CN113795432B - 具有耐化学性和耐湿性的柔性基底 - Google Patents

具有耐化学性和耐湿性的柔性基底 Download PDF

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CN113795432B
CN113795432B CN202080033582.7A CN202080033582A CN113795432B CN 113795432 B CN113795432 B CN 113795432B CN 202080033582 A CN202080033582 A CN 202080033582A CN 113795432 B CN113795432 B CN 113795432B
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copolymer
layer
section
vdf
ctfe
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CN113795432A (zh
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G·M·斯克瓦雷克
卡尔·奥特曼
李钟�
埃里克·雷纳尔
奥德霍特·瓦桑特·科卡尔
A·泰纳潘
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Honeywell International Inc
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Honeywell International Inc
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Abstract

本发明提供了柔性包装物、透皮药物递送装置，以及用于制造包装物的方法。示例性柔性包装物包括由聚(氯三氟乙烯‑共‑偏二氟乙烯)(“P(CTFE‑co‑VDF)”)共聚物形成的耐化学耐湿层。另外，所述示例性柔性包装物包括待递送的物质。所述物质被施加至所述耐化学耐湿层或者被所述耐化学耐湿层封闭。

Description

具有耐化学性和耐湿性的柔性基底
技术领域
技术领域整体涉及包装物和透皮药物递送装置，以及用于制造此类包装物或装置的方法。更具体地讲，技术领域涉及此类包装物和装置中的耐化学性和耐湿性的基底。
背景技术
多种多样的热塑性聚合物以及由热塑性聚合物形成的膜是已知的。热塑性聚合物膜的重要物理特性和化学特性包括阻隔性质，诸如对气体的阻隔性、耐化学性、对香气和湿气的阻隔性，以及其物理特性，诸如耐久性、韧性、耐磨性和耐候性，以及透光性。这些性质在膜应用中尤其重要，诸如，在使用膜作为食品、化妆品或医用产品的包装材料时。
在单个膜结构中产生结合了由各种单独组分表现出的不同性质的多组分结构是本领域已知的。例如，在包装应用中，希望使用含氟聚合物，所述含氟聚合物的阻隔性质、对大多数化学品的惰性、耐高温性和低摩擦系数是为人所知的。聚氯三氟乙烯(“PCTFE”)均聚物和共聚物以及乙烯-氯三氟乙烯(“ECTFE”)交替共聚物由于其优异的湿气阻隔性质而已被频繁使用。
已将多种不同的热塑性物质与含氟聚合物共挤出以形成多层膜。例如，包含含氟聚合物的多层膜可以包括改善韧性的尼龙层，或者作为氧气阻隔层的乙烯-乙烯醇或聚乙烯醇层。然而，含氟聚合物在不借助粘合剂层的情况下，不能牢固地粘附到大多数其他聚合物上。事实上，大多数含氟聚合物的不粘特性为人所知，不但多层膜的层间粘结强度差，而且存在多层膜的分层现象。还已知含氟聚合物膜具有较差的热密封能力性质。
虽然前述材料已被用作封盖产品和包装产品，但仍需要在柔性包装中使用的改进材料。另外，需要此类材料以提供改善的耐化学性和耐湿性。另外，希望将此类材料用于促进在热密封应用或其他塑料焊接技术(诸如激光密封、射频(RF)密封和超声密封)中的使用。
因此，希望提供由表现出改善的耐化学性和耐湿性的一个或多个层形成的柔性包装物或透皮药物递送装置。另外，希望提供用于由此类层产生柔性包装物或透皮药物递送装置的方法。此外，结合附图和此背景技术，其他期望的特征和特点将根据后续具体实施方式和所附权利要求书变得明显。
发明内容
本发明提供了柔性包装物、透皮药物递送装置，以及用于制造包装物的方法。示例性柔性包装物包括由聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物形成的耐化学耐湿层，并且可以包括由相同材料构成的配件、连接头、闭合件和/或管材。另外，示例性柔性包装物包括待递送的物质。该物质被施加至耐化学耐湿层或者被该层封闭。
在另一个示例性实施方案中，提供了透皮药物递送装置。该透皮递送装置包括含有聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物的耐化学耐湿层。P(CTFE-co-VDF)共聚物包含基于该共聚物的总重量计约0重量％至约5重量％的偏二氟乙烯(“VDF”)。另外，该透皮药物递送装置包括可释放地连接到耐化学耐湿层的第二层。另外，该透皮药物递送装置包括位于耐化学耐湿层与第二层之间的药物。
在另一个实施方案中，提供了一种用于制造包装物的方法。该用于制造包装物的方法包括提供聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物组合物以及挤出该共聚物组合物的层。另外，该方法包括由该共聚物组合物的层形成具有边缘的第一区段和具有边缘的第二区段。另外，该方法包括将第一区段的边缘密封至第二区段的边缘，从而形成包装物。
本发明内容被提供以介绍简化形式的一系列概念，该一系列概念在下文具体实施方式中被进一步描述。本发明内容并非旨在识别要求保护的主题的关键特征或本质特征，也并非旨在用于辅助确定所要求保护的主题的范围。
附图说明
下面将结合以下附图来描述各种实施方案，其中相似数字表示相似元件，并且其中：
图1展示了穿过根据本文的一个实施方案的包括由P(CTFE-co-VDF)共聚物形成的层的非封闭柔性包装物的示意性透视图的横截面；并且
图2展示了穿过根据本文的一个实施方案的包括由P(CTFE-co-VDF)共聚物形成的层的非封闭柔性包装物的示意性透视图的横截面。
具体实施方式
以下具体实施方式本质上仅仅是示例性的，并非旨在限制柔性包装物和透皮药物递送装置或制造方法。另外，不意图受前述背景技术或以下详细描述中呈现的任何理论的束缚。
如本文所述，柔性包装物设置有由P(CTFE-co-VDF)共聚物形成的耐化学耐湿层。示例性耐化学耐湿层由P(CTFE-co-VDF)共聚物组成。在其他实施方案中，耐化学耐湿层可以包含P(CTFE-co-VDF)共聚物和丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)。例如，示例性层可以包含由德国科隆的英力士Barex AG公司(INEOS Barex AG，Cologne，Germany)以销售的丙烯腈-丙烯酸甲酯共聚物。可以使用其他适宜的丙烯腈共聚物。在利用P(CTFE-co-VDF)共聚物和丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)的层中，P(CTFE-co-VDF)共聚物可以与其他材料作为单层共挤出，或者可以层合形成子层的层合结构。
该柔性包装物还设置有待递送的物质，诸如药物、治疗剂、化妆品、膏剂、食品、水、溶剂或其他适宜的物质。待递送的物质可以是固体、凝胶、液体、纤维、粉末或其他期望的形式。待递送的物质可以被施加至耐化学耐湿层或者被该耐化学耐湿层封闭。
示例性柔性包装物作为药物递送装置提供，并且包括被施加至一个或多个耐化学耐湿层或者被一个或多个耐化学耐湿层封闭的药物。在使用期间，通过将药物与可以由P(CTFE-co-VDF)共聚物的耐化学耐湿层形成的可剥离衬片分离，或者通过将药物从由P(CTFE-co-VDF)共聚物的耐化学耐湿层形成的小袋或封装件中取出，来使药物暴露。
参见图1，其展示了示例性柔性包装物10。如图所示，柔性包装物10包括耐化学耐湿层12。层12可以被认为是背衬层。示例性层12由聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物形成。例如，层12可以由P(CTFE-co-VDF)共聚物组成，可以是以下材料的共挤出物：P(CTFE-co-VDF)共聚物和丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)，或者可以是层合结构，该层合结构包括一个或多个P(CTFE-co-VDF)共聚物层和一个或多个以下材料的层：丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)，和/或其他物质。
在示例性实施方案中，P(CTFE-co-VDF)共聚物包含基于该共聚物的总重量计约0至约10重量百分比(重量％)的偏二氟乙烯(“VDF”)，诸如约0至约5重量百分比(重量％)的VDF。例如，P(CTFE-co-VDF)共聚物可以包含基于该共聚物的总重量计约4重量％至约5重量％的VDF，诸如约5重量％的VDF。替代性地，P(CTFE-co-VDF)共聚物可以包含基于该共聚物的总重量计约2重量％至约3重量％的VDF，诸如约2.5重量％的VDF。在其他实施方案中，耐化学耐湿层12可以由多于一种P(CTFE-co-VDF)共聚物形成。例如，层12可以由包含约4重量％至约5重量％的VDF的P(CTFE-co-VDF)共聚物形成，以及由包含约2重量％至约3重量％的VDF的P(CTFE-co-VDF)共聚物形成。此类实施方案可以包括共挤出的一个或多个P(CTFE-co-VDF)共聚物层，或者包括每种P(CTFE-co-VDF)共聚物的子层的层合结构，或者包括共挤出的一个或多个层的层合结构。
如图1所示，柔性包装物10还包括待递送的物质14。在图1中，物质14被直接施加至耐化学耐湿层12。例如，物质14可以是包含药物和粘合剂的基质，或者可以是天然粘性的，使得物质14与层12直接接触。在其他实施方案中，柔性包装物10可以被认为包括用于将物质14粘附至层12的附加粘合剂层(未示出)。
在任一实施方案中，物质14均具有背面13和正面15。如图所示，物质14的背面13被直接或间接地施加至耐化学耐湿层12。
如图1所示，包装物10可以还包括第二层18。第二层18可以被认为是可剥离衬片。物质14的正面15被直接或间接地施加至第二层18。
第二层18在组成上可以与耐化学耐湿层12相同，即，由相同的共聚物组合物形成。替代性地，第二层18可以由独立于且不同于层12的组合物形成。例如，第二层18可以由P(CTFE-co-VDF)共聚物形成，或者由P(CTFE-co-VDF)共聚物和选自下列的材料形成：丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)。
柔性包装物10可以被进一步包装，诸如在封装件中。为了使用，将柔性包装物10从外包装中取出，并且将第二层18从物质14上取下。可以将物质14的正面15施加至使用者的皮肤，诸如用于透皮药物递送。在其他实施方案中，可以使用器具将物质14从层12刮除或以其他方式移除。同样，可以处理层12以将物质14施加至另一个制品。
图2展示了呈小袋形式的柔性包装物20的另一个实施方案。在图2中，柔性包装物20包括耐化学耐湿层26。示例性层26由聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物形成。例如，层26可以由P(CTFE-co-VDF)共聚物组成，可以是以下材料的共挤出物：P(CTFE-co-VDF)共聚物和丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)，或者可以是层合结构，该层合结构包括一个或多个P(CTFE-co-VDF)共聚物层和一个或多个以下材料的层：丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)。
在示例性实施方案中，P(CTFE-co-VDF)共聚物包含基于该共聚物的总重量计约0至约10重量百分比(重量％)的偏二氟乙烯(“VDF”)，诸如约0至约5重量百分比(重量％)的VDF。例如，P(CTFE-co-VDF)共聚物可以包含基于该共聚物的总重量计约4重量％至约5重量％的VDF，诸如约5重量％的VDF。替代性地，P(CTFE-co-VDF)共聚物可以包含基于该共聚物的总重量计约2重量％至约3重量％的VDF，诸如约2.5重量％的VDF。在其他实施方案中，耐化学耐湿层26可以由多于一种P(CTFE-co-VDF)共聚物形成。例如，层26可以由包含约4重量％至约5重量％的VDF的P(CTFE-co-VDF)共聚物形成，以及由包含约2重量％至约3重量％的VDF的P(CTFE-co-VDF)共聚物形成。此类实施方案可以包括共挤出的一个或多个P(CTFE-co-VDF)共聚物层，或者包括每种P(CTFE-co-VDF)共聚物的子层的层合结构，或者包括共挤出的一个或多个层的层合结构。
如图2所示，层26包括第一区段21和第二区段22。第一区段21可以被认为是第一层至少一种P(CTFE-co-VDF)共聚物，并且第二区段22可以被认为是第二层至少一种P(CTFE-co-VDF)共聚物。在某些实施方案中，第一区段21和第二区段22可以是一体的。例如，第一区段21和第二区段22可以由共同片材通过在折痕25处折叠该片材而形成。
第一区段21和第二区段22无论是否为一体，均由边缘26界定。如图2所示，第一区段21的边缘26被密封至第二区段22的边缘26。例如，区段21和22的边缘26被热密封在一起。
通过接合区段21和22的边缘26，在区段21与区段22之间限定了封装件或完全封闭的腔体28。如图所示，待递送的物质30位于封闭腔体28中。在某些实施方案中，如图1所述的包装物10可以位于封闭腔体28中。
在其他实施方案中，物质30可以是固体、凝胶、液体、纤维或粉末形式的药物、治疗剂、化妆品、膏剂或食品。在某些实施方案中，物质30可以是注入或以其他方式位于封闭腔体28中的液体。物质30可以在密封过程之前或之后定位在区段21与区段22之间，前提条件是腔体28在被刺穿以填充腔体30的情况下可以被重新密封。
在图2的某些实施方案中，物质30可以被认为是直接施加至耐化学耐湿层28，因为不需要中间粘合剂或其他材料。
上述在图1和图2的实施方案中使用的P(CTFE-co-VDF)共聚物可以经由悬浮聚合方法或乳液聚合方法形成。形成包装物和装置的具有约0重量％至约10重量％的VDF部分的P(CTFE-co-VDF)共聚物组合物可以通过常规的自由基聚合方法来聚合。任何适宜的可商购获得的自由基引发剂均可以用于该方法中。适宜的候选物可以包括热引发剂和氧化-还原或“氧化还原”引发剂体系。热引发剂包括：金属过硫酸盐，诸如过硫酸钾和过硫酸铵；有机过氧化物或氢过氧化物，诸如二酰基过氧化物、酮过氧化物、过氧化酯、二烷基过氧化物和过氧缩酮；偶氮引发剂，诸如2，2′-偶氮二异丁腈及其水溶性类似物；以及它们的混合物和组合。
一般来讲，可以使用已知可用于制备含氟聚合物诸如P(CTFE-co-VDF)的任何氧化还原引发剂体系。典型的氧化还原引发剂体系包含：1)有机或无机氧化剂或它们的混合物；和2)有机或无机还原剂或它们的混合物。适宜的氧化剂包括：金属过硫酸盐，诸如过硫酸钾和过硫酸铵；过氧化物，诸如过氧化氢、过氧化钾、过氧化铵、叔丁基过氧化氢(“TBHP”)((CH3)3COOH))、异丙苯过氧化氢和叔戊基过氧化氢；三乙酸锰；高锰酸钾；抗坏血酸以及它们的混合物。适宜的还原剂包括亚硫酸钠，诸如亚硫酸氢钠、亚硫酸钠、焦亚硫酸钠、间-亚硫酸氢钠(“MBS”)(Na2S2O5)和硫代硫酸钠；其他亚硫酸盐，诸如亚硫酸氢铵；羟胺；肼；亚铁；有机酸，诸如草酸、丙二酸、柠檬酸以及它们的组合。
示例性的自由基引发体系用于在引发聚合的同时乳化聚合物，从而消除对大量表面活性剂的需要。氧化还原引发剂体系可以是优选的自由基引发剂。适宜的氧化还原引发剂体系可以使用MBS还原剂和TBHP氧化剂。在一个示例性实施方案中，氧化还原引发剂体系与过渡金属促进剂结合使用。促进剂可以大大缩短聚合时间。任何可商购获得的适宜过渡金属均可以用作促进剂，包括铜、银、钛、亚铁以及它们的混合物。
用于所述方法中的自由基引发剂的量可以取决于各种单体共聚的相对容易度、聚合物的分子量和所需的反应速率。一般来讲，可以使用约10ppm至约100,000ppm的引发剂，诸如约100ppm至约10,000ppm的引发剂。
任选地，为了进一步促进聚合，氧化还原引发剂体系可以包含附加的基于过氧化物的化合物。附加的基于过氧化物的化合物的用量可以为约10ppm至约10,000ppm，诸如约100ppm至约5,000ppm。自由基引发剂可以在添加和/或消耗用于制备共聚物的单体之前、的同时以及/或者之后立即添加。当使用附加的基于过氧化物的化合物时，其可以以针对初级自由基引发剂所指定的相同间隔添加。
在用于制备P(CTFE-co-VDF)共聚物的示例性方法中包括聚合反应，其中将单体、水和自由基引发剂初始进料引入适宜的聚合容器中。在整个反应期间，以等于消耗速率的速率添加附加的单体，以维持恒定压力。在反应持续期间，将引发剂的附加的增量进料引入容器中，以维持聚合。将反应混合物保持在受控温度处，同时在整个聚合反应期间将所有反应物装入容器中。
用于制备P(CTFE-co-VDF)共聚物的反应容器的唯一要求是其能够被加压和搅拌。该方法可以利用常规的商业高压釜，其可以被密封并且加压至所需的反应压力(诸如出于安全考虑，小于3.36MPa(500psig))。在某些实施方案中，反应容器衬有含氟聚合物或玻璃衬里。
在示例性实施方案中，在其中实施聚合的水性介质可以是去离子的经氮气吹扫的水。一般来讲，使用相当于高压釜容量的大约一半的量。选择聚合物与水的比率，以获得水中含有约20％至约60％的聚合物固体的分散体。将水预先装入高压釜中。
在示例性实施方案中，可以在聚合过程中以半连续方式或连续方式将单体装入反应容器中。“半连续”意指在聚合反应期间将多个批次的单体装入反应器中。
消耗的全部单体与自由基引发剂的摩尔比将取决于所需的分子量。优选地，单体与引发剂的总摩尔比将为：约10摩尔至约10,000摩尔、诸如约50摩尔至约1,000摩尔，以及例如约100摩尔至约500摩尔的全部单体比1摩尔的引发剂。
在示例性实施方案中，自由基引发剂通常在反应过程中增量添加。出于本讨论的目的，引发剂的“初始进料”或“初始装入”是指快速、大量、单次或增量添加引发剂，以引起聚合的开始。在初始进料中，在装入单体之前、之后或期间，在约3分钟至约30分钟的时期内，通常添加介于约10ppm/min至约1,000ppm/min之间的引发剂。“连续进料”或“连续装入”意指在约1小时至约6小时的时期内，或者直至聚合已结束，缓慢、少量、增量添加引发剂。在连续进料中，通常添加介于约0.1ppm/min至约30ppm/min之间的引发剂。
在引发聚合反应期间，将密封反应器及其内容物保持在所需的反应温度处，或替代性地保持变化的温度分布曲线，该温度分布曲线在反应过程中改变温度。控制反应温度是用于确定所产生共聚物的最终分子量的另一个重要因素。一般情况下，聚合温度与产物分子量成反比。通常，反应温度应当为约0℃至约150℃，但也可以设想高于或低于这些值的温度。反应压力可以为约172KPa至约5.5MPa，诸如约345KPa至约4.2MPa。升高的压力和温度将产生更大的反应速率。
在示例性实施方案中，在搅拌下进行聚合以确保适当混合。虽然搅拌速率和反应时间通常将取决于所需的共聚物产物的量，但本领域的普通技术人员能够在不进行过度实验的情况下轻易地优化反应条件。搅拌速率将通常在约5rpm至约800rpm，诸如约25rpm至约700rpm的范围内，具体取决于搅拌器的几何形状和容器的尺寸。反应时间将通常为约1小时至约24小时，诸如约1小时至约8小时。
使用不含表面活性剂的乳液方法制备的分散体获得在水中具有至多40重量％固体的稳定分散体，其无需浓缩步骤即获得。可以添加少量的表面活性剂，以获得水中的较高含量的乳化聚合物(即，约40重量％至约60重量％)。适宜的表面活性剂将是本领域技术人员容易想到的，包括阴离子表面活性剂、阳离子表面活性剂和非离子表面活性剂。示例性分散体为阴离子表面活性剂稳定的胶乳乳液，其具有约0重量％至约0.25重量％的阴离子乳化剂。
示例性表面活性剂为全氟化阴离子表面活性剂。适宜的全氟化阴离子表面活性剂的示例包括全氟化辛酸铵、全氟化烷基/芳基羧酸铵(金属)和全氟化烷基/芳基磺酸锂(金属)，其中烷基基团具有约1个至约20个碳原子。适宜的表面活性剂还包括氟化离子或非离子表面活性剂、基于烃的表面活性剂(诸如烷基苯磺酸盐)，或任何前述物质的混合物。
通过上述方法产生的共聚物可以通过常规方法分离，诸如蒸发水介质、冷冻干燥水性悬浮液，或者添加少量的附聚剂或凝结剂(诸如碳酸铵)，之后进行过滤或离心。替代性地，所制备的共聚物分散体可以按原样使用。
根据所需的应用，还可以包含其他组分，诸如润湿剂和均化剂，诸如辛基苯氧基聚乙氧基乙醇；颜料，诸如二氧化钛；增稠剂，诸如疏水改性的碱溶胀性乳液(HEURASE)；消泡剂；紫外线吸收剂；增塑剂，诸如邻苯二甲酸丁苄酯；杀生物剂；填料，诸如玻璃珠，以及纳米球；防污剂，诸如水性PTFE或细粉PTFE；等。
可以使用熟知的挤出技术将示例性层12或26形成为P(CTFE-co-VDF)共聚物的单层膜。在其他实施方案中，层12或26可以包括一个或多个P(CTFE-co-VDF)共聚物层，一个或多个以下材料的层：丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)，以及通过共挤出彼此附接的任何其他层。
就共挤出而言，将用于各层的聚合物材料馈送到相同数量的挤出机的进料斗中，每个挤出机处理用于所述层中的一个或多个层的材料。可以将来自各个挤出机的熔融且增塑的料流馈送到单歧管共挤出模头中。当处于模头中时，这些层可以是并置的并且被组合，然后作为聚合物材料的单个多层膜从模头出现。离开模头后，将膜浇铸到第一控温浇铸辊上，绕过第一辊，然后浇铸到第二控温浇铸辊上，该第二辊通常比第一辊冷。控温辊主要控制膜离开模头后的冷却速率。可以采用附加的辊。在另一种方法中，成膜设备可以是在本领域中被称为吹塑膜设备的设备，并且包括用于膜泡吹塑膜的多歧管圆形模头，增塑的膜组合物被迫通过该圆形模头并且被形成为膜泡，该膜泡最终可以塌陷并且形成膜。共挤出以形成膜和片材层合物的方法通常是已知的。
替代性地，可以首先将各个子层形成为独立的层，然后在热和压力下将其层压在一起以形成层合结构。层合技术在本领域中是熟知的。通常，通过在足够的热量和压力条件下将单独层定位在彼此上以使得层组合成单一膜来进行层压。可以将各个层彼此叠放，并且通过本领域熟知的技术使组合通过一对加热层压辊的辊隙。通常，层压可以在有或没有中间粘合剂层的情况下进行。在一个示例性实施方案中，在共聚物层之间不使用中间粘合剂层。层压加热可以在约120℃至约225℃，诸如约150℃至约175℃的温度处，以及在约5psig(0.034MPa)至约100psig(0.69MPa)的压力处进行约5秒至约5分钟，诸如约30秒至约1分钟。
每个层均可以在接合之前定向。术语“拉伸比”是拉伸方向上的尺寸增加的指示。在某些实施方案中，将这些层在至少一个方向(即，纵向、横向)上单轴拉伸或者在纵向和横向中的每个方向上双轴拉伸至1.5∶1至5∶1的拉伸比。这些层可以同时双轴取向，例如使增塑膜同时在纵向和横向两个方向上取向。这导致透明度强度和韧性性质的显著改进。这些层可以是双轴取向的，并且不是热定形的，使得这些层在横向和纵向两个方向上都可收缩。替代性地，在接合各个膜层之后，多层膜可以作为整体单轴取向或双轴取向。
虽然膜结构的每个层可以具有不同的厚度，但是一个或多个共聚物层的厚度可以为约8μm至约254μm，诸如约8μm至约102μm，例如约8μm至约13μm。一个或多个丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)层(如果存在)的厚度可以为约1μm至约250μm，诸如约5μm至约225μm，例如约10μm至约200μm。因此，总膜厚度可以为约9μm至约504μm，诸如约13μm至约327μm，例如约18μm至约213μm。虽然公开了这样的厚度，但是应当理解，可以产生其他膜厚度以满足特定需要，并且其仍然落入本发明主题的范围内。
可热密封的包装物、装置和层的水蒸气传输速率(WVTR)可以经由ASTM F1249中所述的规程来测定。在一个示例性实施方案中，在37.8℃和100％RH处，所述包装物、装置和层在总制品中具有以下WVTR：约0.0005克/100平方英寸/天至约1克/100平方英寸/天，诸如约0.001克/100平方英寸/天至约0.1克/100平方英寸/天，例如约0.003克/100平方英寸/天至约0.05克/100平方英寸/天。如本领域所熟知的，水蒸气传输速率直接受到各个膜层的厚度以及总膜厚度的影响。
示例性可热密封层是可热收缩的，通常在长度或宽度或者长度或宽度中的每一者上可热收缩约2％至约30％，诸如约10％至约20％。这些层还可以在层上或层与层之间具有印刷标记。这种印刷通常在所述结构的内表面上，并且施加方法在本领域中是熟知的。
如上所述，示例性层可用于通过将层的多个部分密封到其自身来形成包装物。例如，一种或多种共聚物的单个层可以被挤出或共挤出、折叠并且定位成使得该层覆盖到其自身上，从而形成具有顶部边缘和侧边缘的重叠物，并且将侧边缘和任选地顶部边缘密封在一起以形成包装物。密封过程可以通过热密封应用或通过其他塑料焊接技术(诸如激光密封、射频(RF)密封和超声密封)来进行。热密封技术在本领域中是熟知的，涉及在约150℃至约270℃(诸如约200℃至约250℃)范围内的温度和约10psia至约100psia(诸如约60psi至约100psi)的压力处施加热以使聚合物层的多个部分熔融并熔合在一起。热密封过程在共聚物膜表面之间形成了具有与母体共聚物材料相同的湿气阻隔性质的强效层间粘结，从而避免了对粘合剂接合层的需要，并且克服了与低湿气阻隔性粘合剂材料相关联的湿气阻隔性质的典型降低。
根据本文的实施方案，该柔性包装物能够耐受γ辐射处理和/或低温处理。
虽然在前述具体实施方式中已呈现至少一个示例性实施方案，但应当理解存在大量的变型形式。还应当理解，一个示例性实施方案或多个示例性实施方案仅是示例，并且不旨在以任何方式限制主题的范围、适用性或配置。相反，前述具体实施方式将为本领域的技术人员提供一种用于实现示例性实施方案的便利路线图。应当理解，在不脱离如所附权利要求书中阐述的范围的情况下，可对示例性实施方案中描述的元件的功能和布置进行各种改变。

Claims (9)

1.一种柔性透皮递送装置，其包括：
耐化学耐湿层，所述耐化学耐湿层由聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物形成，其中所述P(CTFE-co-VDF)共聚物包含基于该共聚物的总重量计不超过约5重量％的偏二氟乙烯(“VDF”)；
可释放地连接到耐化学耐湿层的第二层；以及
待递送的物质，其中所述物质位于耐化学耐湿层与第二层之间；
其中所述耐化学耐湿层具有第一侧和第二侧，第二层可释放地连接到耐化学耐湿层的第二侧，所述物质位于耐化学耐湿层的第二侧与第二层之间，并且耐化学耐湿层的第一侧形成透皮递送装置的最外表面。
2.根据权利要求1所述的柔性透皮递送装置，其中所述耐化学耐湿层由P(CTFE-co-VDF)共聚物组成。
3.根据权利要求1所述的柔性透皮递送装置，其中所述耐化学耐湿层包含以下材料的共挤出物：P(CTFE-co-VDF)共聚物和丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)。
4.根据权利要求1所述的柔性透皮递送装置，其中所述耐化学耐湿层包括层合结构，所述层合结构包括P(CTFE-co-VDF)共聚物层和以下材料的层：丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)。
5.根据权利要求1所述的柔性透皮递送装置，其中所述P(CTFE-co-VDF)共聚物包含基于所述共聚物的总重量计约2重量％至约3重量％或者约4重量％至约5重量％的偏二氟乙烯(“VDF”)。
6.根据权利要求1所述的柔性透皮递送装置，其中所述物质是固体、凝胶、液体、纤维或粉末形式的药物、治疗剂、化妆品、膏剂或食品。
7.一种用于制造包装物的方法，所述方法包括：
提供聚(氯三氟乙烯-共-偏二氟乙烯)(“P(CTFE-co-VDF)”)共聚物组合物，其中所述P(CTFE-co-VDF)共聚物包含基于该共聚物的总重量计不超过约5重量％的偏二氟乙烯(“VDF”)；
挤出所述共聚物组合物的层；
由所述共聚物组合物的所述层形成具有边缘的第一区段和具有边缘的第二区段；以及
将所述第一区段的所述边缘密封至所述第二区段的所述边缘，从而形成所述包装物，其中将所述第一区段的所述边缘密封至所述第二区段的所述边缘包括形成完全封闭的腔体。
8.根据权利要求7所述的方法，其中：
挤出所述共聚物组合物的所述层包括将所述共聚物组合物与丙烯腈共聚物、环烯烃共聚物(COC)、聚对苯二甲酸乙二醇酯(PET)、箔和/或双轴取向聚酰胺(BOPA)组合物共挤出，以作为共挤出层形成所述层；
由所述共聚物组合物的所述层形成所述第一区段和所述第二区段包括折叠所述共聚物组合物的所述层，使得所述第一区段和所述第二区段在折痕处连接；并且
将所述第一区段的所述边缘密封至所述第二区段的所述边缘包括通过热密封、激光射频密封或超声密封将所述第一区段的所述边缘密封至所述第二区段的所述边缘。
9.根据权利要求7所述的方法，其进一步包括：
在挤出所述共聚物组合物的所述层之后并且在形成所述第一区段和所述第二区段之后，在所述第一区段和所述第二区段之间设置待递送的物质，其中所述待递送的物质位于将所述第一区段的所述边缘密封至所述第二区段的所述边缘后的所述腔体中。
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