CN105667994B - 用于药物药盒的泡罩包装 - Google Patents

用于药物药盒的泡罩包装 Download PDF

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CN105667994B
CN105667994B CN201610074131.3A CN201610074131A CN105667994B CN 105667994 B CN105667994 B CN 105667994B CN 201610074131 A CN201610074131 A CN 201610074131A CN 105667994 B CN105667994 B CN 105667994B
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迈克尔·S·伯杰
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Abstract

本发明涉及一种用于药物药盒的泡罩包装。本发明公开了一种用于药物药盒或胶囊的泡罩包装。

Description

用于药物药盒的泡罩包装
本申请是申请日为2012年3月30日，申请号为201280026570.7(PCT/US2012/031695)，且发明名称为“用于药物药盒的泡罩包装”的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求2011年4月1日提交的美国临时专利申请No.61/470,982的利益，其全部公开内容通过引用结合于此。
技术领域
公开了用于药物注塑药盒或胶囊的泡罩包装。
背景技术
在制药工业中，泡罩包装***可被用于保护药物制剂(例如胶囊、片剂、粉末和液体)。一般来说，泡罩包装由具有腔体或敞开的泡罩的刚性泡罩基片和封板或盖组成。在包装中，每一个泡罩通常包含粉末、胶囊或片剂形式的药品。
用于吸入的药物给药***包括药盒，该药盒将治疗疾病的干粉制剂输送到肺呼吸道和肺。含在药盒中的药物制剂可以和干粉吸入***一起使用，该***以安全和一致的方式输送药物量。然而，针对肺部吸入，与药盒输送***一起用于肺部吸入的药物制剂可能对降解敏感，例如，暴露在湿气中。因此，含有粉末制剂的药盒可能受益于改进的包装设计，从而保护药盒和制剂免受物理伤害和环境因素。
发明内容
本文描述的是用于保护含有与药物制剂的药盒的泡罩包装，该制剂与吸入器一起使用。在一个实施例中，美国专利号D613849和美国专利申请序列号12/484,137(US2009/0308392)描述了与干粉吸入***一起使用的药盒。可以设计泡罩包装以便包含、保护、分配和/或改善药物制剂的稳定性。在一个实施例中，可以为肺部给药设计治疗疾病(包括全身和内分泌疾病，例如糖尿病)的制剂。该泡罩包装能够提供抵抗所使用的材料卷曲的结构刚度，并且也能够针对环境因素(如水分、光线和/或灰尘)创建屏障；能够给患者方便地分配药剂。在一个实施例中，泡罩包装能够提供高防湿层，以便在使用之前的药品运输、买卖和/或存储期间，保护含有药物制剂的药盒。
在一个实施例中，泡罩包装包括多个泡罩，该泡罩为以行或列排列的均匀的口袋状的井、杯状单元结构和/或腔体；其中，使泡罩包装的每个单元构造成与含有药物制剂的药物药盒和胶囊结构对应匹配。在一个实施例中，每个泡罩井可以容纳相应的药盒。在另一个实施例中，泡罩包装可包括一个或多个不规则形状的腔体或泡罩井，其中，每个腔体或泡罩井包括顶部、底部、外表面、内表面和空穴。底部可以包括具有基本圆的端部或圆顶的外表面，以及基本平坦的端部，或从圆顶区延伸的搁板。在一个实施例中，所述基本平坦的端部可以有一个缺口或凹槽，其在内表面中形成搁板或药盒保持特征，并且可以使空穴区具有一定形状，以便容纳包括杯状容器的药盒。在其它的实施例中，泡罩包装可以包括多个单一单元的泡罩井，其通过与相邻的泡罩井相连的未处理的基体材料的空间或者部分来彼此分离。在这个实施例中，泡罩包装可以包含围绕每个泡罩单元的穿孔或刻痕线，以便分离泡罩单元，从而方便配药。
在一个实施例中，泡罩包装中每个泡罩包装包括一行或多行，每行包括一个或多个泡罩井。在一行泡罩包含两个或更多泡罩井的实施例中，每个泡罩井可以与另一个相连，并且每个泡罩井的内部容积或空穴可以与所有的泡罩井相连通。可选地，在一些具有一个以上彼此相连的泡罩的实施例中，可以对每个泡罩进行分离，从而每个井的容积和/或空穴不与相邻的泡罩井、任何一个或所有其他的泡罩井相连通。在一个实施例中，泡罩包装可以包括一行或多行泡罩井，其中，通过沿着泡罩井的行或者沿着围绕泡罩包装每个单元的线的穿孔线或者刻痕线，可以对每行泡罩进行分离。
一个实施例包括由基体结构或者具有成形腔体的材料组成的泡罩，该腔体由可热成型的基体层压体和盖材料组成，其包括带有热活化密封剂的软化铝箔片。基体材料和/或结构可以包括一层或多层可热成型的塑料，包括聚氯乙烯、聚酯、和/或含氟聚合物，例如，聚氯三氟乙烯(PCTFE)(诸如(霍尼韦尔国际公司，新泽西州))。在本文所公开的实施例的一些方面，泡罩包装可以包括含有层压复合材料的基体材料。在一个实施例中，层压复合材料可以至少包括选自聚氯乙烯和含氟聚合物(如ACLAR层)和/或具有类似的可热成型特性的材料中的三层。在一个实施例中，层压复合材料可以由三层薄膜结构组成，包括第一层聚氯乙烯、或聚对苯二甲酸乙二醇酯(PET)，第二层聚氯乙烯、或PET，以及一层含氟聚合物，包括ACLAR，其中，所述含氟聚合物层包括层压复合材料的中间层。在另一个实施例中，泡罩基板可以包括含氟聚合物，如与PET粘结的PCTFE。
在一些实施例中，形成基体材料的层压复合材料可以被制成具有各种厚度，并且厚度可以依据制剂所需的防潮度。在一个实施例中，泡罩基板的层压复合材料的厚度范围可以从约230μm到约720μm。在另一个实施例中，层压复合材料泡罩基板可以为近360μm到约610μm的厚度。在这个实施例中，由基体层压体制成的泡罩包装使得泡罩具有合适的刚性并且具有厚度大于100μm的防潮层保护。
在特定的实施例中，泡罩包装可包括一个或多个腔体以及封口或盖。使每个腔体构造成保持被构造成适合于干粉吸入器的药盒，并且药盒可以包括肺部给药的制剂。该制剂可以包括活性成分，包括但不限于小分子、蛋白质、肽、核酸分子或其组合。在这个和其他的实施例中，药盒可以包括用于治疗例如糖尿病的制剂，并且制剂中的活性成分可以选自肽，包括但不限于胰岛素、GLP-1、其活性片段、其类似物、或其组合。在其它的实施例中，活性成分可以选自通过肺途径输送的任何肽或活性剂，包括胰岛素、催产素、胰高血糖素、甲状旁腺激素、胃泌酸调节素、肽YY、胰高血糖素样肽1、舒马曲坦、肽基肽酶IV抑制剂、甲状旁腺激素、神经递质受体激动剂和拮抗剂、脱氧核糖核酸I、其活性片段、其类似物、以及其组合。
针对两天或者两天以上的单次剂量、和/或多次剂量，包括，每日剂量的药物制剂提供泡罩包装，或针对每周或者每月所需的供给提供多个泡罩的组合。
在又一个实施例中，泡罩包装可以包括具有用于治疗疾病的制剂的药盒，该制剂包括可吸入的包括二酮哌嗪的干粉组合物。在一个实施例中，二酮哌嗪可以具有公式3,6-I/S-(4-X-氨基丁基)-2,5-二氧代哌嗪，其中，X为选自由琥珀酰基、戊二酰基、马来酰基和富马组成的组分。在一个实施例中，干粉组合物可以包括二酮哌嗪盐，其中二酮哌嗪盐可以是无机盐，包括钠、钾、镁、锂、铯、钙。在另一个实施方案中，二酮哌嗪可以是有机盐，包括三乙胺、三丁胺、二乙醇胺和三乙醇胺。在又一个实施例中，提供干粉组合物，其中，二酮哌嗪是3,6-S-(4-富马-基丁基)-2,5-二氧代哌嗪或其盐，带或不带药学上可接受的载体、或赋形剂。泡罩包装也可以包括含有制剂的药盒，该制剂具有药学上可接受的载体和/或赋形剂，包括但不限于乳糖、葡聚糖、氨基酸等。
附图说明
图1是本文所公开的泡罩包装的实施例的立体图。
图2是描绘了包装内均匀行列的泡罩行的、图1中泡罩包装的第一侧视图。
图3是示出与图2相对的一侧的泡罩行的、图1中泡罩包装的实施例的第二侧视图。
图4是图1中泡罩包装的实施例的底视图，该图表示出了包装内部的泡罩结构。
图5是图1中泡罩包装的实施例的顶部，该图表示出了盖。
图6是图1中泡罩包装的实施例的前视图，该图表示出了含有三个泡罩的行和它们的构造，描绘了圆顶区和它们的侧凹槽或者药盒保持特征。
图7是图1中泡罩包装的实施例的后视图。
图8是通过图1中所示的平面8-8的、泡罩行的剖面。
图9是通过平面9-9、通过泡罩井的中点的泡罩包装的纵向剖面。
图10说明本文所述的泡罩包装的顶视图。
图11A说明本文所述的刺破的密封件的后视图。图11B说明本文所述的可剥的密封件。
图12是从实验中获得的、示出本文所公开的泡罩包装的实施例中典型的水蒸气透过速率(WVTR)的数据图。
图13说明本文所述的泡罩包装的顶视图。
图14说明由三层PVC-ACLAR-PVC材料形成的泡罩包装的厚度轮廓。
图15说明由双层PVC-ACLAR材料形成的泡罩包装的厚度轮廓。
图16说明由双层CoPETG-ACLAR材料形成的泡罩包装的厚度轮廓。
图17说明图表14-16中图表的标准偏差。
本发明公开内容中的实施例只是示例的，并不限于图1-17中所公开的图。
具体实施方式
本文描述的是泡罩包装，使泡罩包装构造成保护含有用于肺部给药的药物制剂的药盒和胶囊。药盒和胶囊可以和吸入器连接使用。
图1示出了本文所述的泡罩包装100的示例实施例的等距视图。泡罩包装100包括泡罩卡或泡罩基板102，其具有在一行或多行106、106'、106”、106”'、106””等中排列的多个模腔104、104'、104”、104”'、104””等。在一个实施例中，每行106中可以出现三个圆顶108。腔体104可以包括基本圆的端部或者圆顶108和有点平坦的区域结构或搁板110，其从圆顶108处突起并且形成药盒盖保持特征112，该特征在腔体外表面形成缺口或凹槽。可以使圆顶108构造成适应单位剂量的药盒容器或杯体，并且可以使搁板110构造成包含并保持药盒盖或顶部中组装在药盒安全壳或者预给药构造内的部分。能被包装在当前的泡罩包装内的药物药盒可以是例如在美国专利D613849和US 2009/038390中描述的一个，其公开内容中他们公开的所有关于药盒的全部内容被并入到本文。
药盒盖保持特征或搁板可以使药盒盖处在适当的位置，和/或防止药盒泡罩中的多个药盒与相邻的药盒接触。在一个实施例中，药盒储存在当前的泡罩单元中，在安全壳或预给药构造中，药盒包括药盒盖和容器，药盒容器适应于泡罩单元的圆顶并且由适应于泡罩的搁板的盖悬滞。以这种方式，可以防止药盒容器移动，并且被保持在安全壳构造中。
图1也说明了每个包含五行106，每行包含三个腔体104的泡罩包装100。此实施例可以适合于每天给患者用药三次。在一些实施例中，对于患有例如但不限于糖尿病的患者来说，每顿的剂量可以是规定的胰岛素或其他药物的指定吸入剂量。根据将要治疗的疾病，可以使用替代的实施例。
其它的实施例中每行可以具有一、二、三、四、五、六、七、八、九、十、十一、十二、十三、十四、或十五个腔体。泡罩包装可以进一步地包括一、二、三、四、五、六、七、八、九、十、十一、十二、十三、十四、或十五行。
可以使图1中所说的泡罩包装100构造成与另一个泡罩包装相嵌套，以使相反包装的泡罩能够嵌在其它包装的两行之间，从而在运输期间减小外包装的尺寸。泡罩包装100可以与另一个倒转过来并且上下颠倒的泡罩包装匹配，以便减小包装的尺寸。可以设想其它方法来减少包装尺寸、体积等。
在本文中的实施例中，可以使泡罩具有一定的形状，以便与将要包装的具体药盒的尺寸相匹配。泡罩包装中行的尺寸也可以根据因素(例如，每行泡罩井的数量和泡罩的尺寸)变化。在一个实施例中，每个泡罩井或腔体104在长度上可以大于约1厘米；顶部108在高度上大于1cm，并且在宽度上大于1厘米。在一个实施例中，腔体104的尺寸可以为约1.5cm宽，约2.5cm长，约1.5cm高；其中，泡罩包装内的行106可以为约6cm长，约3.5cm宽。在这个和其他的实施例中，可以在泡罩包装的泡罩行或段内的中央构造腔体104。
图2和3分别说明图1所说的泡罩包装100的相对的侧视图。图2和3描述的是在泡罩包装100内均匀排列的行106。图2和3还描述了圆顶108和具有整体上基本细长形的搁板110的形状。腔体104可以具有从圆顶结构横向延伸的平坦的端部或搁板。图2和3还说明了形成泡罩井或腔体104的泡罩基板102，并且示出了密封腔体104的盖114。
图4是图1中所说的泡罩包装100的底视图，该图表示出在泡罩包装100内组织的腔体104。在此实施例中，泡罩包装100包括构造成在两行之间具有空间的行106。在一个实施例中，来自第一泡罩包装的圆顶108可以适合于第二泡罩包装中两行之间的空间，并且第一泡罩包装的搁板110可以抵接第二泡罩包装的搁板110。
图5是图1中所说的泡罩包装100的顶视图，该图说明了盖114密封泡罩包装100。盖114可被粘结或者被密封，从而盖114黏附在泡罩基板102的平滑表面上。盖114可以黏附的一部分泡罩基板是腔体104和每个腔体的开口上面之间的空间。盖114黏附在泡罩基板102上可以闭合泡罩包装100，并且密封一个或者多个腔体104内的药盒。在一个实施例中，盖114可以是覆盖整个泡罩基板102并且在腔体104周围的区域与泡罩基板连接的单一板。
在一些实施例中，盖114可以黏附在泡罩基板102的后部，与所有泡罩基板102的底面平齐。在其它实施例中，盖114可以黏附到泡罩基板102的底面，但小于泡罩基板102。在其它实施例中，盖114可以大于泡罩基板102的底面，并包裹在泡罩基板102的边缘。
图6和图7是分别为图1中所说的泡罩包装100的前视图和后视图，该图说明了包含行106的泡罩包装100，该行106包括三个联合腔体104。腔体104的每个部分可以包括圆顶108和具有凹槽与药盒保持特征112的它的横向搁板110；其中，泡罩行用盖114密封。
图8说明了通过平面8-8、通过图1中所述的腔体行的剖面。图8说明了三个相互关联的腔体的内部和行内的彼此关系。这个图说明了内部容积118或空穴106。图8还说明了表示元件层的泡罩基板102的实施例的示意图。在这个实施例中，泡罩基板102包括三层薄膜的层压体，包括第一层120、第二层122和第三层124。三层中的每一个都可以彼此粘结。在其它的实施例中，可以使用多于或少于三层。例如，一、二、三、四、五、六、七、八、九或十层可以使用。在一个实施例中，使用的层的数量可以为基本防止水渗入到密封封装(泡罩基板和盖)内的数量或厚度。
在一个实施例中，可以使用可热成型的塑料制造泡罩基板102。在某些实施例中，泡罩基板102可以是由薄膜形成的可热成型的层压体，该层压体包括一个或一个以上可热成型的塑料层，包括聚酯、聚氯乙烯、和/或含氟聚合物，如在其它实施例中，泡罩包装100包括层压复合材料，该复合材料包括选自聚氯乙烯层、PET和含氟聚合物层中的至少三层，其中，至少一层是含氟聚合物。在本实施例中的一个方面，泡罩基板102可以由含氟聚合物层和两个聚氯乙烯层形成。在一个实施例中，第一层120可以是聚氯乙烯，第二层122可以是含氟聚合物层，第三层124可以是聚氯乙烯。在这种实施例中，第一层120和第三层124，两者都为聚氯乙烯层，形成每个腔体104的内表面126和外表面128。
可单独或与上面组合使用从而形成泡罩基板102的其他聚合物可以包括聚(L-乳酸)、聚己内酯、聚(丙交酯-共-乙交酯)、聚(乙烯-乙酸乙烯酯)、聚(羟基丁酸酯-共-戊酸酯)、聚对二氧环己酮、聚原酸酯、聚酸酐、聚(乙醇酸)、聚(D,L-乳酸)、聚(乙醇酸-共-三亚甲基碳酸酯)、聚磷酸酯、聚磷酸酯氨基甲酸乙酯、聚(氨基酸)、氰基丙烯酸酯、聚(三亚甲基碳酸酯)、聚(亚氨基碳酸)、共聚(醚-酯)、(例如，PEO/PLA)、聚氨酯、硅树脂、聚酯、聚烯烃、聚异丁烯和乙烯-α-烯烃共聚物、丙烯酸类聚合物和共聚物、乙烯-共-乙酸乙烯酯、聚甲基丙烯酸丁酯、乙烯基卤化物的聚合物和共聚物(例如，聚氯乙烯)、聚乙烯醚(例如，聚乙烯基甲基醚)、聚偏二卤化物(例如，聚偏二氟乙烯和聚偏二氯乙烯)、聚丙烯腈、聚乙烯酮、聚乙烯基芳族化合物(例如，聚苯乙烯)、聚乙烯基酯(例如，聚乙酸乙烯酯)、丙烯腈-苯乙烯共聚物，ABS树脂，聚酰胺(例如，尼龙66和聚己内酰胺)、聚碳酸酯、聚甲醛、聚酰亚胺、聚醚、聚氨酯、人造丝、玻璃纸、和羧甲基纤维素。
泡罩基板102可以透明、部分透明或不透明。部分透明包括允许约5％、约10％、约15％、约20％、约30％、约40％、约50％、约60％、约70％、约80％、约90％的光线通过的材料。不透明材料基本上没有光通过并且对于对光敏感的带壳药物可能是有用的。
在形成泡罩基板之前，层压材料的厚度可以是约10μm、约25μm、约50μm、约75μm、约100μm、约125μm、约150μm、175μm、约200μm、约225μm、250μm、约275μm、约300、约325μm、350μm、约375μm、约400μm、约425μm、约450μm、约475μm、约500μm、约525μm、约550、约575μm、约600μm、625μm、约650μm、约675μm、约700μm、725μm、约750μm、约775μm、约800μm、825μm、约850μm、约875μm、约900μm、925μm、约950μm、975μm、1000μm、1025μm、约1050、1075μm、约1100μm、约1125μm、约1150μm、约1175μm、或约1200μm，或者是在这些值中的任一值所限定的或者当中的范围内的任意厚度。在一些实施例中，总厚度的范围可以从约100μm至约750μm。
层压材料中每一层可以具有厚度，并且所有层的总厚度可以代表层压材料的总厚度。每一层的厚度可以为约10μm、约25μm、约50μm、约75μm、约100μm、约125μm、150μm、175μm、约200μm、约225μm、250μm、约275μm、300μm、约325μm、约350μm、约375μm、约400μm、约425μm、约450μm、约475μm、约500μm、约525μm、约550μm、约575μm、约600μm、约625μm、约650μm、675μm、约700μm，约725μm、约750μm、约775μm、约800μm、约825μm、约850μm、约875μm、约900μm、约925μm、约950μm、约975μm、1000μm、约1025μm、约1050μm、1075μm、约1100μm、约1125μm、约1150μm、约1175μm或者是在这些值中的任一值所限定的或者当中的范围内的任意厚度。在使用ALCAR的实施例中，该层的厚度范围可以为从约230μm到约720μm的厚度。
泡罩基板102的结构可以提供所需的蒸气和/或可以提高药物制剂***稳定性的防潮层，同时还提供抵抗层压体卷曲的结构刚性。正如上面所讨论的，泡罩基板和点燃的密封组合基本上可以防止水渗入到密封的封装内。当被制造成所需的尺寸和长度，以便容纳本文所公开的吸入药盒的尺寸时，层压材料的卷曲是现有技术中泡罩具有的特点。
图8中的泡罩包装100还可以包括由薄膜或板形成的顶部或盖114，该薄膜或板可以包括一层或多层材料。适用于制造盖114的材料可以包括，但不限于箔片材料，例如铝、铜和/或聚合物或共聚物。聚合物可以包括聚酯，如聚对苯二甲酸乙二醇酯(PET)和/或二醇改性的聚对苯二甲酸乙二醇酯(PETG)。可以使用的其他聚合物包括聚(L-乳酸)、聚己内酯、聚(丙交酯-共-乙交酯)、聚(乙烯-乙酸乙烯酯)、聚(羟基丁酸酯-共-戊酸酯)、聚对二氧环己酮、聚原酸酯、聚酐、聚(乙醇酸)、聚(D,L-乳酸)、聚(乙醇酸-共-三亚甲基碳酸酯)、聚磷酸酯、聚磷酸酯氨基甲酸乙酯、聚(氨基酸)、氰基丙烯酸酯、聚(三亚甲基碳酸酯)、聚(亚氨基碳酸)、共聚(醚-酯)(例如，PEO/PLA)、聚氨基甲酸乙酯、硅树脂、聚酯、聚烯烃、聚异丁烯和乙烯-α-烯烃共聚物、丙烯酸类聚合物和共聚物、乙烯-共-乙酸乙烯酯、聚甲基丙烯酸丁酯、乙烯基卤化物的聚合物和共聚物(例如，聚氯乙烯)、聚乙烯醚(例如，聚乙烯基甲基醚)、聚偏二卤(例如，聚偏二氟乙烯和聚偏二氯乙烯)、聚丙烯腈、聚乙烯酮、聚乙烯基芳族化合物(例如，聚苯乙烯)、聚乙烯基酯(例如，聚乙酸乙烯酯)、丙烯腈苯乙烯共聚物、ABS树脂、聚酰胺(例如，尼龙66和聚己内酰胺)、聚碳酸酯、聚甲醛、聚酰亚胺、聚醚、聚氨酯、人造丝、玻璃纸、和羧甲基纤维素。
图8中所示的盖114包括两层薄膜。然而，在其它实施例中，盖114可以包括一、二、三、四、五、六、七、八、九、或可以使用十层。在一个实施例中，使用的层的数量可以是基本防止水渗入到密封的封装内所需的数量或总厚度。盖114可以包括总厚度从约5μm到约100μm、从约10μm到约75μm、从约20μm到约50μm。用于形成盖114的每个材料层的厚度可以为约5μm、约10μm、约15μm、约20μm、约25μm、约30μm、约35μm、约40μm、约45μm、约50μm、约55μm、约60μm、约65μm、约70μm、约75μm、约80μm、约85μm、约90μm或约95μm、或是在这些值中的任一值限定或当中的范围内的任意厚度。在一个实施例中，盖114可以为在约30μm到150μm之间的厚度。在另一个实施例中，盖114可以为大约30μm的厚度，并且由软化铝箔片的外层、底漆和过漆层以及热密封聚合物涂层的内层制造。软化箔片可以抵抗穿刺和撕裂，并且可以为包装提供持久性的水平。
图9说明包括五行泡罩、并且通过每行106的圆顶108的泡罩包装100的纵向横截面。在这个图中，只有聚合物材料134的单一层被用于形成泡罩基板102，但是，如上所述，可以使用更多的层。盖114包括两个外层130和内层132。然而，如上所述，可以使用更多或更少的层，来形成盖114。
在如图9所示的实施例中，药盒136形成适合于腔体104的形状。药盒136的杯体部138可以放入圆顶108，该杯体部可以容纳干粉药物，并且药盒的顶部140可放置在搁板110和药盒盖保持特征112的组合处。然而，任何药盒可以适合于本文所述的泡罩包装。泡罩基板可以定制，以适应另外和/或不同的药盒。
图10说明了药盒可被容纳在独立的腔体142内的实施例。这里，泡罩基板144能够与行106中每个腔体142、142'、142”之间的盖114接触。因此，在每个相邻的腔体142之间能够形成通道146，在通道中泡罩基板和盖材料可以相互粘结。如上，这里的每个腔仍可以包括圆顶108、搁板110和药盒盖保持特征112。
此外，在图10中，在泡罩基板144上可以包括穿孔148，以便使患者能够撕掉一行泡罩包装100，从而减少批量运输。如在一些实施方案中，可以指定每天三次剂量，对于一天的药，只需从泡罩包装中撕开一行可能是有用的特征。在其它实施例中，可以包括单独取出泡罩基板144的每个腔体的穿孔。
根据特定的需要，盖114和泡罩基板144(参照图9)之间的粘结可以有所不同。在一个实施例中，盖114和泡罩基板144之间的粘结可以是永久性的，以至于必须对箔片进行破坏来获取腔体中的东西。如图11A所示，盖114可被刺破150，允许从泡罩基板144中的特定腔体104内取出单个药盒。在其它包括泡罩基板102(图4)的实施例中，盖114可以被刺破，允许多个(例如，三个)药盒被揭开。
在另一个实施例中，盖114和泡罩基板102之间的粘结可以是半永久性的，以便可以剥开箔片来获取腔体中的东西。如图11B所说，盖114可以被剥开，允许从泡罩基板144中的特定腔体104内取出单个药盒。在其它包括泡罩基板102的实施例中，(图4)盖114可以被剥开，允许多个(例如，三个)药盒被揭开。在一些实施例中，可以包括剥开穿孔154，以便剥过106后，盖可以在剥开穿孔154处被撕掉和被丢弃。
本文所公开的另一个实施例，是在市售泡罩热成型机中，以自动化的内嵌的方式，制造如本文所述的泡罩包装的方法。该方法可以包括提供基体材料或板和盖膜；以卷的形式将基体材料和盖膜装载到机器上，以及在机器中处理基体材料和盖膜。可以根据制造商的建议执行该方法。在一个实施例中，基体材料被吸入到一个成形工位，在那里，它可以使用温度范围从约120℃到约150℃，或者从约120℃到约135℃的热量成形；和/或以规定的周期(例如，每分钟周期在10到30之间，或每分钟从约12个至约25个周期)使用配置的空气压力和机械插头来形成泡罩腔体或井。在一个实施例中，空气压力可以设定为从约4至约7巴，或从约5至约6巴。使用的热量、空气压力和机械插头依据将被制造的泡罩井和使用的基体材料的尺寸。药盒产品可以被自动地加载到泡罩腔体中，然后，将盖库拉到它上面。成形的和填充的基体材料和盖一起被拉到密封台，在那里，加热工具激活盖上的密封剂层，创建密封的泡罩包装。密封后，成形的和填充的泡罩网被拉到穿孔台，并且最后到达创建最终的泡罩包装的模切站。
在一个实施例中，泡罩包装可以被设计为包含15个填充药盒的药物。在这种实施例中，该填充药盒的药物可以位于五行三列中。在另一个实施例中，泡罩包装可以被设计为包含21个填充药盒的药物。在这种实施例中，该填充药盒的药物可以位于七行三列中。可以与泡罩包装一起使用的药盒可以用于计划肺部给药的药物制剂。在一些实施例中，能被含在药盒内的药物制剂尤其用于输送对降解敏感的生物制剂，包括肽和蛋白质和其他药物。在一些实施例中，泡罩中的药盒包括包含二酮哌嗪的制剂，如在美国专利号7,794,754、7,799,344；7.803,404；6,444,226；6,555,127；6,440,463；6,428,771；6,071,497；5,352,461和5,503,852中所公开的那些，以及专利申请号12/813839(US 2010/317574)和WO 2010/144789，其公开内容中所有他们包含的与二酮哌嗪和药物制剂相关的全部内容被并入本文。示例的二酮哌嗪，包括富马二酮哌嗪(双-3,6-(N-富马-4-氨基丁基)-二酮哌嗪-2,5-二酮；FDKP)。FDKP是一种用于肺部应用的二酮哌嗪，并具有通式：
FDKP提供了有益的微粒矩阵，因为它在酸中具有低的溶解度，但在中性或碱性pH中易溶。这些性质允许FDKP结晶，以及允许晶体在酸性条件下自组装形成微粒，并且适合于肺部给药，其具有在约0.5至约10微米之间的直径，可以到达肺部，成功通过大部分的天然障碍。包含用于肺部给药的包括二酮哌嗪盐的药剂(例如，在美国专利号7,820,676中所公开的那些)的药盒，以及其他用于药盒的药剂也可以封装到当前的泡罩包装内。
在一个实施例中，公开了泡罩包装的组装方法，该包装在每个泡罩内包含有药盒。在一个实施例中，药盒可以是两部分的药盒(如上面所述)，其分别包括美国专利号D613849和美国专利申请序列号12/484,137,(US 2009/0308392)中描述的容器或杯体和盖或顶部。药盒还可以包括安全壳或者预给药构造和给药构造。在其实施例中，该方法包括提供由两个注射模制零件组成的药盒，每个药盒包括盖和杯体；用药物制剂填充杯体；将药盒盖放置在杯体上方，并且将杯体的顶部锁定到运输***或者安全壳构造中，以便将药物粉末密封在杯体中。在这个和其它的实施例中，设计泡罩包装以便运输药盒，同时防止药盒杯体过早运动到给药构造中。
因此，可以设计泡罩包装，以便防止药盒在泡罩腔体的内部移动，其通过形成一系列的内构成特征来实现，该特征使每个药盒搁置在泡罩井内并且还防止它们相互接触。在这个和其他的实施例中，可以配置泡罩包装100，使得每个泡罩或者腔体104包括搁板区110，其中，安全壳构造中的药盒盖能够支撑在搁板区上，这反过来使杯体停止下降到圆顶108或者泡罩的圆形空穴内，从而保护药品免受机械冲击。在这个实施例中，泡罩中药盒杯体的所有面被圆顶状的特征围绕，并且当药盒在泡罩包装内时，杯体可能无法滑到给药位置。
在一个实施例中，可以设计和构造泡罩包装100，使其与另一个泡罩包装中的泡罩嵌套，从而在产品的运输和储存过程中减小分发的包装的尺寸。在一个实施例中，本发明方法包括将泡罩包装100转动或翻转过来，以使一对泡罩包装腔对腔的互相面对，然后把它们放在一起，从而使相对的泡罩上泡罩搁板区110的底面相接触。如果简单地堆放泡罩包装，这样的排列可以允许在较小的空间内对一对泡罩包装一起进行外包装。在一个实施例中，药物包装可以包括一个或多个如本文所述的泡罩包装，其中，泡罩包装被封闭在过度包装的箔片内，并且箔片过度包装包括软化铝材料。
在一个示例性实施例中，泡罩包装100可以每天使用三次，共五天的供应量。这种泡罩包装由五个热成型腔体104构成，对其进行设计以使每行106容纳三个填充药盒的药物。每个含有三个药盒的腔体104可以具有延伸了大约5mm的区域，其在所有四个侧面形成密封，并且密封工具可以被滚花以进一步增大总密封区域。
如上所述，在每个泡罩单元之间(包括部分、或行106)可以提供穿孔，以便使每个部分可以与相邻的部分分离。可以在口袋或钱包中分散地携带例如一个、两个、三个或多个药盒的单个腔体104。以这种方式，最终用户可以只携带与任何所需的特定的加药事件同样多的药品。在一个实施例中，用户用大拇指或食指按压在泡罩圆顶处，使得药盒穿破软箔盖。这种泡罩去除方法通常被称为推动通过。如果认真做，在不移除其他两个的情况下，可以从具有连续容积的例如三个药盒的共同腔体中去除单个药盒。根据将要给药的药物以及在一段时间内患者所需要的剂量的数量可以进行替代构造。
在一些实施例中，处理的泡罩包装可以具有可再现的、通过腔体的厚层压体的厚度。在一些实施例中，标准偏差可以为约0.004mm到约0.023mm之间。
在其它的实施例中，本文所述的泡罩包装一旦密封，在约1周、约1个月、约6个月、约1年、约2年、约3年、约4年或约5年的时间内可以基本上抵抗所有水的侵入。例如，小于约0.05g、小于约0.02g、小于约0.01g、小于约0.001g、或小于约0.0001克的水可能会自行进入密封的泡罩包装或药物内。在另一个实施例中，当在冷藏温度(例如，在4℃)储存时，本文所述的泡罩包装可以抵抗水透过。
在一些实施例中，水蒸气透过率可小于约0.005g水每包每天。在其它实施例中，水的透过率可以是小于0.003g、0.002g、0.001g、0.0005g、0.00005g、0.00001g、或0.000005g水每包每天。在一个实施例中，水的透过不大于约4.0×10-5g水每包每天。
水蒸气透过率也可能受储存温度的影响。当存储温度为约10℃到35℃之间、约15℃到30℃之间、约20℃到25℃之间时，本文所述的泡罩包装可以抵抗水透过。在一个实施例中，当在室温下储存时，本文所描述的泡罩包装可以抵抗水透过。
在一个实施例中，不仅密封了泡罩包装，而且泡罩包装内包括药物的药盒(们)也具有密封容器。在一些实施例中，药物是如本文所述的干粉。在一些实施例中，这种干粉基本可以抵抗所有水的侵入，为期约1周、约1个月、约6个月、约1年、约2年、约3年、约4年、约5年、或约10年。
实施例1
泡罩包装组件制造
提供基体材料或板和盖膜连同商业热成型(Pharmworks TF-2X)。基体材料由美国克勒克纳彭塔普拉斯特(Klockner Pentaplast)公司制造的在两个聚氯乙烯层之间的含氟聚合物层组成。基体材料以约12到25个周期每分钟(cpm)的速度被吸入到成形工位，在那里通过在所需的尺寸上使用专门设计的热量、空气的压力和机械插塞的组合，以形成在图中所定义的泡罩，从而使它成形。在这个例子中，用于软化塑料以形成泡罩井的温度范围可以从约130℃到约150℃。含有药物制剂的药盒自动加载到泡罩的腔体中，然后由软钢铝箔(Alcan)构成的盖被拉到组件上面。将成形的和填充的基体材料和盖材一起拉入密封台，在那里，温度范围为约150℃到约170℃的加热工具和压力导致盖材上的密封剂层被激活，从而创建密封的泡罩。密封后，成形的和填充的泡罩网被拉入穿孔站，然后最后被拉入创建最终的泡罩包装的模切站。
实施例2
泡罩包装的水蒸气透过率
针对水蒸气的透过率，对实施例1中制作的泡罩产品进行测试。包括三层泡罩基板的密封泡罩包装由聚氯乙烯层的外层和内层以及ACLAR的中间层组成，将其与由软化箔盖和由泡罩基板制成的吸塑包装进行对比，该吸塑包装由与三层泡罩基板的测量厚度相似的单层PET组成，并具有软化箔盖。将带有29号(0.33mm×13mm)针的注射器穿过泡罩包装的底部，从而在每个泡罩包装内注射3ml的水(三个泡罩中每个1ml)。注水后，用快速固化的环氧粘接剂塞住基体材料上的孔。在密封的玻璃容器中，通过将干燥的氮气流流过包装以及在一段时间后测量氮气吸取的水分含量，分析穿过包装的水蒸气。在实验开始和在其之后的一段时间内，在膜康(Mocon)Permatran装置中，对穿过包装并释放到密封罐中的水蒸气的测量值进行分析。
图12是对来自实验中的数据进行描述、说明了吸塑包装中典型的水蒸气透过率(WVTR)的图表，其中，在纵轴上示出每天的水分克数，并且在横轴上示出测量的时间点。曲线A(包括ACLAR的三层泡罩基板)和曲线B(PET泡罩基板)说明该实验的结果。该数据说明，经过一段短的时间，在此期间，测试仪器清除它本身的空气，WVTR快速稳定到水蒸气透过率稳定的并且在测试后6天几乎检测不到的值。这表明，随着时间的推移包装的完整性是可以接受的。如图12所示，为来自使用传统的PET层压板制作的泡罩中的比较数据，曲线B表示，在防止水分透过包装时，这种材料不是有效的。在图12中还可以注意到，和曲线A相关的初始峰值为实验开始时罐(大气)中的水蒸气，排出它需要大约12个小时。
实施例3
泡罩基板腔体的均匀性
在这些实验中，类似于实施例1所述来制造三种不同的泡罩基板层压板，为制造泡罩基板，使用的温度设定范围为从120到125℃，并且在12-25周期每分钟时和在约6巴的空气压力下，密封温度设定在155°到165°之间。在图13中指出的各种位置测量泡罩基板上腔体的厚度，以确定泡罩或者腔体的完整性和统一性。
图14是说明图13中沿着截面线列举的不同位置处的厚度。这里的泡罩基板是由三层PVC-ACLAR-PVC的层压体(7.5mil-3.0mil-7.5mil；0.19mm-0.07mm-0.19mm)形成的。泡罩基板的最薄点位于圆顶的顶点处(约0.175mm至约0.075mm)，并且最厚点位于搁板上(约0.275mm至约0.225mm)。
图15是说明图13中沿着截面线列举的不同位置处的厚度。这里的泡罩基板是由双层PVC-ACLAR的层压体(15mil-4.0mil；0.38mm-0.10mm)形成的。泡罩基板的最薄点位于圆顶的顶点处(约0.187mm至约0.125mm)，并且最厚点位于搁板上(约0.225mm至约0.275mm)。
图15是说明图13中沿着截面线列举的不同位置处的厚度。这里的泡罩基板是由双层CoPETG-ACLAR的层压体(12mil-4.0mil；0.30mm-0.10mm)形成的。泡罩基板的最薄点位于圆顶的顶点处(约0.125mm至约0.165mm)，并且最厚点位于搁板上(约0.200mm至约0.275mm)。
在图17的图表中，说明了来自图14-16的各种测量值的标准偏差。基于图14-17中的图表，本领域的技术人员可以理解，被处理的泡罩基板的厚度是可以可再现的，其具有约0.004到约0.023之间的标准差。在同一样品中，信号噪声的范围可以从约0.020至约0.135。
实施例4
水蒸气渗透
因为水蒸气渗透的特点和能力，选择具有铝箔外包装的泡罩基板，以便形成合适的紧密的包装。
当按照ASTM F1249在37.8℃/90％RH下测量时，对于泡罩包装材料中水蒸气渗透的特点来说，针对层压基板薄膜，供应商的规格可以为小于0.058g水/m2/天；针对层压盖，小于0.010g水/m2/天；以及针对层压外包装，小于0.010g水/m2/天。
根据ASTM F1249法-使用调制的红外传感器对通过塑料薄膜和板材的水蒸气透过率进行的标准测量方法，对由泡罩基板和铝箔外包装组成的密封组件单独进行测量。通过将1cc水注射到每个泡罩条以及将不渗透的环氧树脂放置在注射器创建的开口处，来准备泡罩基板样品。这在泡罩卡内创建了水库。通过将1cc水注射到外包装以及将不渗透的环氧树脂放置在注射器创建的开口处，来准备包含嵌套的泡罩包装的箔片外包装。通过将样本放置到Mocon Permatran仪器室中，并且用干燥的空气冲洗室的顶部空间来测定渗透特性。漏出的水蒸气可以通过密封的测试样品来进行扩散和渗透，以及与室的顶部空间内的气体混合并被运送到红外线传感器。红外线传感器测量一部分由水蒸气所吸收的红外能量，并产生电信号，其振幅与水蒸气浓度是成比例的。然后，将试验样品所产生的电信号与通过测量校准薄膜所产生的信号的振幅进行对比，该校准薄膜具有已知的水蒸气透过率。然后，这个信息用来计算水分透过被测材料的速率。测试在25℃/100％RH下进行。
本文所述的具有三层(ACLAR被外层的PVC层夹在中间)的密封泡罩基板具有约0.00004g水/泡罩包装/天的渗水率，并且密封组装外包装的渗水率约为0.040g水/外包装/天。对于含有药物制剂的药盒来说，这些低的值表明包装构造的适用性。在长期的稳定性研究中，通过测试TI粉的水分含量，已在实践中证实了该包装构造。数据显示在任一条件(5℃或25℃/60％RH)下，水分含量没有可辨别的变化，验证与含有(MannKind公司，加利福尼亚州)胰岛素的箔片外包装构造一起使用的泡罩卡的适用性。
虽然参照特定的实施例已经详细地示出和描述了本发明，但应该理解上述公开的变形和其他的特征和功能，或其替代，可以根据需要组合成许多其他不同的***或应用。此外，本领域的技术人员可以做出各种实质性的目前无法预见或未预料到的意图被包含在下面的权利要求中的替代、修改、变形或改进。
除非另有说明，在说明书和权利要求中使用的表示成分的含量、诸如分子量、反应条件等性质的所有数字，应被理解为通过术语“大约”在所有的情况下可修改。因此，除非相反地说明，在下面的说明书和权利要求书中所述的数字参数都是可以根据本发明获得的所需性质而变化的近似值。最低限度地并且不试图限制权利要求的范围的等同物的教导的应用地，每个数字参数至少被解释为关于所报告的明显数字和通过四舍五入得到的数字。
在描述本发明的上下文中(尤其是在后边的权利要求书的上下文中)所使用的术语“一”、“一个”、“这个”和类似的表示，除非被指出或者与上下文明确的相抵触，均解释为覆盖单数和复数。这里的值的范围的陈述仅仅意图用作单独地指落在范围内的每个独立的值的速记方法。除非这里被指出，每个单独的值就像其在这里被单独地陈述一样结合到说明书中。除非这里被指出或者与上下文明确地相抵触，这里所述的所有方法可以任何适合的顺序执行。这里所提供的任何和所有示例或示例性语言(例如，“诸如”)仅意图更好地说明本发明，并且除另有声明外不对本发明的范围进行限制。说明书中的语言不解释为指示本发明的实践所必须的任何未要求保护的组件。
这里所公开的本发明的替代组件或实施例的分组不解释为限制性的。每个组的部件可以单独地或以与组的其他部件任何组合或这里所发现的其他组件指代并且要求。期望为了方便和/或可专利性，组的一个或多个组件可以包含在组内或从组内删除。当这样的包括或删除发生时，说明书在这里被认为包含被修改的组，从而实现在权利要求中使用的所有马库什组的已写说明书。
这里描述了本发明的优选实施例，包括发明人所致的实施本发明的最好方式。当然，阅读了上面的说明后，这些优选实施例的变形对本领域的普通技术人员将显而易见。发明人希望本领域的技术人员适当地使用这些变形，并且发明人意图以除了这里所具体描述的方式实施本发明。因此，本发明包括在如适合的法律所允许的所附权利要求中所述的主题的所有修改和等同物。而且，以各种可能的变化的上述元件的任何组合被包含在本发明中，除非这里被指出或与上下文明确地相抵触。
此外，在整个说明书中多次引用了专利和印刷出版物。以上引用的文献和印刷出版物的各个在这里整体地通过引用单独地结合。
最后，应当理解，这里所公开的本发明的实施例是本发明的原理的说明。在本发明的范围内可以采用其他的修改。因此，以示例而非限制的方式，根据这里的教导可以利用本发明的替换配置。因此，本发明不限于所示的和所述的精确描述。

Claims (18)

1.一种包装，其包括：
泡罩基板，所述泡罩基板包括一个或多个腔体，其中，所述腔体包括圆顶结构和构造成保持一个或多个药盒的搁板，
其中，所述一个或多个药盒构造成容纳含有活性成分和二酮哌嗪的药物制剂，
其中，所述二酮哌嗪为
2.根据权利要求1所述的包装，其中，所述活性成分选自由胰岛素、胰高血糖素样肽1、胰高血糖素、催产素、胃泌酸调节素、肽YY、舒马曲坦、肽基肽酶IV抑制剂、甲状旁腺激素、神经递质受体激动剂、神经递质受体拮抗剂、脱氧核糖核酸酶I、其活性片段、其类似物或其结合组成的组合。
3.根据权利要求1所述的包装，其中，所述药盒包括容器和延伸到所述容器上面的盖或顶部。
4.根据权利要求1所述的包装，其中，所述活性成分是肽、蛋白质、小分子或核酸。
5.根据权利要求1所述的包装，其中，所述活性成分是神经递质受体激动剂和神经递质受体拮抗剂。
6.根据权利要求1所述的包装，其中，所述活性成分是胰岛素。
7.根据权利要求1所述的包装，其中，所述活性成分是胰高血糖素样肽1。
8.根据权利要求1所述的包装，其中，所述活性成分是胰高血糖素。
9.根据权利要求1所述的包装，其中，所述活性成分是催产素、胃泌酸调节素和肽YY中的至少一者。
10.根据权利要求9所述的包装，其中，所述活性成分是催产素。
11.根据权利要求9所述的包装，其中，所述活性成分是胃泌酸调节素。
12.根据权利要求9所述的包装，其中，所述活性成分是肽YY。
13.根据权利要求1所述的包装，其中，所述泡罩基板包括选自聚氯乙烯和ACLAR的至少三层。
14.根据权利要求13所述的包装，其中，所述ACLAR层形成所述泡罩基板的中间层，所述中间层的厚度为约230μm至约720μm。
15.根据权利要求1所述的包装，还包括盖。
16.根据权利要求15所述的包装，其中，所述盖包括箔片，所述箔片包括选自铝、塑料聚合物或共聚物中的一层或多层。
17.根据权利要求15所述的包装，其中，所述盖的厚度为约10μm至75μm。
18.根据权利要求15所述的包装，其中，所述盖的厚度大于100μm。
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