CN108472244A - 为了改进的生物利用度的具有内部隔片的胶囊 - Google Patents
为了改进的生物利用度的具有内部隔片的胶囊 Download PDFInfo
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- CN108472244A CN108472244A CN201680071693.0A CN201680071693A CN108472244A CN 108472244 A CN108472244 A CN 108472244A CN 201680071693 A CN201680071693 A CN 201680071693A CN 108472244 A CN108472244 A CN 108472244A
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- oil
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Abstract
多隔室胶囊可以包含主体、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成分)以及被应用到主体的盖,借此在盖内部和隔片之间的空间限定用于容纳油的第二隔室。双隔室胶囊可以包含主体、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油)以及被应用到主体的盖,借此在盖内部和隔片之间的空间限定用于容纳成分的第二隔室。成分在暴露于油之后可以具有增加的生物利用度。本公开还提供用于这样的胶囊的特定剂型。
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,所述第一隔室适合于容纳油;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,所述第二隔室适合于容纳成分,所述成分在暴露于油之后具有增加的生物利用度;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,第一隔室通过隔片被密封。
在一些实施方案中,油选自由ω-3油、红棕榈油、鱼油、磷虾油、核桃油、锯棕榈油、蓖麻油、蒜油、亚麻油、芥花油、大豆油、印度大麻油、阿甘油、椰子油、薄荷油、夜来香油、牛至油、鸸鹋油、鱼肝油、海藻油、葡萄籽油、玫瑰油、丁香油、维生素E油、蓝莓籽油、覆盆子籽油、南瓜籽油、大麻油、α-亚麻酸及其组合组成的组。
在一些实施方案中,ω-3油选自由α-亚麻酸、二十二碳六烯酸、二十碳五烯酸、磷虾油、鱼油、核桃油、亚麻油、芥花油、大豆油及其组合组成的组。
在一些实施方案中,成分是油、液体、粉末、颗粒、半固体、凝胶、微囊、微珠、液体或其组合。
在一些实施方案中,成分是油、益生菌、植物性药材、草本提取物、消化酶、维生素、类胡萝卜素、胶原、药物或其组合。
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,油包括ω-3油,并且成分是多种维生素粉末、或多种维生素粉末和辅酶Q10。
在一些实施方案中,油包括ω-3油,并且成分是抑制素、或抑制素和辅酶Q10。
在一些实施方案中,油包括ω-3油,并且成分是维生素K2。
在一些实施方案中,油包括α-亚麻酸,并且成分选自铬、或铬和辅酶Q10。
在一些实施方案中,油是锯棕榈油,并且成分是碘塞罗宁钠(T3)粉末。
在一些实施方案中,油是红棕榈油,并且成分选自维生素D、维生素K2、多种维生素或其组合。
在一些实施方案中,油是ω-3油,并且成分选自阿司匹林、抑制素或其组合。
本文中所描述的一些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,所述第一隔室适合于容纳成分;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,所述第二隔室适合于容纳油;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,第二隔室被密封以防止油泄漏。
在一些实施方案中,成分在暴露于油时具有增加的生物利用度。
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,并且其中第一隔室包括油,并且第二隔室包括成分。
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743mm3的体积,并且第二(上部)隔室具有176mm3的体积,并且其中第一隔室包括油,并且第二隔室包括成分。
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“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。
这样的双隔室胶囊的示例性益处可以包含增加的患者依从性、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)。
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。对于一些应用,在这样的胶囊中递送的一种或更多种成分是当其溶解在一种或更多种油中时具有改进的生物利用度的成分可以是有利的。
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,第一隔室通过隔片被密封。在一些实施方案中,一种或更多种固体成分包括油、液体、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,第一隔室的内容物和第二隔室的内容物可以被同时释放。此同时释放可以发生,因为多隔室胶囊的每个端包括相同或大体上相同的材料组成和厚度,使得当胶囊被消化时,两个隔室被同时降解。在一些实施方案中,此同时释放可以是有利的,其中第一隔室的内容物和第二隔室的内容物当通过这样的释放合并时可以提供改进的生物利用度或其他协同效应。
在一些实施方案中,第一隔室包括油。在一些实施方案中,第二隔室包括成分。在一些实施方案中,第二成分适合于容纳在暴露于油之后具有增加的生物利用度的成分。在一些实施方案中,第一隔室包括在暴露于油之后具有增加的生物利用度的成分,并且第二隔室包括油。下面描述的示例性剂型可以与任一隔室中的油一起使用。
在一些实施方案中,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,通过将隔片插入和密封到胶囊主体中密封第一隔室。
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,油选自由ω-3油、红棕榈油、鱼油、磷虾油、核桃油、锯棕榈油、蓖麻油、蒜油、亚麻油、芥花油、大豆油、印度大麻油、阿甘油、椰子油、薄荷油、夜来香油、牛至油、鸸鹋油、鱼肝油、海藻油、葡萄籽油、玫瑰油、丁香油、维生素E油、蓝莓籽油、覆盆子籽油、南瓜籽油、大麻油、α-亚麻酸、共轭亚油酸、二十二碳六烯酸、姜油、熏衣草油及其组合组成的组。
在一些实施方案中,ω-3油选自由α-亚麻酸、二十二碳六烯酸、二十碳五烯酸、磷虾油、鱼油、核桃油、亚麻油、芥花油、大豆油及其组合组成的组。ω-3油可以为约10mg至约2000mg的量。
在一些实施方案中,油可以包括维生素E的形式或衍生物。在一些实施方案中,油可以包括从约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。
在一些实施方案中,成分是油、液体、粉末、颗粒、半固体、凝胶、微囊、微珠、液体或其组合。在一些实施方案中,成分是油、益生菌、植物性药材、草本提取物、消化酶、维生素、类胡萝卜素、胶原、药物或其组合。在一些实施方案中,成分可以包括α-胡萝卜素、β-胡萝卜素、生物素、镉、咖啡因、钙、肉桂、铜、姜黄素、右哌甲酯、磷酸二钙、二十二碳六烯酸、叶酸、乳香、葡糖胺、武靴叶属、武靴叶属提取物、碘、铁、亚油酸、硫辛酸、LOWAT、黄体素、番茄红素、镁、硬脂酸镁、锰、褪黑激素、钼、烟酸、油酸、棕榈酸、泛酸、西番莲、磷、植物甾醇、反式白藜芦醇、硒、角鲨烯、人参、生育酚、维生素A、维生素B1、维生素B2、维生素B6、维生素C、维生素K、锌或其组合。
在一些实施方案中,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(gauifenesin)、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、三碘甲腺原氨酸(T3)、碘塞罗宁钠及其组合组成的组。
在一些实施方案中,成分包括阿司匹林。在一些实施方案中,阿司匹林包括从约10mg至约500mg。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约10mg至约500mg的量的阿司匹林。
在一些实施方案中,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,第一隔室包括约10mg至约500mg的量的阿司匹林,并且第二隔室包括约10mg至约2000mg的量的油。在一些实施方案中,油是ω-3油。
在一些实施方案中,胶囊可以在第一隔室中在有或没有红棕榈油的情况下包含ω-3油,并且在第二隔室中包含CoQ10。ω-3油可以为约10mg至约2000mg的量。红棕榈油可以为约10mg至约2000mg的量。CoQ10可以为约10mg至约1000mg的量。
在一些实施方案中,油包括ω-3油,并且成分是多种维生素、或多种维生素和辅酶Q10。ω-3油可以为约10mg至约2000mg的量。CoQ10可以为约10mg至约1000mg的量。多种维生素可以为约1mg至约5000mg的量。
在一些实施方案中,油包括ω-3油,并且成分是抑制素、或抑制素和辅酶Q10。ω-3油可以为约10mg至约2000mg的量。抑制素为约1mg至约100mg的量。CoQ10可以为约10mg至约1000mg的量。
在一些实施方案中,油包括ω-3油,并且成分是维生素K2。ω-3油可以为约10mg至约2000mg的量。维生素K2可以为约10mcg至约1000mcg的量。
在一些实施方案中,油包括α-亚麻酸,并且成分选自铬、或铬和辅酶Q10。α亚麻酸可以为约10mg至约500mg的量。铬可以为约10mcg至约1000mcg的量。CoQ10可以为约10mg至约1000mg的量。
在一些实施方案中,油是锯棕榈油,并且成分是碘塞罗宁钠(T3)。锯棕榈油可以为约10mg至约1000mg的量。碘塞罗宁钠可以为约5mcg至约500mcg的量。
在一些实施方案中,油是红棕榈油,并且成分选自维生素D、维生素K2、多种维生素或其组合。红棕榈油可以为约10mg至约2000mg的量。维生素D可以为约10IU至约3000IU的量。维生素K2可以为约10mcg至约1000mcg的量。多种维生素可以为约1mg至约5000mg的量。
在一些实施方案中,油是红棕榈油,并且成分选自黄体素、番茄红素、生物素、硒、硒(甲硫氨酸)、锌、锌(葡糖酸盐)或其组合。红棕榈油可以为约10mg至约2000mg的量。黄体素可以为约1mg至约30mg的量。番茄红素可以为约1mg至约30mg的量。生物素可以为约0.01mg至约10mg的量。硒或硒(甲硫氨酸)可以为约1mcg至约200mcg的量。锌或锌(葡糖酸盐)可以为约1mg至约45mg的量。
在一些实施方案中,油是ω-3油,并且成分选自乳香、武靴叶属、武靴叶属提取物、肉桂、铬、铬(吡啶甲酸盐)、维生素B6、维生素B12或其组合。ω-3油可以为约10mg至约2000mg的量。乳香可以为约1mg至约500mg的量。武靴叶属或武靴叶属提取物可以为约10mg至约1000mg的量。肉桂可以为约10mg至约1000mg的量。铬或铬(吡啶甲酸盐)可以为约10mg至约1000mg的量。维生素B6可以为约10mg至约1000mg的量。维生素B12可以为约10mcg至约1000mcg的量。
在一些实施方案中,油是ω-3油,并且成分选自反式白藜芦醇、硫辛酸、CoQ10、叶酸、维生素B6、维生素B12或其组合。ω-3油可以为约10mg至约2000mg的量。反式白藜芦醇可以为约10mg至约1000mg的量。硫辛酸的量可以为约1mg至约1000mg的量。CoQ10可以为约10mg至约1000mg的量。叶酸可以为约0.1mcg至约1000mcg的量。维生素B6可以为约10mg至约1000mg的量。维生素B12可以为约10mcg至约1000mcg的量。
在一些实施方案中,油选自磷虾油、红棕榈油或其组合,并且成分选自油酸、亚油酸、生育三烯酚、生育酚、β-胡萝卜素、α-胡萝卜素、角鲨烯、植物甾醇、CoQ10、多种维生素或其组合。磷虾油可以为约10mg至约2000mg的量。红棕榈油可以为约10mg至约2000mg的量。油酸可以为约10mg至约1000mg的量。亚油酸可以为约1mg至约1000mg的量。生育三烯酚可以为约1mg至约1000mg的量。生育酚可以为约1mg至约1000mg的量。β-胡萝卜素可以为约1mg至约1000mg的量。α-胡萝卜素可以为约1mg至约1000mg的量。角鲨烯可以为约0.1mg至约1000mg的量。植物甾醇可以为约1mg至约1000mg的量。CoQ10可以为约0.01mg至约1000mg的量。多种维生素可以为约1mg至约5000mg的量。
在一些实施方案中,油选自磷虾油、ω-3油(如,例如,二十二碳六烯酸(DHA))或其组合,并且成分选自维生素C、锌、磷酸二钙、维生素D、维生素K、镁、钙或其组合。磷虾油可以为约10mg至约2000mg的量。DHA可以为约10mg至约2000mg的量。维生素C可以为约1mg至约1000mg的量。锌可以为约1mg至约1000mg的量。磷酸二钙可以为约1mg至约1000mg的量。维生素D可以为约10IU至约3000IU的量。维生素K可以为约10mcg至约1000mcg的量。镁可以为约0.1mg至约1000mg的量。钙可以为约1mg至约1000mg的量。
在一些实施方案中,油是磷虾油,并且成分选自多种维生素、CoQ10、维生素A、维生素D、维生素D3、维生素E、生物素、叶酸、烟酸、泛酸、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、维生素K、钙、铬、铜、碘、镁、硬脂酸镁、锰、钼、磷、硒、锌或其组合。磷虾油可以为约10mg至约2000mg的量。多种维生素可以为约1mg至约5000mg的量。CoQ10可以为约0.01mg至约1000mg的量。维生素A可以为约10IU至约4000IU的量。维生素D或维生素D3可以为约10IU至约3000IU的量。维生素E可以为约10IU至约3000IU的量。生物素可以为约10mcg至约1000mcg的量。叶酸可以为约0.1mcg至约1000mcg的量。烟酸可以为约1mg至约1000mg的量。泛酸可以为约1mg至约1000mg的量。维生素B1可以为约1mg至约1000mg的量。维生素B2可以为约1mg至约1000mg的量。维生素B2可以为约1mg至约1000mg的量。维生素B6可以为约1mg至约1000mg的量。维生素B12可以为约10mcg至约1000mcg的量。维生素C可以为约1mg至约1000mg的量。维生素K可以为约10mcg至约1000mcg的量。钙可以为约1mg至约1000mg的量。铬可以为约1mcg至约1000mcg的量。铜可以为约0.1mg至约100mg的量。碘可以为约0.01mg至约100mg的量。镁可以为约0.1mg至约1000mg的量。硬脂酸镁可以为约0.1mg至约1000mg的量。锰可以为约0.1mg至约100mg的量。钼可以为约1mcg至约1000mcg的量。磷可以为约1mg至约100mg的量。硒可以为约1mcg至约200mcg的量。锌可以为约1mg至约1000mg的量。
在一些实施方案中,油是红棕榈油,并且成分选自人参、CoQ10、维生素B12、咖啡因、咖啡因微囊或其组合。红棕榈油可以为约10mg至约2000mg的量。人参可以为约10mg至约1000mg的量。CoQ10可以为约0.01mg至约1000mg的量。维生素B12可以为约10mcg至约1000mcg的量。咖啡因或咖啡因微囊可以为约1mg至约1000mg的量。
在一些实施方案中,油是磷虾油,并且成分选自维生素D、维生素D3、钙或其组合。磷虾油可以为约10mg至约2000mg的量。维生素D或维生素D3可以为约10IU至约3000IU的量。钙可以为约1mg至约1000mg的量。
在一些实施方案中,油是ω-3油,并且成分是益生菌。ω-3油可以为约10mg至约2000mg的量。益生菌可以为约1百万至约1亿CFU的量。
在一些实施方案中,油是磷虾油,并且成分选自维生素K2、葡糖胺、胶原、UC2胶原或其组合。磷虾油可以为约10mg至约2000mg的量。维生素K2可以为约0.01mg至约100mg的量。葡糖胺可以为约10mg至约1000mg的量。胶原或UC2胶原可以为约1mg至约1000mg的量。
在一些实施方案中,油是ω-3油(如,例如,α-亚麻酸(ALA)),并且成分选自咖啡因、咖啡因微囊或其组合。ALA可以为约10mg至约2000mg的量。咖啡因或咖啡因微囊可以为约1mg至约1000mg的量。
在一些实施方案中,油是姜油,并且成分是姜黄素。姜油可以为约10mg至约2000mg的量,并且姜黄素可以为约10mg至约1000mg的量。
在一些实施方案中,油是ω-3油,并且成分选自维生素D、维生素D3、维生素E、叶酸、维生素B2、维生素B6、维生素B12、维生素C、铁、磷酸二钙或其组合。ω-3油可以为约10mg至约2000mg的量。维生素D或维生素D3可以为约10IU至约3000IU的量。维生素E可以为约1IU至约3000IU的量。叶酸可以为约0.1mcg至约1000mcg的量。维生素B2可以为约1mg至约1000mg的量。维生素B6可以为约1mg至约1000mg的量。维生素B12可以为约1mcg至约1000mcg的量。维生素C可以为约1mg至约1000mg的量。铁可以为约1mg至约1000mg的量。磷酸二钙可以为约1mg至约1000mg的量。
在一些实施方案中,油是磷虾油,并且成分选自维生素D、维生素D3、维生素K2、维生素E、维生素E生育三烯酚或其组合。磷虾油可以为约10mg至约2000mg的量。维生素D或维生素D3可以为约10IU至约3000IU的量。维生素K2可以为约0.01mg至约100mg的量。维生素E或维生素E生育三烯酚可以为约10mg至约1000mg的量。
在一些实施方案中,油是熏衣草油,并且成分选自褪黑激素、西番莲、柠檬、柠檬提取物或其组合。熏衣草油可以为约10mg至约2000mg的量。褪黑激素可以为约1mg至约1000mg的量。西番莲可以为约10mg至约1000mg的量。柠檬或柠檬提取物可以为约10mg至约1000mg的量。
在一些实施方案中,油是共轭亚油酸(CLA),并且成分选自蒌叶叶子、双花扁豆籽提取物或其组合,如LOWAT。CLA可以为约10mg至约2000mg的量。蒌叶叶子、双花扁豆籽提取物或其组合(如LOWAT)可以为约10mg至约1000mg的量。
在一些实施方案中,油是磷虾油,并且成分是阿司匹林。磷虾油可以为约10mg至约2000mg的量,并且阿司匹林可以为约10mg至约500mg的量。
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分别施用治疗有效剂量的油和成分。
下表1列出了可以在一些实施方案中存在的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
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,对所公开的实施方案的修改和改进对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 (22)
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,并且在所述隔片的外表面和所述主体的内表面之间限定第一隔室,所述第一隔室适合于容纳油;以及
盖,所述盖被安装到所述主体的外表面并且与所述隔片相对,并且在所述隔片的内表面和所述盖之间限定第二隔室,所述第二隔室适合于容纳成分,所述成分在暴露于所述油之后具有增加的生物利用度;
其中所述隔片的所述两个侧壁沿所述主体的所述内表面延伸,并且与所述主体的开口端对准。
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,其中所述油选自由ω-3油、红棕榈油、鱼油、磷虾油、核桃油、锯棕榈油、蓖麻油、蒜油、亚麻油、芥花油、大豆油、印度大麻油、阿甘油、椰子油、薄荷油、夜来香油、牛至油、鸸鹋油、鱼肝油、海藻油、葡萄籽油、玫瑰油、丁香油、维生素E油、蓝莓籽油、覆盆子籽油、南瓜籽油、大麻油、α-亚麻酸、共轭亚油酸、二十二碳六烯酸、姜油、熏衣草油及其组合组成的组。
4.如权利要求3所述的胶囊,其中所述ω-3油选自由α-亚麻酸、二十二碳六烯酸、二十碳五烯酸、磷虾油、鱼油、核桃油、亚麻油、芥花油、大豆油、海藻油及其组合组成的组。
5.如权利要求1所述的胶囊,其中所述成分是油、液体、粉末、颗粒、半固体、凝胶、微囊、微珠、液体或其组合。
6.如权利要求1所述的胶囊,其中所述成分选自由油、益生菌、植物性药材、草本提取物、消化酶、维生素、类胡萝卜素、胶原、药物、阿司匹林、抑制素、α-胡萝卜素、β-胡萝卜素、生物素、镉、咖啡因、钙、肉桂、铜、姜黄素、右哌甲酯、磷酸二钙、二十二碳六烯酸、叶酸、乳香、葡糖胺、武靴叶属、武靴叶属提取物、碘、铁、亚油酸、硫辛酸、LOWAT、黄体素、番茄红素、镁、硬脂酸镁、锰、褪黑激素、钼、烟酸、油酸、棕榈酸、泛酸、西番莲、磷、植物甾醇、反式白藜芦醇、硒、角鲨烯、人参、生育酚、维生素A、维生素B1、维生素B2、维生素B6、维生素C、维生素K、锌及其组合组成的组。
7.如权利要求1所述的胶囊,其中所述隔片的所述底部是弯曲的。
8.如权利要求1所述的胶囊,其中所述隔片的所述底部是平的。
9.如权利要求1所述的胶囊,其中所述油包括ω-3油,并且所述成分选自由多种维生素粉末、辅酶Q10及其组合组成的组。
10.如权利要求1所述的胶囊,其中所述油包括ω-3油,并且所述成分选自由抑制素、辅酶Q10及其组合组成的组。
11.如权利要求1所述的胶囊,其中所述油包括ω-3油,并且所述成分是维生素K2。
12.如权利要求1所述的胶囊,其中所述油包括α-亚麻酸,并且所述成分选自由铬、铬、辅酶Q10及其组合组成的组。
13.如权利要求1所述的胶囊,其中所述油是锯棕榈油,并且所述成分是碘塞罗宁钠。
14.如权利要求1所述的胶囊,其中所述油是红棕榈油,并且所述成分选自由维生素D、维生素K2、多种维生素及其组合组成的组。
15.一种多隔室胶囊,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,并且在所述隔片的外表面和所述主体的内表面之间限定第一隔室,所述第一隔室适合于容纳成分;以及
盖,所述盖被安装到所述主体的外表面并且与所述隔片相对,并且在所述隔片的内表面和所述盖之间限定第二隔室,所述第二隔室适合于容纳油;
其中所述隔片的所述两个侧壁沿所述主体的所述内表面延伸,并且与所述主体的开口端对准。
16.如权利要求15所述的胶囊,其中所述第二隔室被密封以防止油泄漏。
17.如权利要求15所述的胶囊,其中所述油选自由ω-3油、红棕榈油、鱼油、磷虾油、核桃油、锯棕榈油、蓖麻油、蒜油、亚麻油、芥花油、大豆油、印度大麻油、阿甘油、椰子油、薄荷油、夜来香油、牛至油、鸸鹋油、鱼肝油、海藻油、葡萄籽油、玫瑰油、丁香油、维生素E油、蓝莓籽油、覆盆子籽油、南瓜籽油、大麻油、α-亚麻酸、共轭亚油酸、二十二碳六烯酸、姜油、熏衣草油及其组合组成的组。
18.如权利要求15所述的胶囊,其中所述成分选自由油、液体、粉末、颗粒、凝胶、半固体、微囊、微珠、液体及其组合组成的组。
19.如权利要求15所述的胶囊,其中所述成分选自由油、益生菌、植物性药材、草本提取物、消化酶、维生素、类胡萝卜素、胶原、药物、阿司匹林、抑制素、α-胡萝卜素、β-胡萝卜素、生物素、镉、咖啡因、钙、肉桂、铜、姜黄素、右哌甲酯、磷酸二钙、二十二碳六烯酸、叶酸、乳香、葡糖胺、武靴叶属、武靴叶属提取物、碘、铁、亚油酸、硫辛酸、LOWAT、黄体素、番茄红素、镁、硬脂酸镁、锰、褪黑激素、钼、烟酸、油酸、棕榈酸、泛酸、西番莲、磷、植物甾醇、反式白藜芦醇、硒、角鲨烯、人参、生育酚、维生素A、维生素B1、维生素B2、维生素B6、维生素C、维生素K、锌及其组合组成的组。
20.如权利要求15所述的胶囊,其中所述成分在暴露于所述油时具有增加的生物利用度。
21.如权利要求15所述的胶囊,其中所述隔片的所述底部是弯曲的。
22.如权利要求15所述的胶囊,其中所述隔片的所述底部是平的。
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PCT/US2016/056285 WO2017062954A1 (en) | 2015-10-09 | 2016-10-10 | Capsule with internal diaphragm for improved bioavailability |
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CN201680071693.0A Pending CN108472244A (zh) | 2015-10-09 | 2016-10-10 | 为了改进的生物利用度的具有内部隔片的胶囊 |
CN201680071694.5A Pending CN108366970A (zh) | 2015-10-09 | 2016-10-10 | 具有内部隔片和固体成分的胶囊 |
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EP3359131A4 (en) | 2019-05-01 |
WO2017062951A1 (en) | 2017-04-13 |
US20180296489A1 (en) | 2018-10-18 |
WO2017062956A1 (en) | 2017-04-13 |
EP3359130A4 (en) | 2019-05-01 |
US11357732B2 (en) | 2022-06-14 |
EP3359140A1 (en) | 2018-08-15 |
CN108366970A (zh) | 2018-08-03 |
US11160759B1 (en) | 2021-11-02 |
US20220160641A1 (en) | 2022-05-26 |
CN108366959A (zh) | 2018-08-03 |
WO2017062954A1 (en) | 2017-04-13 |
EP3359130A1 (en) | 2018-08-15 |
EP3359131A1 (en) | 2018-08-15 |
US11478429B2 (en) | 2022-10-25 |
EP3359140A4 (en) | 2019-05-01 |
US20180289625A1 (en) | 2018-10-11 |
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