CN114727956A - 提高非处方药(otc)和制药药品生物利用度的方法 - Google Patents
提高非处方药(otc)和制药药品生物利用度的方法 Download PDFInfo
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- CN114727956A CN114727956A CN202080070651.1A CN202080070651A CN114727956A CN 114727956 A CN114727956 A CN 114727956A CN 202080070651 A CN202080070651 A CN 202080070651A CN 114727956 A CN114727956 A CN 114727956A
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Abstract
本发明涉及用于增强药物化合物功效的组合物和方法。本发明利用包含一种或多种微生物产生的生物表面活性剂和/或其异构体的佐剂组合物来增强药物在受试者中的生物利用度、稳定性和定位,减少所需总剂量,并提高药物的施用前稳定性。
Description
相关申请的交叉引用
本申请要求获得2019年8月10日提交的美国临时申请序列号62/885,233的利益,通过引用将该美国临时专利申请的全部内容并入本文。
背景技术
生物利用度对于制药药品或非处方药(OTC)化合物的功效至关重要。生物利用度定义为在受试者体内以不变应万变的方式达到循环的施用化合物的数量。静脉注射化合物定义为完全生物可利用的化合物;然而,存在几个主要因素影响其他施用方法的生物利用度:溶解度、稳定性和膜或组织渗透性。此外,一些药物由于无法经由血脑屏障或血睾屏障从体循环中转移,因而无法在所需部位定位。每个因素均对递送到靶细胞、组织、器官或液体的原型药物量造成单独的或依赖性的影响。
有些药物在水中的溶解度很差。如果一种化合物在处于室温且pH值呈中性的水溶液中,其溶解浓度小于10mg/ml,则通常被视为水难溶性化合物。水难溶性药物的示例包括布洛芬、萘普生和茚地那韦。由于结晶型不可溶茚地那韦增加了肾结石的风险,因此目前不建议采用它来治疗艾滋病。
上皮组织是众多药物的另一个阻碍。除溶解度以外,造成无法渗透胃肠道或其他上皮组织的潜在因素包括药物的主动分泌或无法穿越上皮细胞之间的连接点。
血脑屏障(BBB)在细胞之间存在紧密连接,从而可抑制大多数药物化合物通过组织。当药物能够通过血脑屏障或上皮组织转移时,运输机制可将它们分别从血脑屏障或体循环中分泌出来。
由于消除半衰期短,一些药物化合物的疗效可从受试者体内缓释中受益。二甲双胍用于治疗2型糖尿病,而卡培他滨(CB)是一种用于治疗各种癌症的合成药物,包括乳腺癌、胃癌、前列腺癌和结直肠癌。CB和二甲双胍的疗效受短消除半衰期的影响。延长消除半衰期会增加受试者接触药物的时间。许多口服抗生素必须每天服用多次,持续数周,以致不依从规定的抗生素疗程。更持久的药物缓释可减少服用剂量,增加病人坚持处方药疗程的可能性。其他药物在口服时不稳定,或可出现口服睾酮时观察到的中毒症状。
化学表面活性剂通常用于药物和OTC组合物。现有化学表面活性剂存在缺陷,包括毒性和处置过程中产生的废水污染。十二烷基硫酸钠(SDS)是一种化学表面活性剂,其广泛用于药物组合物来增强血脑屏障的渗透性,增加布洛芬的溶解度,并提高阿奇霉素通过小鼠皮肤的流量。然而,SDS和其他化学表面活性剂一样,可通过改变蛋白激酶C细胞信号转导级联来刺激皮肤。此外,医院排出的废水通常含有戊二醛,其与SDS和溴化十六烷基三甲基铵(CTAB)等表面活性剂一起作为杀菌剂使用。SDS对无脊椎动物和甲壳类动物有毒;且与戊二醛结合时,毒性还会增加。
因此,需要有安全、有效的组合物和方法来提高各种OTC和药物化合物的疗效。
发明内容
本发明提供了使用微生物来源的生物表面活性剂改善药物和OTC化合物功效的组合物和方法。此外,这些生物表面活性剂有助于以经济实惠的方式制备无毒药物组合物。
在一个实施例中,本发明提供了包含活性成分和佐剂成分的治疗组合物,其中所述活性成分可以是药物和/或OTC药物,例如,达托霉素、克林霉素、阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、培非格司亭、卡培他滨、阿霉素、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、睾酮、西地那非、伐地那非、他达拉非和茚地那韦的制药或OTC药物化合物,或上述化合物的任何替代形式。
在某些实施例中,活性成分是维生素、矿物质、补充剂、草药提取物或其他健康促进物质。
在优选实施例中,通过使用由一种或多种微生物来源的生物表面活性剂组成的本发明的佐剂成分,提高了活性成分的生物利用度、稳定性和/或定位。
在某些实施例中,提供了改善活性成分(即,药物)的生物利用度、稳定性和/或定位的方法,其中受试者同时服用活性成分与佐剂成分或在例如施用佐剂成分之前或之后的5分钟内服用。
同时使用生物表面活性剂与药物化合物,除了提高药物在受试者体内的生物利用度、稳定性和定位,以及减少药物组合物中化学表面活性剂的用量之外,还可以产生其他效果。例如,在一些实施例中,生物表面活性剂可增加药物组合物在向受试者施用前的保质期和稳定性,特别是对于在水溶液中的难溶药物。生物表面活性剂使药物化合物能在水溶液中保持溶解,并能抵抗高温和紫外线照射。
在某些实施例中,本组合物的生物表面活性剂可为糖脂生物表面活性剂或脂肽生物表面活性剂。在具体优选实施例中,糖脂选自槐糖脂、鼠李糖脂、海藻糖脂、纤维二糖脂和甘露糖赤藓糖醇脂;而脂肽选自表面活性素、伊枯草素、地衣素和丰原素。在某些实施例中,槐糖脂是一种酸性槐糖脂,其结构包含槐糖碳水化合物头部和脂肪酸尾部,长度为16或18个碳原子。
在某些实施例中,脂肽是表面活性素,其结构包含由七个氨基酸组成的肽环和长为13至15个碳的疏水脂肪酸链。在具体实施例中,氨基酸包含L-天冬氨酸、L-谷氨酸、两个L-亮氨酸、两个D-亮氨酸和L-缬氨酸。
在某些实施例中,脂肽为伊枯草素。伊枯草素含有组成肽基的多种氨基酸残基和组成生物表面活性剂疏水尾的多种脂肪酸或脂肪酸衍生物。在优选实施例中,伊枯草素为伊枯草素A,其包含由七个氨基酸组成的肽环,这些氨基酸是包括D-天冬酰胺、L-天冬酰胺、D-酪氨酸、L-谷氨酰胺、L-脯氨酸和L-丝氨酸,以及其长度可为14到17个碳的β-氨基脂肪酸链。
在某些实施例中,生物表面活性剂以临界胶团浓度(CMC)存在于本组合物中。在某些实施例中,该组合物进一步包含一种或多种药物载体。在其他实施例中,该组合物进一步包含基于生物表面活性剂的纳米粒子递送系统。
在优选实施例中,本治疗组合物被配制成口溶食用产品,例如,食品、胶囊、药丸和可饮用液体。本发明的组合物也可配制成可通过例如注射施用的溶液,其中包括静脉注射、腹腔注射、肌肉注射、肝内注射或皮下注射。在其他实施例中,本组合物被配制成通过皮肤贴片或直接在皮肤上施用产生局部或全身效果。组合物可通过舌下、口腔、直肠或阴道方式形成和施用。进一步地,组合物可形成用于雾化、喷入鼻内通过鼻膜吸收、经口或鼻吸入或在眼或耳内施用。
在某些实施例中,本组合物的生物表面活性剂在受试者体内和给药用水溶液中均能提高药物溶解度。例如,可以提高硝唑尼特、厄洛替尼、醋酸阿比特龙、硼替佐米、阿奇霉素、莫西沙星、茚地那韦、布洛芬、萘普生、阿司匹林、睾酮、伐地那非、他达拉非、西地那非、来那度胺或这些药物的任何替代品的溶解度。这些药物在室温下的水中最大溶解度均小于10mg/ml。
在另一实施例中,本组合物的生物表面活性剂减少了向受试者递送的表面活性剂分子和/或药物化合物的总剂量。即使是溶解度大于10mg/ml的药物,加入生物表面活性剂也可减少化学表面活性剂的用量,例如与制药和OTC组合物中使用的泊咯沙姆和SDS。
在另一实施例中,本组合物的生物表面活性剂增加了药物经上皮组织的渗透性。例如,可以增加来那度胺、醋酸阿比特龙、卡培他滨、二甲双胍、硝唑尼特和/或其他药物的渗透性。这些药物的每一种都被经常使用,然而所有药物均不能有效穿过肠道上皮细胞屏障进入体循环。
在另一实施例中,本组合物的生物表面活性剂增加了药物的消除半衰期,从而降低了施用频率。例如,卡培他滨、克林霉素、二甲双胍、硝唑尼特、茚地那韦和/或其他药物的消除半衰期可以延长。这些药物中的每一种的消除半衰期都很短,通常规定每天服用多次(例如,每天多达4次)来维持受试者体内的药物治疗水平。
在另一实施例中,本组合物的生物表面活性剂延长了受试者体内的药物释放时间。由夹在胶束或其他基于生物表面活性剂的药物递送系统中的药物促使药物释放延长。例如,达托霉素、克林霉素、阿奇霉素、莫西沙星、来那度胺、醋酸阿比特龙、卡培他滨、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、西地那非、他达拉非、茚地那韦和/或其他药物的释放时间均可被延长。这些药物中的每一种均为或可为每天至少服用一次。通过使用生物表面活性剂胶束或基于生物表面活性剂(包括纳米颗粒、脂质体或纳米乳剂)的药物递送,在受试者服用组合物后,药物可以随着生物表面活性剂的相对浓度降低而长时间释放。这有助于减少受试者为达到治疗效果而服用的剂量数量。
在另一实施例中,本组合物的生物表面活性剂改善了药物通过血脑屏障(BBB)的运动。例如,硼替佐米、来那度胺、多奈哌齐、伐尼克兰、硝唑尼特、茚地那韦、西地那非、伐地那非、他达拉非和/或其他药物穿越血脑屏障均可得以改善。这些药物中的每一种在血脑屏障内均有治疗作用,但血脑屏障是从体循环进入脑脊液(CSF)的一个显著障碍。血睾屏障也是茚地那韦等药物的一个重要障碍。如有生物表面活性剂,茚地那韦可以更容易地进入血睾屏障,与存在于睾丸中的逆转录病毒发生作用。然而,如果药物能够进入CSF,P-糖蛋白(P-gp)易于抽出作为这种ATP结合盒(ABC)转运蛋白底物的药物。
在另一实施例中,本组合物的生物表面活性剂抑制分泌系统,增加了药物在CSF内的停留时间。生物表面活性剂的存在改变了这些分泌系统所处的膜,从而改变了泵的功效。例如,可增加茚地那韦、克林霉素、达托霉素、莫西沙星、硼替佐米、来那度胺、卡培他滨、阿霉素、厄洛替尼、西地那非、伐地那非、他达拉非和/或其他药物在CSF中停留的时间。P-gp是分泌系统的一个常见示例,该分泌系统可被抑制分泌上述药物,但还有其他分泌药物流出泵的示例。
在另一实施例中,本组合物的生物表面活性剂减少了在受试者体内达到最大药物浓度的时间。例如,多奈哌齐用于治疗阿尔茨海默病,且必须进入CSF才能发挥其作用。然而,在目前已知的治疗方案中,多奈哌齐无法达到3个月内的稳态浓度,在治疗开始后的12至24个月内,观察到受试者体内的浓度增加50%。
在某些实施例中,本组合物的生物表面活性剂减少或消除了化学表面活性剂的用途。在一些实施例中,本组合物的生物表面活性剂在施用后减少药物在受试者体内的改性;修饰可由例如胃肠道中的酸或结合的蛋白质引起。
在另一实施例中,本组合物的生物表面活性剂增加了受试者施用前药物的稳定性,有可能消除对冷链的严格要求。这提供了更大的能力,例如,向缺乏足够传统冷链存储设施的地区分发药物。
有利的是,本发明的材料和方法在无需使用化学表面活性剂的情况下,可提高众多制药和OTC药物对有需要的受试者的疗效。
具体实施方式
本发明提供了用于提高制药和OTC药物的生物利用度、稳定性和/或定位的材料和方法。特别是,本发明提供了具有微生物来源的生物表面活性剂的治疗组合物用于提高活性成分(例如,药物化合物)的功效。本发明所产生的组合物和方法无毒且性价比高,而且有利的是,可有助于在制药和OTC药物中减少化学表面活性剂的使用。
本文进一步描述了利用各种手段提高药物生物利用度的方法,其中包括,例如,提高药物的溶解度、消除半衰期和/或经由上皮组织的渗透性;延长药物递送时间段;和/或提高在向受试者施用前的药物稳定性。在具体示例性实施例中,受试者施用本发明的组合物时,改善了通过抑制P-糖蛋白(P-gp)分泌和其他分泌系统运作的药物定位,使血脑屏障和血睾屏障的穿透力得以增强。
选择性定义
如本文所用,术语“佐剂”是指可帮助、有助于和/或增强与佐剂一起施用物质的有效性的辅助化合物。例如,佐剂可与药物化合物一起施用,和/或包含在由药物化合物组成的治疗组合物内,以便无论其是何用途,均有助于提高药物的有效性(例如,治疗疾病症状,或增强体内器官或系统的功能)。
如本文所用,“生物膜”是微生物(例如,细菌)的复合聚集体,其中细胞使用通常由但不限于多糖材料组成的基质彼此粘附。生物膜中的细胞在生理上与同一生物的浮游细胞不同,浮游细胞为单细胞,可在液体或气体介质中漂浮或游动,或存在于固体或半固体表面上或固体或半固体表面中。单个微生物细胞也可以成细丝状,亦可以细胞链形式捆绑在一起,但不形成明显的生物膜。尽管细胞的细丝状属性可有助于产生生物膜。
如本文所用,“药物”是指制造、生产、提取或以其他方式获得,作为药物和/或治疗剂使用的化合物。药物可以是被递送到血液和/或淋巴循环、组织或器官,最终到达受试者体内的某个部位,对受试者的健康产生局部或全身积极影响的任何一种或多种分子。药物可以是需要医疗服务人员的处方才能获得的"制药"药品,亦可为无需处方就可以购买的"非处方药(OTC)"。在某些实施例中,"药物"还可以包括健康促进物质,诸如维生素、矿物质、氨基酸(包括必需氨基酸和支链氨基酸)的补充剂来源、肽、蛋白质、微量元素、脂肪、脂肪酸、脂类、碳水化合物、甾醇、聚酮化合物、生物聚合物、草药提取物和酶等等。
药物可包括,例如,缓解疼痛、发烧和/或炎症的药剂,减轻过敏或感冒症状的药剂,抑制或治疗病毒的药剂,治疗细菌或真核生物感染的药剂,治疗癌症或减轻影响或提高传统癌症治疗效果的药剂,抑制或预防癫痫发作的药剂,降低或控制胆固醇的药剂,控制糖尿病的药剂,治疗抑郁症或焦虑症的药剂,控制体重的药剂,降低或提高生育能力的药剂,治疗或缓解痴呆症(包括阿尔茨海默病)的药剂,治疗或缓解勃起功能障碍的药剂,治疗缓解肺动脉高压的药剂,治疗化学物质成瘾的药剂,或治疗或缓解性功能减退症的药剂。
如本文所用,关于"基于微生物的组合物"或"微生物来源的组合物"是指包含由于微生物或其他细胞培养物生长而产生的成分的组合物。基于微生物的组合物可以包含微生物本身,或者微生物可从培养它们的液体培养基或培养基中分离。该组合物可包含残留细胞成分和/或微生物生长副产物。微生物生长副产物可以是,例如,代谢物(例如,生物表面活性剂)、细胞膜成分、合成蛋白质和/或其他细胞成分。优选地,根据本治疗组合物不包含含有任何微生物的微生物组合物。
本发明进一步提供了"微生物产品",其将应用于实践中以达到预期效果。微生物产品可以是简单从微生物培养过程中收获的基于微生物的组合物。或者,微生物产品可包含已添加的进一步成分。这些额外成分可包括,例如,稳定剂、缓冲剂和/或适当载体(例如,水或盐溶液)。微生物产品可包含基于微生物组合物的混合物。微生物产品还可包含以某种方式处理过的微生物组合物的一种或多种成分,例如,但不限于过滤、离心、裂解、干燥、纯化等。
如本文所用,"分离"或"纯化"化合物基本上不含在自然界中与之相关或在生产中与之相关的其他化合物(例如,细胞材料)。在某些实施例中,纯化化合物按重量计(干重)至少占相关化合物重量的60%。优选地,制剂按重量计至少是75%,更优选地至少90%,最优选地至少99%的相关化合物。例如,优选地,纯化化合物按重量计是至少90%、91%、92%、93%、94%、95%、98%、99%或100%(w/w)的所需化合物。纯度通过任何适当的标准方法来测量,例如,柱色谱法、薄层色谱法或高效液相色谱法(HPLC)分析。
“代谢物”是指由新陈代谢产生的任何物质(例如,生长副产物)或参与特定代谢过程所必需物质。代谢物可为一种作为起始材料、中间物或代谢最终产物的有机化合物。代谢物示例包括但不限于生物表面活性剂、酶、酸、溶剂、气体、醇类、蛋白质、维生素、矿物质、微量元素、氨基酸和聚合物。
如本文所用,"预防"健康状况、疾病或机体紊乱是指避免、推迟、阻止或尽量减少这种病症、疾病或机体紊乱的特定体征或症状的发生。预防可以是绝对的或完全的预防,但不是必须的预防;也就是说,这种体征或症状可能在以后的一段时间内仍会出现。预防可包括降低这种病症、疾病或机体紊乱的严重程度或缩小发病范围,和/或抑制病症、疾病或机体紊乱发展的更为严重或涉及范围更广。
本文提供的范围被理解为该范围内所有值的简写。例如,1至20的范围被理解为包括来自由1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19或20的组,以及上述整数之间的所有中间小数值(例如,1.1、1.2、1.3、1.4、1.5、1.6、1.7、1.8和1.9)中的任何数字、数字组合或子区间。关于子区间,要对从范围的任一端点延伸的“嵌套子范围”进行特别考虑。例如,1至50的示例性范围的嵌套子范围可在一个方向上包括1至10、1至20、1至30和1至40的区间,或者在另一个方向上包括50至40、50至30、50至20和50至10的区间。
“减少值”是指至少1%、5%、10%、25%、50%、75%或100%的负变化。“增加值”是指至少1%、5%、10%、25%、50%、75%或100%的正变化。
“参考条件”是指标准或控制条件。
如本文所用,术语“受试者”指需要或希望递送药物化合物提供益处的动物。动物可以是,例如人、猪、马、山羊、猫、小鼠、大鼠、狗、猿、鱼、黑猩猩、猩猩、豚鼠、仓鼠、牛、羊、鸟、鸡以及任何其他脊椎动物或无脊椎动物。这些益处可以包括但不限于治疗健康状况、疾病或机体紊乱;预防健康状况、疾病或机体紊乱;增强免疫健康;和/或增强体内器官、组织或系统的功能。本发明上下文中的优选受试者是人。在一些实施例中,受试者正在遭受健康状况、疾病或机体紊乱的折磨,而在一些实施例中,受试者处于良好的健康状态(例如,基本上没有损伤或疾病),但希望增强特定器官、组织或身体系统的健康和/或功能。受试者可以是任何年龄或发展阶段的受试者,包括婴儿、幼儿、青少年、少年、成人或老年人。
如本文所用,术语“治疗有效量”、“治疗有效剂量”、“有效量”和“有效剂量”用于指化合物或组合物的量或剂量,当将其施用于受试者时,能够治疗或预防病症、疾病或机体紊乱,或者能够增强器官、组织或身体系统的健康或功能。换言之,当施用于受试者时,该量为“治疗有效量”实际量依据各种因素而变化,这些因素包括但不限于被治疗或被预防的特定病症、疾病或机体紊乱;病情的严重程度;需要增强健康或功能的特定器官、组织或身体系统;患者的体重、身高、年龄和健康状况;以及施用途径。
如本文所用,“表面活性剂”是指降低相与相之间的表面张力(或界面张力)的表面活性物质。表面活性剂用作例如洗涤剂、湿润剂、乳化剂、起泡剂和/或分散剂。由微生物产生的表面活性物质被称为“生物表面活性剂”。
如本文所用,术语“治疗”是指根除、减少、减轻、改善或逆转健康状况、疾病或机体紊乱的任何程度的体征或症状,包括但不要求完全治愈所述病症、疾病或机体紊乱。治疗可治愈或部分减轻病症、疾病或机体紊乱。“治疗”还可包括改善或增强病症或特征,例如,使体内特定系统的功能达到更高的健康或体内平衡状态。
与“包括”或“含有”同义的过渡术语“包含”是包含性或开放式术语,且不排除未叙述的附加元件或方法步骤。相比之下,过渡短语“由......组成”排除了权利要求中未指定的任何元件、步骤或成分。过渡短语“基本上由......组成”将权利要求的范围限制为特定材料或步骤“和那些实质上不影响要求保护的发明的基本和新颖特征的材料或步骤”,例如,提高物质生物利用度的能力。术语“包含”的使用考虑了“由”和/或“基本上由”所述元件组成的其他实施例。
除非特别说明或者从上下文中显而易见,否则如本文所用,术语“或”应理解为包含性术语。除非特别说明或者从上下文中显而易见,否则如本文所用,术语“一个”、“一种”和“所述”应理解为单数或复数。
除非具体说明或从上下文中显而易见,否则本文所用的术语“大约”应理解为在本领域的正常公差范围内,例如,在平均值的2个标准偏差范围内。术语“大约”可以理解为在所述值的10%、9%、8%、7%、6%、5%、4%、3%、2%、1%、0.5%、0.1%、0.05%或0.01%之内。
本文中变量的任何定义中的化学基团列表的叙述包括该变量作为任何单个基团或所列基团组合的定义。本文对变量或方面的实施例的叙述包括该实施例作为任何单一实施例或与任何其他实施例或其部分的结合。
本文提供的任何组合物或方法均可与本文提供的任何其他组合物和方法中的一种或多种相结合。
本发明的其他特征和优点将从以下对其优选实施例的描述以及权利要求书中显而易见。本文引用的所有参考文献均特此纳入参考。
治疗组合物的配制和递送
本发明提供了包含微生物来源生物表面活性剂的治疗组合物,其用于提高药物疗效。有利的是,本发明的组合物和方法无毒且经济实惠。
更具体地说,在某些实施例中,治疗组合物包含活性成分和佐剂成分,所述活性成分包括一种或多种制药或OTC药物;其中所述佐剂成分包含增效量的生物表面活性剂;以及与由不包含佐剂成分的相同药物的组合物相比,药物的生物利用度、定位和/或稳定性得以增强。
根据本发明的活性成分可为任何药物,包括制药或OTC药物。例如,活性成分可以是莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、培非格司亭、卡培他滨、阿霉素、厄洛替尼、阿司匹林、萘普生、布洛芬、多奈哌齐、硝唑尼特、伐尼克兰、睾酮、西地那非、伐地那非、他达拉非、茚地那韦、利巴韦林、二甲双胍,以及它们的任何替代形式,
例如,磷酸克林霉素、盐酸克林霉素、盐酸克林霉素棕榈酸酯、阿奇霉素二水合物、盐酸莫西沙星、阿比特龙、非格司亭、盐酸阿霉素、聚乙二醇脂质体阿霉素、非聚乙二醇脂质体阿霉素、聚乙二醇阿霉素、盐酸厄洛替尼、盐酸多奈哌齐、萘普生钠、布洛芬钠、盐酸多奈哌齐、酒石酸伐伦克林、十一酸睾酮、环戊丙酸睾酮、庚酸睾酮、丙酸睾酮、枸橼酸西地那非、盐酸伐地那非、盐酸伐地那非三水合物和硫酸茚地那韦。
其他活性成分可以包括,例如,对乙酰氨基酚、过氧化苯甲酰、新霉素、多粘菌素、炉甘石(氧化锌/氧化铁)、水杨酸、二甲基硅氧烷、氢化可的松(可的松)、遮光剂(例如,氧苯酮、阿伏苯宗、辛水杨酯、奥克立林、胡莫柳酯或肉桂酸辛酯),马拉硫磷、苄氯菊酯,抗酸剂/质子泵抑制剂(例如,水杨酸亚铋、法莫替丁、兰索拉唑、盐酸雷尼替丁、奥美拉唑、碳酸钙)、洛哌丁胺、葡萄糖、胰岛素、氯苯甲嗪、抗组胺(例如,溴苯那敏、西替利嗪、氯苯吡胺、氯马斯汀、非索非那定、氯雷他定)、愈创甘油醚、右美沙芬、羟甲唑啉、苯肾上腺素、伪麻黄碱、克霉唑、咪康唑、克霉唑、替奈丁、酮康唑、苯佐卡因和薄荷醇。
进一步的附加活性成分可以包括各种抗生素,例如,包括青霉素类(如青霉素G、青霉素V、氨苄西林、阿莫西林、巴氨西林、羧苄西林、卡茚西林、替卡西林、阿洛西林、美洛西林、甲氧西林、哌拉西林等)、四环素类(如金霉素、土霉素、甲烯土霉素、多西环素、二甲胺四环素等)、头孢菌素类(如头孢羟氨苄、头孢氨苄、头孢拉啶、头孢噻吩、头孢匹林、头孢唑啉、头孢克洛、头孢羟唑、头孢尼西、头孢西丁、头孢替坦、头孢呋辛、头孢呋辛酯、头孢内唑、头孢丙烯、氯碳头孢、头孢雷特、头孢吡肟、头孢哌酮、头孢噻肟、头孢唑肟、头孢曲松钠、头孢他啶、头孢克肟、头孢泊肟、头孢布烯等),氟喹诺酮类(如左氧氟沙星)、喹诺酮类(如萘啶酸、西诺沙星、环丙沙星和诺氟沙星等)、林可霉素类(如克林霉素)、大环内酯类(如红霉素、阿奇霉素)、砜类(如氨苯砜)、磺胺类(如磺胺、磺胺嘧啶、磺胺甲恶唑、磺胺异噁唑、磺胺乙酰胺、磺胺甲恶唑)、脂肽类(如达托霉素)、多肽类(如杆菌肽)、糖肽类(如万古霉素)、氨基糖苷类(如链霉素、庆大霉素、妥布霉素、阿米卡星、奈替米星、卡那霉素等)、硝基咪唑类(如甲硝唑)和/或碳青霉烯类(如噻那霉素)。
然而,又一步的附加示例可以包括肌肉松弛剂;助消化药(例如,反流抑制剂、通便药、益生菌、益生元和止泻药);心血管药(例如,β-受体阻滞药、钙通道阻滞剂、利尿剂、血管收缩剂、血管扩张剂、强心剂、抗心律失常剂、硝酸盐);血压/高血压药(例如,血管紧张素转化酶抑制、α-阻断剂、血管紧张素受体阻断剂);凝血药(如抗凝血剂、肝素、抗血小板药、溶纤维蛋白药、抗血友病因子和止血药);他汀类药物(如低密度脂蛋白胆固醇抑制剂和降血脂药);内分泌辅助药(如雄激素、抗雄激素、雌激素、促性腺激素、皮质激素、HGH、加压素);抗糖尿病药(如磺酰脲、双胍、二甲双胍、噻唑烷二酮、胰岛素);甲状腺激素和抗甲状腺药物;泌尿生殖系统药(如抗真菌药、碱化剂、喹诺酮类、抗生素、胆碱能药、抗胆碱能药、生育药、激素类避孕药);中枢神经系统药物(例如,迷幻药、催眠药、麻醉药、抗精神病药、抗抑郁药(包括三环素、单胺氧化酶抑制剂、锂盐和SSRI)、止吐药、抗惊厥药/抗癫痫药、兴奋剂、苯丙胺、多巴胺激动剂、抗组胺药、大麻素、5-HT拮抗剂);眼科药(如局部麻醉剂、拟交感神经药、副交感神经药、催眠药、环流药、肥大细胞抑制剂);抗菌药(如抗生素、抗菌药、抗真菌药、抗寄生虫药、抗原虫药、杀阿米巴药);抗病毒药(例如,阿昔洛韦、利巴韦林、伐昔洛韦、泛昔洛韦、更昔洛韦)、抗组胺药、抗胆碱药、防腐剂、耵聍溶解剂、支气管扩张剂、抗感冒药、粘液溶解剂、减充血剂、抗疟药、抗毒素、抗毒剂、疫苗;免疫球蛋白、免疫抑制剂、干扰素、单克隆抗体、化学治疗药物和/或能够治疗任何健康状况、疾病或机体紊乱或以任何方式增强健康的任何其他类别的化合物。
在一些实施例中,治疗组合物包含一种或多种其他健康促进物质,例如维生素、矿物质和/或补充剂。这些其他物质可以包括,例如,氨基酸(包括必需氨基酸和支链氨基酸)、肽、蛋白质、微量元素、脂肪、脂肪酸、脂质、碳水化合物、甾醇、聚酮、生物聚合物、草药提取物和酶的来源。
在某些实施例中,其他健康促进物质是治疗组合物中的活性成分。在其他实施例中,其他健康促进物质是除了制药或OTC活性成分之外存在的物质,如上文列出的那些。
在一个实施例中,健康促进物质是一种维生素,例如,维生素A、维生素C、维生素D、维生素E、维生素K、维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸)、维生素B6、维生素B7(生物素)、维生素B12、叶酸盐(或叶酸)、泛硫酸盐、烟酸、氯化胆碱、肉碱、肌醇和对氨基苯甲酸。在某些实施例中,佐剂组合物可有助于促进亲脂性维生素溶解,例如,维生素A、维生素D、维生素E和/或维生素K。
在一个实施例中,健康促进物质是巨量矿物质和/或微量矿物质,例如,钙、磷、镁、钠、钾、氯、硫、铁、锰、铜、碘、锌、钴、氟化物和硒。
在一个实施例中,健康促进物质是一种补充剂,例如,咖啡因、松果菊、鱼油、人参、葡萄糖胺、硫酸软骨素、大蒜提取物、圣约翰草、锯棕榈、银杏、ω-3脂肪酸、ω-6脂肪酸、褪黑激素、β-胡萝卜素、类黄酮(例如,花青素)、胶原蛋白肽、阿萨伊、活性炭、紫花苜蓿、山金车、黄芪、芦荟、南非醉茄、蜂花粉、颠茄、小檗碱、覆盆子、甜菜碱、苦瓜、苦橙、黑升麻、欧车前、红茶、水飞蓟、白车前子、蓝莓、蓝绿藻、硼、款冬、金盏花、大麻二酚(CBD)、辣椒素、辣椒、软骨、猫爪藤、洋甘菊、女贞子、壳聚糖、肉桂、丁香、椰子、鱼肝油、胶质银、蔓越莓、肌酸、蒲公英、鹿茸、南非钩麻、DHEA、当归、刺五加、麻黄、桉树,接骨木,月见草,葫芦巴,野甘菊、亚麻籽、墨角藻、生姜、甘草酸、枸杞、白毛茛、葡萄、葡萄籽、葡萄柚、生咖啡,绿茶,瓜拉那、瓜尔胶、匙羹藤、山楂、大麻、木槿、蜂蜜、和厚朴酚、胡蝶亚、啤酒花、七叶树、淫羊藿、马尾草、硫酸肼、卡瓦、可乐果、薰衣草、柠檬草、甘草、叶黄素、番茄红素、玛卡、山竹、甲磺酰甲烷、奶蓟、槲寄生、单月桂酸、烟酰胺、诺丽果、燕麦、橄榄、牛至、棕榈油、木瓜、保哥果、花生油、薄荷油、薄荷、石榴、蜂胶、槲皮素、玫瑰果、覆盆子酮、红三叶草、红曲米、灵芝菌、白藜芦醇、玫瑰果、鼠尾草、锯棕榈、巴赫蒂亚里香薄荷油(Satureja bachtiarica oil)、番泻叶、榆树、大豆、绿薄荷、甜叶菊、酸樱桃、茶树油、雷公藤、甜菜根、特里马素II、姜黄、缬草、乳清蛋白、野山药、柳树皮、巴拉圭茶、育亨宾、5-HTP及其他。
在一个实施例中,健康促进物质是一种酶,例如,纳豆激酶、辅酶Q10、脂肪酶、菠萝蛋白酶、木瓜蛋白酶、糜蛋白酶A、糜蛋白酶B、木瓜肽酶A、胰蛋白酶、糜蛋白酶、蛋白酶、脂肪酶、淀粉酶、胰脂酶、消化酶、乳糖酶、α-乳糖酶、纤维素酶、植酸酶和β-葡聚糖酶。
其他健康促进物质可以包括但不限于抗氧化剂、β-葡聚糖、胆汁盐、胆固醇、类胡萝卜素和许多其他物质。
在某些实施例中,本组合物包括用于提高药物生物利用度、稳定性和/或定位的佐剂组合物,其中该佐剂组合物包含增效量的一种或多种生物表面活性剂。在优选实施例中,"增效量"是指与包含相同药物但不含本佐剂成分的其他组合物相比(或本治疗组合物的佐剂成分),提高药物(或本治疗组合物的活性成分)的性能和/或有效性的佐剂组合物的量。
佐剂成分包含生物表面活性剂,它由微生物产生的一组结构多样的表面活性物质组成。生物表面活性剂安全且可生物降解,并且可在可再生基质中或可再生基质上使用选定有机体,以低成本轻松生产。
所有生物表面活性剂均为两亲性生物表面活性剂。它们由两部分组成:极性(亲水)基团和非极性(疏水)基团。由于其双亲结构,生物表面活性剂可以增加疏水性水不溶物质的表面积,增加此类物质的水溶性,并改变细菌细胞膜的特性。生物表面活性剂聚集在界面上,降低液体、固体和气体分子之间的表面张力及界面张力,一旦浓度达到临界胶团浓度(CMC),就会在溶液中形成聚集微细胞结构。
生物表面活性剂包括糖脂(例如,鼠李糖脂(RLP)、甘露糖赤藓糖醇脂(MEL)、槐糖脂(SLP)、纤维二糖脂和海藻糖脂)、脂肽(例如表面活性素、伊枯草素、丰原素和地衣素)、黄素脂(FL)、脂肪酸、磷脂(例如,心磷脂、磷脂酰甘油)和高分子量聚合物(例如,脂蛋白、脂多糖-蛋白质复合物和多糖-蛋白质-脂肪酸复合物)。
大多数生物表面活性剂产生生物体会根据烃源(如油、糖、甘油等)的存在作出反应,从而生成生物表面活性剂促进吸收。其他介质成分(例如,铁浓度)可以对生物表面活性剂的产生造成显著影响。微生物生物表面活性剂由各种微生物(例如,细菌、真菌和酵母菌)产生。非限制性示例包括假单胞菌属(例如,铜绿假单胞菌、恶臭假单胞菌、荧光假单胞菌、莓实假单胞菌和丁香假单胞杆菌)、丁香假单胞菌、芽孢杆菌属(例如,枯草芽孢杆菌、短小芽胞杆菌、蜡样芽胞杆菌、解淀粉芽孢杆菌和地衣芽孢杆菌)、弯曲杆菌属、红球菌属、节杆菌属、棒状杆菌属、假丝酵母菌属(如球拟假丝酵母),威克汉姆酵母(如异常威克汉姆酵母),念珠菌属(如白色念珠菌、皱褶假丝酵母、热带念珠菌、解脂假丝酵母、光滑念珠菌和白球拟酵母),酵母菌属、酿酒酵母、嗜露酵母菌),毕赤酵母属(如异常毕赤酵母和西方毕赤酵母)和季也蒙酵母属(如季也蒙毕赤酵母)。生物表面活性剂可通过本领域已知发酵过程获得,诸如固态发酵、浸没式发酵或其组合等。
在具体实施例中,佐剂成分包含一种或多种糖脂生物表面活性剂和/或一种或多种脂肽生物表面活性剂。
在某些优选实施例中,佐剂成分包含槐糖脂(SLP)。SLP是糖脂生物表面活性剂,由例如假丝酵母支系的各种酵母菌产生。SLP由与长链羟脂肪酸相连的槐二糖组成。它们可以包含部分乙酰化2-O-β-D-吡喃葡萄糖基-D-吡喃葡萄糖单元,其以β-糖苷方式与17-L-羟基十八烷酸或17-L-羟基-Δ9-十八烯酸相连。羟基脂肪酸一般为16或18个碳原子,并可包含一个或多个不饱和键。进一步地,槐糖残基可在6-和/或6'-位上被乙酰化。脂肪酸羧基可为游离基团(酸性或线性形式),也可为在4″位被内部酯化(乳酸形式)的基团。球拟假丝酵母产生一种特定酶,(称为球拟假丝酵母内酯酶),其催化线性SLP酯化以产生内酯型SLP。
在一个实施例中,SLP为酸性或线性SLP。SLP也可为乳酸型,非乙酰化槐糖脂、单乙酰化槐糖脂、双乙酰化槐糖脂或其任何异构体。
在某些实施例中,生物表面活性剂为RLP,例如,单鼠李糖脂、双鼠李糖脂或其任何其他异构体。
在某些实施例中,生物表面活性剂是MEL,例如MEL-A、MEL-B、MEL-C或MEL-D,或具有不同脂肪酸长度和/或疏水段的任何异构体。
在某些实施例中,生物表面活性剂是海藻糖脂或其任何异构体。
在某些实施例中,生物表面活性剂是脂肽。在某些优选实施例中,脂肽是表面活性素,其结构包含由七个氨基酸组成的肽环和长为13至15个碳的疏水脂肪酸链。有利的是,脂肪酸链可穿透细胞膜。在具体实施例中,氨基酸包含L-天冬氨酸、L-谷氨酸、两个L-亮氨酸、两个D-亮氨酸和L-缬氨酸。
在某些实施例中,脂肽为伊枯草素。伊枯草素具有构成肽部分的氨基酸残基和构成生物表面活性剂的疏水尾部的各种脂肪酸或脂肪酸衍生物。在优选实施例中,脂肽是伊枯草素A,其结构包含由七个氨基酸组成的肽环,这些氨基酸为两个D-天冬酰胺、L-天冬酰胺、D-酪氨酸、L-谷氨酰胺、L-脯氨酸和L-丝氨酸,以及其长度从14到17个碳不等的β-氨基脂肪酸链。
MEL、海藻糖脂、鼠李糖脂、槐糖脂、表面活性素或伊枯草素,或其任何组合优选地以治疗有效量存在于本佐剂组合物中。在一个实施例中,这意味着生物表面活性剂以临界胶团浓度(CMC)存在。CMC是表面活性剂的浓度,在此浓度以上会形成胶团,任何添加到组合物中的额外表面活性剂均会产生额外胶团或纳入现有胶团中。可作为药物递送系统的胶团或相关变体,例如脂质体、纳米颗粒或纳米乳剂液滴等对本发明的方法有利。
在某些实施例中,组合物中生物表面活性剂的治疗有效量按重量计为0.001wt%至90%(wt%),优选为50%或更少,更优选为25wt%或更少,甚至更优选为10wt%、8wt%、5wt%、4wt%、3wt%或2wt%或更少。在某些实施例中,生物表面活性剂的含量超过0.01%、0.02%、0.03%、0.05%、0.08%、0.1%、0.2%或0.5%。
一种或多种生物表面活性剂可以进一步地选自:生物表面活性剂的改性形式、衍生物、馏分、异构体或亚型,包括天然或人工改性形式。使用生物表面活性剂的不同异构体或形式是有益的,因为熟练的技术人员可根据其与特定药物的相互作用来定制佐剂组合物。也就是说,由于化合物的化学结构等原因,某种生物表面活性剂的某种异构体可能对某种药物更有效。
在一些实施例中,治疗组合物包含与活性成分预混合的佐剂成分。或者,佐剂成分可与活性成分分开,其中佐剂成分旨在与活性成分同时施用(例如,在活性成分之前或之后1、5、10、15、30或60分钟或更短)。
在一个实施例中,佐剂成分被配制成药物化合物的递送系统,其中佐剂成分的生物表面活性剂形成脂质体、纳米胶囊、微乳液滴、胶团或其他药物化合物被包裹在其中的基于生物表面活性剂的递送系统。在一个实施例中,可包括额外的生物聚合物,以便为基于生物表面活性剂的递送系统提供进一步结构。
基于生物表面活性剂的递送系统可通过多种方式提高药物化合物的生物利用度、稳定性和/或定位。在某些实施例中,递送系统保护药物化合物不受血液中可能结合并阻止其到达目标部位的成分影响。在其他实施例中,递送系统通过影响P-gp所在膜或阻止P-gp识别药物作为底物而抑制P-gp向化合物分泌。此外,在某些实施例中,递送系统可以延长药物化合物的半衰期,否则这些药物化合物可能会被酸或酶降解。由于其对酸或酶形成了一个屏障,可促进药物化合物的施用。进一步地,在一些实施例中,递送系统制剂允许药物定时释放,从而减少药物在受试者中的潜在毒性或副作用和/或减少必须施用的剂量数量。
在一个实施例中,本治疗组合物被配制成口溶食用产品,例如,食品、胶囊、药丸或可饮用液体。口服递送药物是指通过在胃肠道或口腔粘膜中初步吸收而递送的任何药物。本组合物也可以配制成可通过例如注射施用的溶液,其中包括静脉注射、腹腔注射、肌肉注射、肝内注射或皮下注射。在其他实施例中,本组合物被配制成通过皮肤贴片或直接在皮肤上施用产生局部或全身效果。这些组合物可通过舌下、口腔、直肠或阴道方式施用。进一步地,组合物可喷入鼻腔通过鼻膜吸收,进行雾化,通过口或鼻吸入,或在眼睛或耳朵内施用。
根据本发明的口溶食用产品是任何适合于消耗、营养、口腔卫生或愉悦的制剂或组合物,用于进入人类或动物口腔停留一段时间后,要么被吞咽(例如,即食食物或药丸),要么再次从口腔中取出(例如,口香糖或口腔卫生产品或医用漱口水)。虽然口服递送药物可以配制成口服产品,而口溶食用产品可以包含口服递送药物,但这两个术语在本文中并不意味着可以互换使用。
口溶食用产品包括拟由人类或动物摄取的所有加工、半加工或未加工状态物质或产品。这也包括在生产、处理或加工过程中添加到口溶食用产品(特别是食品和药品)中并用于进入人类或动物口腔的物质。
口溶食用产品也可以包括用于人类或动物吞食,然后在未改性、未制备或未加工的状态下被消化的物质;因此,根据本发明的口溶食用产品也包括旨在与产品一起吞食或预计要吞食的外壳、涂层或其他封装物。
在一个实施例中,口溶食用产品是含有所需口服物质的胶囊、药片、糖浆、乳剂或液体悬浮液。在一个实施例中,口溶食用产品可以包含粉末状口服物质,它可与水或其他液体混合产生可饮用口溶食用产品。
在一些实施例中,根据本发明的口溶食用产品可以包含一种或多种营养或愉悦制剂。这些产品特别包括烘焙产品(如面包、干饼干、蛋糕和其他糕点)、糖果(如巧克力、巧克力棒产品、其他棒状产品、果胶、涂层片、硬糖、太妃糖和焦糖以及口香糖)、酒精或非酒精饮料(如可可、咖啡、绿茶、红茶、富含绿茶或红茶提取物的红茶或绿茶饮料、南非博士茶、其他草药茶、含水果柠檬水、等渗饮料、软饮料、花蜜、水果和蔬菜汁,以及水果或蔬菜汁制剂),速溶饮料(如速溶可可饮料、速溶茶饮料和速溶咖啡饮料),肉制品(如火腿、新鲜或生香肠制剂,以及调味或腌制的新鲜肉或咸肉制品),蛋或蛋制品(如干全蛋、蛋白和蛋黄),谷类制品(如早餐谷类、麦片棒和预煮速食米制品),奶制品(如全脂或减脂或脱脂牛奶饮料、大米布丁、酸奶、酸乳酪、硬奶酪、干奶粉、乳清、黄油、酪乳以及含有牛奶蛋白的部分或全部水解产品),由大豆蛋白或其他大豆馏分制成的产品(如豆奶及其制备的产品、含有分离或酶处理的大豆蛋白的饮料、含有大豆粉的饮料、含有大豆卵磷脂的制剂、发酵产品(如豆腐或豆豉)及其制备的产品和与水果制剂的混合物,以及可选地,调味物质)、水果制剂(如果酱、水果冰淇淋、水果酱和水果馅),蔬菜制剂(如番茄酱、酱汁、干菜、深冻蔬菜、预煮蔬菜和水煮蔬菜),零食制品(如烘烤或油炸的薯片(脆片)或基于玉米或花生的马铃薯面团产品和挤出物),基于脂肪和油或其乳剂的产品(如蛋黄酱、蛋黄酱和调味品),其他现成膳食和汤类(如干汤、速食汤和预煮汤)、调味品(例如,撒上调味品)、甜味剂组合物(例如,片剂、袋装和其他甜化或美白饮料或其他食品的制剂)。本组合物也可作为半成品,其用于生产其他旨在实现营养或愉悦的组合物。
在某些实施例中,受试者的治疗组合物可进一步包含一种或多种药学上可接受的载体和/或赋形剂,并可配制成制剂,例如固体、半固体、液体或气态形式制剂,诸如片剂、胶囊、粉末、颗粒、软膏、溶液、栓剂、注射剂、吸入剂和气雾剂等等。
本文所用术语“药学上可接受的”是指与药物组合物的其他成分兼容,并且对接受者无害。
根据本发明的载体和/或赋形剂可以包括任何及所有溶剂、稀释剂、缓冲剂(例如,中性缓冲盐水、磷酸盐缓冲盐水、或可选地三羟甲基氨基甲烷盐酸盐、乙酸盐或磷酸盐缓冲剂)、水包油或油包水乳剂、水性组合物、包括或不包括适合例如血管内超声弹性成像的有机辅助溶剂、增溶剂(如聚山梨酯65,聚山梨酯80)、胶体、分散介质、载体、填料、螯合剂(如EDTA或谷胱甘肽)、氨基酸(如甘氨酸)、蛋白质、崩解剂、粘合剂、润滑剂、润湿剂、乳化剂、甜味剂、着色剂、调味剂、芳香剂、增稠剂(如卡波姆、明胶或海藻酸钠)、涂层、防腐剂(如硫柳汞、苯甲醇、聚季铵)、抗氧化剂(如抗坏血酸、焦亚硫酸钠)、补液控制剂、吸收延迟剂、佐剂、膨胀剂(如乳糖、甘露醇)等。在药物和补充剂领域使用载体和/或赋形剂是众所周知的。除了任何与目标健康促进物质或与佐剂组合物不相容的常规介质或制剂,可以考虑在本组合物中使用载体或赋形剂。
在一个实施例中,治疗组合物可被制成气雾制剂,以便例如可以雾化或吸入。适合以气雾剂或喷雾剂形式施用的制剂是例如粉末、颗粒、溶液、悬浮液或乳剂等。用于口服或鼻腔气雾或吸入施用的制剂也可以用载体配制,包括例如生理盐水、聚乙二醇或乙二醇、DPPC、甲基纤维素,或与粉状分散剂或碳氟化合物混合使用。气雾剂可放入加压推进剂,诸如二氯二氟甲烷、丙烷、氮、碳氟化合物和/或本领域已知的其他增溶剂或分散剂。举例来说,可通过使用一次性递送装置、雾化器、呼吸激活粉末吸入器、喷雾式药剂定量吸入器(MDI)或本领域内现有的众多雾化器递送装置中的任何其他装置施用。此外,也可以使用喷雾帐篷或通过气管内导管直接施用。
在一个实施例中,治疗组合物可配制为例如溶液或悬浮液通过注射施用。溶液或悬浮液可以包含合适的无毒、胃肠外可接受稀释剂或溶剂,诸如甘露醇、1,3-丁二醇、水、林格氏溶液或生理盐溶液,或合适的分散剂或润湿和悬浮剂,诸如包括合成单或双甘油酯的无菌、无刺激的固定油,以及包括油酸的脂肪酸。静脉使用载体的一个示例包括10%的USP乙醇、40%的USP丙二醇或聚乙二醇600和其余的USP注射用水(WFI)的混合物。其他静脉注射的示例性载体包括10%的USP乙醇和USP WFI;USP WFI中的0.01-0.1%三乙醇胺;或USPWFI中的0.01-0.2%二棕榈酸磷脂酰胆碱;以及1-10%的角鲨烯或肠胃外植物油包水乳液。水或盐水溶液以及葡萄糖和甘油水溶液均可优选地用作载体,特别是注射溶液。皮下或肌肉注射载体的示例包括磷酸盐缓冲盐水(PBS)溶液、WFI中5%的葡萄糖和5%的葡萄糖或0.01-0.1%的三乙醇胺、0.9%的氯化钠,或10%的USP乙醇、40%的丙二醇和其余可接受等渗液(如5%的葡萄糖或0.9%的氯化钠)的1:2或1:4混合物;或USP WFI中0.01-0.2%的二棕榈酸磷脂酰胆碱和1-10%的角鲨烯或肠胃外植物油包水乳液。
在一个实施例中,治疗组合物可以配制成通过局部施用到皮肤上的施用方式,例如,作为局部组合物,其中包括冲洗、喷雾或滴剂、洗剂、凝胶、软膏、霜剂、泡沫、粉末、固体、海绵、胶带、蒸气、糊剂、酊剂,或使用透皮贴。合适外用制剂除了包含任何药物活性载体外,还可以包含润肤剂,例如棕榈蜡、十六烷基醇、十六烷基酯蜡、乳化蜡、水合羊毛脂、羊毛脂、羊毛脂醇、微晶蜡、石蜡、石腊、聚乙二醇、硬脂酸、硬脂醇、白蜂蜡或黄蜂蜡。此外,组合物可包含保湿剂,诸如甘油、丙二醇、聚乙二醇、山梨醇溶液和1,2,6六醇等,或渗透促进剂,诸如乙醇、异丙醇或油酸等。
在某些实施例中,使用本组合物中生物表面活性剂,减少药物化合物有效所需的化学表面活性剂(如十二烷基硫酸钠)的量。在一些实施例中,使用生物表面活性剂可以完全消除化学表面活性剂的使用。
在某些实施例中,在本组合物中使用生物表面活性剂可以增加药物化合物的施用前稳定性,从而降低在受试者施用之前运输和储存组合物的健全冷链需求。该组合物可以在-20℃和4℃之间的温度下、约4℃的温度下、4℃和室温之间的温度下、约室温的温度下或高于室温但低于37℃的温度下储存更长的时间。
在一些实施例中,在本组合物中使用生物表面活性剂可以增加药物对紫外光降解的抗性。例如,莫西沙星与其他氟喹诺酮类和四环素类一样,在储存过程中对紫外线照射很敏感。当暴露于紫外光时,活性化合物可根据紫外光强度、暴露时间和组合物中伴随的化学物质进行部分或全部降解。
如本领域技术人员所确定的,可向组合物中加入其它成分,例如,缓冲剂、载体、粘度调节剂、防腐剂、调味剂、染料和其它特定预期用途的成分。本领域技术人员将意识到,以上描述是说明性描述,而非穷尽性描述。事实上,本领域技术人员熟知许多其他制剂技术和药学上可接受的赋形剂和载体溶液适用于特定施用模式。
增强复方保健品功效的方法
本发明进一步提供了一种方法,用于在需要其的受试者中增强药物化合物的生物利用度、稳定性和/或定位,其中,所述药物化合物作为根据本发明的治疗组合物的一部分向受试者施用。在某些实施例中,该方法还可用于缩小药物化合物的使其具有治疗效果所必需的单位剂量施用体积。
在一些实施例中,生物利用度可定义为药物进入体循环不变的比例。在优选实施例中,通过施用药物治疗有效量的根据本发明的佐剂组合物来提高药物的生物利用度。
药物化合物可与佐剂成分一起施用,例如作为单一预混合组合物的一部分。或者,药物化合物可与佐剂成分分开施用。在该可选实施例中,在施用佐剂组合物之前或之后立即施用药物化合物,其中“之前立即”或“之后立即”是指施用药物之前或之后60分钟、30分钟、15分钟、10分钟、5分钟、4分钟、3分钟、2分钟、1分钟、30秒或更短时间。
在优选实施例中,佐剂组合物的生物表面活性剂选自例如糖脂、脂肽及其任何改性形式、衍生物、片段、异构体或亚型。还对生物表面活性剂及其各种形式的组合进行了设想。
如本文所用,“施用”组合物是指将其递送至受试者,使其接触该组合物可对该目标或部位产生药效的目标或部位。该药效可以是,例如,由于药物化合物的作用,由于生物表面活性剂组合物,或由于生物表面活性剂和药物化合物的联合作用产生的药效。施用可以是急性或慢性施用方式(例如,每小时、每天、每周、每月等),也可与其他药剂联合施用。本组合物只要是通过这种途径配制,均可以通过任何施用途径施用。因此,本发明的方法和组合物能达到的治疗效果根据本发明的特定应用需要,可以是例如,全身性治疗效果、局部治疗效果、组织特异性治疗效果等。
在某些实施例中,这些方法提高了药物在水溶液中的溶解度,以便给受试者施用。在示例性实施例中,可溶于浓度低于10mg/ml的药物特别值得关注。这些药物包括,例如,阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、厄洛替尼、阿司匹林、萘普生、布洛芬、硝唑尼特、睾酮、西地那非、伐地那非、他达拉非、茚地那韦,或这些药物的任何替代形式。可替代形式可以包含,例如,各种市场上销售的睾酮形式,包括未经改性的睾酮和睾酮酯,诸如环戊丙酸睾酮和丙酸睾酮。通过向受试者施用治疗有效剂量的药物和溶解度增强生物表面活性剂,每单位剂量可递送更多药物。此外,由于溶解度增加,药物可更易于进入循环系统而不被排除或发生结晶。
在某些实施例中,该方法可经由受试者的上皮组织使某些药物的膜渗透潜力增强,例如,来那度胺、醋酸阿比特龙、卡培他滨、二甲双胍、硝唑尼特,或其任何替代形式。施用本治疗组合物有利于药物转移,例如,从胃肠道转移到循环系统。
在某些实施例中,该方法可导致某些药物从循环系统通过血脑屏障或血睾屏障的转移增加,例如,硼替佐米、来那度胺、多奈哌齐、硝唑尼特、伐尼克兰、西地那非、伐地那非、他达拉非、茚地那韦或其任何替代形式。西地那非已被证明是大脑中的磷酸二酯酶5抑制剂,采用这种药物治疗可能会限制阿尔茨海默病造成的影响。睾丸和大脑可为病毒库,包括逆转录病毒。随着通过这些屏障的渗透性增强,茚地那韦可以消除病毒,西地那非可以增强大脑功能。
在某些实施例中,该方法可导致某些药物的消除半衰期增加,例如,克林霉素、卡培他滨、二甲双胍、硝唑尼特、茚地那韦或其在受试者体内的任何替代物。这些药物在人体中的消除半衰期从33分钟到8.7小时不等,因此必须每天施用1到4次。由生物表面活性剂在施用组合物中产生的胶团可具有多种增加消除半衰期的机制,包括但不限于增加药物的溶解度、提高药物的渗透性以及通过在胶团或其他相关生物表面活性剂聚集体中递送药物来延长药物的递送。此类和其他机制均可以组合使用或单独使用,以延长药物的消除半衰期。
在某些实施例中,该方法可导致某些药物的施用剂量之间的时间增加,所述药物为例如达托霉素、克林霉素、阿奇霉素、莫西沙星、来那度胺、醋酸阿比特龙、卡培他滨、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、西地那非、伐地那非、他达拉非、茚地那韦或其任何替代形式。这些药物中的每一种均被规定或可被规定为每天服用一次以上。根据本发明,对受试者施用这些药物的方法可以通过将药物包封在生物表面活性剂聚集体中来延长两次施用之间的时间。在给受试者施用后,生物表面活性剂在受试者体内的浓度逐渐降低。随着相对生物表面活性剂浓度降低至CMC且最终低于CMC,则药物稳定释放。这种药物释放方式比传统的“一次性全部”施用方式更慢,有助于减少每种药物的施用频率。
在某些实施例中,在将佐剂成分与药物一起施用时,该方法可抑制受试者分泌系统,所述药物为例如达托霉素、克林霉素、莫西沙星、硼替佐米、来那度胺、卡培他滨、阿霉素、厄洛替尼、西地那非、伐地那非、他达拉非、茚地那韦或其任何替代形式。P-gp是可以被根据本发明的生物表面活性剂组合物抑制的分泌系统。生物表面活性剂可以改变受试者的膜脂,从而对依赖完整稳定细胞膜的P-gp功能造成影响。在一些实施例中,将生物表面活性剂与药物一起施用的效果不仅限于P-gp抑制,还可能导致可逆抑制。
在某些实施例中,所述方法可导致潜伏期缩短,从而在脑脊液中达到某些药物的最大浓度,例如多奈哌齐或其任何替代形式。生物表面活性剂可促进药物在受试者脑脊液中的累积速率增加,也可促进持续浓度增加。受试者先前的最大脑脊液浓度可能需要2年的时间才能通过施用普通药物达到。
本发明中举例说明的每种药物均有预期用途;然而,新增研究会经常改变或增加最初所需的治疗目的。由于对FDA批准药物的再利用研究,本公开中举例说明的治疗实例是非限制性实例。达托霉素、克林霉素、阿奇霉素和莫西沙星均为抗生素化合物。克林霉素和阿奇霉素通过结合50S rRNA抑制蛋白质合成。达托霉素破坏细菌细胞膜中带负电荷的磷脂。莫西沙星抑制DNA回旋酶和拓扑异构酶。目前正在研究阿奇霉素作为抗疟药的用途。硼替佐米、来那度胺、醋酸阿比特龙、卡培他滨、阿霉素和厄洛替尼均为抗癌药物。培非格司亭经常与抗癌治疗一起施用,以刺激骨髓产生更多的中性粒细胞。此外,硼替佐米可用于治疗系统性红斑狼疮,厄洛替尼已被用作抗病毒药。阿司匹林、萘普生和布洛芬是通过抑制环氧化酶来治疗疼痛和发热的非甾体类抗炎药(NSAID)。阿司匹林经常被用来预防心血管疾病。阿司匹林和布洛芬均具有间接抗菌特性。二甲双胍用于治疗2型糖尿病和多囊卵巢综合征,最近它还被证实可用于治疗多种皮肤病,包括痤疮和银屑病。多奈哌齐用于治疗阿尔茨海默病,最近还被证实可用于治疗多发性硬化症。硝唑尼特是一种也可以抑制胶质母细胞瘤的抗寄生虫药物。伐尼克兰是烟碱型乙酰胆碱受体的激动剂,其可改善与衰老和精神分裂症相关的认知能力。睾酮用于治疗男性性腺功能减退症和某些乳腺癌。西地那非、伐地那非和他达拉非均为治疗勃起功能障碍和肺动脉高压的药物。已经证实他达拉非还治疗良性前列腺增生、逆转肿瘤特异性免疫抑制,并抑制P-gp中的P-gp过度合成癌细胞。西地那非还抑制癌细胞中的P-gp分泌,并已被用于利用阿霉素治疗乳腺癌,抑制结直肠癌细胞,同时还是大脑中的磷酸二酯酶抑制剂。茚地那韦是一种抗逆转录病毒药物,其也可用于治疗埃博拉病毒感染。
Claims (38)
1.一种包含活性成分和佐剂成分的组合物,所述活性成分包含药物化合物、维生素、矿物质、补充剂、酶和/或草药提取物;
其中所述佐剂成分包含增效量的生物表面活性剂;和
其中,与包含所述相同活性成分而不含所述佐剂成分的组合物相比,所述活性成分的生物利用度、定位和/或稳定性得以增强。
2.根据权利要求1所述的组合物,其进一步包含药学上可接受的载体。
3.根据权利要求1所述的组合物,其中,所述生物表面活性剂选自脂肽和糖脂。
4.根据权利要求3所述的组合物,其中,所述糖脂选自槐糖脂、鼠李糖脂、海藻糖脂、纤维二糖脂和甘露糖赤藓糖醇脂。
5.根据权利要求3所述的组合物,其中,所述脂肽选自表面活性素、伊枯草素、地衣素和丰原素。
6.根据权利要求1所述的组合物,其中,生物表面活性剂以临界胶团浓度CMC存在。
7.根据权利要求1所述的组合物,所述组合物被配制成通过选自口服、注射、直肠、阴道、眼、耳、鼻、粘膜、吸入、雾化和皮肤的施用途径向受试者施用。
8.根据权利要求1所述的组合物,所述组合物被配制成生物表面活性剂递送系统,其中所述药物被封装在生物表面活性剂颗粒中。
9.根据权利要求1所述的组合物,其中,所述活性成分包含选自达托霉素、克林霉素、阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、培非格司亭、卡培他滨、阿霉素、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、睾酮、西地那非、伐地那非、他达拉非和茚地那韦的制药或OTC药物化合物。
10.根据权利要求1所述的组合物,其中,所述活性成分包含选自维生素A、维生素D、维生素E和维生素K的维生素。
11.根据权利要求1所述的组合物,其中,所述活性成分包含大麻二酚。
12.根据权利要求1所述的组合物,其中,所述活性成分包含选自CoQ10和纳豆激酶的酶。
13.一种增强选自药物化合物、维生素、矿物质、补充剂、酶和草药提取物的活性成分的生物利用度、稳定性和/或定位的方法,所述方法包括将治疗有效量的所述活性成分与包含生物表面活性剂的佐剂成分同时或依次向受试者施用。
14.根据权利要求13所述的方法,其中,所述活性成分的溶解度增加。
15.根据权利要求13所述的方法,其中,所述活性成分穿过上皮组织、血脑屏障和/或血睾屏障的运动得以改善。
16.根据权利要求13所述的方法,其中,所述活性成分的消除半衰期被增强。
17.根据权利要求13所述的方法,其中,所述活性成分在所述受试者体内的长效释放时间延长。
18.根据权利要求13所述的方法,其中,用于使所述活性成分达到最大治疗浓度的潜伏期被缩短。
19.根据权利要求13所述的方法,其中,分泌所述活性成分的分泌系统被抑制。
20.根据权利要求13所述的方法,其中,所述受试者有效治疗所需的所述活性成分的总质量减少或总体积缩小。
21.根据权利要求13所述的方法,其中,所述受试者体内发生的活性成分化学和/或结构改性被减少。
22.根据权利要求13所述的方法,其中,所述活性成分为选自达托霉素、克林霉素、阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、培非格司亭、卡培他滨、阿霉素、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、睾酮、西地那非、伐地那非、他达拉非和茚地那韦中的一种或多种的制药或OTC药物化合物。
23.根据权利要求22所述的方法,其中,所述阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、厄洛替尼、阿司匹林、萘普生、布洛芬、硝唑尼特、睾酮、西地那非、伐地那非、他达拉非和/或茚地那韦在待施用于所述受试者的制剂中的溶解度增加。
24.根据权利要求22所述的方法,其中,所述阿奇霉素、莫西沙星、硼替佐米、来那度胺、醋酸阿比特龙、厄洛替尼、阿司匹林、萘普生、布洛芬、硝唑尼特、睾酮、西地那非、伐地那非、他达拉非和/或茚地那韦在所述受试者的溶解度增加。
25.根据权利要求22所述的方法,其中,所述来那度胺、醋酸阿比特龙、卡培他滨、二甲双胍和/或硝唑尼特经由上皮组织到达所述受试者体循环的运动得以增强。
26.根据权利要求22所述的方法,其中,所述克林霉素、卡培他滨、二甲双胍、硝唑尼特和/或茚地那韦的消除半衰期被增强。
27.根据权利要求22所述的方法,其中,所述受试者体内的达托霉素、克林霉素、阿奇霉素、莫西沙星、来那度胺、醋酸阿比特龙、卡培他滨、厄洛替尼、阿司匹林、萘普生、布洛芬、二甲双胍、多奈哌齐、硝唑尼特、伐尼克兰、西地那非、伐地那非、他达拉非和/或茚地那韦释放时间被延长。
28.根据权利要求22所述的方法,其中,所述通过血脑屏障增强硼替佐米、来那度胺、多奈哌齐、硝唑尼特、伐尼克兰、西地那非、伐地那非、他达拉非和/或茚地那韦的运动。
29.根据权利要求22所述的方法,其中,所述茚地那韦或茚地那韦的任何替代形式的运动通过血睾屏障得以增强。
30.根据权利要求22所述的方法,其中,用于使在所述受试者脑脊液中多奈哌齐或多奈哌齐的任何替代形式达到最大治疗浓度的潜伏期被缩短。
31.根据权利要求13所述的方法,其中,所述活性成分为选自维生素A、维生素D、维生素E和维生素K的维生素。
32.根据权利要求13所述的方法,其中,所述活性成分为大麻二酚。
33.根据权利要求13所述的方法,其中,所述活性成分为选自CoQ10和纳豆激酶的酶。
34.根据权利要求13所述的方法,其中,使用生物表面活性剂作为佐剂成分减少或消除了在药物和补充剂制剂中使用化学表面活性剂的需要。
35.根据权利要求13所述的方法,其进一步包含在向所述受试者施用之前,将与所述佐剂成分混合的所述活性成分储存一段时间,其中所述活性成分的稳定性得以增强,使得所述活性成分在整个储存过程中和在向所述受试者施用后均保持治疗有效性。
36.根据权利要求35所述的方法,其中在-20℃和37℃之间的温度下储存时,稳定性增强。
37.根据权利要求35所述的方法,其中,通过增强所述活性成分的抗紫外光降解性来增强稳定性。
38.一种组合物,其包含药物化合物、维生素、矿物质、补充剂、酶或草药提取物和增效量的生物表面活性剂佐剂,其中与包含相同药物化合物、维生素、矿物质、补充剂、酶或草药提取物但不含生物表面活性剂佐剂的组合物相比,所述药物化合物、维生素、矿物质、补充剂、酶或草药提取物具有增强的生物利用度、定位和/或稳定性。
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- 2020-08-10 EP EP20852331.6A patent/EP4009954A4/en active Pending
- 2020-08-10 KR KR1020227006793A patent/KR20220045167A/ko unknown
- 2020-08-10 WO PCT/US2020/045587 patent/WO2021030250A1/en active Application Filing
- 2020-08-10 CA CA3147335A patent/CA3147335A1/en active Pending
- 2020-08-10 JP JP2022507907A patent/JP2022543695A/ja active Pending
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- 2020-08-10 US US17/634,172 patent/US20220313659A1/en active Pending
- 2020-08-10 CN CN202080070651.1A patent/CN114727956A/zh active Pending
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EP4009954A4 (en) | 2023-07-26 |
KR20220045167A (ko) | 2022-04-12 |
EP4009954A1 (en) | 2022-06-15 |
MX2022001802A (es) | 2022-03-11 |
CA3147335A1 (en) | 2021-02-18 |
JP2022543695A (ja) | 2022-10-13 |
US20220313659A1 (en) | 2022-10-06 |
WO2021030250A1 (en) | 2021-02-18 |
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