CN117584579A - 用于泡罩包装的盖膜及泡罩包装 - Google Patents

用于泡罩包装的盖膜及泡罩包装 Download PDF

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CN117584579A
CN117584579A CN202310962251.7A CN202310962251A CN117584579A CN 117584579 A CN117584579 A CN 117584579A CN 202310962251 A CN202310962251 A CN 202310962251A CN 117584579 A CN117584579 A CN 117584579A
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layer
cover film
polypropylene
film according
sealing
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C·格里姆巴赫尔
M·赫尔曼
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Sadepek Pharmaceutical Packaging Co ltd
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Abstract

本发明涉及一种用于泡罩包装的底膜的盖膜,包括两个外层,即顶层和密封层,以及设置在顶层和密封层之间的一个或更多个中间层。本发明还涉及一种泡罩包装。本发明的目的是省去铝,同时低成本地满足高品质药物对水和氧气的高阻隔性的要求。在此描述的本发明通过以下方式实现了这一点,即顶层和密封层是聚丙烯层。

Description

用于泡罩包装的盖膜及泡罩包装
技术领域
本发明涉及一种用于泡罩包装的盖膜,包括两个外层,即顶层和密封层,以及设置在顶层和密封层之间的一个或更多个中间层。本发明还涉及一种泡罩包装。
背景技术
特别是对于高品质药物,包装用于保护药物应免受环境的影响,特别是氧气和湿气的影响。这是活性成分或药物成分保持其在摄入时应发挥的作用的唯一方法。因此所谓的泡罩包装通常用于片剂形式的药物。其通常由所谓的推穿式泡罩和盖膜组成,推穿式泡罩也称为底部件或底膜,是具有凹陷或空腔的成型件,通常由塑料组成,但也可以由铝制成,盖膜也称为泡罩膜,其通常可以被推穿,并且主要由铝制成,这样人们就可以通过盖膜将药物从底膜的空腔中推出。泡罩包装的基本优点在此是它们易于使用、包装尺寸紧凑以及相应药物易于携带的同时保护其免受任何环境影响。
铝的使用在此主要用于将药物与水和氧气隔离,因为铝具有较高的水蒸气和氧气阻隔性,并且在此同时根据膜的强度或厚度可以相对容易地由使用者将在底膜的空腔中的相应药物通过盖膜从泡罩包装中压出。然而,铝作为一种能源和资源密集型材料,尽管铝可以回收利用,但它仍然需要大量能源。
因此,从现有技术中已知用于减少或完全去除泡罩包装中的铝、同时提供与铝相同的材料特性的不同方法。
例如,从DE 10 2008 056 123 A1中已知一种泡罩包装,其包括专门由不同的塑料或聚合物层组成的多层膜,因此可以完全省去铝。在此特别地,这是一种具有低水蒸气和氧气渗透性的可深拉的多层膜,其适合于药物泡罩包装并且优选具有PVC/PVDC/PCTFE/PVC类型的层状组合。
此外,US2009/0208729 A1公开了一种膜结构,其特征在于其包括至少五层。其具有由聚烯烃组成的两个外层,在每个外层的相对侧上设置有形成气体阻隔的层,其中在上述两个阻气层之间设置有泡沫塑料层。两个外层在此均由聚烯烃和粘合剂的混合物组成,这使得该聚烯烃层能够粘合至形成气体阻隔的层。
US2019/0009963 A1公开了一种用于泡罩、特别是片剂泡罩的塑料膜模制品,其包括具有半透明功能层的透明载体基底。半透明功能层在此以这样的方式形成,即该塑料膜模制品在入射光下观察时具有第一视觉上可识别的颜色,并且在透射光下观察时具有第二视觉上可识别的颜色。
此外,从德国实用新型DE 20 2021 002 835 U1中已知一种聚烯烃泡罩包装,其具有一个或更多个通过热成型产生的用于容纳待包装物品的凹深部,并且由连接至底膜的盖膜构成。该泡罩包装的特征在于,底膜和盖膜基本上由聚烯烃组成,并且至少50重量%的盖膜由环烯烃聚合物组成。
另外,从瑞士专利申请CH 701 216A1中已知一种生产用于推穿式包装的盖膜的方法。在这种方法中,用电子照射盖膜以设定期望的可推穿性。
发明内容
从这种现有技术出发,在此描述的本发明的目的是提供一种泡罩包装、盖膜和底膜,其中每一个都可以省去铝并且利用它们低成本地满足高品质药物对水和氧气的高阻隔性的要求。
该目的通过根据所适用的权利要求1的盖膜来实现。此外,该目的通过根据独立权利要求17的泡罩包装来实现。有利的实施方式可以在从属权利要求中找到。
本发明的第一方面涉及一种用于密封药物泡罩包装的底膜的盖膜,包括两个外层,即顶层和密封层。因此,盖膜本身是多层膜,其中顶层是盖膜的面向外界或环境的一侧。密封层在此是盖膜的面向底膜通常存在的空腔内的药物的一侧。在这些外层,即顶层和密封层之间,存在一个或更多个中间层。
本发明的显著之处在于,顶层和密封层由聚丙烯组成,即它们是聚丙烯层。聚丙烯与经常用于泡罩包装或泡罩包装的覆盖件和底部件的聚氯乙烯的价格相当,但具有更高的水蒸气阻隔性。
为了减少脆性和将相应的药物从底部件推动穿过盖膜所消耗的力,在有利的实施例中,本发明针对盖膜设定了两个外层之间的一个或更多个中间层是共聚物层、优选多相共聚物层。这在此特别优选为多相聚丙烯共聚物层。多相共聚物层,也称为嵌段共聚物,包含具有分散的橡胶状共聚物相的聚合物基质。该基质是均聚物或统计共聚物基质。橡胶状共聚物相是无定形橡胶、橡胶状聚合物(通常是多相聚丙烯共聚物中的乙烯/丙烯共聚物(橡胶))和半结晶共聚物的混合物。
一个或更多个中间层中的至少一个共聚物层优选具有20至260μm的层厚度、特别优选100至180μm的层厚度。在这样的层厚度下,盖膜仍然保持紧凑,同时提高了机械性能,即使用者推穿片剂形式的药物的能力。
替代地或附加地,在另一有利的实施例中,本发明针对盖膜还设定了一个或更多个中间层包括至少一个滑石增强聚丙烯层。滑石增强聚丙烯在此例如是聚丙烯和滑石的组合物,其中滑石的比例通常在20%至35%的范围内变化。与纯聚丙烯相比,该滑石增强聚丙烯具有更高的耐热性和承载能力以及更高的刚性。然而,后一种特性意味着塑料也更容易破裂。然而,根据滑石增强聚丙烯层的层厚度,此时正是需要这种性质,以便实现盖膜的更容易的推穿。
此外,在另一有利实施例中,本发明针对盖膜设定了一个或更多个中间层包括至少一个环烯烃层、优选环烯烃共聚物层。环烯烃层的存在显着改善了水蒸气阻隔性,其中水蒸气阻隔性的高低能够简单地通过环烯烃层的层厚度来改变,其中该层厚度可以在20至260μm、优选在80至100μm的范围内,并且特别优选具有80μm。后一个层厚度在此是改善的水蒸气阻隔性和盖膜所需的可推穿性之间的最佳折衷。
然而,为了也能够满足一些药物对高氧气阻隔性的要求,在另一有利实施例中,本发明针对盖膜设定了一个或更多个中间层包括至少一个聚乙烯醇层、优选乙烯-乙烯醇共聚物层。由于聚乙烯醇内存在的氢键位于各个聚合物链之间且与晶体结构相连接,聚乙烯醇是可用的最佳氧气阻隔之一。聚乙烯醇层的层厚度在此优选为5至15μm。
根据盖膜的期望特性,在另一有利实施例中,本发明设定了用于外层,即顶层和密封层的不同材料。
在第一替代实施例中,顶层和/或密封层由聚丙烯均聚物层组成。聚丙烯均聚物与无规聚丙烯的区别在于,由于基团(此处为亚甲基)的全同立构取向,其结晶度、熔点、拉伸强度、刚性和硬度得到提高。高水平的全同立构规整度最终会导致脆性增加,这继而有利于提高盖膜的可推穿性。聚丙烯均聚物层的层厚度在此优选为10至140μm、特别优选为60至110μm。
在另一替代实施例中,顶层和/或密封层由聚丙烯共聚物层组成。在此可以区分聚丙烯嵌段共聚物和聚丙烯无规共聚物。在聚丙烯嵌段共聚物的情况下,共聚物单体以嵌段形式构建到聚合物链中,而在聚丙烯无规共聚物的情况下,其以无规分布的方式进入分子链。分别获得的聚丙烯共聚物的性能尤其可以受到共聚物嵌段或相应所用的嵌段共聚物单体的不同长度和数量的影响。特别是,它们的韧性行为和刚性会受到影响。最终,聚丙烯共聚物层的使用又可以影响盖膜的穿透脆性(Durchbrüchigkeit)或韧性。
在另一替代实施例中,顶层和/或密封层由成核聚丙烯均聚物层组成。成核或核形成可用于促进无规聚丙烯中结晶区域的形成。因为聚丙烯的机械性能会受到现有晶体结构的尺寸和类型的影响。因为并非聚丙烯链的所有区域都是全同立构或间同立构的,所以并非聚合物链的所有区域都可以并入微晶中。通常,聚丙烯均聚物的全同立构区域以α-球晶的形式结晶。然而,添加合适或特殊的成核剂可能导致形成β-球晶,这伴随着由它们获得的聚丙烯的冲击韧性增加。因此,根据所需的性能和应用领域,使用具有α-球晶或具有β-球晶的成核聚丙烯均聚物作为盖膜的顶层和/或密封层是有利的。该成核聚丙烯均聚物层在此特别优选具有120至200μm的层厚度。
为了进一步改善水蒸气和氧气的阻隔性,在另一有利实施例中,本发明针对密封层设定了在其上涂有密封漆。该漆用于进一步增强水蒸气或氧气的阻隔性,而不会对盖膜的所需性能,特别是对任何药物穿过盖膜的可推穿性的脆性产生过度的负面影响。
为了对任何药物泡罩包装进行儿童防护,现有技术中通常增加铝膜的层厚度或将泡罩包装设计成使得盖膜不能被推穿而只能利用小孩子无法施加的力而拉开。为了还能够为在此描述的泡罩包装提供儿童防护,在另一有利的实施例中,本发明设定了其在盖膜的顶层上具有阻隔涂层、优选可移除的阻隔涂层。该涂层特别优选是双向拉伸聚丙烯层。双向拉伸聚丙烯通过特殊的拉伸方法而获得其特殊性能,在该方法中首先沿辊方向拉伸,然后垂直于辊方向拉伸,然后固定,其中其首要特点是高拉伸强度、化学、机械和热稳定性以及透明度。因此,其非常适合保护任何药物泡罩包装,防止儿童意外打开,因为其应用到了盖膜,在没有相应的力的情况下,无法再将其从泡罩包装的底部件移除。
在第二个也是最后一个方面,本发明涉及一种药物泡罩包装,其包括根据本发明的盖膜。
附图说明
下面参考示例性实施例更详细地解释本发明。
附图中:
图1示出了根据本发明的多层膜的示意图;
图2示出了根据本发明的多层盖膜的第一示例性实施例;
图3示出了根据本发明的多层盖膜的第二示例性实施例;
图4示出了根据本发明的多层盖膜的第三示例性实施例;以及
图5示出了根据本发明的多层盖膜的第四示例性实施例。
附图标记列表
1盖膜
2底膜
3顶层
4密封层
5中间层
6聚丙烯均聚物层
7共聚物层
8环烯烃层
9聚乙烯醇层
10成核聚丙烯均聚物层
具体实施方式
图1示出了根据本发明的多层膜的示意图。盖膜1和底膜2均由两个外层,即顶层3和密封层4组成。顶层3是盖膜1的面向外界或环境的一侧。另一方面,密封层4是盖膜1的面向底膜2通常存在的空腔内的药物的一侧。在这些外层,即顶层3和密封层4之间,存在一个或更多个中间层5。
图2在此示出了根据本发明的盖膜1的第一示例性实施例。其在此包括两个外层和一个中间层5,其中顶层3和密封层4在此是聚丙烯均聚物层6,并且中间层5是共聚物层7,特别是多相无规共聚物层。这适合于对水和氧气不太敏感的药物,并且由于中间层5与外层相比显着更大而具有易于推穿的特性,因为与聚丙烯均聚物层6相比,由多相无规共聚物7制成的中间层5脆性或刚性更高,因此弹性更小。
图3中示出了根据本发明的盖膜1,其也适用于水敏性药物。其具有两个聚丙烯均聚物层6(作为顶层3和密封层4)之间的作为中间层5的环烯烃层8。
为了能够提供防水和氧气保护,图4中还示出了相应的盖膜。其还包括分别作为顶层3和密封层4的聚丙烯均聚物层6,以及总共三个中间层5。直接邻接外层,即顶层3和密封层4的前两个中间层5各自为环烯烃层8。最后,聚乙烯醇层9布置在两个环烯烃层8之间,其由于其材料特性而具有高氧气亲和力。因此,图4所示的盖膜1具有高的水蒸气阻隔性和氧气阻隔性。
最后,图5示出了根据本发明的盖膜1,其中两个外层,即顶层3和密封层4是成核聚丙烯均聚物层10,并且其具有三个中间层5。在此,环烯烃层8分别邻接两个外层,环烯烃层又包围多相无规共聚物层7。
因此,以上示出了用于泡罩包装的盖膜和药物泡罩包装,利用该盖膜和泡罩包装可以省去膜中的铝并且可以低成本地满足高水蒸气和氧气阻隔性的要求。

Claims (17)

1.一种用于密封药物泡罩包装的底膜(2)的盖膜(1),所述盖膜(1)包括两个外层,即顶层(3)和密封层(4),以及设置在所述顶层(3)和所述密封层(4)之间的一个或更多个中间层(5),
其特征在于,所述顶层(3)和所述密封层(4)为聚丙烯层(6,7,10)。
2.根据权利要求1所述的盖膜,其特征在于,所述一个或更多个中间层(5)包括至少一个共聚物层(7),优选聚丙烯共聚物层。
3.根据权利要求2所述的盖膜,其特征在于,所述至少一个共聚物层(7)的层厚度为20至260μm,优选100至180μm。
4.根据权利要求1至3中任一项所述的盖膜,其特征在于,所述一个或更多个中间层(5)包括至少一个滑石增强聚丙烯层。
5.根据权利要求1至4中至少一项所述的盖膜,其特征在于,所述一个或更多个中间层(5)包括至少一个环烯烃层(8),优选环烯烃共聚物层。
6.根据权利要求5所述的盖膜,其特征在于,所述至少一个环烯烃层(8)的层厚度为20至260μm,优选80至100μm,特别优选80μm。
7.根据权利要求1至6中至少一项所述的盖膜,其特征在于,所述一个或更多个中间层包括至少一个聚乙烯醇层(9),优选乙烯-乙烯醇共聚物层。
8.根据权利要求7所述的盖膜,其特征在于,所述至少一个聚乙烯醇层(9)的层厚度为5至15μm。
9.根据权利要求1至8中至少一项所述的盖膜,其特征在于,所述顶层(3)和/或所述密封层(4)为聚丙烯均聚物层(6)。
10.根据权利要求9所述的盖膜,其特征在于,所述聚丙烯均聚物层(6)的层厚度为10至140μm,优选60至110μm。
11.根据权利要求1至8中至少一项所述的盖膜,其特征在于,所述顶层(3)和/或所述密封层(4)为聚丙烯共聚物层。
12.根据权利要求1至8中至少一项所述的盖膜,其特征在于,所述顶层(3)和/或所述密封层(4)为成核聚丙烯均聚物层(10)。
13.根据权利要求12所述的盖膜,其特征在于,所述成核聚丙烯均聚物层(10)的层厚度为120至200μm。
14.根据前述权利要求中至少一项所述的盖膜,其特征在于,在所述密封层(4)上涂有密封漆。
15.根据前述权利要求中至少一项所述的盖膜,其特征在于,所述顶层(3)具有阻隔涂层,优选可移除的阻隔涂层。
16.根据权利要求15所述的盖膜,其特征在于,所述阻隔涂层是双向拉伸聚丙烯层。
17.一种药物泡罩包装,包括根据权利要求1至16中至少一项所述的盖膜(1)。
CN202310962251.7A 2022-08-10 2023-08-01 用于泡罩包装的盖膜及泡罩包装 Pending CN117584579A (zh)

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