CN110869005A - 含有药物活性成分或饮食补充剂的增溶剂的分配胶囊 - Google Patents
含有药物活性成分或饮食补充剂的增溶剂的分配胶囊 Download PDFInfo
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- CN110869005A CN110869005A CN201880024507.7A CN201880024507A CN110869005A CN 110869005 A CN110869005 A CN 110869005A CN 201880024507 A CN201880024507 A CN 201880024507A CN 110869005 A CN110869005 A CN 110869005A
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- solubilizate
- dispensing capsule
- dispensing
- pharmaceutically active
- capsule
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- QYNMSPKSYXPZHG-UHFFFAOYSA-M sodium;4-ethoxycarbonylphenolate Chemical compound [Na+].CCOC(=O)C1=CC=C([O-])C=C1 QYNMSPKSYXPZHG-UHFFFAOYSA-M 0.000 description 1
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 description 1
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Abstract
本发明涉及一种用于分配流体增溶物的分配囊,一种使用这种分配囊的饮料系统以及一种借助这种饮料系统制备饮料的方法。水溶性差的膳食补充剂或药物活性剂可以用这种新剂型供给,以增加这些物质的生物利用度。增溶物不含聚山梨酯。
Description
本专利申请涉及一种增溶剂分配囊,用于增加药物活性剂或饮食补充剂的溶解度,公开了合适的分配囊和用于生产这种增溶剂的技术。进一步地,本专利申请还涉及一种含有这种分配囊的饮料系统。
已知各种各样的物质,已经在体外实验中发现了对人体健康有潜在有益作用的物质。然而,由于现有技术中已知的施用形式可实现的生物利用度差,严重限制了其中许多药物的使用。在药理学中,生物利用度是一个参数,它指示最终在全身循环中可用的未改变药物的给药剂量分数,因此可以提供所需的药理作用。这种不良的生物利用度通常是由于不良的水溶性,或者是由于要施用的活性剂的亲脂性。因此,当使用标准剂型时,这种物质作为药物活性剂或膳食补充剂的使用受到损害。
有多种方法可提高此类药物的溶解度,在许多情况下,还可以通过使用特定的增溶技术来提高其生物利用度。此处,通过添加第三种物质可提高药物在介质中的溶解度。作为增溶剂(增溶剂),例如可以与要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,增溶剂的另一种作用机理是增加了溶剂的溶解能力。例如,通过破坏水的团簇结构,这种结构破坏剂的实例是甘油(甘油)和大分子醇(聚乙二醇,PEG)。
第三种增溶机理是胶束和脂质体施用技术。在过去的几十年中,它们得到了广泛的关注。在此,待输送的物质被封闭在表面活性剂分子的球形聚集体中。这些分子的特征是极性头基和长的非极性链(“尾部”),当将它们引入水性介质时,这些分子倾向于通过将极性头基朝向周围介质和非极性分子定向聚集成球形结构而缔合。当这些球仅由一层这样的两亲分子组成时,它们称为胶束。根据两亲分子的性质和反应条件,也可以形成一个以上的球这里,在球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,而极性头基团朝向球的内部取向。在结构上,它们类似于细胞膜的脂质双层。通常相同或结构相关的成分是如从细胞膜已知的用于脂质体的脂质体,因此表现出相似的物理化学性质。还存在多层脂质体,其中至少两个脂质体球彼此形成,从而形成多球形聚集体。当在亲脂性介质中给予这些物质时,这些物质趋于建立倒球形结构,其中亲脂性链朝向溶液介质取向,并且其他层相应地排列。
长期以来已知将物质封闭在这种球形结构内是可能的。此类负载球的不同用途已在本领域中描述,其中它们用作用于施用亲脂性物质和/或用于增加封闭物质的生物利用度的剂型。在胶束中,封闭的非极性物质集中在两亲分子非极性链所朝向的球的内部空间中。然而,在脂质体中,球的内部空间是水性或亲水性介质。它可以用于包装亲水分子。然而,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。
从经验的药代动力学测量得知,胶束以及脂质体在胃肠道中从生物体中被吸收得相对较高,特别是从肠绒毛中吸收。因此,填充在这种球形聚集物中的物质被更高程度地吸收到全身血流中,通过不同的生理和非生理机制,一定百分比的封闭物质被释放到全身血流中。因此,该物质具有生物利用性,并可以在生物体内发挥作用。如果需要,它可以通过细胞膜被运输到细胞内部。每种物质在细胞膜上的迁移或吸收速率是每种物质的固有特征,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是否存在合适的转运蛋白分子。通常,由于细胞膜脂质双层的亲脂性,亲脂性物质更容易在细胞膜上运输。从脂质体中,还已知它们能够通过内陷与细胞膜融合,从而将封闭的物质以相当大的程度输送到细胞质中。某些细胞类型,特别是吞噬细胞,例如巨噬细胞,单核细胞和嗜中性粒细胞,优选摄入脂质体,然后脂质体可能会进行代谢消化,从而将封闭的物质递送至这些细胞。
脂质体的应用已在医学和药理学中得到广泛讨论,并且已开发出许多用于生产脂质体的先进技术。但是,它们的用法不是很常见。一个原因是相对较高的生产成本,另一个原因是可能的不利副作用。特别地,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。口服剂型很少发生该问题。
自乳化药物递送系统(SEDDS)是增溶亲脂性化合物的另一种方法。它们过去是油,表面活性剂,溶剂和可选的助溶剂的各向同性混合物。取决于所使用的组分,它们可以在水稀释和任选地温和搅拌下形成增溶剂或稳定的水包油(o/w)乳液。
另一种增溶技术是形成要与环糊精如α-,β-或γ-环糊精或环糊精衍生物如2-羟丙基-β-环糊精,甲基-β-环糊精或三甲基-β-环糊精。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形(分别为圆锥形或桶形)结构。内部空间的亲水性比外部接触水性环境的亲水性小。环糊精通过酶处理从淀粉生产。它们通过分散过程,装载需要增溶的化合物。然后可以通过使这些络合物与水接触,通过pH或温度变化(这取决于具体的组成)来释放待溶解的化合物。环糊精可用于膳食补充剂(例如,德国Wacker Chemie的)或用于药物递送(例如,用于双氯芬酸(EP 0 658 347 A2)或克拉霉素(Allsopp,(2013年),《开发可溶性大环内酯制剂并确定其潜在的益处慢性鼻-鼻窦炎》,昆士兰大学,医学博士论文(MPhil Thesis,University of Queensland))。如果待溶解的化合物在一定的最终浓度以上会发生重结晶,则通常要加入乳化剂,例如聚山梨酯(例如20;EP 1 609 481 A1)。
在US 2013/150396 A1,EP 2468111 A1和US 2003/091627 A1中公开了增溶的膳食补充剂和/或药物活性剂的实例。拜耳澳大利亚公司提供一种基于维生素的膳食补充剂,包装在带有分装囊的塑料罐中,分装囊装有泡腾片,该泡腾片可以释放到容器的液体中(Performance)。它使用聚山梨酯60作为乳化剂。类似的系统,在Kello的文章(JCritical Reviews,2016,3,6-10)中也有描述;其中将水溶性维生素/矿物质组合物包装在VPTC分配囊中,可以用相应容器中的液体溶解。分配囊中的所含的制剂可以以干燥的形式或溶解在液体(稀释剂)中。该配方使用吐温80作为乳化剂。
US 2017/0000741 A1公开了一种具有分配囊的液体容纳容器。分配囊中含有用于医疗目的的微囊可以用容器内的液体溶解。所述微胶囊,使用水包油乳液制备。
EP 2894110 A1公开了一种具有不可渗透的分配室的分配囊,包含粉末,颗粒或小丸形式的饮食维生素组合物,当其放入到具有可饮用液体的容器时,可溶解在其中。
通常,水溶性差的物质通过诸如聚山梨酸酯的增溶剂来增溶。例如,广泛使用的是聚山梨酯20、40、60、65或80。到目前为止,该技术已用于生产口香糖,在食品工业中用作乳化剂,并用于某些肠胃外药物制剂。但是,关于聚山梨酯对健康的有害影响一直存在争议。聚山梨酯20被认为含有未反应的1,4-二恶烷和环氧乙烷污染(至少是来自某些供应商的产品)。这些是已知的可透过皮肤的致癌物质(参见截至2017年6月7日的httpz://www.fda.qov/ohrms/dockets/98fr/060199a.txt)。最近发现,Polysorbate-80对鼠肠道菌群有有害作用,从而促进了肥胖症和炎性肠病(Chassaing等人,Nature,2015,519,92-96)。基于聚山梨酯的溶液的另一个问题是它们的肥皂味。这使得它们对膳食补充剂和口服液体药物没有吸引力,并导致其在兽药中的使用困难。一项研究也引起了人们的关注,即聚山梨酯80可能会降低大鼠的生育能力(Gajdova等人,Food Chem Toxicol,1993,31,183-190)。因此,使用增溶技术用于水溶性差的物质时,理想的情况是采用合适的口服剂型且不含聚山梨酯的组成。
通常,如果增溶剂需要与稀释剂混合,则不很理想。它通常被认为很劳烦,特别是当混合操作花费时间或终饮料需要搅拌或搅动。一个主要问题是这种方法的吸引力,特别是当饮料不是由医务人员而是由消费者或患者本人来制备时。消费者非常喜欢快速的制备方法和易于处理的方法。例如,尽管如今是相对安全的,但要自己打开安瓿瓶许多消费者和患者会产生强烈的不安。在用药的情况下,这通常可能导致患者依从性差,从而导致随之而来的问题。此外,混合过程常常不充分,因而可能导致饮料和/或液体药剂的溶解性差。另一个方面是,增溶过程通常会导致由于增溶剂(或其他浓缩物)的不完全溶解而引起的斑马效应或条纹现象。摄入这样的饮料不是特别有吸引力。
因此,需要有可以克服上述问题的新的或可替代的剂型,用于饮食补充剂或药物活性剂的增溶剂。
因此,本发明的目的是提供一种满足以下标准的消费者友好且安全的液体口服剂型,适用于食品添加剂或药物活性剂:
·易于处理
·易于生产
·耐受良好的增溶剂,优选具有额外的营养和/或健康益处
·不需要昂贵的设备
·廉价的材料和生产成本
·适用于各种水溶性差的药物活性剂
·不需要添加Tween增溶剂。
发明内容
令人惊讶地,本发明发现含有增溶剂的分配囊能够解决上述问题。因此,本发明涉及一种分配囊,该分配囊包含至少一种药物活性剂和/或膳食补充剂的增溶剂。本发明公开了一种分配囊,其具有至少一个可填充腔室,该可填充腔室包含至少一种药物活性剂和/或膳食补充剂的增溶剂,其中该分配囊被适当地配置为安装在饮料容器的出口处,并且可通过操作分配囊的释放机构将增溶剂释放到饮料容器中。所述增溶剂含有已溶解在内的至少一种药物活性剂和/或膳食补充剂,其不含聚山梨酯,不用稀释剂,在室温下为流体。特别地,本发明涉及一种包含至少一种药物活性剂和/或饮食补充剂的增溶剂的分配囊,其中增溶剂是由至少一种水溶性差的物质或提取物制备的。
增溶主要是针对水溶性差的药物活性剂或膳食补充剂。然而,在本发明的另一方面,水溶性药物活性剂或饮食补充剂也可以通过本发明的增溶方法之一溶解并包装在根据本发明的分配囊中。取决于不同的化合物,这可以增加其吸收和/或生物利用度。
优选地,所述增溶剂通过胶束,脂质体,自乳化或环糊精络合技术制备。
分配囊是饮料容器的封闭件,其易于将其内容物释放到饮料容器内部的液体中。它们具有一个用于储存待释放内容物的腔室,在一个常见实施例中,消费者必须推下分配囊表面上的柱塞,柱塞直接驱动一个锋利的工具,该工具刺穿将分配囊腔室与饮料容器内的液体分隔开的膜,从而使该腔室中的内容物释放到饮料中。分配囊的一些实施例将分配囊的存储选项与运动饮料的饮用舒适性相结合。在此,所谓的推拉机构与分配囊结合。此机制也称为运动帽系统(sports cap system)。在推下所述柱塞之后,分配囊的一个组合部件被拉回并变成壶嘴,从而能够从瓶中进行受控饮用并在其后重新封闭。先进的分配囊可以包括一个以上的腔室,用于储存要释放的不同物质。在释放到饮用液体中之后,这些物质至少被部分溶解。因此,可以防止在水性环境中过早发生氧化,光或热降解。
然而,新鲜制剂不能自动确保高生物利用度。在药物活性剂或膳食补充剂通过肠道的过程中,其吸收速率有限,常常会妨碍所需的效果。相当一部分特定物质没有被吸收就通过了肠道,或者吸收时间延长,因此无法达到特定的生理有效性需要的第一峰浓度。当涉及到旨在使几种物质同时达到峰值时,(为了寻求互补作用或叠加作用),设置就变得更加复杂。
因此,本发明专利的目的是提供在饮用水中的水溶性差的药物活性剂或饮食补充剂的新鲜制剂。理想地,该剂型导致该物质的生物利用度显着提高。
令人惊讶地发现,该目的可以通过本发明的分配囊解决。下文和权利要求将进一步描述有利的实施例。
根据本发明的分配囊必须具有至少一个腔室,该腔室可以填充有至少一种药物活性剂或饮食补充剂的增溶剂。默认情况下,该至少一个腔室与饮料容器的内部分隔开,所述增溶剂将被释放到其中。所述增溶剂可以通过两种主要的机制,从分配囊的至少一个腔室释放到饮料容器内的可饮用液体中。
首先,分配囊有一可移动部件,其由分配囊的释放机构操控。它的移动,使得至少一种补充剂释放。例如,这可以通过折叠机制,倾斜机制,活板门机制,枢转锁定机制,隔膜(孔)机制,输送机机制,螺旋输送机机制。在被触发时,这种机制可以允许在时间和/或空间上限制释放或无限释放至少一种补充剂。这种释放机构的优点是可以有重新填充的选项,即用相同或另一种增溶剂重新填充分配囊的至少一个腔室。在本专利的范围内,这种分配囊将被称为触发器释放型分配囊。
第二种分离类型包括至少一个膜,隔膜,薄膜或密封箔,其完全跨在分配囊的至少一个腔室和饮料容器的内部之间,从而将这两者室完全分开。它必须可穿孔和/或可拆卸地连接到分配囊分配室底侧的边缘。该膜,隔膜,薄膜或密封箔足以承受增溶剂的重量而不会过早破裂。另外,例如当用作运动饮料的一部分时,它还必须承受容器的正常运输运动或轻微到中等的振动,震荡或搅动。为了释放溶解剂,该膜,隔膜,膜或密封箔片需有由锋利的切割工具或冲孔器,刺穿或切割而产生开口,该开口允许在时间和/或空间上控制增溶剂的释放或即刻完全释放。这和方法的优点是可溶物与氧气,湿气,光,紫外线辐射和/或热有更好地隔离。在本专利的范围内,这种分配囊将被称为密封型分配囊。
因此,本发明还涉及一种分配囊,其中,所述分配囊选自触发器释放型分配囊和密封型分配囊。
在优选的实施方式中,选择适合的膜,隔膜,膜或密封箔与切割工具的组合,以确保几乎没有碎屑进入饮料容器的可饮用液体或污染要释放的可溶物。在另一优选实施例中,所述膜,隔膜,薄膜或密封箔片带有刺穿线,从而方便在操作所述切割工具时实现受控的切割。
所述膜,隔膜,膜或密封箔片可以由金属(例如铝箔,锡箔,银箔,金箔,铜箔),聚合物(例如聚烯烃,聚乙烯,聚丙烯,聚氯乙烯,聚苯乙烯,聚碳酸酯,玻璃纸,纤维素酯(例如醋酸纤维素和硝化纤维素),聚乳酸,聚酯,尤其是聚羟基链烷酸酯,例如聚3-羟基丁酸酯,聚羟基戊酸酯和聚羟基己酸酯,聚酰胺11,聚对苯二甲酸乙二醇酯,淀粉共混物,封口膜),金属塑料复合材料,纸(例如书写纸,卷纸,香蕉纸,防水纸,羊皮纸,防油纸,蜡纸,硬纸板,包装纸),橡胶塞(例如在现行药典中规范化的)或源自上述材料的复合材料(例如blisters)。
在优选的实施方案中,金属箔的厚度小于20μm,更优选小于18μm,最优选小于15μm。
在优选的实施方案中,金属箔的极限拉伸强度在20-220N/mm2的范围内,更优选在30-160N/mm2的范围内,甚至更优选在40-125N/mm2的范围内,最优选在45-95N/mm2的范围内。
在优选的实施方案中,基于聚合物的箔的厚度小于100μm,更优选小于80μm,最优选小于50μm。
在优选的实施方案中,基于聚合物的箔的极限拉伸强度在20-300N/mm2的范围内,更优选在40-250N/mm2之间,甚至更优选在60-200N/mm2之间,最优选在80-180N/mm2之间。
在优选的实施方案中,所述纸的厚度小于200μm,更优选小于160μm,最优选小于120μm。
在优选的实施方案中,所述纸的破裂强度为100-700KPa,更优选为150-500KPa,甚至更优选为200-400KPa,最优选为250-300KPa。
对于需要特别密封的箔片的实施例(例如为了避免氧进入对氧化敏感的补充剂如维生素C),优选金属箔。
使用箔材料的一个问题是使用后的降解,特别是在环境中。这些材料中的许多在自然条件下极难降解,并可能在数年内造成对环境负荷。此外,许多基于塑料的材料都来自石油。考虑到资源稀缺和生产所需的能量消耗,这并不总是理想的。因此,在优选的实施方案中,使用无毒的生物可降解材料。而且,它们有更好的能量平衡。这种优选的箔材料是乙酸纤维素,硝酸纤维素,聚乳酸,聚-3-羟基丁酸酯,聚羟基戊酸酯,聚羟基己酸酯,聚酰胺11,淀粉混合物。
另一个问题是,在切割或打孔铝箔时,常常无法完全避免铝箔的细小碎屑进入饮料容器中的液体,从而有可能被消费者吸收。尽管目前尚无关于此类箔片碎片对健康的危害的长期研究,但肯定最好通过以下方式避免或降低此类风险:a)采用在使用时产生最少量碎片的切割工具,b)使用可降解材料可以被有机体相对较快地降解,无论是被胃酸还是被肠道中的好氧或厌氧细菌降解,或c)使用生物相容性物质,其原封不动地通过肠道而不会在生物体内积聚。
这种生物相容性箔材料的优选实例是聚丙烯。
所述的至少一个膜,隔膜,薄膜或密封箔片可以整体或逐个腔室地分别冲压,刺穿或切割。
切割工具可以具有打孔器,压模,刀片,刀,切割盘,剪刀,铣刀,钻头,凿子的形式。可以垂直或倾斜角度切入要切割的材料。它可以由金属,医用不锈钢,合金,硬质塑料,玻璃,陶瓷,钻石,氮化硼制成。
所述至少一个腔室简单地可以就是分配囊的内部空间,该腔室被完整的密封箔包围。然而,在分配囊内部可以有更紧凑的分隔,从而为一个或多个可填充腔室创造了一个封闭的空间。分隔壁的结构可根据要存储在其中的增溶物的不同而变化。这些隔室壁的材料最好与分配囊的材料相同。因此,整个分配囊可以通过注塑技术由热塑性塑料制成。
在现有技术中,已知各种分配囊,它们满足上述要求或可以按上述要求适配。他们包含VizCap,囊,Optima功能囊,BioGaia囊,Cedevita囊,INCAP,Yoli Blast囊,Mojo有机物容囊,Tap-the-Dispensing瓶囊,CapStaticX,Berocca Fusion囊,(智能输送囊),VPTC(瓶带柱塞和可撕下的容囊),点击囊(Tap the Cap)。有关各自的操作方式和生产者以及各自的优缺点的全面概述,请参阅安东·斯蒂曼(AntonSteeman)的三方文章系列(来自2012年《配药囊的发展-概述》),网址为http://bestinpackaging.com(截至017年2月6日)。这里通过引用将其包含在本文中。
因此,根据本发明,可以使用任何这些分配囊类型,首选使用INCAP。
在一些实施例中,分配囊还具有可移动的保护罩,以保护分配囊的释放机构,例如在运输,存储或处理期间免受机械损坏,或由粗心的使用者非自愿地过早地激活释放机构。它也可以用作防尘罩。
这样的保护罩应易于拆卸。可以将其从适当的分配囊中拉出作为单独的零件,也可以是一个集成的翻盖机构(保护罩通过柔软的塑料条与适当的分配囊铰接在一起)或是一个撕条机构(必须从保护罩上取下一条条带,这样才能卸下保护罩)。
前两种类型的优点是可以在适当的分配囊上更换。撕条机构具有的优点是,它特别紧密地密封,并且确保饮料系统或分配囊以前从未使用过。这对于分配储存特别有价值的补充剂例如药物活性剂是很理想的。
因此,优选具有撕条机构的保护罩。
根据本发明,还可以将不同的增溶物储存在分配囊的分开的多个腔室中。当所述增溶物可能以不希望的方式相互作用而可能降低有效含量并因此最终使所述增溶物中包含的物质的生物利用度受损,这种分配囊将是有利的。来自这些分开的腔室的溶解物可以伴随地或先后地释放到饮用液体中。它们可以通过整个分配囊的一个箔纸或每个腔室的单独箔纸与容器密封。后一种方式允许以交错的间隔释放。因此,用户可以在某个特定时间分别决定应释放的量,增溶物或增溶物组合的量。通过为用户提供更多选择自由度,可以增加用户的舒适度,例如,对于产品的吸引力,这可能是有利的。它也可能允许更个性化的联合用药。这种自由的交错释放既可以通过每个腔室的单独切割工具进行,也可以通过一个可以由用户单独分施加于特定腔室的切割工具进行。在具有定量交错释放选项的实施例中,这可以通过切削工具的旋转运动控制来实现,从而逐一地切开连续的腔室。用户可以通过轻微的咔嗒声或咔嗒声直观地跟踪切削工具的进程。
如前所述的分配囊易于容纳各种各样的增溶物。因此,它们适用于许多不同的应用领域,从标准的膳食补充剂,生活方式产品到创新的药物剂型。
根据美国食品药品监督管理局(FDA)当前的定义,膳食补充剂(dietarysupplements)一词是指不是药品,香料或防腐剂等食品添加剂(food additives)或常规食品的物质或产品,还满足以下任何标准:
1)该产品旨在补充人的饮食,尽管不能用作膳食替代品。
2)该产品是或含有维生素,营养元素,作为草药的植物药或用作药用植物的植物,氨基酸,有助于其他食物的任何物质,或任何浓缩物,代谢物,代谢成分,提取物,或这些物质的组合。
3)该产品被标记为膳食补充剂。
草药产品是由一种或多种草药制成的。如果使用一种以上的草药,则也可以称为混合草药产品。成品草药产品和混合草药产品除活性成分外还可能包含赋形剂。但是,添加了化学成分定义的活性物质(包括合成化合物和/或从草药中分离出的成分)的最终产品或混合物产品则不被视为草药。
由于药物活性剂或膳食补充剂可能对氧化过程敏感,因此在本发明的另一个实施方案中,增溶过程和/或将由此产生的增溶物填充到根据本发明的分配囊的操作是在屏蔽气体下进行。合适的气体例如为二氧化碳,氮气,氦气和氩气,优选的是二氧化碳和氮气。
在另一个实施方案中,将至少一种药物活性剂和/或饮食补充剂的增溶物在真空下包装到根据本发明的分配囊中。从而从分配囊的至少一个可填充腔室中除去氧气,以避免氧化过程。
术语“可溶物”的混淆甚至矛盾的定义可以在本领域中出现。为了避免任何歧义,根据本发明的增溶物定义如下:
增溶物(solubilisate)是至少一种要增溶的物质和根据本发明定义的增溶剂(solubilizing agent)的组合物,优选如本申请实施例所述。根据本发明的增溶物中不包括溶剂或稀释剂。首先制备本发明的增溶物(例如通过上述增溶技术之一),然后填充到根据本发明的分配囊中。
在采用胶束,脂质体或环糊精技术的情况下,本发明的增溶物的特征在于由各自增溶技术形成的各自的分子复合物,以及增溶在这些各自的复合物中的至少一种饮食补品和/或药物活性剂。
在采用自乳化技术的情况下,本发明的增溶物的特征在于该物质基本上完全溶解,因此是近乎完美的溶液,其中分子在溶液中的行为完全是作为独立的个体,符合布朗运动的分布和热力学规律。该溶液不同于与稀释剂(例如水)的混合物。所述溶液(溶解物)适合于在第二步骤中溶解在稀释剂中。因此,这样的增溶物是包含高浓度的各自的药物活性剂和/或饮食补充剂的澄清溶液。当这样的增溶物在稀释剂中稀释时,药物活性剂和/或饮食补充剂相应的浓度随稀释剂的添加量而减少。
通常,增溶物不经稀释不能摄入。在大多数情况下,根据本发明的分装增溶物占几毫升的体积。
根据本发明的增溶物在室温下为流体。
在本发明的范围内,术语“增溶聚集体”("solubilization aggregate”)或“增溶精”(“solubilization essence”)与“增溶物”(“solubilisate”)同义。
本发明的增溶物必须与悬浮液(胶体悬浮液,colloidal suspension)区分开。术语“悬浮液”定义为一种含有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,乳液定义为通常不混溶的两种液体的混合物。为了增加物质的生物利用度,高度溶解是高度优选的。因此,增溶物优于悬浮液或乳液。本发明不涉及悬浮液或乳液在分配囊中的使用。
本发明的增溶物也必须与浓缩物区分开。浓缩物是一种化合物,或是没有稀释剂的化合物的组合物。当浓缩物释放到稀释剂中时,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物和/或溶剂的相互作用,因为其本质上可溶于水或水溶液中。本发明不涉及在分配囊中使用浓缩物。本发明的增溶物还必须与已经以任何形式的溶剂重构的冻干物区分开。冷冻干燥是用于保存易变质的化合物,优选药物活性剂的脱水技术。冷冻至少一种化合物的制剂,然后降低周围压力,使得材料中的冷冻水直接从固相升华到气相。正确密封后,所得冻干物可在室温下保存。因此,可以大大提高敏感产品的货架寿命。可以通过将冻干物溶解在合适的溶剂中来重构产物。通常添加冻干保护剂或冷冻保护剂。本发明不涉及冻干物在分配囊中的使用,既不是固体也不是重构形式。
必须将本发明使用的术语“增溶物”与终溶液或待被吸收的饮用液区别开来。这些终溶液是指通过在稀释剂,优选在水溶液中稀释本发明的增溶物来产生根据本发明的成品溶液,以便产生易于由消费者或患者摄取的饮料或流体剂型。
在本申请范围内,稀释剂是稀释剂(稀释剂,减稠剂)。它不是本发明的增溶物的一部分,并且不包含在本发明的分配囊中。
在本专利申请的范围内,术语“增溶物”(“solubilisate”)仅是指打算包装或已经包装在根据本发明的分配囊中的溶解物。它不是指在本发明的分配囊内的增溶物释放到饮料容器内的“成品溶液”中的过程中可能短暂产生的流体。在本专利申请的范围内,该过渡流体应被称为“过渡流体”(“interim fluid”)。过渡流体与增溶物不同。
在本申请的范围内,术语“增溶剂”(“so|ubilizing agent")是指添加到饮食补充剂和/或药物活性剂中使之溶解的任何化学物质,以便使此膳食补充剂和/或药物活性剂可以在水溶液中溶解。应该和“溶解物”(“solubilizer”)应同义使用。
在本申请范围内的替代术语中,“第一液体”是指“增溶物”,“第二液体”是指“成品溶液”。
在本申请的范围内,术语“医学”应包括人类医学和兽医学。
这种增溶物的最大优点在于其体积小。因此,可以很容易地将其分配给患者或对消费者友好的设备,或者可以以低成本运输相对大量的增溶物质。为了产生终溶液,医务人员,患者或消费者可以容易地在水性介质(例如自来水或矿泉水)中稀释增溶物。
在本发明的另一方面,本发明的分配囊可用来包装对氧化敏感,对光(包括UV辐射)敏感,对热敏感和/或对湿气敏感的膳食补充剂和/或药物活性剂。
在一个特别优选的实施方案中,使用自乳化技术来增溶本发明的增溶物,如WO2018/046120中所公开的,该文献通过引用结合到本文中。简而言之,在这种增溶方法中,药物活性剂或膳食补充剂按以下步骤的被增溶:
-在室温和0.2巴至1巴的压力下,取至少一种占总重量含量为0.5%至25%的药物活性剂或膳食补充剂;
-以任何顺序添加至少一种磷脂酰胆碱的增溶物,其占总重量比为20%至80%,
-至少一种中链甘油三酸酯,其总重量范围为10%至70%,
-至少一种溶血磷脂酰胆碱,其总重量比为1%至15%,
-总重量范围为1%至20%的至少一种C2至C4醇,和
-硬脂酸甘油酯和/或饱和或不饱和的C14至C20脂肪酸中的至少一种,其总重量比为0.5%至10%,
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食品添加剂和/或药学上可接受的赋形剂;
-在20到60分钟的时间内,以连续的增量从0.5℃/min升高到3℃/min的温度连续升高温度,小心加热上述所得的混合物;
-在30℃至125℃的温度范围内,当达到澄清溶液后立即停止升温;使所得的增溶物冷却至室温。
任选地,添加至少一种总重量为0.01-10%的抗氧化剂,所述抗氧化剂是食品添加剂和/或药学上可接受的赋形剂。
因此,本申请还涉及本发明的分配囊,其中所述增溶物通过前述自乳化方法(self-emulsification)制备。
因此,本申请还涉及一种具有至少一个可填充腔室的分配囊,该可填充腔室包含至少一种药物活性剂和/或膳食补充剂的增溶物,其中该分配囊被适当地配置为安装在饮料容器的出口处,并且可通过操作分配囊的释放机构将增溶物释放到饮料容器中,所述至少一种药物活性剂和/或膳食补充剂的所述增溶物已经通过该方法增溶并且在室温下为流体。
通过这种增溶技术制备的膳食补充剂或药物活性剂的增溶物和终溶液应具有长期的稳定性,从而提供合理的保质期。否则,它们对生产商,销售商以及最终对客户或患者都不太有吸引力。对于许多增溶物而言,尤其是在口服液体剂型中,难以获得如此长期的稳定性。如在实施例中所见,在本发明分配囊中的根据本发明的增溶物以及根据本发明的终溶液显示出非常好的长期稳定性。优选地,根据本发明的增物剂的稳定性至少为一个月,更优选至少为两个月,甚至更优选至少为六个月,并且最优选至少为十二个月。同样,优选地,包装在根据本发明的分配囊中的根据本发明的增溶物的稳定性至少为一个月,更优选至少为两个月,甚至更优选至少为六个月,最优选至少为十二个月。
国际公认的BCS(生物制药分类系统)将药物分为四类:1类(高溶解度-高渗透性),2类(低溶解度-高渗透性),3类(高溶解度-低渗透性和4类(低溶解度)-低渗透性)。
在此,术语“溶解度”是指应遵守FDA生物豁免要求的最高剂量强度(https://www.fda.gov/OHRMS/DOCKETS/98fr/3657gd3.pdf,截至2017年3月7日)。当最高剂量强度可在1-7.5的pH范围内溶于250毫升或更少的水性介质中时,药物被分类为高度可溶。相应地,那些不能溶解的药物则被归类为难溶(=不易溶解)。
在本文中,术语“渗透性”是指药物在穿过人肠膜(粘膜)的吸收程度。根据确定的定义,如果90%或更多的口服剂量在胃肠道中被吸收,则该药物被归类为高渗透性。相应地,吸收率小于90%的药物被分类为低渗透性。
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以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中的那部分,该物质的生物利用度不仅取决于吸收,还取决于血液中的蛋白质结合以及药代动力学参数,例如首过代谢。
根据本发明,在优选的实施方案中,将如上所定义的溶解性差的药物用于生产增溶物。
根据本发明,优选将如上文所定义的渗透性差的药物用于生产增溶物。
根据本发明,特别优选将具有如上所述的较差的溶解性和较差的渗透性的药物用于生产增溶物(即第4类化合物)。
第4类药物的例子包括但不限于:对乙酰氨基酚(扑热息痛),阿昔洛韦,硫唑嘌呤,阿奇霉素,骨化三醇,卡来普罗多,头孢地尼,头孢克肟,头孢呋辛酯,头孢氨苄,氯噻嗪,氯噻酮,克拉霉素,硫酸环孢菌素,呋喃西地那啶,地松酮,地塞米松,地塞米松,地塞米松,地塞米松,地塞米特,伊拉地平,利奈唑胺,洛哌丁胺,甲苯达唑,巯基嘌呤,美沙拉敏,甲基泼尼松龙,莫达非尼,萘丁美酮,奈非那韦,甲磺酸酯,诺列非司汀,制霉菌素,奥卡西平,羟考酮盐酸,孕酮,乙氧嘧啶磺胺嘧啶,三甲氧嘧啶,三羟甲基磺胺嘧啶,利托那那韦,利托那那韦,利托那非,
对于膳食补充剂,术语生物利用度的使用略有不同。在大多数情况下,它们是口服的。因此,该术语定义了摄入剂量被吸收的比例。
根据本发明,优选将生物利用度差的饮食补剂用于增溶物的生产。优选生物利用度小于50%,更优选小于40%,更优选小于30%,甚至更优选小于20%,特别优选小于15%,最优选小于10%。
已知具有较低生物利用度的用作膳食补充剂的化合物或植物提取物的例子包括但不限于:黄酮,黄酮醇,黄酮-3-醇,黄酮,黄酮类,白藜芦醇,姜黄,姜黄素,姜黄素,去甲氧基姜黄素,双去甲氧基姜黄素,双-邻去甲基姜黄素,槲皮素,鞣花酸,柚皮苷,甜菜碱,甜菜碱,甜菜碱,泛醌(Q10,辅酶Q),谷胱甘肽,二十碳五烯酸(EPA),二十二碳六烯酸(DHA),尿苷,二氯化铬,L-肉碱,熊果酸,儿茶素,表儿茶素,表没食子儿茶素(EGC),表没食子儿茶素没食子酸酯(EGCG),表儿茶素没食子酸酯(ECG),多酚,小檗碱,褪黑素,多肽,异黄酮,脂溶性维生素A(视黄醇,视网膜),D,E(生育酚),F,K,α-和β-酮-乳香酸,L-色氨酸,5-羟基色氨酸,L-甘氨酸,肌醇,β-胡萝卜素,生育三烯酚,抗坏血酸棕榈酸酯,卵磷脂,叶黄素,木犀草素,番茄红素,玉米黄质,β-隐黄质,红三叶草,锯棕榈脂提取物,ω-3脂肪酸,类固醇萜烯,非类固醇萜烯,萜类化合物;皂苷,皂甙元,薯蓣皂甙元,薯蓣提取液,薯蓣提取液,原薯蓣皂苷,蒺藜提取物,香精油,金丝桃素,黄根醇,邻苯三酚,染料木黄酮,汉黄芩素、桑色素、山奈酚、巴考帕提取物,杆菌肽,杆菌肽A,杆菌肽A3,杆菌肽B,黄嘌呤,人参提取物,银杏叶提取物,碧萝芷,辣椒素,茜草提取物,劳森尼亚提取物,芦荟提取物,胡椒粉,硫辛酸,菠萝蛋白酶,根皮苷、番红花苷、番红花酸、生物素、针叶,原花青素,花色苷花青素水飞蓟宾,水飞蓟素,姜醇,神经酰胺,异戊二烯,泼尼醇,异戊酸,香叶菊香叶焦磷酸酯,桉油精,柠檬烯,pin烯,法呢基焦磷酸酯,青蒿素,比沙波洛尔,香叶基香叶菊香叶膦酸,植醇,紫杉醇,紫杉醇,酚例如鲨鱼或其他软骨鱼油,植物油或from菜籽,大米,小麦胚芽或橄榄中的油;角鲨烯,类维生素A,单宁酸,肉桂酸,木质素,以及植物甾醇,例如月桂醇β-谷甾醇酯,月桂酸α-谷甾醇月桂酸酯,γ-谷甾醇月桂酸酯,豆甾醇甾醇甾醇酸酯,樟脑甾醇硬脂酸酯油酸酯,β-谷甾醇棕榈酸酯,β-谷甾醇油酸酯,γ-谷甾醇油酸酯,β-谷甾醇肉豆蔻酸酯,β-谷甾醇蓖麻油酸酯,樟脑甾醇月桂酸酯,樟脑甾醇蓖麻油酸酯,樟脑甾醇,樟脑甾醇油酸酯,豆甾醇异油酸酯,豆甾醇九酸酯,豆甾醇癸酸酯,α-谷甾醇硬脂酸酯,谷甾醇肉豆蔻酸酯,γ-谷甾醇棕榈酸酯,樟脑甾醇蓖麻甾醇酸酯,蓖麻油酸酯,β-谷固醇,α-谷固醇,γ-谷固醇,菜油甾醇,柱头rol和豆甾醇硬脂酸酯;适应性植物的提取物,例如西番莲叶人参,细叶人参,刺五加,玫瑰红景天,五味子五味子,五味子,人参,绞股蓝,角叶绞股蓝,巴戟天,印度桑树),香菇(香菇),灵芝规格。(灵芝,灵芝蘑菇),如灵芝,灵芝tsu和灵芝,灰树花(舞茸,木鸡),姬松茸。(杏仁蘑菇),如姬松茸和姬松茸,索马里风(ashwagandha,冬日樱花),圣罗勒(图尔西),梅耶尼勒皮杜菌(Lepidum meyenii,玛卡),穿心莲(Kantmegh),大麻,印度大麻,刺柏(Tapebuiaimpetiginosa)(lapacho)),黄芪(astragalus)。
根据经验已知,水溶性差的药物活性剂或膳食补充剂在通过合适的方法溶解后可实现改善的吸收和/或生物利用度。因此,本申请还涉及根据本发明的分配囊,其中至少一种药物活性剂和/或饮食补充剂的增溶物增强了上述药物活性剂或饮食补充剂中至少一种的吸收和/或生物利用度(与非增溶的物质相比)。
借助于上述增溶技术已经发现可以增溶所选择的药物活性剂和/或饮食补充剂,使其物质增溶物(参见实施例1至12)。因此,本申请还涉及一种分配囊,其中增溶物是从选自异胡萝卜素,辅酶Q10,胡椒碱,绿茶提取物,叶酸和槲皮素的物质制备的(如果是作为饮食补充剂)或选自速尿,阿奇霉素,阿昔洛韦,氢氯噻嗪,格列吡嗪和克拉霉素(如果是作为药物活性剂)。
本发明的另一方面是某些药物(药品)或膳食补充剂本质上具有苦味或令人不快的味道。对于药物,这可能会严重损害患者的依从性;对于膳食补充剂,这种味道可能会成为严重的商业障碍。根据本发明的增溶物可通过笼罩该物质而显着地帮助掩盖该苦味或令人不快的味道。胶束,脂质体或自乳化增溶物具有中性口味,环糊精增溶物具有微甜的味道。
因此,本发明还涉及一种分配囊,该分配囊包含至少一种药物或膳食补充剂的增溶物,其中至少一种药物或膳食补充剂的苦味和/或令人不愉快的味道被该增粘剂掩盖。优选地,该掩味增溶物通过胶束,脂质体,自乳化或环糊精络合技术制备。
当以口服剂型向需要其的动物施用具有苦味或令人不快的味道的兽药时,这在兽药中特别有用。
具有苦味或令人不愉快的药物的实例包括但不限于:对乙酰氨基酚,沙丁胺醇,氨基胍盐酸盐,氨茶碱,阿米替林,三水合阿莫西林,氨苄青霉素,苯磺酸氨氯地平,阿司匹林,阿奇霉素,巴比妥酸盐,小ber碱氯化物,咖啡因,碳酸钙,泛酸钙,头孢菌素,氯苯二甲胺,氯苯二甲酰氯,氯安定西咪替丁,环丙沙星,克拉霉素,可待因,地美洛尔,右美沙芬,洋地黄毒苷,地高辛,盐酸地尔硫卓,苯海拉明,二苯乙内酰脲,甲磺酸多沙唑嗪,多西拉敏琥珀酸,依曲曲坦,依诺沙星,氢氧萘啶,依法肾上腺素,依法肾上腺素布洛芬,盐酸去氧恶嗪,利多卡因,洛莫替尔,氯雷他定,卢比丁,氧化镁,美克嗪,乙酰甲胆碱,吗啡,新斯的明,尼非替丁,尼哌替丁,尼扎替丁,氧氟沙星,对乙酰氨基酚,培氟沙星,青霉素,苯那巴那明,苯丙嗪哌啶酸,盐酸吡比洛尔,吡罗昔康,泼尼松龙,盐酸普萘洛尔,伪麻黄碱,吡啶酮羧酸抗菌剂,雷尼替丁,罗沙替丁,水杨酸,盐酸舍曲林盐酸盐,西地那非,螺内酯,舒巴坦钠,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,磺胺嘧啶,甲氧苄啶,图瓦替丁,伐地考昔,扎替丁和唑尼沙胺。
在一个优选的实施方案中,分配囊中的增溶物包含具有苦味或令人不愉快的味道的BCS4类药物,其中所述味道可以被本发明的增溶物掩盖。合适的实例包括对乙酰氨基酚(扑热息痛),阿奇霉素,克拉霉素,格列吡嗪和甲氧苄啶。
许多膳食补充剂也具有苦味或令人不愉快的味道,尤其是许多植物化学物质,如生物碱、单宁、酚类或多酚类化合物、类黄酮、异黄酮、异黄酮苷、硫代葡萄糖苷、异硫氰酸盐、葫芦素、含氧四环三萜。
另一方面是一些增溶物在一定程度上粘附于分配囊的内壁,在制备饮料时不会不会100%从分配囊释放。这主要取决于要溶解的物质和所用的溶解技术的组合以及分配囊的材料及其特定形状。在触发释放机构之后,通过用安装的分配囊搅动饮料容器,可以克服或至少显著地减轻该问题。因此,饮料容器内的可饮用液体通过其破裂的膜在分配囊内部进行冲刷,以便溶解仍粘附在分配囊内壁上的增溶物。
在另一个实施方案中,将不粘涂膜(non-stick coating film)施加到分配囊的内壁上。这种不粘涂膜应该是惰性的,生物相容的,并且在运输和储存的一般温度下不应崩解或分离。这种不粘涂膜的有用实例是聚四氟乙烯,例如PTFE(聚四氟乙烯),FEP(氟化乙烯丙烯共聚物),PFA(全氟烷氧基)和ETFE(乙烯四氟乙烯共聚物),阳极氧化铝和有机硅。将这种不粘涂膜施加到分配囊的内壁上的合适技术包括阳极氧化,浸涂,阴极浸涂,纳米涂,湿涂,粉末涂,锌热扩散,聚合物涂,热喷涂,鼓式喷涂,真空涂层,铬替代物和等离子体沉积。优化精确的工艺参数是本领域技术人员的基本知识。
因此,本申请还涉及一种适于容纳增溶物的分配囊,其中所述囊的内表面部分或完全覆盖有不粘涂层。
在本发明的又一个实施方案中,在填充饮料容器的水或水溶液中提供了至少一种另外的饮食补充剂和/或药物活性剂。
如下面所说,可以单独地或组合地将前述药物或饮食补充剂的增溶物与本发明的分配囊和/或饮料容器中的液体中的多种赋形剂和/或添加剂组合。
然而,赋形剂和/或添加剂不是本发明的增溶物的一部分。
合适的维生素是例如维生素C(L-抗坏血酸,L-抗坏血酸钠,L-抗坏血酸钙,L-抗坏血酸钾,L-抗坏血酸6-戊酸酯),维生素A(视黄醇,乙酸视黄酯,棕榈酸视黄酯,β-胡萝卜素),维生素D(胆固醇钙化醇,麦角钙化醇),维生素E(D-α-生育酚,DL-α-生育酚,D-α-生育酚乙酸酯,DL-α-生育酚乙酸酯,Da|pha-生育酚琥珀酸酯),维生素K(叶醌),维生素B1(硫胺素盐酸盐,硫胺素单硝酸盐),维生素B2(核黄素,核黄素5'-磷酸钠),烟酸(烟酸,烟酰胺),泛酸(D-泛酸钙,D-泛酸钠,D-泛醇),维生素B6(盐酸吡rid醇,吡ido醇5'-磷酸盐),叶酸(蝶呤单谷氨酸),维生素B12(氰基钴胺,羟钴胺),生物素(D-生物素)。
可用的合适矿物质是例如钙(碳酸钙,氯化钙,柠檬酸钙盐,葡萄糖酸钙,甘油磷酸钙,乳酸钙,正磷酸钙盐,氢氧化钙,氧化钙),镁(乙酸镁,镁碳酸盐,氯化镁,柠檬酸镁盐,葡萄糖酸镁,甘油磷酸镁,正磷酸镁盐,乳酸镁,氢氧化镁,氧化镁,硫酸镁),铁(碳酸铁,柠檬酸铁,柠檬酸铁铵,葡萄糖酸铁),富马酸铁,二磷酸铁钠,乳酸铁,硫酸铁,二磷酸铁,蔗糖铁,元素铁),铜(碳酸铜,柠檬酸铜,葡萄糖酸铜,硫酸铜,赖氨酸铜络合物),碘(碘化钠,碘酸钠),碘化钾,碘酸钾),锌(醋酸锌,氯化锌,柠檬酸锌,葡萄糖酸锌,乳酸锌,氧化锌,碳酸锌,锌硫酸盐),锰(碳酸锰,氯化锰,柠檬酸锰,葡萄糖酸锰,甘油磷酸锰,硫酸锰),钠(碳酸氢钠,碳酸钠,氯化钠,柠檬酸钠,葡萄糖酸钠,乳酸钠,氢氧化钠,正磷酸酸性钠盐),钾(碳酸氢钾,碳酸钾,氯化钾,柠檬酸钾,葡萄糖酸钾,甘油磷酸钾,乳酸钾,氢氧化钾,正磷酸钾盐),硒(亚硒酸钠,亚硒酸钠氢,亚硒酸钠)),铬(氯化铬(III),硫酸铬(III)),钼(钼酸铵(钼(VI),钼酸钠(钼(VI))),氟(氟化钠,氟化钾),氯,磷。
微量元素是有机体生长,发育和生理所需的微量矿物质,例如作为辅酶。它们中的一些实际上总是以足够的量存在于有机体中,而其他的,对于有需要的人,则必须另外提供。它们可以选自铬,钴,铁,碘,铜,锰,钼,硒,锌,氟化物,硅,砷,镍,铷,锡,钒。它们可以作为纯元素或以上述任何一种矿物形式提供。
在世界范围内兴奋剂经常用于饮料中。根据世界卫生组织(WHO),该术语是指增加,加速或改善神经元活动的任何种类的物质。这些物质通常具有拟心理作用。最受欢迎的刺激物包括黄嘌呤,例如咖啡因,茶碱和可可碱。瓜拉那含有上述的黄嘌呤。另一受欢迎的刺激剂是烟碱或烟酸。但是,有大量的兴奋剂,在许多国家,这些都是受法律禁止的,或预计在不久的将来会被禁止,或受卫生当局的严格监管,需要医生开具处方。这是由于他们的依赖潜力以及对消费者健康的其他危害,交通中的注意力缺陷等,或者是对社交生活的负面影响。该类包含苯丙胺及其衍生物,哌嗪衍生物,可卡因和用于治疗嗜睡症和注意缺陷多动障碍(ADHD)的药物。因此,也有可能根据本发明使用这组物质,优选使用咖啡因。
合适的抗氧化剂可以选自乳酸,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,棕榈酸抗坏血酸酯,抗坏血酸硬脂酸酯,生育酚,α-生育酚,γ-生育酚,δ-生育酚,没食子酸丙酯,没食子酸辛酯,没食子酸十二烷基酯,没食子酸乙酯,愈创木脂树脂,异抗坏血酸,异抗坏血酸钠,异抗坏血酸,异抗坏血酸钠,叔丁基对苯二酚,丁基化羟基茴香醚,丁基化羟基甲苯,单、二、二、三磷酸钠,单、二、三磷酸钾,抗氧剂,乙氧基喹,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。
合适的酸度调节剂可以选自乙酸,乙酸钾,乙酸钠,二乙酸钠,乙酸钙,二氧化碳,丙二酸,富马酸,乳酸钠,乳酸钾,乳酸钙,乳酸铵,乳酸镁,柠檬酸。酸,柠檬酸单、二、三钠,柠檬酸单、二、三钾,柠檬酸单、二、三钙,酒石酸,酒石酸单、二钠,酒石酸单、二钾,酒石酸钾钠,原酸磷酸,卵磷脂柠檬酸盐,柠檬酸镁,苹果酸铵,苹果酸钠,苹果酸氢钠,苹果酸钙,苹果酸氢钙,己二酸,己二酸钠,己二酸钾,己二酸铵,琥珀酸,富马酸钠,富马酸钾,富马酸钙,富马酸铵,1,4-庚内酯,柠檬酸三铵,柠檬酸铁铵,甘油磷酸钙,柠檬酸异丙酯,碳酸钾,碳酸氢钾,碳酸铵,碳酸氢铵,碳酸镁,碳酸氢镁,碳酸亚铁,硫酸铵,硫酸铝钾,硫酸铝铵,氢氧化钠,氢氧化钾,氢氧化铵,氢氧化镁,葡萄糖酸。
酸化剂是用来产生或变成酸的无机化学品。合适的例子是:氯化铵,氯化钙。
药物活性剂或饮食补充剂通常以盐的形式提供。对于药学活性剂,药学上可接受的盐各自在药典中列出。因此,它们可以选自相应的钠,钾,钙,锂,镁盐作为阳离子盐,或相应的氯化物,溴化物,硫酸盐,磷酸盐,醋酸盐,柠檬酸盐,草酸盐,丙二酸盐,水杨酸盐,对氨基水杨酸盐,苹果酸盐,富马酸盐,琥珀酸盐,抗坏血酸盐,马来酸盐,磺酸盐,膦酸盐,高氯酸盐,硝酸盐,甲酸盐,丙酸盐,葡萄糖酸盐,二葡萄糖酸盐,乳酸,酒石酸酯,羟基马来酸酯,丙酮酸,乙酸苯酯,苯甲酸酯,对氨基苯甲酸酯,对羟基苯甲酸酯,二硝基苯甲酸酯,氯苯甲酸酯,甲磺酸酯,乙磺酸酯,亚硝酸盐,羟乙磺酸盐,乙烯磺酸酯,甲苯磺酸酯,萘磺酸萘酯,4-氨基甲苯磺酸酯,樟脑磺酸酯,藻酸酯癸酸盐,马尿酸盐,果胶酸盐,邻苯二甲酸盐,奎宁酸盐,扁桃酸盐,扁桃酸邻甲酯,苯磺酸氢盐,苦味酸盐,环戊烷丙酸酯,酒石酸对甲苯酯,酒石酸盐,苯磺酸盐,苯甲酸α-甲基苯酯,(邻,间,对-)甲基|苯甲酸酯,萘胺磺酸酯,肉桂酸酯,丙烯酸酯,三氟乙酸酯,异丁酸酯,丁酸苯基酯,庚酸酯,二甲苯磺酸酯,己二酸酯,天冬氨酸,硫酸氢根,硼酸酯,丁酸酯,樟脑酸酯,十二烷基硫酸酯,月桂酸酯,葡庚糖酸2-羟基己二酸甘油酯,磷酸二羟甘油酯-乙磺酸盐,乳糖酸盐,月桂基硫酸盐,烟酸盐,油酸盐,棕榈酸盐,棕榈酸盐,过硫酸盐,3-苯基丙酸酯,新戊酸酯,硬脂酸酯,硫氰酸酯,十一酸酯,戊酸酯,三氟甲磺酸酯和乙醇酸酯。可以认为这些盐也可以用于本发明所用的膳食补充剂的制剂中。
通常,由低pKa的酸制备的盐在水性介质中显示出良好的溶解性。对于此类盐,并非必须使用上述定义的增溶技术。在解离状态下,这些盐甚至可能干扰某些所述溶解技术。因此,优选使用由pKa>2.0的酸产生的盐,更优选pKa>3.0,还更优选pKa>4.0,最优选pKa>5.0。
术语“药物赋形剂”是指与药物活性剂一起添加到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,增强所需的药代动力学特性或制剂的稳定性,以及便于制造工艺过程。本发明可用的赋形剂的类别包括但不限于调味剂,着色剂,防腐剂,甜味剂,载体,另外的增溶剂,缓冲剂,防腐剂,遮光剂。
将一种或多种药学上可接受的载体添加到药学活性剂中可能是有益的,或者是强制性的。合格的载体是本领域已知的所有载体及其组合。对于液体剂型和乳剂,合适的载体是例如额外的增溶剂,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。
在一些实施方案中,可能希望在终溶液中产生一些泡沫。可以通过添加降低液体表面张力从而促进气泡形成的发泡剂来实现这种效果,或者通过抑制气泡的聚结来增加其胶体稳定性。或者,它可以稳定泡沫。合适的例子包括矿物油,奎拉娅提取物,柠檬酸三乙酯,月桂基醚硫酸钠,月桂基硫酸钠,月桂基硫酸铵。
可选择地,一些本发明的增溶物在制备时可能看起来有点泡沫。尽管这不会干扰所需的应用,但可能会影响患者的依从性(对于药物)或可能会影响商业成功(对于膳食补充剂)。因此,可能需要向增溶物中加入药学上或营养上可接受的消泡剂(anti-foamingagent)。膳食补充剂中的聚二甲基硅氧烷或硅油或药物中的二甲硅油是实例。
因此,本申请还涉及一种分配囊,其中将营养和/或药学上可接受的消泡剂添加到至少一种药物活性剂和/或饮食补充剂中。
着色剂属于赋形剂,使饮料的成分或剂型着色。这些赋形剂可以是食用色素。它们可以被吸附在合适的吸附物上如粘土或氧化铝上。着色剂的量可在终溶液的每重量的0.01%至10%之间,优选在每重量的0.05%至6%之间,更优选在每重量的0.1%至4%之间,最优选在每重量的0.1%至1%之间。
合适的食用色素为姜黄素,核黄素,核黄素-5'-磷酸盐,酒石黄,链烷烃,喹诺酮黄WS,坚牢黄AB,核黄素5'-磷酸钠,黄2G,日落黄FCF,橙色GGN,胭脂红,胭脂红酸,柑桔红2Carmoisine,a菜红,胭脂红4R,胭脂红SX,胭脂红6R,赤藓红,红色2G,诱惑红AC,茚达蒽蓝RS,漆蓝V,靛蓝胭脂红,亮蓝FCF,叶绿素和叶绿素,叶绿素和叶绿素的铜配合物,绿S,坚牢绿色FCF,普通焦糖,亚硫酸焦糖,氨焦糖,亚硫酸氨焦糖,黑PN,炭黑,植物碳,棕FK,棕HT,α-胡萝卜素,β-胡萝卜素,γ-胡萝卜素,安纳托,联苯胺,去甲毒素,辣椒红油树脂,辣椒红素,辣椒红素,番茄红素,β-载脂蛋白8'-胡萝卜素,β-载脂蛋白8'-胡萝卜素的乙酯,黄酮黄质,叶黄素,隐黄质,红黄质,紫罗黄质,紫黄质,角黄质,玉米黄质,虾青素,甜菜碱,花色苷,藏红花,碳酸钙,二氧化钛,氧化铁,氢氧化铁,铝,银,金,色素红宝石,单宁,兽精,葡萄糖酸亚铁,乳酸亚铁。
增味剂被广泛用于食品和饮料。合适的例子是谷氨酸,谷氨酸一钠,谷氨酸一钾,二谷氨酸钙,谷氨酸一铵,二谷氨酸镁,鸟苷酸,鸟苷酸钠,鸟嘌呤二钠,鸟苷酸二钾钾,鸟嘌呤钙,肌苷酸,肌苷钙二钠,肌苷钙二钠,肌苷二钠'-核糖核苷酸,5'-核糖二钠,甘氨酸,甘氨酸钠,醋酸锌,苯甲酸胶,索马汀,甘草甜素,新哌啶二氢查耳酮,单乙酸甘油酯,双乙酸甘油酯。
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,是指体系通过加入酸或碱或通过用溶剂稀释来抵抗pH变化的能力。优选的缓冲系统可以选自甲酸,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,椰油酰胺(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)-丙磺酸,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之间的其他缓冲液。
优选的是碳酸缓冲剂,例如乙酸盐缓冲剂和二羧酸缓冲剂,例如富马酸酯,酒石酸酯和邻苯二甲酸酯,以及三羧酸缓冲剂,例如柠檬酸酯。
另一组优选的缓冲剂是无机缓冲剂,例如氢氧化硫酸盐,氢氧化硼酸盐,氢氧化碳酸盐,草酸氢氧化物,氢氧化钙和磷酸盐缓冲剂。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。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-丙烷磺酸(EEPS),4-吗啉代丙烷磺酸(MOPS)和N,N-双-(2-羟乙基)-2-氨基乙磺酸(BES)。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-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,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-乙酰基赖氨酸,ω-N-甲基精氨酸,瓜氨酸,鸟氨酸及其衍生物。
可以根据需要使用液体剂型或补充剂的防腐剂。它们可以选自山梨酸,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,苯甲醇,苯扎氯铵,苯乙醇,甲酚,鲸蜡基吡啶鎓氯化物,氯代丁醇,硫柳汞(2-(乙基汞硫代)钠苯甲酸),二氧化硫,钠亚硫酸盐,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,噻菌灵,乳酸链球菌素,游霉素,甲酸,甲酸钠,甲酸钙,己胺,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,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。
合适的附加乳化剂可以选自例如以下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,2至60摩尔环氧乙烷与蓖麻油的加成产物和/或硬化的蓖麻油,羊毛蜡油(羊毛脂),脱水山梨醇酯,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,1,2-二醇海藻酸丙烷,角叉菜胶,加工后的全麦海藻,刺槐豆胶,黄蓍胶,阿拉伯胶,卡拉亚胶,吉兰糖胶,加蒂胶,葡甘露聚糖,果胶,酰胺化果胶,磷酸铵,溴化植物油,乙酸异丁酸蔗糖酯,木松香甘油酯,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,多磷酸钙钠,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,交叉羧甲基纤维素,酶水解的羧甲基纤维素,单和脂肪酸二甘油酯,单硬脂酸甘油酯,二硬脂酸甘油酯,脂肪酸单甘油酯和二甘油酯的乙酸酯,脂肪酸甘油单酯和甘油二酯的乳酸酯,脂肪酸甘油单酯和甘油二酯的柠檬酸酯,酒石酸酯脂肪酸的单和二甘油酯,脂肪酸的单和二甘油酯的单和二乙酰酒石酸酯,脂肪酸的单和二甘油酯的混合乙酸和酒石酸酯,琥珀酰化的单甘油酯,脂肪酸的蔗糖酯,蔗糖甘油酯,脂肪酸的聚甘油酯,聚甘油油酸酯,脂肪酸的1,2-丙二醇酯,脂肪酸的丙二醇酯,甘油和丙烷1的乳酸化脂肪酸酯,热氧化的大豆油与脂肪酸的单甘油酯和甘油二酯,磺基琥珀酸二辛酯钠,硬脂酰-2-乳酸酯钠,硬脂酸2-乳酸钙,硬脂酸硬脂酸酯,柠檬酸硬脂酯,富马酸硬脂酰硬脂酸钠,硬脂酸富马酸硬脂酸钙,硬脂酸硬脂酸酯,柠檬酸硬脂基酯,硬脂酸富马酸钠,硬脂酰富马酸钙,八烷基硫酸钠,乙氧基化的单和二甘油酯,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,淀粉辛烯基琥珀酸琥珀酸琥珀酸酯,乙酰化淀粉。
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良变化的物质。尽管稳定剂不是真正的乳化剂,但它们也可能有助于乳液或增溶物的稳定性。稳定剂的合适实例是羟丁硬脂,黄原胶,琼脂,燕麦胶,瓜耳胶,塔拉胶,阿斯巴甜-乙酰磺胺盐,淀粉酶,蛋白酶,木瓜蛋白酶,菠萝蛋白酶,丝氨酸,蔗糖酶,聚葡萄糖,聚乙烯吡咯烷酮,聚乙烯基聚吡咯烷酮,柠檬酸三乙酯,麦芽糖醇,麦芽糖醇糖浆。
适合用作其他表面活性增溶物(增溶物)的有,例如二甘醇单乙酯,聚丙丙二醇共聚物,环糊精(如α-和β-环糊精),甘油单硬脂酸酯,如Solutol HS 15(来自BASF的Macrogol-15-羟基硬脂酸酯,PEG 660-15羟基硬脂酸酯),脱水山梨醇酯,聚乙烯醇,十二烷基硫酸钠,(阴离子)甘油单油酸酯等。
合适的芳香和调味物质(调味剂)首先包括可用于该目的的香精油。通常,该术语是指具有各自特征性气味的植物或植物部分的挥发性提取物。它们可以通过蒸汽蒸馏从植物或植物的一部分提取。
例子有:香精油,分别来自鼠尾草,丁香,洋甘菊,茴香,八角茴香,百里香,茶树,薄荷,薄荷油,薄荷醇,桉树脑,桉树油,芒果,无花果,薰衣草油,洋甘菊花,松针,柏树,橘子,花梨木,李子,醋栗,樱桃,桦木叶,肉桂,酸橙,葡萄柚,橘子,杜松,缬草,柠檬香脂,柠檬草,帕尔马罗萨,蔓越莓,石榴,迷迭香,姜,菠萝,番石榴,紫锥菊,常春藤叶提取物,蓝莓,柿子,甜瓜等或其混合物,以及薄荷醇,薄荷和八角茴香油的混合物或薄荷醇和樱桃香精的混合物。
这些芳香或调味物质的含量可以为终溶液重量的0.0001至10%,优选为重量的0.001至6%,更优选为重量的0.001至4%,最优选为重量的0.01至1%。与具体应用个例有关,不同应用使用不同的量的有益的。
合适的甜味剂可以选自甘露醇,甘油,乙酰磺胺酸钾,阿斯巴甜,甜蜜素,异麦芽酮糖,异麦芽糖醇,糖精及其钠盐,钾盐和钙盐,三氯蔗糖,阿利坦,索马甜甘草甜素,新橙皮苷二氢查耳酮,甜菊糖苷,-乙磺胺盐,麦芽糖醇,麦芽糖醇糖浆,乳糖醇,木糖醇,赤藓糖醇。
合适的等渗剂是例如药学上可接受的盐,特别是氯化钠和氯化钾,糖例如葡萄糖或乳糖,糖醇例如甘露醇和山梨糖醇,柠檬酸盐,磷酸盐,硼酸盐及其组合。
在需要的情况下,遮光剂是使饮用液体不透明的物质。它们的折射率必须与溶液(在大多数情况下为水)不同。同时,它们应对组合物的其他成分呈惰性。合适的例子包括二氧化钛,滑石粉,碳酸钙,二十二碳烷酸,鲸蜡醇或其组合。
根据本发明,所有上述赋形剂和赋形剂类别都可以不受限制地单独使用或以其任何可能的组合使用,只要影响本发明的增溶物的使用,不发生可能的毒性作用,或不违反各自的国家法规即可。
因此,本申请还涉及一种分配囊,其中,非增溶物质中的至少一种包括维生素,矿物质,微量元素,兴奋剂,膳食补充剂,草药产品,适应原,抗氧化剂,着色剂,调味剂,增味剂此外,将芳族物质,甜味剂,等渗剂,发泡剂,药物活性剂,药物赋形剂,酸化剂,酸度调节剂,缓冲剂,防腐剂,稳定剂,pH调节剂和乳浊剂额外地装入所述增溶物中至所述分配囊的至少一个填充室中。
在另一方面,本专利申请还涉及一种包括分配囊和饮料容器的饮料系统。
饮料容器必须能够在一定时间段内存储饮用液。因此,饮料容器的材料必须足够耐用,并且饮料容器的设置优选具固有的稳定性。此外,它必须提供合理的容积来存储与饮用液体的目标用途相对应的合适的液体容积。因此,所述饮料容器可以从包括以下的组中选择:瓶,烧瓶,小瓶,安瓿,饮料纸盒,利乐(Tetra),罐,水壶,马克杯,大啤酒杯,小袋,立式小袋,桶,小桶,软管形容器。首选的容器是瓶,罐,小瓶和饮料纸盒。
一个前提条件是,所述饮料容器具有出口、开口或凹口,使得本发明的增溶物可通过该出口或开口释放到容器内部的饮用液体中。分配囊必须安装在该开口或凹槽上方。如许多瓶子或饮料容器类型中已知的那样,可以通过具有互锁螺纹的螺帽方式来完成,或者通过夹紧机构,折叠机构,压接机构,防摆动机构,触发器盖,密封带。优选的是螺帽方式。
在本发明的又一个实施方案中,在饮料容器填充的水或水溶液中提供了至少一种如上所述的赋形剂和/或添加剂。
本专利申请还公开了用作药物剂型的所述饮料系统,其中所述增溶物由至少一种药物活性剂制备。
在另一方面,本发明专利涉及一种用于提供所述饮料系统的方法,包括以下步骤:
a)提供如上定义的饮料容器;
b)提供如上定义的分配囊;
c)通过如上所定义的增溶技术产生至少一种药物活性剂和/或饮食补充剂的增溶物;
d)将由步骤c)得到的增溶物填充到分配囊的至少一个可填充室中;
e)利用有适当构造的密封膜或通过组装分配囊的各个部件,紧密地封闭分配囊的所述至少一个填充室;
f)可选地,将可饮用的液体填充到饮料容器中;和
g)将由此填充的分配囊安装到饮料容器上。
在另一方面,本专利申请还涉及一种由
a)提供一种如上所定义的饮料系统,其中,所述饮料容器预先填充有饮用液体,
b)触发如上定义的所述分配囊的释放机构,以将所述增溶物释放到饮用水中,以及
c)可选地,搅动饮料系统以使可饮用液体和释放的增溶物更好地混合。本发明专利还涉及所述用于医学终溶液,其中所述增溶物由至少一种药物活性剂产生
实施例
在所有随后的实施例中,增溶物的溶解步骤进行了三次,以便分别从每种增溶物原液中产生三种终溶液。在所有示例中,发现三次终溶液的结果都是彼此一致的。
实施例1:
为了产生利尿剂速尿(furosemide,BCS IV类药物)的增溶物,将4.5g的泊洛沙姆188(Poloxamer188)和1.25g的α-生育酚加热至60℃直至融化。将4.76ml的净水(25%)加热至60℃,并覆盖于熔融混合物上。等待直到形成凝胶。在第二溶液中,提供14.29ml的净水(75%),并在搅拌下加入0.2g的速尿。然后将该第二溶液添加到上述凝胶中(用于WO 2007/104173 A2的方法)。因此产生了增溶物,形成包围待增溶的化合物的稳定胶束。由于需要加入给定量的水,因此必须将其视为增溶物而不是浓缩物。该增溶物(25毫升)大约具有以下组成:
将5ml的这种增溶物填充到INCAP分配囊的底部。将INCAP的上部放在其上,并通过向下按压上部将两部分紧密地封闭。将如此装满的分配囊安装到具有标准螺纹(28毫米,右旋)的500毫升PET瓶,并将瓶充满矿泉水。将可溶物释放到矿泉水中,并搅动整个饮料系统,便产生了一种饮料,其中含有40mg速尿(该药物的标准剂量)。重复三次该实验(n=3)。每次均生成无任何浆液的澄清溶液。在两个小时的观察期内,没有出现化合物沉淀,絮凝或重结晶。
实施例2
为了产生非常亲脂的膳食补充剂β-胡萝卜素的增溶物。β-胡萝卜素是维生素A的前体,是胡萝卜,南瓜等多种植物中所含的萜类化合物。将4.5克泊洛沙姆188和1.25克α-生育酚,按实施例1中所述,加热至60℃直至其熔化。将4.81ml的净水(25%)加热至60℃并用于覆盖熔融混合物。等待直到形成凝胶。在第二溶液中,提供14.41ml的净水(75%),并在搅拌下添加30mg的β-胡萝卜素。然后将该第二溶液加入上述凝胶中。当添加任何数量的水时,形成稳定胶束将待增溶物包入,因此产生了增溶物。该增溶物(25毫升)大约具有以下组成:
将2ml上述增溶物加入一融合囊(Fusion Cap)。按实施例1中所述方法,制备终溶液,并重复三次(n=3)。这样产生的饮料含有6mgβ-胡萝卜素,这是该膳食补充剂的建议每日剂量。每次均产生澄清的浅橙色溶液,没有任何浆液。在四个小时的观察期内,将饮料冷却至室温后,没有出现化合物沉淀,絮凝或重结晶。
实施例3:
阿奇霉素(Azithromycin)是一种广谱抗生素,广泛用于抵抗某些革兰氏阳性,某些革兰氏阴性和许多非典型细菌的感染。阿奇霉素属于BCS 4类(低溶解度-低渗透性)药物。
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生20ml增溶物。取阿奇霉,然后在5分钟内,室温(20±5℃)和大气压下,搅拌并逐一混合增溶化合物。
然后在连续搅拌下将上述组合物小心地加热,以约2℃/min的温度增量。约8分钟(约36℃)后,组合物开始变成透明溶液。此增溶过程再持续约7分钟。这样,在约15分钟后(约50℃),便得到本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
将2ml的所得增溶物填充到VizCap分配囊的圆顶形腔中,盖紧盖子并将分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上并填充矿泉水。通过将增溶物释放到矿泉水中来制备终溶液(n=3)。终溶液很快变得澄清,外观略带白色。这使得饮料中含有500毫克阿奇霉素,这是通常建议的每日剂量。
阿奇霉素的苦味通常会引起依从性问题,尤其是对于儿童而言。该增溶物可能覆盖这种苦味。
实施例4:
阿昔洛韦(Aciclovir)是一种抗病毒药物。它通常用于治疗单纯疱疹感染,带状疱疹和水痘。阿昔洛韦属于BCS 4类(低溶解度低渗透性)药物:
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生了20ml增溶物。取阿昔洛韦,然后在5分钟内室温(20±5℃)和大气压下搅拌将增溶化合物一一混合。
然后在连续搅拌下将组合物小心地加热,以大约1℃/min的温度增量。约45分钟(约65℃)后,组合物开始变成澄清溶液,再让此增溶过程持续了约5分钟。这样,在约50分钟70℃后,便获得本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
将5ml的这种增溶物填充到INCAP分配囊的底部。将INCAP的上部放在其上,并通过向下按压上部将两部分紧密地封闭。将如此装满的分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上,并充满矿泉水。将增溶物释放到矿泉水中,并搅拌整个饮料系统,便产生外观略带白色的饮料,其中含有200mg阿昔洛韦。这对应于该药物的标准片剂剂量。重复三次实验(n=3)。每次均生成无任何浆液的澄清溶液,在八小时的观察期内,没有化合物沉淀,絮凝或重结晶。
患者常称阿昔洛韦的味道令人不快,有时是金属味,该增溶物可以掩盖它的味道。
实施例5:
氢氯噻嗪(Hydrochlorothiazide)是利尿剂。它通常用于治疗高血压,积液引起的肿胀,尿崩症,肾小管酸中毒以及预防肾结石风险高的人。氢氯噻嗪属于BCS 4类(低溶解度低渗透性)药物。
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生20ml增溶物。取氢氯噻嗪,然后在5分钟内室温(20±5℃)和大气压下在搅拌,将增溶化合物一一混合。
然后在连续搅拌下将组合物小心地加热,以大约1℃/min的温度增量。约38分钟
(约58℃)后,组合物开始变成澄清溶液。再让此增溶过程持续了约7分钟。这样,在约45分钟65℃后,获得本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
将5ml的这种增溶物填充到28mm ViCap分配囊的填充腔中,并组装分配囊。将如此装满的分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上,并将其充满矿泉水。将可溶物释放到矿泉水中,并搅拌整个饮料系统。得到的饮料外观略带白色,含有25mg氢氯噻嗪,这是标准的片剂剂量。重复三次(n=3),每次均生成无任何浆液的澄清溶液。在四个小时的观察期内,没有出现化合物沉淀,絮凝或重结晶。
这种增溶物可以掩盖氢氯噻嗪的味道(患者通常将其描述为金属味)。
实施例6:
辅酶Q10(别名:泛醌,泛肽,辅酶Q,CoQ10)是大多数动物中普遍存在的辅酶。已知辅酶Q10有三种氧化还原状态。该分子起2个电子载体和1个电子载体的作用(取决于其在电子传输链中的作用)并作为自由基清除剂。辅酶Q10在水性环境中几乎不溶,在体内吸收较差。但是,它是一种广泛销售的膳食补充剂。
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生20ml增溶物。取辅酶Q10,然后在5分钟内室温(20±5℃)和大气压下在搅拌,将增溶化合物一一混合。
然后在连续搅拌下将组合物小心地加热,以大约0.5℃/min的温度增量。约36分钟(约38℃)后,组合物开始变成澄清溶液。再让此增溶过程持续了约12分钟。这样,在约48分钟44℃后,获得本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
将5ml的这种增溶物填充到INCAP分配囊的底部。将INCAP的上部放在其上,并通过向下按压上部将两部分紧密地封闭。将如此装满的分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上,并充满矿泉水。将增溶物释放到矿泉水中,并搅拌整个饮料系统,产生了一种乳白色淡黄色的饮料,其中含有400mg辅酶Q10。这对应于该膳食补充剂的经常推荐的每日剂量。实验重复三次(n=3)。每次均生成无任何浆液的澄清溶液。在两个小时的观察期内,没有出现化合物沉淀,絮凝或重结晶。
实施例7:
胡椒碱(Piperine,IUPAC名称:1-[5-(1,3-苯并二恶唑-5-基)-1-氧代-2,4-戊二烯基]哌啶)是胡椒(黑胡椒)的主要生物碱,通常由醇提取获得。在室温下为无色至黄色固体,水溶性差。象许多辛辣物质一样,胡椒碱刺激新陈代谢和胃肠道分泌,并显示出抗菌作用。此外,它是生物利用度的增强剂。已发现它抑制人CYP3A4和P-糖蛋白,这是与异源生物首过代谢有关的两种酶。因此,它可用作膳食补充剂和/或其他物质(主要是其他膳食补充剂)的生物利用度增强剂。
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生10ml增溶物。取胡椒碱,然后在5分钟内室温(20±5℃)和大气压下在搅拌,将增溶化合物一一混合。
然后在连续搅拌下将组合物小心地加热,以大约1.5℃/min的温度增量。约27分钟(约60℃)后,组合物开始变成澄清溶液。再让此增溶过程持续了约16分钟。这样,在约43分钟84℃后,获得本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
2ml的这种增溶物填充到Fusion Cap。按实施例1中所述制备方法,制备终溶液(重复三次,n=3)。如此产生的饮料,含有10毫克胡椒碱,这在该膳食补充剂每日的建议剂量(5-15毫克/天)的范围内。在搅拌下,该终溶液迅速变得清澈并具有淡白色外观。在四个小时的观察期内,将饮料冷却至室温后,没有出现化合物沉淀,絮凝或重结晶。
该增溶物可以覆盖胡椒碱特有的辛辣味(更准确地说,是气味)。
实施例8:
绿茶提取物是从绿茶(茶树)中提取的。主要成分是儿茶素(catechins),例如表没食子儿茶素-3-没食子酸酯(EGCG),表儿茶素(EC),表儿茶素-3-没食子酸酯(ECg),表没食子儿茶素(EGC),儿茶素和没食子儿茶素(GC),其中EGCG是绿茶提取物中最富含的成分。绿茶提取物通常用作膳食补充剂,这归因于儿茶素的健康功效,其包括抗氧化,抗癌,抗炎和抗辐射作用。然而,儿茶素,特别是EGCG,显示出较差的生物利用度,并且在水中的溶解度相当有限。
增溶物的制备:
以下标示的量是指混合物的重量百分比,大约产生20ml增溶物。取绿茶提取物(来自萨宾莎,朗根,德国),然后在5分钟内室温(20±5℃)和大气压下在搅拌,将增溶化合物一一混合。
然后在连续搅拌下将组合物小心地加热,以大约2.5℃/min的温度增量。约33分钟(约102℃)后,组合物开始变成澄清溶液。再让此增溶过程持续约4分钟。这样,在约37分钟112℃后,获得本发明的增溶物。然后停止加热和搅拌,并使所得的增溶物冷却至室温。
将5ml的这种增溶物填充到INCAP分配囊的底部。将INCAP的上部放在其上,并通过向下按压上部将两部分紧密地封闭。将如此装满的分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上,并充满静止的矿泉水。将增溶物释放到静止的矿泉水中,并搅拌整个饮料系统,便产生了含有500mg绿茶提取物的饮料。该绿茶提取物含有约50%(重量)的EGCG。因此,饮料中包含约250mg EGCG,这是该膳食补充剂的建议每日剂量。重复三次(n=3)。在搅拌下,终溶液迅速变得澄清,并具有浅白褐色外观。每次试验均生成无任何浆液的澄清溶液。在两个小时的观察期内,没有出现化合物沉淀,絮凝或重结晶。
这种增溶物可掩盖稀释的绿茶提取物的草味(草药味)。对于有时有些苦味的绿茶来说,其也可同样被掩盖(这些苦味使得绿茶在某些人群中不受欢迎)。
实施例9:
制备25ml的基于磺酰脲类抗糖尿病药物格列吡嗪(glipizide,BCS IV类药物)的脂质体增溶物。脂质体由磷脂1,2-二肉豆蔻酰基-sn-甘油-3-磷酸胆碱(DPMC)产生。将50mgDPMC溶解在2.5ml叔丁醇中,并将其在37℃水浴中加热5分钟以便磷脂溶解。然后将溶液在-20℃下储存在密闭的容器中,以避免光照。将50mg格列吡嗪溶解在500pl DMSO中,并在-20℃下保存在密闭的容器中,避免光照。第二天,将溶液解冻,并将2.5ml的DPMC溶液,500pl的格列吡嗪溶液和22ml的叔丁醇一起充分混合(对于脂质体技术,参见US 2008/0103213A1)。所得增溶物具有以下组成:
将5ml的这种增溶物填充到28mm ViCap分配囊的填充腔中,并组装分配囊。将分配囊安装在一个500ml的PET瓶上,该瓶具有标准螺纹(28毫米,右旋)并装满起泡矿泉水。触发其释放机构,并轻轻搅拌所得的终溶液。这样制得的饮料中含有10mg格列吡嗪,这是该药物的标准剂量。重复三次(n=3)。每次均生成无任何浆液的澄清溶液。在四个小时的观察期内,没有出现化合物沉淀,絮凝或重结晶。溶液是透明的,略带黄色,具有中性的可接受的味道。
实施例10:
类似于实施例5,制备25ml基于脂质体的叶酸增溶物(维生素B9)。脂质体由磷脂1,2-二肉豆蔻-sn-甘油-3-磷酸胆碱(DPMC)产生。将50mg DPMC溶解在2.5ml叔丁醇中,并将其在37℃水浴中加热5分钟以便磷脂溶解。然后将溶液在-20℃下储存在密闭的容器中,以避免光照。将2mg叶酸溶解在500ul DMSO中,并在-20℃的密封容器中保存,以避免光照。第二天将溶液解冻,并将2.5ml的DPMC溶液,500pl的叶酸溶液和22ml的叔丁醇一起充分混合。所得增溶物具有以下组成:
将5ml的该增溶物填充到ViCap分配囊。将该分配囊安装在装有气泡水的500mlPET瓶中,触发其释放机制,并轻轻搅拌所得的终溶液。这产生了含有400pg叶酸的饮料,这是该膳食补充剂的建议每日剂量。重复三次(n=3)。所得溶液均是透明的,略带黄色,具有中性的可接受的味道。
实施例11:
为了制备抗生素克拉霉素(clarithromycin,BCS IV类药物)的增溶物,产生了10ml的组合物。首先,将克拉霉素(2.5克),β-环糊精(70毫克)和富马酸(500毫克)微粉化,然后一起分散在商购HPC分散体中(7%/w)中。添加少量的二甲硅油乳液以消泡分散体。在行星式混合器(planetary mixer)中制备非离子聚合物羟丙基纤维素(630毫克)和未微粉化的β-环糊精(100毫克)的混合物。再向混合物中添加克拉霉素分散体,然后将整个混合物通过挤出机。将所得材料在45℃下干燥。将干燥的材料再次研磨。然后将其分散在6.2ml水净水中。(有关方法,请参见US 2003/0091627 A1)。
该增溶物具有以下组成:
按前所述的方法,向VizCap分配囊中注入2ml所得的增溶物溶液并制备终溶液。这样产生的饮料含有500mg克拉霉素,这是该抗生素的标准剂量。重复三次(n=3),每次均生成没有任何可见颗粒的终溶液。与许多大环内酯类抗生素一样,克拉霉素具有苦味。在本制剂中,该味道被掩盖,饮料略带甜味。
范例12:
为了制备作为饮食补充剂摄取的生物类黄酮槲皮素(quercetin)的增溶物,产生了20ml的组合物。与实施例11相似,首先将槲皮素(4g),β-环糊精(140mg)和富马酸(1g)微粉化,然后一起分散在HPC的商品分散体中(7%w/w)。添加少量的二甲硅油乳液以消泡分散体。在行星式混合器中制备非离子聚合物羟丙基纤维素(1.26g)和未微粉化的[3-环糊精(200mg)的混合物。再向混合物中添加槲皮素分散体,然后使整个混合物通过挤出机。将所得材料在45℃下干燥。将干燥的材料再次研磨。然后将其分散在12.4ml净水中。
所得增溶物具有以下组成:
将5ml的这种增溶物填充到INCAP分配囊的底部。将INCAP的上部放在其上,并通过向下按压上部将两部分紧密地封闭。将如此装满的分配囊安装在具有标准螺纹(28毫米,右旋)的500毫升PET瓶上,并将瓶充满矿泉水。将增溶物释放到矿泉水中,并搅动整个饮料系统,得到的饮料中含有1克槲皮素,为建议的每日剂量。重复三次(n=3)。每次均生成没有任何可见颗粒的溶液。在两个小时的观察期内,没有化合物沉淀,絮凝或重结晶。
苦味是多酚类黄酮(例如槲皮素)的典型特征。本增溶物掩盖了该苦味,该饮料带甜味。
Claims (15)
1.一种具有至少一个可填充腔室的分配囊,所述可填充腔室包含至少一种药物活性剂和/或膳食补充剂的增溶物,其中所述分配囊被适当地配置为安装在一个饮料容器的出口上,并且通过操作所述分配囊的一个释放机构可将所述增溶物释放至饮料容器中,并且所述至少一种药物活性剂和/或膳食补充剂的增溶物不含有聚山梨醇酸酯,也不包含稀释剂并且在室温下为流体。
2.根据权利要求1所述的分配囊,其中,所述增溶物由至少一种水溶性差的物质或提取物制备。
3.根据权利要求1或2中任一项所述的分配囊,其中,所述增溶物通过胶束,脂质体,自乳化或环糊精络合技术制备。
4.根据权利要求3所述的分配囊,其中,所述增溶物通过自乳化方法制备,所述自乳化方法包括以下步骤:
-在室温和0.2巴至1巴的压力下,提供至少一种占总重量0.5%至25%的药物活性剂或膳食补充剂;
-以任何顺序添加至少一种磷脂酰胆碱的增溶化合物,其占总重量的20%至80%,
-至少一种中链链甘油三酸酯,其占总重量的10%至70%,
-至少一种溶血磷脂酰胆碱,其占总重量的1%至15%,
-至少一种C2至C4醇,其占总重量的1%至20%,和
-至少一种硬脂酸甘油酯和/或饱和或不饱和的C14至C20脂肪酸,其占总重量的0.5%至10%,
其中所有成分的相对重量百分比总计为100%,并且所有增溶化合物彼此独立地为食品添加剂和/或药学上可接受的赋形剂;
-通过在20至60分钟的时间内以0.5℃/min至3℃/min的连续温度增量,连续升高温度来小心加热所得的混合物;
-在30℃至125℃的温度范围内,溶液达到澄清后立即停止升温;和
-让所得的增溶物冷却至室温。
5.根据权利要求1至4中任一项所述的分配囊,其中,所述分配囊选自触发器释放型分配囊和密封型分配囊。
6.根据权利要求1至5中任一项所述的分配囊,其中,所述分配囊的所述至少一个腔室是限制氧气和/或水分接触的,和/或所述增溶物的制备过程和/或所述所述增溶物装入所述少一个腔室的过程是在保护气体或真空下进行的。
7.根据权利要求1至6中任一项所述的分配囊,其中,所述增溶物由选自作为药物活性剂的速尿,格列吡嗪,克拉霉素,阿奇霉素,阿昔洛韦和氢氯噻嗪的物质制备,或选自作为膳食补充剂的β-胡萝卜素,叶酸,槲皮素,辅酶Q10,胡椒碱和绿茶提取物。
8.根据权利要求1至7中的任一项所述的分配囊,其中,所述增溶物使其内被增溶的至少一种药物活性剂和/或膳食补充剂在人体内的吸收和/或生物利用度,相比于没有被增溶的同等物质,增强。
9.根据权利要求1至8中任一项所述的分配囊,其中,所述增溶物使其内被增溶的至少一种药物活性剂和/或膳食补充剂的苦味和/或令人不愉快的味道得到掩盖。
10.根据权利要求1至9中任一项所述的分配囊,其中,至少一种选自维生素,矿物质,微量元素,兴奋剂,膳食补充剂,草药产品,适应原,抗氧化剂,着色剂,调味剂,增香剂,芳香族物质,甜味剂,等渗剂,发泡剂,药物活性剂,药物赋形剂,酸化剂,酸度调节剂,缓冲液,防腐剂,稳定剂,pH调节剂和遮光剂的非被增溶的物质,被额外地加入到所述增溶物中而装入分配囊的至少一个可填充腔室。
11.一种饮料系统,包括一个饮料容器和一个如权利要求1所述的分配囊。
12.根据权利要求11的饮料系统,其用作药物剂型,其中所述增溶物由至少一种药物活性剂制备。
13.一种提供根据权利要求11或12中任一项所述的饮料系统的方法,包括以下步骤:
a)提供如权利要求11所述的饮料容器;
b)提供如权利要求5所述的分配囊;
c)通过权利要求3所定义的增溶技术产生至少一种药物活性剂和/或饮食补充剂的增溶物;
d)将由步骤c)得到的增溶物填充到分配囊的至少一个可填充室中;
e)通过一个适当构造的密封膜或通过组装分配盖的各个部件,紧密地封闭分配囊的至少一个腔室;
f)可选地,将可饮用的液体填充到所述饮料容器中;和
g)将上述填充好的分配囊安装到饮料容器上。
14.一种终溶液,由下述步骤制备:
a)提供如权利要求11或12中任一项所述的饮料系统,其中,所述饮料容器预先填充有可饮用液体,
b)触发如权利要求1所述的分配囊的释放机构,将所述增溶物释放到饮用水中,以及
c)可选地,搅动饮料系统以使可饮用液体和释放的增溶物更好地混合。
15.根据权利要求14的用于药物的终溶液,其中所述增溶物由至少一种药物活性剂制备。
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- 2017-04-12 EP EP17000630.8A patent/EP3388054A1/en not_active Ceased
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2018
- 2018-04-11 EP EP18720962.2A patent/EP3609475A1/en not_active Withdrawn
- 2018-04-11 US US16/603,969 patent/US20200113824A1/en not_active Abandoned
- 2018-04-11 CN CN201880024507.7A patent/CN110869005A/zh active Pending
- 2018-04-11 WO PCT/EP2018/000190 patent/WO2018188797A1/en unknown
- 2018-04-11 CA CA3061437A patent/CA3061437A1/en active Pending
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Cited By (5)
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CN109922793A (zh) * | 2016-09-06 | 2019-06-21 | 雅典娜股份公司 | 水溶性差的膳食补充剂和药物活性剂的溶解方法 |
CN113265692A (zh) * | 2021-05-21 | 2021-08-17 | 江西科技师范大学 | 一种含有氨基酸螯合物的微弧氧化电解液及一种制备抗菌性氧化膜的方法 |
CN117502646A (zh) * | 2023-11-29 | 2024-02-06 | 航天神舟生物科技集团有限公司 | 一种高含量、可水溶的辅酶q10组合物及其制备方法 |
CN117682499A (zh) * | 2024-02-02 | 2024-03-12 | 四川易纳能新能源科技有限公司 | 一种超疏水改性磷酸焦磷酸铁钠正极材料及其制备方法和应用 |
CN117682499B (zh) * | 2024-02-02 | 2024-04-19 | 四川易纳能新能源科技有限公司 | 一种超疏水改性磷酸焦磷酸铁钠正极材料及其制备方法和应用 |
Also Published As
Publication number | Publication date |
---|---|
EP3609475A1 (en) | 2020-02-19 |
EP3388054A1 (en) | 2018-10-17 |
WO2018188797A8 (en) | 2019-05-16 |
CA3061437A1 (en) | 2018-10-18 |
US20200113824A1 (en) | 2020-04-16 |
WO2018188797A1 (en) | 2018-10-18 |
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