CN112334118A - 单独剂量包装 - Google Patents
单独剂量包装 Download PDFInfo
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- CN112334118A CN112334118A CN201980039514.9A CN201980039514A CN112334118A CN 112334118 A CN112334118 A CN 112334118A CN 201980039514 A CN201980039514 A CN 201980039514A CN 112334118 A CN112334118 A CN 112334118A
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Abstract
本发明的多个方面涉及一种单独剂量包装。该单独剂量包装可包含单份料盒和围绕单份料盒整体并将该单份料盒密封于其中的外包装，其中外包装为防儿童的并且产生防止液体和气体通过的不能渗透的屏障。单份料盒可包含杯子、在该杯子中提供的至少一种药物活性成分和附加到杯子上的盖子。外包装是多层结构，其包含为双轴定向聚对苯二甲酸乙二醇酯层的第一层、为聚乙烯层的第二层、为铝箔层的第三层和为离聚物层的第四层。
Description
技术领域
本发明的多个方面涉及包含单份料盒(single serving pod)的单独剂量包装，所述单份料盒包含密封在防儿童外包装内的至少一种药物活性成分，所述防儿童外包装提供了环境因素不可渗透的屏障。
背景技术
用于自动冲泡机的单份料盒提供了一种制造单份饮料以供消费的方便方法。该方法特别适用于制备包含药物活性成分的饮料，因为这种产品的使用者通常寻求易用性和方便性。另外，使用者友好的单份料盒通过简化准备过程而鼓励使用者使用包含对其健康和幸福有益的药物活性成分的产品。冲泡单份饮料还通过避免准备多于使用者所需量而避免浪费。
单份料盒目前是可得的，并且通常涉及用于咖啡、茶等。这样的产品不适合用于药物活性成分，这可归因于该成分的敏感性特质。具体地，标准单份料盒不能保护敏感的药物活性成分免于暴露于环境。关键是这样的产品设计为通过防止暴露于水、氧和其他环境因素来保持成分的质量。因此，敏感的药物必须被包装在屏蔽包装内以在其有效期的持续时间内防止降解和保持功效和安全性。
另外，重要的是用于容纳药物的任何产品均要包装在防儿童的包装中以防止儿童摄入潜在危险的物质。当前的统计数据表明，所报告的儿科接触有毒物质的儿童中几乎有三分之一是由于误食药物引起的，而由此而造成的小儿死亡的百分之七十以上是由于意外接触危险物质引起的。因此，在过去的几十年中，防儿童的包装一直是重要的研究领域。
除了容纳在防儿童的包装中之外，同样重要的是，药物活性成分的包装可用于具有手部灵活性问题的老年人。患有关节炎的人和残疾人的人均药品消费率更高。打开防儿童的包装可能会导致患有关节炎和类似疾病的使用者的腕掌关节疼痛。这可能会阻止老年人使用此类产品并获得重要药品。
基于上述考虑，非常需要将这样的单份料盒：其包含密封在儿童安全并且老年人易使用的包装中的至少一种药物活性成分，该包装还提供了环境因素不能渗透的屏障。
发明概述
本发明的多个方面涉及一种用于自动冲泡机的单独剂量包装，其包含：单份料盒，该单份料盒包含：具有底部部分和从底部部分延伸到围绕开口的边缘的侧壁部分并且底部部分与侧壁部分之间的空间界定了内部空间的杯子，提供在杯子的内部空间中的至少一种药物活性成分，和附加到杯子的边缘从而封闭开口并将至少一种药物活性成分封牢在杯子的内部空间中的盖子；以及围绕单份料盒整体并将该单份料盒密封于其中的外包装，其中外包装是防儿童的并且产生防止液体和气体通过的不能渗透的屏障，并且其中外包装是多层结构，其包含为双轴定向聚对苯二甲酸乙二醇酯层的第一层、为聚乙烯层的第二层、为铝箔层的第三层，和为离聚物层的第四层。
本发明还提供了至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素、右美沙芬、苯海拉明、布洛芬、伪麻黄碱、愈创甘油醚、乙酰半胱氨酸、氯苯那敏、西替利嗪、左西替利嗪、琥珀酸多西拉敏、氯雷他定、多西拉敏或其组合。在本发明的一个实施方式中，至少一种药物活性成分是对乙酰氨基酚。在本发明的另一个实施方式中，至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素和右美沙芬的组合。在本发明的另一个实施方式中，至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素和苯海拉明的组合。在本发明的另一个实施方式中，至少一种药物活性成分是愈创甘油醚和右美沙芬的组合。
本发明还提供了单剂量包装通过防儿童测试测定为防多于70％的儿童的。在本发明的一个优选实施方式中，单剂量包装通过防儿童测试测定为防100％儿童。
本发明还提供了外包装的厚度为约70-100微米。本发明还提供了外包装的第一层的厚度为约20-30微米。本发明还提供了外包装的第二层的厚度为约10-20微米。本发明还提供了外包装的第三层的厚度为约7-12微米。本发明还提供了外包装的第四层的厚度为30-40微米。
本发明还提供了外包装的水蒸气透过率小于0.001g H2O/100in2/24小时。本发明还提供了外包装的氧透过率小于0.001cc/100in2/24小时。
本发明还提供了当平放时，外包装的长度为约130-140mm且宽度为约80-90mm。
本发明还提供了外包装的一端的第四层被折叠和粘附到外包装的另一端的第四层以产生密封的部分和将单份料盒密封在外包装中。
附图说明
图1图示了本发明的单份料盒的透视图；
图2图示了本发明的单独剂量包装的透视图；
图3图示了本发明的外包装的透视图；和
图4图示了本发明的外包装的多层的截面图。
具体实施方式
本发明的多个方面涉及一种包含单份料盒的单独剂量包装，所述单独剂量包装用于自动冲泡机以冲泡包含至少一种药物活性成分的单份饮料。单份料盒用作至少一种药物活性成分的第一包装。单份料盒还被包装和密封在第二包装内，该第二包装是产生围绕包的防儿童且老年人易使用的密封的外包装。此外，外包装提供了对包括但不限于水和氧的环境来说不能渗透的屏障。
根据本发明的单独剂量包装250大体上如图2中所描绘。具体地，图2图示了单份料盒100的透视图，该单份料盒100包含至少一种药物活性成分200，包装和密封在外包装300中。在使用中，可将单份料盒100从外包装300中取出，并放置在自动冲泡机中进行准备。
图1图示了根据本发明的单份料盒100的透视图。如图1所示，单份料盒100包含杯子110和盖子120。杯子11O具有底部部分150和从底部部分150延伸至围绕开口170的边缘130的侧壁部分160。开口170通向由杯子110的侧壁部分160和底部部分150界定的内部空间140。盖子120可附加到杯子110的边缘130以产生永久气密性密封。在冲泡周期中，盖子120、底部部分150和/或侧壁部分160可被自动冲泡机刺穿或以其他方式穿透，由此使得液体如水可进入杯子110与药物活性成分200混合，并且制成的饮料可从杯子110中释放出来。
可加入到杯子110、盖子120或外包装300的层压材料中的材料的非限制性示例包括聚苯乙烯、乙烯-醋酸乙烯酯、聚乙烯、双轴定向聚对苯二甲酸乙二醇酯、聚乙烯-醋酸乙烯酯、高密度聚乙烯、环烯烃共聚物、双轴定向聚酰胺、离聚物、聚三氟氯乙烯、聚丙烯、聚酯、无定型聚对苯二甲酸乙二醇酯、聚氯乙烯、聚乙烯、铝箔、聚对苯二甲酸乙二醇酯二醇、聚对苯二甲酸乙二醇酯、定向聚酰胺、低密度聚乙烯、聚偏二氯乙烯或其任一组合。杯子110、盖子120或外包装300的层压材料的每一层可经由粘合剂粘附到相邻层。
在一个优选实施方式中，包括底部部分150和侧壁部分160的杯子110可以是由提供理想屏障性质的任何合适材料制成的多层结构。优选地，杯子110至少包含外部的聚苯乙烯层、中间的乙烯-醋酸乙烯酯(EVOH)层和内部的聚乙烯层。
在标准自动冲泡机的冲泡过程中，杯子110可能暴露于极热液体；因此，杯子110应当在冲泡过程的持续时间内维持其形状并将药物活性成分200牢固地保持在内部空间140中。聚苯乙烯可用作杯子110的外层，因为其在极端温度下具有高稳定性。此外，自动冲泡机可刺穿杯子110的底部部分150以允许制成的饮料穿过杯子110进入使用者的容器中以供消费。聚苯乙烯是脆性的，即，当其经受应力而无显著变形时会破裂，并且使杯子110的底部部分150被任何标准自动冲泡机容易可靠地刺穿。制成以供消费的饮料可以是任何体积。在某些实施方式中，制成的饮料可以是5液体盎司，8液体盎司，或10液体盎司。在一个优选实施方式中，制成的饮料为8液体盎司。
杯子110可包括中间的EVOH层，该中间的EVOH层因其低氧透过率而保护药物活性成分200免于降解。这增加了存储在杯子110的内部空间140中的药物活性成分200的有效期和可靠性。
在杯子110的内部空间140内提供的药物活性成分200可以是可用于治疗和/或预防疾病和/或为使用者提供整体健康和保健益处的任何化合物或组合物。药物活性成分的非限制性示例包括非处方药(over the counter actives)、柜台后药物(behind thecounter actives)、处方药、维生素、矿物质、植物来源材料、能量增强材料(energyboosting materials)、益生菌、纤维、益生元、减充血剂、抗炎药、止咳药、祛痰药、抗组胺药、镇咳剂、镇痛药或其任意组合。
药物活性成分200可以是对乙酰氨基酚、苯肾上腺素、右美沙芬、苯海拉明、布洛芬、伪麻黄碱、愈创甘油醚、乙酰半胱氨酸、氯苯那敏、西替利嗪、左西替利嗪、琥珀酸多西拉敏、氯雷他定、多西拉敏或其任一组合。然而，本发明可用于任何药物活性成分，或任何药物活性成分组合，或药物活性成分与一种或多种赋形剂的组合。药物活性成分200可具有任何合适的形式，包括但不限于粉末、液体、凝胶或片。
在一个优选实施方式中，药物活性成分可以是对乙酰氨基酚、苯肾上腺素和右美沙芬的组合。在另一个优选实施方式中，药物活性成分可以是对乙酰氨基酚、苯肾上腺素和苯海拉明的组合。在另一个优选实施方式中，药物活性成分可以是对乙酰氨基酚。
在某些实施方式中，一种或多种药物活性成分可以约1mg至约2,000mg的量存在。在其中药物活性成分200包含对乙酰氨基酚的实施方式中，其以约300mg至约1,000mg的量存在。在一个优选实施方式中，对乙酰氨基酚以约650mg的量存在。在另一个优选实施方式中，对乙酰氨基酚以约500mg的量存在。在其中药物活性成分200包含苯肾上腺素的实施方式中，其以约5mg至约30mg的量存在。在一个优选实施方式中，苯肾上腺素以约10mg的量存在。在其中药物活性成分200包含右美沙芬的实施方式中，其以约5mg至约30mg的量存在。在一个优选实施方式中，右美沙芬以约20mg的量存在。在其中药物活性成分包含苯海拉明的实施方式中，其以约5mg至约50mg的量存在。在一个优选实施方式中，苯海拉明以约25mg的量存在。
赋形剂的非限制性示例包括香料、填充剂、崩解剂、助流剂、润滑剂、抗氧化剂、增甜剂、颜料、防腐剂、润滑剂、吸附剂或其任一组合。合适的香料可包括例如薄荷、薄荷脑、胡椒薄荷、冬青油、甜薄荷、绿薄荷、香草醛、焦糖、巧克力、咖啡、肉桂、丁香、柑橘、柠檬、绿茶、白茶、洋甘菊、酸橙、橙子、葡萄、樱桃、草莓、果汁潘趣酒(fruit punch)、蜂蜜、蜂蜜柠檬、其他水果香料或其任一组合。合适的填充剂可包括例如麦芽糖糊精、二氧化硅、柠檬酸钠、磷酸三钙、无水柠檬酸、柠檬酸钠、各种级别的微晶纤维素(如Avicel PH101、Avicel PH102&Avicel PH200)、玉米淀粉或其任一组合。合适的崩解剂可包括例如羟乙酸淀粉钠[Explotab]、交联聚乙烯吡咯烷酮、玉米淀粉、阿拉伯树胶、交联羧甲基纤维素钠[Ac-di-sol]、羧甲基纤维素钠、铝镁硅酸盐、藻酸盐或其任一组合。合适的助流剂可包括例如滑石、玉米淀粉、硬脂酸、硬脂酸钙、聚乙烯二醇、二氧化硅、硬脂富马酸钠、硬脂酸镁、植物油和矿物油或其任一组合。合适的润滑剂可包括例如硬脂酸镁、硬脂酸及其可药用碱金属盐、硬脂酸钙、硬脂酸钠、Cab-O-Sil、Syloid、月桂基硫酸钠、氯化钠、月桂基硫酸镁、滑石或其任一组合。合适的抗氧化剂可包括例如α-生育酚、β-生育酚、γ-生育酚、δ-生育酚、丁羟甲苯(BHT)、丁羟茴醚(BHA)、抗坏血酸、富马酸、苹果酸、抗坏血酸棕榈酸酯、没食子酸丙酯、抗坏血酸钠、焦亚硫酸钠或其任一组合。合适的增甜剂可包括例如乙酰磺胺酸钾、阿斯巴甜、蔗糖或其任一组合。合适的颜料可包括例如FD&C蓝1号、FD&C红40号、D&C黄10号、FD&C蓝1号、FD&C红40号。
在一个优选实施方式中，盖子120可以是由提供了理想的屏障性质的任何合适的材料制成的多层结构。优选地，盖子120至少包括外部底漆层、中间铝箔层和内部密封层。盖子120可经由盖子120的内部密封层牢固地永久密封到杯子110的边缘130上，药物活性成分200在杯子110的内部空间140中。内部密封层可在盖子120和杯子110之间产生气密性密封，这也保护了药物活性成分200。
盖子120的总体厚度为约65微米至约82微米。优选地，盖子120的总体厚度为约73.8微米。外部底漆层的厚度为约4微米至约9微米。优选地，外部底漆层具有约6.8微米的厚度。中间铝箔层的厚度为约34微米至约40微米。优选地，中间铝箔层具有约37微米的厚度。内部密封层的厚度为约27微米至约33微米。优选地，内部密封层具有约30微米的厚度。盖子120的总厚度在凸刻(embossing)之后为约100微米至约150微米。优选地，盖子120的总厚度在凸刻之后为约125微米。盖子120的总体多层结构具有小于0.05g/100in2/24小时的水蒸气透过率。
尽管如上所述的杯子110和盖子120提供了屏障性质，它们自身可能不足以包含本发明的敏感的药物活性成分200。因此，单份料盒100可被进一步包装和密封在多层外包装300中以提供相对于水、氧和其他环境因素的额外保护。外包装300可围绕单份料盒100整体，从而将单份料盒100密封在外包装300中。
具体地，外包装300实现了药物产品所需的防水和防儿童水平。这是比用于茶、咖啡或其他这种饮料的单份料盒的生产商所需更高的标准。当在其中没有密封单份料盒100的情况下平放在表面上时，外包装300的长度可以是约135mm至约140mm且宽度为约80mm至约90mm。优选地，当在其中没有密封单份料盒100的情况下平放在表面上时，外包装300的长度为约135mm，且外包装300的宽度为约86.5。此外，外包装300的总厚度可以是约70微米至约100微米。优选地，外包装300的厚度为约79.2微米。
图4图示了本发明的外包装300的多层的截面图。外包装300可有提供理想的屏障性质的任何合适的材料制成。在一个优选实施方式中，外包装300包含为双轴定向聚对苯二甲酸乙二醇酯(BoPET)层的第一层410。第一层410是由在两个不同方向拉伸以改善机械定向的聚对苯二甲酸乙二醇酯制成的聚酯膜。第一层410为本发明提供了若干有益特性，包括但不限于，高抗拉强度、耐久性、屏障性质和透明度。
此外，外包装300的第一层410的厚度为约20微米至约30微米。优选地，第一层410的厚度为约23微米。第一层410的厚度增加了外包装300的强度并允许其为防儿童的。通常，用于类似产品的BoPET层的厚度将会小得多；然而，这样的类似产品将不能防儿童，因此不能用于药物成分。
在一个优选实施方式中，外包装300包含为厚度为约10微米至约20微米的聚乙烯(PE)层的第二层420。优选地，第二层420的厚度为约13微米。具体地，第二层420可以是白PE层。第二层420可提供用于印花的白背景并粘合第一层410与第三层430。
在一个优选实施方式中，外包装300包含为铝箔层的第三层430。第三层430的厚度为约7微米至约12微米。优选地，第三层430的厚度为约8.9微米。第三层430使得外包装300防止液体和气体(包括水和氧等)通过。具体地，由于铝箔的分子结构对环境因素的敏感性，其产生了可理想地用于药物成分的强屏障。
第三层430消除了对液体和气体的暴露；从而延长了本发明的有效期并维持保存在杯子110中的药物活性成分200的质量和功效。此外，第三层430是持久和强有力的，同时也是轻质和有延展性的；因此，其可理想地用于包装各种形状和尺寸的产品而不会使其屏障性质有任何损失。
在一个优选实施方式中，外包装包括为离聚物层的第四层440。第四层440的厚度为约30微米至约40微米。优选地，第四层440的厚度为约34.3微米。第四层440是密封物，并且其自身可折叠以产生围绕单份料盒100的密封。
如图4中可见，第一层410可以是外包装300外侧上的最外层。第二层420可以设置在第一层410和第三层430之间。第三层430可以设置在第二层420和第四层440之间。第四层440可以是外包装300的密封侧或内侧上的最内层。
图3图示了密封在外包装300中的单份料盒100的透视图。如图3中可见，外包装300的一端的第四层440可以密封到外包装300的另一端的第四层440上以产生密封的部分310。密封的部分310提供了完美密封以进一步保护保存在单份料盒100中的药物活性成分200。
外包装300的水蒸气透过率小于0.005g H2O/100in2/24小时。优选地，外包装300的水蒸气透过率小于0.001g H2O/100in2/24小时。外包装的水蒸气透过率在100°F的温度和90％的相对湿度下测试。此外，外包装300的氧透过率小于0.005cc/100in2/24小时。优选地，外包装300的氧透过率小于0.001cc/100in2/24小时。氧透过率在73°F的温度和0％的相对湿度下测试。因此，外包装300具有极好的隔氧和隔水性质，这对于可用于单独计量包装250中的药物活性成分200来说是理想的。
此外，外包装300提供了用于单份料盒100的防儿童和耐撕的包装。耐撕是指在经受可由个体施加的力时，能够经历合理水平的应力和/或变形而不会经历完整性的显著丧失的材料。重点在于外包装300是防儿童的，从而防止儿童摄入可保存在本发明的杯子110内的潜在危险的物质，如药物活性成分200。
对本发明实施根据16.C.F.R.§1700Poison Prevention Packaging(防毒包装)的标准化防儿童测试。测试不合格定义为任何儿童开启了包装或得以接触包装的内含物。在一实施方式中，本发明可以是防儿童的，并且可被给予称为F值的评级。F值是对其的访问被视为测试不合格的单位剂量数。F值是根据25磅(11.4kg)儿童可导致儿童的严重人身伤害或严重疾病的单位剂量数来测定的。在本发明的一个实施方式中，单独剂量包装250可以是F＝1个包装。在另一实施方式中，本发明的单独剂量包装250可以是F＝3个包装。在另一实施方式中，本发明的单独剂量包装250可以是F＝4个包装。在另一实施方式中，本发明的单独剂量包装250可以是F＝5个包装。在本发明的一个优选实施方式中，单独剂量包装是F＝2个包装。
防儿童测试的结论是，当包装是F＝1、F＝2、F＝3、F＝4或F＝5个包装时，单独剂量包装250能防多于70％儿童开启。在另一实施方式中，当包装是F＝1、F＝2、F＝3、F＝4或F＝5个包装时，单独剂量包装能防多于80％儿童开启。在一个优选实施方式中，当包装是F＝1、F＝2、F＝3、F＝4或F＝5个包装时，单独剂量包装能防100％儿童开启。
另外，对本发明的外包装300实施根据16.C.F.R.§1700Poison PreventionPackaging(防毒包装)的老年人测试以确保具有灵巧性问题的成年人能够使用单份料盒100。在一实施方式中，多于90％的受测老年人使用剪刀或其他合理手段成功开启了外包装300。在一个优选实施方式中，100％的受测老年人使用剪刀或其他合理手段成功开启了外包装300。
本发明的其他方面可涉及治疗感冒和/或流感、过敏或其他疾病的症状的方法，包括制备本文所述的饮料和施用或消费制成的饮料。本发明的其他方面可涉及如本文所述制成的饮料用于治疗感冒和/或流感、过敏或其他疾病的用途。
实施例1
实施例1描述了本发明的稳定性和适当的有效期。具体地，对于本发明的如下实施方式进行稳定性研究：其中药物活性成分200是650mg对乙酰氨基酚、10mg苯肾上腺素和20mg右美沙芬的组合。
本发明在如下条件下进行测试：在25℃温度和60％相对湿度的长期存储条件下，在30℃温度和65％相对湿度的中间存储条件下，以及在40℃温度和75％相对湿度的加速存储条件下。
如下表1-3中所示，研究的结论大体上是在所有时间点和存储条件下评价数据均与规范一致。具体地，在所有时间点和存储条件下，颗粒和溶液的外观所产生的数据与规范一致。在所有时间点和存储条件下，每项活性测定所产生的数据与规范一致，且随时间的变化最小化。在所有时间点和存储条件下，对乙酰氨基酚所产生的数据显示降解没有增加，且最大结果小于0.05％。在每个规划的时间点和存储条件下，PHL021、PHL033、PHL052+PHL021-2、未指明降解物最大值以及总降解物之和所产生的数据均在规范限制内。在每个规划的时间点和存储条件下，DEX921、DEC922-1、未指明降解物以及总降解物最大值和总降解物之和均在规范限制内。针对总需氧菌计数、酵母菌总数和霉菌计数以及特定微生物大肠杆菌，已对本发明的微生物纯度进行了评估。对于所有待测样品，微生物纯度已显示满足最终产品规范的要求。
基于上述结果，稳定性研究的结论是，以下内容具有高度可信性：本发明足够牢固，并且单份料盒100能为杯子110的内部空间140中的药物活性成分200提供长期稳定性。
长期和加速稳定性数据验证了当包装在单份料盒100中时，本发明不会受到不利影响。因此，当包装在本发明的单份料盒100中并且存储在25℃以下的温度或同等条件下时，本发明的有效期为24个月。
进行温度循环研究以调查当存储在冰冻条件下并随后使其解冻时本发明的稳定性。对于冻融暴露，本发明在-20℃下暴露12小时，随后在10℃下12小时，总共5个循环和10个循环。此外，在50℃进行2周的高温静态研究。该研究的结果的结论是本发明对于冻融条件和高温来说不是温度敏感的。
表1注释
注：不合格＝测试超出Spec(s)sS
NT＝未测试，ND＝未检出，NS＝未规划
NMT＝不超过
NR＝无结果
N/A＝不适用
实施例2
实施例2描述了本发明的稳定性和适当的有效期。具体地，对本发明的以下实施方式进行稳定性研究：其中药物活性成分200是650mg对乙酰氨基酚、10mg苯肾上腺素和25mg苯海拉明的组合。
本发明以下条件下进行测试：在温度25℃和相对湿度60％的长期存储条件下，在温度30℃和相对湿度65％的中间存储条件下，和在温度40℃和百分比相对湿度75％的加速存储条件下。
如下表4-6中可见，研究的结论大体上是在所有时间点和存储条件下评价数据均与规范一致。具体地，在所有时间点和存储条件下，颗粒和溶液的外观所产生的数据与规范一致。在所有时间点和存储条件下，每项活性测定所产生的数据与规范一致，且随时间的变化最小化。在所有时间点和存储条件下，对乙酰氨基酚所产生的数据显示降解没有增加，且最大结果小于0.05％。在每个规划的时间点和存储条件下，PHL021、PHL033、PHL052+PHL021-2、未指明降解物最大值以及总降解物之和所产生的数据均在规范限制内。在每个规划的时间点和存储条件下，DEX921、DEC922-1、未指明降解物以及总降解物最大值和总降解物之和均在规范限制内。针对总需氧菌计数、酵母菌总数和霉菌计数以及特定微生物大肠杆菌，已对本发明的微生物纯度进行了评估。对于所有待测样品，微生物纯度已显示满足最终产品规范的要求。
基于上述结果，稳定性研究的结论是，以下内容具有高度可信性：本发明足够牢固，并且单份料盒100能为杯子110的内部空间140中的药物活性成分200提供长期稳定性。
长期和加速稳定性数据验证了当包装在单份料盒100中时，本发明不会受到不利影响。因此，当包装在本发明的单份料盒100中并且存储在25℃以下的温度或同等条件下时，本发明的有效期为24个月。
进行温度循环研究以调查当存储在冰冻条件下并随后使其解冻时本发明的稳定性。对于冻融暴露，本发明在-20℃下暴露12小时，随后在10℃下12小时，总共5个循环和10个循环。此外，在50℃进行2周的高温静态研究。该研究的结果的结论是本发明对于冻融条件和高温来说不是温度敏感的。
实施例3
实施例3详述了对本发明进行的防儿童测试的测试方法和测试结果以确保其符合The Poison Prevention Packaging Act 1970 Regulations和The Code of FederalRegulations Title 16：Part 1700.2。测试方法和测试结果在下文中详述。
防儿童测试方法：
在两种单独的测试环境中，对年龄在42个月至52个月(含)的25名男孩和25名女孩进行了成对测试。30％的孩子年龄为42-44个月，40％的孩子年龄为45-48个月，30％的孩子年龄为49-51个月。所有孩子均预先做好准备并提供了详细信息。
首先，将一对孩子放在房间内，递给他们相同的包装，并由管理员提示“请试着为我打开它”。随后给每名孩子5分钟以尝试打开他/她的包装。在测试的全部时间，管理员近距离观察孩子们，并且不以任何方式影响孩子们，无论是在口头上还是非口头上。允许孩子自由移动以处理他们的包装，即，允许孩子们站起、坐在地板上、摔打或撬开包装。还允许孩子们就打开包装彼此交谈，并可以彼此观察尝试打开包装。如果一名孩子打开了包装，管理员说“谢谢你”，并将包装从孩子手中取回并放在孩子不能触及处。不要求孩子第二次打开包装。
在5分钟结束时，如果一个孩子都没有打开他/她的包装，则管理员示范如何打开包装。管理员使用包装好的单独示范进行演示。在演示之前，要求孩子们将他们的包装放在一边，并且不允许继续尝试打开他们的包装。在演示过程中，管理员将包装放在离孩子们约两英尺的地方，并且以正常速度打开包装，就好像管理员正要使用内容物一样。管理员不夸大任何动作。管理员也不讨论或描述如何打开包装。
在演示之后，管理员通过提示“现在你们试着打开你们的包装”来指示孩子们开始第二个5分钟测试期。如果一个或两个孩子在第一个5分钟测试期内没有使用他们的牙齿来打开他们的包装，则管理员在开始第二个5分钟测试期之前指示孩子“如果你们想要，那么你们可以使用你们的牙齿”。随后管理员在第二个5分钟测试期内观察孩子们，或者直到两个孩子都打开他们的包装为止，以先到者为准。
防儿童测试结果：
在第一个5分钟测试期(演示之前)内记录了零次打开。另外，在第二个5分钟测试期(演示之后)内记录了零次打开。对于整个10分钟的测试而言，这对应于0.00％的总百分比，这在US 16 CFR§1700.20的容许范围内。因此，本发明符合US 16 CFR§1700.20的防儿童测试要求，如表7中所示。
这些结果是基于以下假设：将打开包装定义为儿童接触到该包装内装入的1个(或多个)单位的情况。这对应于F＝1的失败率。下表7列出了根据US 16CFR§1700.20的规定，在第一个5分钟测试时间和整个10分钟测试中，构成通过、需要继续测试或构成失败的打开包装的数量。
表7：打开数-接受(通过)、继续测试和拒绝(失败)标准
实施例4
实施例4详述了对本发明进行的老年人测试的测试方法和测试结果，以确保其符合The Poison Prevention Packaging Act of 1970 Regulations和The Code ofFederal Regulations Title 16：Part 1700。20。测试方法和测试结果详述如下。
老年人测试方法：
针对100名参与者进行测试，其中70％是女性，而30％是男性。25％的参与者年龄在50-54岁之间，25％的参与者年龄在55-59岁之间，50％的参与者年龄在60-70岁之间。每个参与者都单独参加了测试，并且没有其他参与者或旁观者在场。测试在光线充足且无干扰的空间中进行。
管理员通过指示参与者按照包装上的说明打开提供的包装来开始第一个5分钟测试期。允许参与者最多5分钟阅读说明并打开包装。5分钟后，或当参与者打开包装后，以先到者为准，管理员从参与者那里拿走了所有测试材料。
接下来，管理员通过给参与者另一个相同的包装来开始第二个测试期。第二个测试期持续1分钟。管理员指示参与者这是一个相同的包装，然后根据说明再次打开它。另外，管理员告知参与者，要打开包装，他们需要用剪刀沿端部密封切开。在第二个测试期之后，或者当参与者打开包装时，以先到者为准，管理员从参与者处拿走了所有测试材料。
老年人测试结果：
16CFR§1700.20允许10％的不成功打开率。根据所述程序进行的老年人测试的结果显示，在第一个测试期记录了零次不成功的打开包装的尝试。在第二次测试期内，记录了零次不成功的打开包装的尝试。对于整个10分钟测试，这对应于0.00％的总百分率，这在US16 CFR§1700.20的容许范围内。因此，本发明符合16 CFR§1700.20的成年人测试要求。
Claims (26)
1.一种用于自动冲泡机的单独剂量包装，包含：
单份料盒，其包含：
杯子，其具有底部部分和从所述底部部分延伸到围绕开口的边缘的侧壁部分，所述底部部分和所述侧壁部分之间的空间界定内部空间，
至少一种药物活性成分，其提供在所述杯子的内部空间中，和
盖子，其附加到所述杯子的边缘，从而闭合所述开口并且将所述至少一种药物活性成分封牢在所述杯子的内部空间中；和
外包装，其围绕所述单份料盒的整体并将所述单份料盒密封于其中，其中所述外包装产生防止液体和气体通过的不能渗透的屏障，和
其中所述外包装是多层结构，其包含为双轴定向聚对苯二甲酸乙二醇酯层的第一层、为聚乙烯层的第二层、为铝箔层的第三层和为离聚物层的第四层。
2.根据权利要求1所述的单独剂量包装，其中所述至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素、右美沙芬、苯海拉明、布洛芬、伪麻黄碱、愈创甘油醚、乙酰半胱氨酸、氯苯那敏、西替利嗪、左西替利嗪、琥珀酸多西拉敏、氯雷他定、多西拉敏或其组合。
3.根据权利要求2所述的单独剂量包装，其中所述至少一种药物活性成分是对乙酰氨基酚。
4.根据权利要求2所述的单独剂量包装，其中所述至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素和右美沙芬的组合。
5.根据权利要求2所述的单独剂量包装，其中所述至少一种药物活性成分是对乙酰氨基酚、苯肾上腺素和苯海拉明的组合。
6.根据权利要求2所述的单独剂量包装，其中所述至少一种药物活性成分是愈创甘油醚和右美沙芬的组合。
7.根据权利要求1所述的单独剂量包装，其中所述单剂量包装通过防儿童测试测定为防多于70％儿童。
8.根据权利要求6所述的单独剂量包装，其中单剂量包装通过防儿童测试测定为防100％儿童。
9.根据权利要求1所述的单独剂量包装，其中所述外包装的厚度为约70-100微米。
10.根据权利要求1所述的单独剂量包装，其中所述外包装的第一层的厚度为约20-30微米。
11.根据权利要求1所述的单独剂量包装，其中所述外包装的第二层的厚度为约10-20微米。
12.根据权利要求1所述的单独剂量包装，其中所述外包装的第三层的厚度为约7-12微米。
13.根据权利要求1所述的单独剂量包装，其中所述外包装的第四层的厚度为约30-40微米。
14.根据权利要求1所述的单独剂量包装，其中所述外包装具有小于0.001g H2O/100in2/24小时的水蒸气透过率。
15.根据权利要求1所述的单独剂量包装，其中所述外包装具有小于0.001cc/100in2/24小时的氧透过率。
16.根据权利要求1所述的单独剂量包装，其中在平放时，所述外包装的长度为约130-140mm且宽度为约80-90mm。
17.根据权利要求1所述的单独剂量包装，其中所述外包装的一端的第四层被折叠和粘附到所述外包装的另一端的第四层以产生密封的部分并将所述单份料盒密封在所述外包装中。
18.一种多层外包装，包含：
第一层，其为双轴定向聚对苯二甲酸乙二醇酯层；
第二层，其为聚乙烯层；
第三次，其为铝箔层；
和第四层，其为离聚物层，
其中所述外包装为防儿童的并且产生防止液体和气体通过的不能渗透的屏障。
19.根据权利要求17所述的多层外包装，其中所述多层外包装为通过防儿童测试测定为防多于70％儿童。
20.根据权利要求18所述的多层外包装，其中所述多层外包装为通过防儿童测试测定为防100％儿童。
21.根据权利要求17所述的多层外包装，其中所述多层外包装的第一层的厚度为约20-30微米。
22.根据权利要求17所述的多层外包装，其中所述多层外包装的第二层的厚度为约10-20微米。
23.根据权利要求17所述的多层外包装，其中所述多层外包装的第三层的厚度为约7-12微米。
24.根据权利要求17所述的多层外包装，其中所述多层外包装的第四层的厚度为约30-40微米。
25.根据权利要求17所述的多层外包装，其中所述多层外包装具有小于0.001g H2O/100in2/24小时的水蒸气透过率。
26.根据权利要求17所述的多层外包装，其中所述多层外包装具有小于0.001cc/100in2/24小时的氧透过率。
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| US16/004,858 | 2018-06-11 | ||
| PCT/US2019/036446 WO2019241176A1 (en) | 2018-06-11 | 2019-06-11 | Individual dose pack |
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| CN112334118A true CN112334118A (zh) | 2021-02-05 |
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| CN (1) | CN112334118A (zh) |
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| WO (1) | WO2019241176A1 (zh) |
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| ES2477885T5 (es) * | 2009-06-17 | 2017-07-11 | Koninklijke Douwe Egberts B.V. | Membrana Rhea no tejida |
| TWM598286U (zh) * | 2020-04-27 | 2020-07-11 | 大江生醫股份有限公司 | 具海洋回收塑料層的積層膜的包裝體 |
| WO2024118700A1 (en) * | 2022-11-29 | 2024-06-06 | Haleon Us Holdings Llc | An individual dose pod |
| GR1010650B (el) * | 2023-01-17 | 2024-03-12 | Ιουλια Κλεωνος Τσετη | Φαρμακευτικη συνθεση παρακεταμολης υπο υδατοδιαλυτη μορφη εντος ερμητικα κλειστου δοχειου για παρασκευη ζεστου ροφηματος |
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2019
- 2019-06-11 WO PCT/US2019/036446 patent/WO2019241176A1/en unknown
- 2019-06-11 CA CA3102134A patent/CA3102134A1/en active Pending
- 2019-06-11 EP EP19818603.3A patent/EP3810063A4/en active Pending
- 2019-06-11 CN CN201980039514.9A patent/CN112334118A/zh active Pending
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Also Published As
| Publication number | Publication date |
|---|---|
| US10881582B2 (en) | 2021-01-05 |
| EP3810063A1 (en) | 2021-04-28 |
| WO2019241176A1 (en) | 2019-12-19 |
| EP3810063A4 (en) | 2022-04-13 |
| US20190374433A1 (en) | 2019-12-12 |
| CA3102134A1 (en) | 2019-12-19 |
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