CN108366970A - 具有内部隔片和固体成分的胶囊 - Google Patents
具有内部隔片和固体成分的胶囊 Download PDFInfo
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- CN108366970A CN108366970A CN201680071694.5A CN201680071694A CN108366970A CN 108366970 A CN108366970 A CN 108366970A CN 201680071694 A CN201680071694 A CN 201680071694A CN 108366970 A CN108366970 A CN 108366970A
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- Prior art keywords
- capsule
- compartment
- solid constituent
- lactobacillus
- constituent includes
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Abstract
双隔室胶囊包含主体、在中间的隔片(所述隔片密封主体并且提供第一隔室以容纳第一干燥成分)以及被应用至主体的盖,借此在盖的内部和隔片之间的空间限定用于容纳第二干燥成分的第二隔室。本公开还提供用于这样的胶囊的特定剂型。实施例包含益生菌、消化酶、祛痰药、支气管扩张药、大便松软剂、血小板聚集抑制剂、维生素E的形式或衍生物、抑制素和阿司匹林。
Description
相关申请的交叉引用
本申请要求于2015年10月9日提交的题目为“具有体积可调整的内部隔片的胶囊(Capsule with Volume-Adjustable Internal Diaphragm)”的美国临时申请序列号62/239,435、于2015年10月9日提交的题目为“为了改进的生物利用度的具有内部隔片的胶囊(Capsule with Internal Diaphragm for Improved Bioavailability)”的美国临时申请序列号62/239,454,以及于2015年10月9日提交的题目为“具有内部隔片和固体成分的胶囊(Capsule with Internal Diaphragm and Solid Ingredients)”的美国临时申请序列号62/239,442的优先权和权益,上述申请中的每个特此以引用方式被整体并入本文。
概述
本文中所描述的实施方案针对多隔室胶囊,所述多隔室胶囊包括主体;隔片,所述隔片具有两个侧壁和底部,所述隔片延伸到主体内,并且在隔片的外表面和主体的内表面之间限定第一隔室;以及盖,所述盖被安装到主体的外表面并且与隔片相对,并且在隔片的内表面和盖之间限定第二隔室;其中隔片的两个侧壁沿主体的内表面延伸,并且与主体的开口端对准。在一些实施方案中,胶囊为00号胶囊。
在一些实施方案中,第一隔室是密封的。在一些实施方案中,一种或更多种固体成分包括粉末、颗粒、半固体、微珠、微囊或其组合。
在一些实施方案中,隔片的底部可以是平的。在一些实施方案中,隔片的底部可以是弯曲的。在一些实施方案中,隔片的底部可以是大体上或部分平的。
在一些实施方案中,第一隔室和第二隔室每个具有充足的体积以施用治疗有效剂量的成分。
在一些实施方案中,一种或更多种固体成分包括益生菌。益生菌可以选自由嗜酸乳杆菌、干酪乳杆菌、加氏乳杆菌、瑞士乳杆菌、保加利亚乳杆菌、德氏乳杆菌、胚牙乳杆菌、副干酪乳杆菌、唾液乳杆菌、罗伊乳杆菌、鼠李糖乳杆菌、短乳杆菌(Lactobacillusbrevis)、短乳杆菌(Lactobacillus breve)、嗜热链球菌、婴儿双岐杆菌、乳酸双岐杆菌、长双岐杆菌、两歧双岐杆菌、凝结双岐杆菌、短双岐杆菌、动物双岐杆菌、枯草双岐杆菌、布拉迪酵母及其组合组成的组。在一些实施方案中,一种或更多种固体成分包括从约1百万菌落形成单位(CFU)至约1000亿CFU的益生菌。
在一些实施方案中,一种或更多种固体成分包括消化酶。消化酶可以选自由淀粉酶、α-淀粉酶、蛋白酶、α-半乳糖苷酶、β-葡聚糖酶、半乳甘露聚糖酶、乳糖酶、脂肪酶、纤维素酶、半纤维素酶、肌醇六磷酸酶、蔗糖酶、转化酶、果胶酶、麦芽糖酶、麦芽淀粉糖化酶、葡糖淀粉酶、木聚糖酶、支链淀粉酶、肽酶和二肽酰基肽酶IV、沙雷氏菌肽酶、溶菌酶、菠萝蛋白酶、木瓜蛋白酶及其组合组成的组。在一些实施方案中,一种或更多种固体成分包括从约50mg至约1000mg的消化酶。在一些实施方案中,第一隔室包括从约一百万CFU至约100亿CFU的益生菌,并且第二隔室包括从约50mg至约1000mg的消化酶。在一些实施方案中,第一隔室包括从约10mg至约1000mg的消化酶,并且第二隔室包括从约1百万CFU至约1000亿CFU的益生菌。
在一些实施方案中,一种或更多种固体成分包括药物药剂。在一些实施方案中,药物药剂选自由阿司匹林、抑制素、依普黄酮(ipriflavone)、升麻类药草、仙人掌属植物(castus)、辅酶Q10(CoQ10)、愈创甘油醚、药蜀葵根(althea root)、五硫化二锑、木馏油、愈创木酚磺酸酯、吐根(吐根糖浆)、左旋马鞭草烯酮(levoverbenone)、碘化钾、美远志、泰洛沙泊、氯化铵、沙丁胺醇(salbutamol)、沙丁胺醇(albuterol)、左旋沙丁胺醇(levosalbutamol)、左旋沙丁胺醇(levalbuterol)、吡布特罗、肾上腺素、麻黄碱、特布他林、沙美特罗、克仑特罗、福莫特罗(formoterol)、班布特罗(bambuerol)、茚达特罗、硫酸肝配蛋白(ephrinesulfate)、噻氯匹定、氯吡格雷(clopidogrel)、普拉格雷(prasugrel)、替卡格雷(ticagrelor)、西洛他唑(cilostazol)、沃拉帕沙(vorapaxar)、三氟柳(trifusal)、双嘧达莫、生育三烯酚及其组合组成的组。在一些实施方案中,一种或更多种固体成分包括阿司匹林。在一些实施方案中,一种或更多种固体成分包括从约81mg至约324mg的阿司匹林。在一些实施方案中,阿司匹林可以为约10mg至约500mg的量。
在一些实施方案中,一种或更多种固体成分包括抑制素。抑制素可以选自由阿托伐他汀(atorvastatin)、氟伐他汀(fluvastatin)、洛伐他汀(lovastatin)、匹伐他汀(pitavastatin)、普伐他汀(pravastatin)、罗苏伐他汀(rosuvastatin)、辛伐他汀(simvastatin)及其组合组成的组。抑制素可以为约1mg至约100mg的量。在一些实施方案中,抑制素可以为约5mg至约40mg的量。
附图描述
图1图示说明本文实施方案的胶囊的横截面视图,其中第一(下部)隔室具有约423mm3的体积,并且第二(上部)隔室具有约497mm3的体积,并且每个隔室包括固体成分。
图2图示说明本文实施方案的胶囊的横截面视图,其中第一(下部)隔室具有约743mm3的体积,并且第二(上部)隔室具有约176mm3的体积,并且其中每个隔室包括固体成分。
图3图示说明具有平的底部的本文实施方案的胶囊的横截面视图,其中每个隔室包括固体成分。
图4A、4B和4C图示说明可以在本文中所描述的一些实施方案中使用的标准的和伸长的TORPAC胶囊尺寸。
详细说明
在描述本发明的组合物和方法之前,可以理解的是,本发明不限于所描述的特定过程、组合物或方法,因为这些可以变化。还可以理解的是,说明书中使用的术语仅用于描述特定版本或实施方案的目的,而不旨在限制本发明的范围,本发明的范围将仅由所附权利要求书限制。除非另外定义,否则本文使用的全部技术术语和科学术语具有与本领域普通技术人员通常理解的含义相同的含义。尽管在本发明的实施方案的实践或测试中可以使用与本文中所描述的那些类似或等同的任何方法和材料,但是现在描述优选的方法、装置和材料。本文提到的全部出版物通过引用被整体并入。本文的任何内容不能被解释为承认本发明由于在先的发明而无权先于这样的公开。
还必须注意的是,除非上下文另外明确指出,否则如本文和所附权利要求书中使用的,单数形式“一(a)”、“一(an)”和“所述”包含复数提及。因此,例如,对“一种成分”的提及是对本领域技术人员已知的一种或更多种成分及其等同物的提及等。
如本文所使用的,术语“约”意为其正在使用的数字的数值的加或减10%。因此,约50mg意为在45mg-55mg的范围中。
如本文所使用的,术语“患者”或“受试者”是患有可以通过本文所描述的治疗剂和/或组合物治疗的有害的疾病或病况的动物(特别是人)。
“可选的”或“可选地”意为随后描述的事件或状况可以发生或可以不发生,并且描述包含事件发生的情况和事件不发生的情况。
贯穿本申请的说明书,使用各种术语,如“主要的”、“次要的”、“第一”、“第二”等。这些术语是用于区分不同要素的方便的词语,并且这样的术语不旨在限制可以如何使用不同要素。
如本文所使用的,术语“药物”或“治疗剂”意为用于治疗、对抗、减轻、预防或改善受试者的有害的病况或疾病的药剂。
组合物的“治疗有效的量”或“有效的量”是获得期望的结果所必需的量或足以获得期望的结果的量。本文实施方案预期的活性包含(视情况而定)医学治疗、美容治疗和/或预防疾病的治疗。本文实施方案的化合物的治疗有效的量通常是使得当所述化合物在生理上可耐受的赋形剂组合物中被施用时,足以在组织中或组织上获得有效的系统性浓度或局部浓度以获得期望的治疗结果或临床结果的量。
如本文所使用的,术语“治疗(treat)”、“治疗(treated)”或“治疗(treating)”指治疗性治疗、美容治疗、和/或预防疾病的措施或预防性的措施,其中目的是预防或减缓(减轻)不期望的生理病况、紊乱或疾病,或获得有益的或期望的临床结果。为了本发明的目的,有益的或期望的临床结果包含但不限于症状的缓和;病况、紊乱或疾病的程度的减小;病况、紊乱或疾病的状态的稳定(即,不恶化);病况、紊乱或疾病的发作的延迟或病况、紊乱或疾病的进展的减缓;病况、紊乱或疾病状态的减轻;以及病况、紊乱或疾病的缓解(无论是部分或全部的),无论是可检测的或不可检测的),或改进(enhancement)或改善。治疗包含引起临床显著的反应,而没有过度水平的副作用。
如本文所使用的,术语“由......组成(consist of)”或“由...组成(consistingof)”意为剂型仅包含在特定要求保护的实施方案或权利要求中明确列举的要素、步骤或成分。
如本文所使用的,术语“基本上由......组成(consisting essentially of)”或“基本上由...组成(consist essentially of)”意为治疗指定病况的剂型或方法中唯一的活性药物成分是特定实施方案或权利要求中明确列举的治疗剂。
通常以某些标准尺寸(如被称作TORPAC尺寸的由数字(如000、00等)命名的胶囊尺寸)制造胶囊。这样的胶囊通常具有两部分:盖和主体,所述盖和主体被结合或装配在一起。00胶囊是最常见的尺寸之一。与其他胶囊一样,典型的00号胶囊具有标准化的标称容积。例如,00号胶囊具有大约0.95毫升的容积。在下面描述的一些实施方案中,多隔室胶囊是00号胶囊。在一些实施方案中,胶囊尺寸可以是000号、0号、1号、2号、3号、4号、或5号、或这些尺寸之间的任何非标准尺寸。在下面描述的一些实施方案中,胶囊尺寸可以被伸长(“EL”),使得尺寸可以是,例如,00EL。在一些实施方案中,伸长可以是任何标准长度或非标准长度。在一些实施方案中,伸长的胶囊可以将从约50mm3至约150mm3的附加的体积增加至第一隔室、第二隔室或其组合。在一些实施方案中,伸长的胶囊可以将约110mm3的附加的体积增加至第一隔室、第二隔室或其组合。在一些实施方案中,如果隔片的直径减小,则可以可能的是将较长的隔片插入胶囊中,从而改变第一隔室和第二隔室两者中的可利用体积。在一些实施方案中,缩放本文中所描述的多隔室胶囊的尺寸规格可以导致具有与本文中所描述的基本相同的比例的更大或更小的胶囊。在一些实施方案中,缩放本文中所描述的多隔室胶囊的尺寸规格可以导致具有不同于本文中所描述的那些的比例的更大或更小的胶囊。
对于一些应用,以具有两个隔室的胶囊的形式递送一种或更多种成分可以是有利的。用于一些应用,在这样的胶囊中递送的一种或更多种成分是固体成分可以是有利的。这样的双隔室胶囊的示例性益处可以包含增加的依从性、双室控制释放、由于共同施用而增加的成分的功效或生物利用度、增加的稳定性,以及将成分的困难组合配制成一个胶囊的能力(如现在可以共同施用的不相容的活性物)。
本文中所描述的实施方案针对多隔室胶囊,所述多隔室胶囊包括主体;隔片,所述隔片具有两个侧壁和底部,所述隔片延伸到主体内,并且在隔片的外表面和主体的内表面之间限定第一隔室;以及盖,所述盖被安装到主体的外表面并且与隔片相对,并且在隔片的内表面和盖之间限定第二隔室;其中隔片的两个侧壁沿主体的内表面延伸,并且与主体的开口端对准。在一些实施方案中,胶囊是00号胶囊。
在一些实施方案中,多隔室胶囊可以包括主体;隔片,所述隔片具有两个侧壁和底部,所述隔片延伸到主体内并且形成由隔片的第一表面和主体限定的第一隔室;以及盖,所述盖被安装到主体并且与隔片相对,所述盖形成由隔片的相对表面和盖限定的第二隔室;其中隔片的两个侧壁沿主体的内表面延伸,并且与主体的开口端对准;并且其中第一隔室和第二隔室每个适合于容纳一种或更多种固体成分。在一些实施方案中,第一隔室是密封的。在一些实施方案中,一种或更多种固体成分包括粉末、颗粒、半固体、微珠、微囊或其组合。
在一些实施方案中,隔片的底部可以是平的。较平的底部可以允许下部隔室中更多的体积。在一些实施方案中,隔片的底部可以是弯曲的。在一些实施方案中,隔片的底部可以是大体上或部分平的。
在一些实施方案中,第一隔室包括固体成分。在一些实施方案中,第二隔室包括固体成分。在一些实施方案中,第一隔室和第二隔室每个括一种或更多种固体成分。在一些实施方案中,第一隔室和第二隔室每个具有充足的体积以施用治疗有效剂量的一种或更多种成分。
在一些实施方案中,第一隔室可以具有约50mm3至约1000mm3的体积,并且第二隔室可以具有约50mm3至约1000mm3的体积。例如,如图1中所示,本文实施方案的胶囊可以具有第一(下部)隔室和第二(上部)隔室,所述第一(下部)隔室具有约423mm3的体积,并且所述第二(上部)隔室具有约497mm3的体积。在一些实施方案中,如图2中所示,本文实施方案的胶囊可以具有第一(下部)隔室和第二(上部)隔室,所述第一(下部)隔室具有约743mm3的体积,并且所述第二(上部)隔室具有约176mm3的体积。
在一些实施方案中,一种或更多种固体成分可以是阿司匹林、抑制素、月经止痛药、用于增加骨密度的药剂、用于减轻热潮红的药剂、CoQ10、胆固醇降低剂、甲状腺激素、支气管扩张药(例如硫酸麻黄碱)、祛痰药、减充血剂(例如伪麻黄碱或愈创甘油醚)、抗炎药剂(例如NSAID)、益生元、益生菌、消化酶、大便松软剂、抗血小板聚集剂、维生素(例如维生素D3或维生素E)、止痛药、异黄酮衍生物(例如依普黄酮)、草药(例如升麻类药草或仙人掌属植物)、皮质类固醇(例如地塞米松)、质子泵抑制剂、任何其他固体药物药剂、或其组合。
在一些实施方案中,一种或更多种固体成分包括益生菌。益生菌可以选自由嗜酸乳杆菌、干酪乳杆菌、加氏乳杆菌、瑞士乳杆菌、保加利亚乳杆菌、德氏乳杆菌、胚牙乳杆菌、副干酪乳杆菌、唾液乳杆菌、罗伊乳杆菌、鼠李糖乳杆菌、短乳杆菌(Lactobacillusbrevis)、短乳杆菌(Lactobacillus breve)、嗜热链球菌、婴儿双岐杆菌、乳酸双岐杆菌、长双岐杆菌、两歧双岐杆菌、凝结双岐杆菌、短双岐杆菌、动物双岐杆菌、枯草双岐杆菌、布拉迪酵母及其组合组成的组。在一些实施方案中,一种或更多种固体成分包括从约1百万菌落形成单位(CFU)至约1000亿CFU的益生菌。在一些实施方案中,一种或更多种固体成分可以包括,例如,约1百万CFU的益生菌、5000万CFU的益生菌、1亿CFU的益生菌、2亿CFU的益生菌、3亿CFU的益生菌、4亿CFU的益生菌、5亿CFU的益生菌、6亿CFU的益生菌、7亿CFU的益生菌、8亿CFU的益生菌、9亿CFU的益生菌、10亿CFU的益生菌、约20亿CFU的益生菌、约30亿CFU的益生菌、约40亿CFU的益生菌、约50亿CFU的益生菌、约60亿CFU的益生菌、约70亿CFU的益生菌、约80亿CFU的益生菌、约90亿CFU的益生菌、约100亿CFU的益生菌、约110亿CFU的益生菌、约120亿CFU的益生菌、约130亿CFU的益生菌、约140亿CFU的益生菌、约150亿CFU的益生菌、约200亿CFU的益生菌、约300亿CFU的益生菌、约400亿CFU的益生菌、约500亿CFU的益生菌、约600亿CFU的益生菌、约700亿CFU的益生菌、约800亿CFU的益生菌、约900亿CFU的益生菌、约1000亿CFU的益生菌或任何这些值之间的任何范围(包含端点)。
在一些实施方案中,一种或更多种固体成分包括消化酶。消化酶可以选自由淀粉酶、α-淀粉酶、蛋白酶、α-半乳糖苷酶、β-葡聚糖酶、半乳甘露聚糖酶、乳糖酶、脂肪酶、纤维素酶、半纤维素酶、肌醇六磷酸酶、蔗糖酶、转化酶、果胶酶、麦芽糖酶、麦芽淀粉糖化酶、葡糖淀粉酶、木聚糖酶、支链淀粉酶、肽酶和二肽酰基肽酶IV、沙雷氏菌肽酶、溶菌酶、菠萝蛋白酶、木瓜蛋白酶及其组合组成的组。在一些实施方案中,一种或更多种固体成分包括从约10mg至约10000mg的消化酶。在一些实施方案中,一种或更多种固体成分可以包括,例如,约10mg的消化酶、约20mg的消化酶、约30mg的消化酶、约40mg的消化酶、约50mg的消化酶、约60mg的消化酶、约70mg的消化酶、约80mg的消化酶、约90mg的消化酶、约100mg的消化酶、约200mg的消化酶、约300mg的消化酶、约400mg的消化酶、约500mg的消化酶、约600mg的消化酶、约700mg的消化酶、约800mg的消化酶、约900mg的消化酶、约1000mg的消化酶或任何这些值之间的任何范围(包含端点)。
在一些实施方案中,第一隔室包括从约一百万CFU至约1000亿CFU的益生菌,并且第二隔室包括从约10mg至约1000mg的消化酶。在一些实施方案中,第一隔室包括从约10mg至约1000mg的消化酶,并且第二隔室包括从约1百万CFU至约1000亿CFU的益生菌。
包括益生菌的隔室可以具有约50mm3至约1000mm3的体积,并且包括消化酶的隔室可以具有约50mm3至约1000mm3的体积。
在一些实施方案中,一种或更多种固体成分包括药物药剂。在一些实施方案中,药物药剂选自,例如,阿司匹林、抑制素、依普黄酮、升麻类药草、仙人掌属植物、辅酶Q10(CoQ10)、愈创甘油醚、药蜀葵根、五硫化二锑、木馏油、愈创木酚磺酸酯、吐根(吐根糖浆)、左旋马鞭草烯酮、碘化钾、美远志、泰洛沙泊、氯化铵、沙丁胺醇(salbutamol)、沙丁胺醇(albuterol)、左旋沙丁胺醇(levosalbutamol)、左旋沙丁胺醇(levalbuterol)、伪麻黄碱、地塞米松、吡布特罗、肾上腺素、麻黄碱、特布他林、沙美特罗、克仑特罗、福莫特罗、班布特罗、茚达特罗、硫酸肝配蛋白、噻氯匹定、氯吡格雷、普拉格雷、替卡格雷、西洛他唑、沃拉帕沙、三氟柳、双嘧达莫、生育三烯酚及其组合。
在一些实施方案中,一种或更多种固体成分包括阿司匹林。在一些实施方案中,一种或更多种固体成分包括从约10mg至约500mg的阿司匹林。在一些实施方案中,阿司匹林可以为约50mg至约500mg、约100mg至约500mg、约150mg至约500mg、约200mg至约500mg、约50mg至约400mg、约100mg至约400mg、约150mg至约400mg、约200mg至约400mg或这些值中的任何两个之间的范围的量。在一些实施方案中,阿司匹林包括从约81mg至约324mg。在一些实施方案中,第一隔室或第二隔室中的一个包括阿司匹林,并且另一个隔室可以包括抑制素。在一些实施方案中,抑制素可以为约1mg至约100mg、约1mg至约50mg、约1mg至约30mg、约1mg至约20mg、约1mg至约10mg、约10mg至约100mg、约20mg至约100mg、约30mg至约100mg、约50mg至约100mg、约75mg至约100mg、约1mg、约10mg、约25mg、约50mg、约75mg、约100mg或这些值中的任何两个之间的范围的量。
在一些实施方案中,包括阿司匹林的隔室具有约50mm3至约1000mm3的体积,并且另一个隔室具有约50mm3至约1000mm3的体积。
在一些实施方案中,两个隔室两者都可以包括阿司匹林。例如,第一隔室或第二隔室可以包括约300mg的阿司匹林,并且另一个隔室可以包括约200mg的阿司匹林。
在一些实施方案中,第一隔室或第二隔室可以包括阿司匹林,而另一个隔室可以包括抑制素、维生素D3或其组合。
在一些实施方案中,一种或更多种固体成分可以是胆固醇降低剂、止痛药、抗血小板聚集剂或其组合。
在一些实施方案中,第一隔室或第二隔室可以包括阿司匹林,而另一个隔室可以包括依普黄酮、升麻类药草、仙人掌属植物或其组合。
在一些实施方案中,第一隔室或第二隔室可以包括阿司匹林,而另一个隔室可以包括伪麻黄碱、地塞米松或其组合。在一些实施方案中,伪麻黄碱可以为约10mg至约500mg、约50mg至约500mg、约100mg至约500mg、约150mg至约500mg、约200mg至约500mg、约50mg至约400mg、约100mg至约400mg、约150mg至约400mg、约200mg至约400mg、约50mg、约100mg、约120mg、约140mg、约150mg、约200mg或这些值中的任何两个之间的范围的量。在一些实施方案中,地塞米松可以为约5mg至约100mg、约5mg至约50mg、约10mg至约100mg、约10mg至约50mg、约5mg至约40mg、约10mg至约40mg、约5mg、约10mg、约15mg、约20mg、约25mg、约30mg、约35mg、约40mg或这些值中的任何两个之间的范围的量。例如,第一隔室或第二隔室可以包括约500mg阿司匹林,并且另一个隔室可以包括约120mg的伪麻黄碱和约10mg至约40mg的地塞米松。
在一些实施方案中,第一隔室或第二隔室可以包括萘普生,并且另一个隔室可以包括伪麻黄碱。在一些实施方案中,萘普生为约10mg至约500mg、约50mg至约500mg、约100mg至约500mg、约150mg至约500mg、约200mg至约500mg、约50mg至约400mg、约100mg至约400mg、约150mg至约400mg、约200mg至约400mg、约50mg至约300mg、约100mg至约300mg、约150mg至约300mg、约200mg至约300mg、约50mg、约100mg、约150mg、约200mg、约250mg、约300mg或这些值中的任何两个之间的范围的量。例如,在一些实施方案中,第一隔室或第二隔室可以包括约300mg的萘普生,并且另一个隔室可以包括约120mg的伪麻黄碱。在一些实施方案中,第一隔室或第二隔室可以包括阿司匹林,并且另一个隔室可以包括质子泵抑制剂。在一些实施方案中,质子泵抑制剂可以选自奥美拉唑、兰索拉唑、右兰索拉唑、雷贝拉唑、泮托拉唑、埃索美拉唑或其组合。在一些实施方案中,质子泵抑制剂可以为约5mg至约100mg、约10mg至约100mg、约15mg至约100mg、约20mg至约100mg、约25mg至约100mg、约30mg至约100mg、约5mg至约50mg、约10mg至约50mg、约15mg至约50mg、约20mg至约50mg、约25mg至约50mg、约30mg至约50mg、约5mg至约30mg、约10mg至约30mg、约15mg至约30mg、约20mg至约30mg、约25mg至约30mg、约5mg、约10mg、约15mg、约20mg、约25mg、约30mg、约35mg、约40mg、约45mg、约50mg或这些值中的任何两个之间的范围的量。例如,在一些实施方案中,第一隔室或第二隔室可以包括约500mg阿司匹林,并且另一个隔室可以包括约30mg的质子泵抑制剂。在一些实施方案中,一种或更多种固体成分可以是月经止痛药、用于增加骨密度的药剂、用于减轻热潮红的药剂或其组合。在一些实施方案中,第一隔室或第二隔室可以包括抑制素,并且另一个隔室可以包括CoQ10、阿司匹林或其组合。在一些实施方案中,一种或更多种固体成分可以是胆固醇降低剂、CoQ10或其组合。在一些实施方案中,第一隔室或第二隔室可以包括愈创甘油醚,并且另一个隔室可以包括硫酸肝配蛋白。在一些实施方案中,一种或更多种固体成分包含支气管扩张药和祛痰药。在一些实施方案中,第一隔室或第二隔室可以包括用于肠道健康的益生元和大便松软剂。在一些实施方案中,第一隔室或第二隔室可以包括益生元,并且另一个隔室可以包括多库酯。
在一些实施方案中,第一隔室或第二隔室包括阿司匹林,并且另一个隔室包括噻氯匹定。在一些实施方案中,一种或更多种固体成分是抗血小板聚集剂、阿司匹林及其组合。在一些实施方案中,第一隔室或第二隔室包括阿司匹林,并且第二隔室包括生育三烯酚。在一些实施方案中,一种或更多种固体成分处于粉末或微囊形式。
在一些实施方案中,一种或更多种固体成分包括抑制素。抑制素可以选自由阿托伐他汀、氟伐他汀、洛伐他汀、匹伐他汀、普伐他汀、罗苏伐他汀、辛伐他汀及其组合组成的组。抑制素可以为约1mg至约100mg的量。在一些实施方案中,抑制素可以为约1mg、约10mg、约20mg、约30mg、约40mg、约50mg、约100mg或这些值中的任何两个之间的范围的量。在一些实施方案中,抑制素可以为约5mg至约40mg的量。在一些实施方案中,第一隔室或第二隔室中的一个包括约1mg至约100mg的量的抑制素。在一些实施方案中,另一个隔室可以包括第二成分,如,例如,阿司匹林、三碘甲腺原氨酸、抑制素、益生菌、消化酶或其组合。
在一些实施方案中,包括抑制素的隔室具有约50mm3至约1000mm3的体积,并且另一个隔室具有约50mm3至约1000mm3的体积。
在一些实施方案中,第一隔室可以包括从约10mg至约500mg的阿司匹林,并且第二隔室可以包括从约10mg至约500mg的依普黄酮、约1mg至约150mg的升麻类药草、约10mg至约1000mg的仙人掌属植物或其任何组合。在一些实施方案中,依普黄酮可以为约10mg至约1000mg的量。在一些实施方案中,依普黄酮可以为约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1000mg或这些值中的任何两个之间的范围的量。在一些实施方案中,升麻类药草可以为约1mg至约150mg的量。在一些实施方案中,升麻类药草可以为约1mg、约10mg、约20mg、约30mg、约40mg、约50mg、约100mg、约150mg或这些值中的任何两个之间的范围的量。在一些实施方案中,仙人掌属植物可以为约10mg至约1000mg的量。在一些实施方案中,仙人掌属植物可以为约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1000mg或这些值中的任何两个之间的范围的量。
在一些实施方案中,第一隔室可以包括从约1mg至约100mg的抑制素,并且第二隔室可以包括从约10mg至约500mg的阿司匹林、约10mg至约1000mg的CoQ10、或其任何组合。在一些实施方案中,CoQ10可以为约10mg至约1000mg的量。在一些实施方案中,CoQ10可以为约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1000mg或这些值中的任何两个之间的范围的量。
在一些实施方案中,第一隔室可以包括从约10mg至约1200mg的祛痰药,并且第二隔室可以包括从约5mg至约150mg的支气管扩张药。在一些实施方案中,祛痰药可以为约10mg至约1000mg的量。在一些实施方案中,祛痰药可以为约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1000mg、约1100mg、约1200mg或这些值中的任何两个之间的范围的量。在一些实施方案中,支气管扩张药可以为约10mg至约150mg的量。在一些实施方案中,支气管扩张药可以为约10mg、约20mg、约30mg、约40mg、约50mg、约100mg、约150mg或这些值中的任何两个之间的范围的量。在一些实施方案中,祛痰药可以是,例如,愈创甘油醚、药蜀葵根、五硫化二锑、木馏油、愈创木酚磺酸酯、吐根(吐根糖浆)、左旋马鞭草烯酮、碘化钾、美远志、泰洛沙泊、氯化铵或其任何组合。在一些实施方案中,支气管扩张药可以是,例如,沙丁胺醇(salbutamol)、沙丁胺醇(albuterol)、左旋沙丁胺醇(levosalbutamol)、左旋沙丁胺醇(levalbuterol)、吡布特罗、肾上腺素、麻黄碱、特布他林、沙美特罗、克仑特罗、福莫特罗、班布特罗、茚达特罗、硫酸肝配蛋白或其任何组合。
在一些实施方案中,第一隔室或第二隔室包括非类固醇类抗炎药(NSAID),并且另一个隔室包括质子泵抑制剂。在一些实施方案中,NSAID可以为约10mg至约1000mg的量。在一些实施方案中,NSAID可以为约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1000mg或这些值中的任何两个之间的范围的量。在一些实施方案中,NSAID可以选自阿司匹林、布洛芬、萘普生、二氟尼柳、水杨酸以及其他水杨酸酯、双水杨酯、右旋布洛芬、非诺洛芬、酮洛芬、右酮洛芬、氟比洛芬、奥沙普秦、洛索洛芬、乙酸衍生物、吲哚美辛、托美丁、舒林酸、依托度酸、酮咯酸、双氯芬酸、醋氯芬酸、萘布美酮、烯醇酸、吡罗昔康、美洛昔康(meloxicam)、替诺昔康、屈恶昔康(droxicam)、氯诺昔康(lornoxicam)、伊索昔康、苯基丁氮酮、邻氨基苯甲酸衍生物、扑湿痛、甲氯芬那酸、氟灭酸、托芬那酸、塞来昔布(celecoxib)、罗非考昔、伐地考昔、帕瑞考昔(parecoxib)、罗美昔布(lumiracoxib)、艾托考昔、非罗考昔(firocoxib)、磺酰苯胺、尼美舒利(nimesulide)、氯尼辛、利考非隆、H-哈巴苷(H-harpagide)或其组合。
在一些实施方案中,第一隔室可以包括从约1百万CFU至约1000亿CFU的益生菌,并且第二隔室可以包括从约10mg至约500mg的大便松软剂。在一些实施方案中,大便松软剂可以是,例如,多库酯。
在一些实施方案中,第一隔室可以包括从约10mg至约500mg的阿司匹林,并且第二隔室可以包括从约10mg至约500mg的血小板聚集抑制剂。在一些实施方案中,血小板聚集抑制剂可以是,例如,噻氯匹定、氯吡格雷、普拉格雷、替卡格雷、西洛他唑、沃拉帕沙、三氟柳、双嘧达莫或其任何组合。
在一些实施方案中,第一隔室可以包括从约10mg至约500mg的阿司匹林,并且第二隔室可以包括从约10mg至约500mg的维生素E的形式或衍生物。在一些实施方案中,维生素E的形式或衍生物可以是生育三烯酚,如,例如,α生育三烯酚、β生育三烯酚、γ生育三烯酚、δ生育三烯酚或其任何组合。
下表1列出了可以在一些实施方案中存在的固体成分的一些可能的组合。将被理解的是,表1内的任何成分可以在任何组合存在,并且可以在本文中所描述的胶囊的任一隔室中存在。还将被理解的是,表1中描述的实施方案并不意为限制性的,而仅是说明性的。
表1
本领域技术人员将理解,上述实施例并不意为是限制性的,而是说明可以被包含在隔室中的成分的类型。在上面的实施例中,第一隔室中的一种或多种成分可以在第二隔室中,反之亦然。
本文中所描述的制造多隔室胶囊的类型的方法不同于本领域中通常使用的方法,因为在本胶囊中,隔片被结合或装配至胶囊的主体,实现主体的下端和隔片的外表面之间的密封的隔室,从而将第一隔室与第二隔室分隔并且防止泄漏或渗漏。此外,例如,在典型的胶囊包胶囊设计中,外部的胶囊的干燥成分不能被移置以便为内部的胶囊提供位置。内部的胶囊将仅仅位于粉末的顶部,并且留下不充足的空间用于重新加盖,或更糟糕的,由于粉末不能被移置而被压碎。此外,典型的胶囊包胶囊设计中粉末的配量(胶囊插入之后的剂量)使得配量侧壁之间的粉末非常具有挑战性(尤其是1号胶囊)。
下表2示出可以在本文中所描述的一些实施方案中使用的标准和伸长的TORPAC胶囊尺寸的各种尺寸规格。
表2
推荐储存条件:59°-77℉/15°-25℃ RH 35-65%
下表3示出可以在本文中所描述的一些实施方案中使用的标准和伸长的TORPAC胶囊尺寸的附加的尺寸规格。
表3
尽管已经参考本发明的某些优选的实施方案相当详细地描述了本发明,但其他版本也是可能的。因此,所附权利要求书的精神和范围不应该限于本说明书中含有的描述和优选版本。根据本公开,对公开的实施方案的修改和改进对于本领域技术人员将是显而易见的,并且旨在落入权利要求书的范围内。
Claims (30)
1.一种多隔室胶囊,所述多隔室胶囊包括:
主体;
隔片,所述隔片具有两个侧壁和底部,所述隔片延伸到所述主体内,并且形成由所述隔片的第一表面和所述主体限定的第一隔室;以及
盖,所述盖被安装到所述主体并且与所述隔片相对,所述盖形成由所述隔片的相对表面和所述盖限定的第二隔室;
其中所述隔片的所述两个侧壁沿所述主体的内表面延伸,并且与所述主体的开口端对准;并且
其中所述第一隔室和第二隔室每个适合于容纳一种或更多种固体成分。
2.如权利要求1所述的胶囊,其中所述第一隔室是密封的。
3.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括阿司匹林、抑制素、月经止痛药、用于增加骨密度的药剂、用于减轻热潮红的药剂、CoQ10、胆固醇降低剂、甲状腺激素、支气管扩张药、祛痰药、减充血剂、抗炎药剂、益生元、益生菌、消化酶、大便松软剂、抗血小板聚集剂、维生素、止痛药、异黄酮衍生物、草药、皮质类固醇、质子泵抑制剂、固体药物药剂或其组合。
4.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括粉末。
5.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括颗粒。
6.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括益生菌。
7.如权利要求6所述的胶囊,其中所述益生菌选自由选自由嗜酸乳杆菌、干酪乳杆菌、加氏乳杆菌、瑞士乳杆菌、保加利亚乳杆菌、德氏乳杆菌、胚牙乳杆菌、副干酪乳杆菌、唾液乳杆菌、罗伊乳杆菌、鼠李糖乳杆菌、短乳杆菌、短乳杆菌、嗜热链球菌、婴儿双岐杆菌、乳酸双岐杆菌、长双岐杆菌、两歧双岐杆菌、凝结双岐杆菌、短双岐杆菌、动物双岐杆菌、枯草双岐杆菌、布拉迪酵母及其组合组成的组的组。
8.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括从约1百万菌落形成单位至约1000亿菌落形成单位的益生菌。
9.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括消化酶。
10.如权利要求9所述的胶囊,其中所述消化酶选自由淀粉酶、α-淀粉酶、蛋白酶、α-半乳糖苷酶、β-葡聚糖酶、半乳甘露聚糖酶、乳糖酶、脂肪酶、纤维素酶、半纤维素酶、肌醇六磷酸酶、蔗糖酶、转化酶、果胶酶、麦芽糖酶、麦芽淀粉糖化酶、葡糖淀粉酶、木聚糖酶、支链淀粉酶、肽酶和二肽酰基肽酶IV、沙雷氏菌肽酶、溶菌酶、菠萝蛋白酶、木瓜蛋白酶及其组合组成的组。
11.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括从约10mg至约1000mg的消化酶。
12.如权利要求1所述的胶囊,其中所述第一隔室包括从约1百万菌落形成单位至约1000亿菌落形成单位的益生菌,并且所述第二隔室包括从约10mg至约1000mg的消化酶。
13.如权利要求1所述的胶囊,其中所述第一隔室包括从约10mg至约1000mg的消化酶,并且所述第二隔室包括从约1百万菌落形成单位至约1000亿菌落形成单位的益生菌。
14.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括药物药剂。
15.如权利要求14所述的胶囊,所述药物药剂选自由选自由阿司匹林、抑制素、依普黄酮、升麻类药草、仙人掌属植物、辅酶Q10(CoQ10)、愈创甘油醚、药蜀葵根、五硫化二锑、木馏油、愈创木酚磺酸酯、吐根(吐根糖浆)、左旋马鞭草烯酮、碘化钾、美远志、泰洛沙泊、氯化铵、沙丁胺醇、沙丁胺醇、左旋沙丁胺醇、左旋沙丁胺醇、吡布特罗、肾上腺素、麻黄碱、特布他林、沙美特罗、克仑特罗、福莫特罗、班布特罗、茚达特罗、硫酸肝配蛋白、噻氯匹定、氯吡格雷、普拉格雷、替卡格雷、西洛他唑、沃拉帕沙、三氟柳、双嘧达莫、生育三烯酚及其组合组成的组的组。
16.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括阿司匹林。
17.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括从约10mg至约500mg的阿司匹林。
18.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括抑制素。
19.如权利要求18所述的胶囊,其中所述抑制素可以选自由阿托伐他汀、氟伐他汀、洛伐他汀、匹伐他汀、普伐他汀、罗苏伐他汀、辛伐他汀及其组合组成的组。
20.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括从约1mg至约100mg的抑制素。
21.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括质子泵抑制剂。
22.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括非类固醇类抗炎药。
23.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括辅酶Q10。
24.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括祛痰药。
25.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括支气管扩张药。
26.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括大便松软剂。
27.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括血小板聚集抑制剂。
28.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括维生素E。
29.如权利要求1所述的胶囊,其中所述一种或更多种固体成分包括维生素D3。
30.如权利要求1所述的胶囊,其中所述一种或更多种固体成分是粉末、颗粒、半固体、微珠、微囊或其组合。
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US20230357623A1 (en) * | 2022-04-24 | 2023-11-09 | Southwest Petroleum University | Double-chamber microcapsule for drilling fluid and self-reversing reversible water-in-oil drilling fluid and preparation method thereof |
Also Published As
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WO2017062954A1 (en) | 2017-04-13 |
US11160759B1 (en) | 2021-11-02 |
EP3359140A4 (en) | 2019-05-01 |
US20220160641A1 (en) | 2022-05-26 |
US20180289625A1 (en) | 2018-10-11 |
CN108472244A (zh) | 2018-08-31 |
WO2017062956A1 (en) | 2017-04-13 |
EP3359130A4 (en) | 2019-05-01 |
EP3359131A1 (en) | 2018-08-15 |
EP3359130A1 (en) | 2018-08-15 |
US11357732B2 (en) | 2022-06-14 |
EP3359131A4 (en) | 2019-05-01 |
CN108366959A (zh) | 2018-08-03 |
US20180296489A1 (en) | 2018-10-18 |
WO2017062951A1 (en) | 2017-04-13 |
EP3359140A1 (en) | 2018-08-15 |
US11478429B2 (en) | 2022-10-25 |
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