一制剂和第二制剂用分散器缓慢混合并均质化2-3分钟。当冷却至35℃时,加入由Rokonsal组成的第三制剂并均匀搅拌。将该混合物在约45℃下再均质化1分钟。然后使所得混合物在搅拌下冷却至室温,在此避免包含空气。如果需要,可以用NaOH或柠檬酸调节pH。
乳膏的pH为5.40。护肤霜的稳定性在40℃下为最小6个月。在该温度下没有发生相分离。
将50ml的所得乳膏包装至本领域已知的合适的铝制软管中。
实施例9:水凝胶形式的局部剂型的制备
通过略微修改US 2010/0129448A1中公开的方法来制备水凝胶。
通过将5ml的实施例1的增溶物与WFI(注射用水)混合,然后高压灭菌将CMC完全溶解至溶液中来制备3%CMC(羧甲基纤维素)溶液,得到CMC水凝胶的形式。通过将溶解在WFI中的所述增溶物添加至CMC水凝胶中来制备悬浮液。将稳定剂(TEA,柠檬酸)添加至CMC水凝胶中。如US 2005/0175707中所述,在升高的温度(40至50℃)下,在高剪切条件下(桨式混合器和超声处理)混合所得的混合物。甘油和额外的WFI也添加至悬浮液中。控制添加到水凝胶中的赋形剂的量,以达到含5-氨基-2,3-二氢-1,4-酞嗪二酮的所需浓度。
将3%CMC水凝胶悬浮液进一步混合20分钟,导致形成本体(bulk)水凝胶悬浮液。在光学显微镜下以100倍的放大率观察本体水凝胶悬浮液。悬浮颗粒的一次粒径小于约10μm,因此允许将组合物局部施用到开放的伤口或其他组织上而无磨损。
实施例10:栓剂形式的固体剂型的制备
栓剂基料的组成(以重量%计):
可可脂 97.9%
抗坏血酸 0.1%
单硬脂酸铝 2.0%
1)为了熔融,将栓剂基料加热至50–52℃,然后将熔融的脂肪基料缓慢冷却至36℃。
2)对于每种待铸形的栓剂,将0.5ml的各自量的实施例3的增溶物添加至脂肪基料中。形成软基料。
3)将所述软基料填充至栓剂模具中,该栓剂模具配置为用于生产重量为约2g的3cm长的鱼雷形直肠栓剂。
4)将栓剂冷却至室温,然后收集。
根据本发明的增溶物的使用允许在不使用额外的乳化剂和/或增塑剂的情况下制备栓剂。因此,根据本发明的这种栓剂不含聚山梨酯。
Claims (15)
1.一种用于增溶5-氨基-2,3-二氢-1,4-酞嗪二酮的方法,其包括以下步骤:
a)在室温和0.2bar至1bar的压力下,提供总范围为0.1重量%至25重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮;
b)以任意顺序添加各自为以下的增溶剂:
总范围为20重量%至80重量%的至少一种磷脂酰胆碱、
总范围为10重量%至70重量%的至少一种中链甘油三酯、
总范围为1重量%至15重量%的至少一种溶血磷脂酰胆碱、
总范围为1%重量至20重量%的至少一种C2至C4醇、和
总范围为0.5重量%至10重量%的至少一种硬脂酸甘油酯和/或至少一种饱和或不饱和的C14至C20脂肪酸,
其中所有成分的相对重量百分比合计为100%,并且所有增溶剂彼此独立地为食品添加剂和/或药学上可接受的赋形剂;
c)通过在20–60分钟的时间内以0.5℃/分钟至3℃/分钟的连续温度增量连续升高温度来小心地加热所得混合物;
d)一旦达到澄清溶液就在30℃至125℃的温度范围内停止升温;和
e)使所得增溶物冷却至室温。
2.根据权利要求1所述的方法,
其中在室温和0.2bar至1bar的压力下,以钠盐、钾盐或锂盐或它们的混合物的形式提供总范围为0.1重量%至2重量%的5-氨基-2,3-二氢-1,4-酞嗪二酮。
3.根据权利要求1或2所述的方法,其中,所述至少一种饱和或不饱和的C14至C20脂肪酸是油酸。
4.根据权利要求1至3中任一项所述的方法,其中所述至少一种C2至C4醇是乙醇。
5.根据权利要求1至4中任一项所述的方法,其中在步骤b)中另外添加总范围为0.01重量%至10重量%的至少一种抗氧化剂,所述至少一种抗氧化剂为药学上可接受的赋形剂。
6.根据权利要求5所述的方法,其中所述至少一种抗氧化剂是抗坏血酸棕榈酸酯和/或至少一种生育酚。
7.一种5-氨基-2,3-二氢-1,4-酞嗪二酮或其钠盐、钾盐或锂盐或它们的混合物的增溶物,其通过权利要求1至6中任一项所述的方法而制备。
8.根据权利要求7所述的增溶物在医学中的预防或治疗用途。
9.根据权利要求7或8所述的增溶物作为用于治疗具有过度免疫反应的病况或具有免疫缺陷背景的病况的免疫调节剂的用途。
10.根据权利要求8至9中任一项所述的增溶物的预防或治疗用途,其用于增强5-氨基-2,3-二氢-1,4-酞嗪二酮的吸收和/或生物利用度。
11.一种药物组合物,其含有配制成根据权利要求6所述的增溶物的5-氨基-2,3-二氢-1,4-酞嗪二酮和至少一种药学上可接受的赋形剂。
12.根据权利要求11所述的药物组合物,其中所述药物组合物适合于口服、肠胃外或局部给药。
13.根据权利要求6所述的增溶物和至少一种药物活性剂的组合,其用于预防和/或治疗具有过度免疫反应的病况或具有免疫缺陷背景的病况中的用途,所述药物活性剂选自包含以下的组:甾体类和非甾体类抗炎药;免疫调节剂;免疫刺激剂;免疫抑制剂;抗生素;抗感染药;抗病毒剂;抗真菌剂;抗原生动物剂;驱虫剂;镇痛剂;局部麻醉剂;抗凝剂;抗血小板药;肌肉松弛剂;补剂;和同化剂。
14.根据权利要求12所述的药物组合物,其中所述至少一种药学上可接受的赋形剂选自包含以下的组:载体、粘合剂、润滑剂、助流剂、崩解剂、着色剂、缓冲剂、防腐剂、乳化剂、渗透增强剂、抗氧化剂、稀释剂、pH调节剂、加脂剂、溶剂、稠度增强剂、水溶助剂、甜味剂、酸化剂、增稠剂、抗粘剂、填料、调味剂、甜味剂、遮光剂、矫味物质和芳香物质。
15.根据权利要求12或14所述的药物组合物,其用于在医学中的用途。
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