CN112239015A - 紫外光管理包装件和保护覆盖件 - Google Patents

紫外光管理包装件和保护覆盖件 Download PDF

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CN112239015A
CN112239015A CN202010691601.7A CN202010691601A CN112239015A CN 112239015 A CN112239015 A CN 112239015A CN 202010691601 A CN202010691601 A CN 202010691601A CN 112239015 A CN112239015 A CN 112239015A
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bowl
cover
package
contact lens
light
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J·斯瓦米
冈萨雷斯 M·德弗雷塔斯
S·安塞尔
R·阿布拉姆斯
V·勒斯
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Johnson and Johnson Vision Care Inc
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Abstract

本发明题为“紫外光管理包装件和保护覆盖件”。本发明描述了一种接触镜片包装件，该接触镜片包装件包括用于保持接触镜片的碗状物。碗状物由接合碗状物的膜密封，以便将接触镜片保持在所述碗状物和膜之间。透镜被放置在碗状物和膜之间的盐水中。最后，存在附接到碗状物的光管理保护覆盖件。这控制通过所述覆盖件并到达所述碗状物上的光的类型。通常，覆盖件是紫外光不可透过的。

Description

紫外光管理包装件和保护覆盖件
相关申请
本申请是于2019年7月17日提交的序列号16/514437的部分继续申请，该申请的内容以引用方式全文并入本文。
背景技术
本发明涉及由接触镜片的消费者使用的包装件。更具体地讲，本发明的包装件有助于抑制紫外光透过包装件，从而保护接触镜片免受紫外光暴露。该属性将可用于包装包含任何光或紫外线敏感化合物(诸如药物)和/或光敏化合物(诸如光致变色化合物)的接触镜片。据认为，将紫外光或可见光暴露于镜片可导致光敏化合物的功效受到损害，这种损害不是对用户造成危险，而是由于其损失独特的产品有益效果。
附图说明
图1为接触镜片包装覆盖件的透视图，该包装覆盖件用于与如图1B和图1C(分别为无覆盖件的情况下的平移视图(pan view)和正视图)所示的接触镜片泡罩碗状物一起使用，该包装覆盖件是根据本文所包含的本发明的说明制成的；
图2为图1的包装件的变型的透视图；
图3A和图3B和图3C为本发明的另外的变型，其中覆盖件超声焊接到包装件；
图4A、图4B和图4C为图3A、图3B和图3C的覆盖件的变型；
图5描述了将覆盖件附接到包装件的另外的配置；并且
图6A和图6B描述了将覆盖件附接到镜片包装件的其它变型。
发明内容
接触镜片目前正在扩展其产品选择，使得产品组合将包括包含光或紫外线吸收化合物的接触镜片，诸如光致变色接触镜片，或高能可见(HEV)光吸收接触镜片，这些接触镜片中的一些接触镜片是光敏的。
例如，当前的初级包装(聚丙烯泡罩和箔层合盖材)不能防止紫外线或可见光透射，并且可允许光致变色镜片的潜在激活，从而导致镜片的光疲劳和其功效的损失。
光敏感度的另一个示例包括包含光敏化合物(诸如HEV光吸收化合物)的接触镜片，该光敏化合物在暴露于紫外光时表现出光降解。光敏感度可通过在400nm至450nm的波长范围内平均透射率的至少2％的变化来证实。可使用各种暴露方法。光曝光的优选方法是1996年11月公布的International Conference on Harmonisation(ICH)of TechnicalRequirements for Registration of Pharmaceuticals for Human Use guideline，Q1BPhotostability Testing of New Drug Substances and Products描述的那些。优选地，在ICH光稳定性指南下，使用选项2光源，优选地在控制在25℃/Amb RH的光稳定性室中，以1.5192×106Lux小时的估计光照暴露(168.8小时暴露时间)和259.4瓦特小时/m2的估计紫外线照射暴露(16.2小时暴露时间)进行曝光。在暴露之后，收集样品的紫外/可见光谱并与已被保护免于暴露的样品的光谱进行比较。以举例的方式，包含根据本发明的光敏化合物的接触镜片在如上述的ICH指南Q1B条件(有时在本文中简写为“ICH指南Q1B”或“Q1B条件”)下暴露于光之后，在400nm至450nm的波长范围内表现出其平均透射率的至少2％、或至少5％、或至少7％、或至少10％的变化。此类变化可被计算为在有曝光和没有曝光的情况下(在所指示的波长范围内)的平均透射率之间的差的绝对值。
“光致变色化合物”可被认为是在暴露于特定强度和波长的光时大体可逆地变暗的化合物。
限制一种或多种波长的高能可见光(例如在400nm至450nm的范围内)透射穿过镜片的化合物可被认为是“高能可见光吸收”或“HEV光吸收”化合物。材料吸收某些波长的光的能力可通过测量其紫外/可见透射或吸收光谱来确定。
紫外光可被认为是波长在100nm至400nm范围内的光。
开发了“光管理保护覆盖件”(LMPC)以解决过早曝光于光致变色和其它光敏产品的问题。LMPC是用于当前接触镜片初级包装表面上的可附接或粘附/粘结的覆盖件/遮罩，以防止/限制曝光(包括但不限于紫外光)于其内容物(包括但不限于接触镜片)。
LMPC在灭菌后施加到接触镜片碗状物的下侧，并且旨在保持附连到初级包装的外侧。因此，本发明将不影响与镜片包装一起使用的热密封或消毒过程，这是用于确保无菌屏障包装***的两种最重要的加工技术。此外，LPMC覆盖件不与包装溶液或物理镜片本身接触，并且初级包装碗状物在覆盖件和镜片之间提供足够的屏障。因此，该溶液减轻了对于从覆盖件浸出到包装的任何内部、包含镜片的溶液中或进入镜片本身的任何材料的影响–因为所有这些元件从不与LPMC接触。
如图1所示，描述了待与标准接触镜片包装件200一起使用的覆盖件100上的按扣，如图1B所见。覆盖件100具有按扣特征件，该按扣特征件被呈现为放置在覆盖件100的一端处的突片105。这些突片105与包装件200上的凸缘205配合。因此，覆盖件100能够附接到包装件200的碗状部分210，而不需要将覆盖件100粘结到碗状物210或实际上粘结到包装件200。
如前所述，覆盖件100是不透明的并且阻挡紫外光，使得如果存在放置在碗状物210中的接触镜片以使得镜片被光活化，则覆盖件将防止镜片的意外活化，或者另选地防止存在于镜片中的药物的劣化。
图2描述了图1的覆盖件的变型。如在图2中可见，描述了覆盖件120，该覆盖件包含凸缘122、124上的按扣。这些凸缘122、124设置在覆盖件120的任一端121、123处，使得覆盖件120可附接在泡罩包装件200(即，在图1的覆盖件100的描述中表征的相同的包装件200)的两端处。图2的修改的设计120确保了覆盖件120和包装件200之间更好的接触，从而降低了光从中通过的概率。该特征件使得覆盖件120能够附接到包装件200的碗状物210，而不必在覆盖件120和碗状物210之间形成任何种类的粘结。
图3A、图3B和图3C描述了前述设计的另外的变型。如这些图所示，覆盖件100、120的“按扣”特征件被移除。此时，覆盖件140、145和150包含用于超声焊接的特征件。这些被描述为在这三个图中的每一者中看到的突片142、147、152。这些变型此时进一步降低了镜片暴露于光的概率。如图3A、图3B和图3C所示，覆盖件140、145或150与碗状物210之间的接触进一步增强，使得消除任何按扣特征件。凸缘142、147、152中的每一者可通过超声波或热尖端焊接工艺熔合粘结或焊接到碗状物210，该工艺为包装工业中已知的标准技术。
图4A、图4B和图4C描述了图3A、图3B和图3C的概念的另外的变型。此时，如在图4A、图4B和图4C中可见，提供了较大的焊点，提供了与包装件200的邻接碗状物210的热密封环状物220隔开的距离。这些延伸的翼部或尾部129、149、159使得覆盖件225能够焊接到与热密封环状物220隔开的包装碗状物210。该特征件确保对碗状物210和包装盖材之间已形成的热密封粘结的最小损坏，并且保持包装件200上的无菌屏障。盖材由能够压力成形的箔形成，包含层合的聚酯和铝箔层合的复合物。
最后，图5示出了图4C中所见覆盖件的“正方形向上”变型，使得降低了光渗出的可能性。将覆盖件500附接到包装件550使得存在增大的焊接表面积。该特征件提供对碗状物510的增强的覆盖，以使碗状物510更容易焊接到覆盖件500，并且更远离热密封环状物。
如图5最佳所示，覆盖件500和包装件550的理想样式被设计用于容纳光致变色接触镜片。包装件被配置成能够解决光致变色接触镜片的紫外光暴露并使紫外光暴露最小化。用于覆盖件500的优选材料为具有紫外线阻滞剂和TiO2的聚丙烯。当与由聚丙烯形成并且具有介于0.55mm和0.85mm之间的壁厚的典型接触镜片包装一起使用时，覆盖件500的优选材料厚度为约0.375mm。这允许覆盖件为柔韧的但牢固地附接到包装件550。然而，应当理解，覆盖件500的厚度可在0.025mm至1.0mm的范围内以满足特定产品要求。同样，如下所述，其它材料当然也是可能的。
可用作LMPC覆盖件的材料的范围被认为相当广泛。所选择的材料应当与初级包装件550且尤其是碗状物510中所用的材料相容，使得在熔合粘结或焊接时在这两种材料之间形成粘结。例如，如果碗状物510由聚丙烯制成，则用作覆盖件500的优选材料也为聚丙烯，但是可使用任何其它热塑性聚合物，诸如基于丙烯的弹性体、聚丙烯和聚乙烯的共混物、EVA等。所需要的是，覆盖件500能够限制紫外光通过。
类似地，如果碗状物510由环烯烃聚合物(COP)制成，则LMPC覆盖件500的优选材料选项也为COP，但是可使用任何其它热塑性聚合物，诸如COP共混物、环烯烃共聚物(COC)或COC共混物、EVA等、或任何其它紫外光限制材料。根据产品临界质量要求(CTQ)和初级包装碗状物510的材料组成，覆盖件500应当包含相容的热塑性树脂，该热塑性树脂具有或不具有添加剂诸如TiO2、紫外光阻滞剂、有色母料等。覆盖件500中的紫外光吸收剂可为材料的添加剂，诸如苯并***；二苯甲酮；三嗪；或这些添加剂中的两种或更多种的组合。
覆盖件500应固定地附接到包装件550。优选的固定方法是通过将覆盖件500热焊接到泡罩包装件(诸如通过使用热刀头作为外部热源，以便在覆盖件500周围的特别有用的区域中施加热量)，来将该覆盖件粘结到泡罩包装件。在此施加热将趋于最低限度地但充分地熔融形成覆盖件500的聚合物，从而实现覆盖件500的表面与包装件550之间的机械粘结。自然地，可以设想，可利用其它附接方式，诸如热附接(激光、红外)和摩擦(诸如振动、超声)粘结技术的形式。
如在图6A和图6B中可见，描述了本发明的包装件的另外的变型。此处，包装件600具有附接到碗状物605的预成型覆盖件601。该覆盖件601通常通过注塑制成。覆盖件601通常在生产后通过激光焊接附接到碗状物605。当然，它是紫外光不可透过的，符合本发明的公开内容。覆盖件601通常压力配合到碗状物605中，但另选地，该覆盖件可激光焊接或声波焊接到碗状物605。如在图605中可见，包装件的配置使得可在生产中形成包装条600。然后可连续地将覆盖件601施加到碗状物605。
以这种方式，包装的打开和闭合功能不受影响，因为它一定不受影响。然而，在本发明的覆盖件附接到接触镜片包装件的情况下，阻止某些形式的光诸如紫外光穿透包装件诸如包装件550和包含在其内的溶液中的接触镜片570。该布置保留了透镜的多色方面的功能。
上述实施方案中所述的包装件还可用于保护包含其它光敏化合物(包括光敏HEV吸收化合物)的接触镜片。
考虑到所有适当的等同物，应结合所附权利要求书来理解上述发明。

Claims (18)

1.一种接触镜片包装件，所述接触镜片包装件包括：
碗状物，所述碗状物用于保持接触镜片；
膜，所述膜接合所述碗状物，以便将接触镜片保持在所述碗状物和所述膜之间；和
以及光管理保护覆盖件，所述光管理保护覆盖件附接到所述碗状物，使得所述覆盖件控制通过所述覆盖件并到达所述碗状物上的光的类型。
2.根据权利要求1所述的包装件，其中所述覆盖件防止紫外光通过。
3.根据权利要求1所述的包装件，其中所述碗状物为大体半透明的。
4.根据权利要求1所述的包装件，其中所述覆盖件按扣在所述碗状物上。
5.根据权利要求1所述的包装件，其中所述覆盖件被焊接到所述碗状物。
6.根据权利要求1所述的包装件，其中所述覆盖件还包含凸缘，所述凸缘用于由用户的手指抓持。
7.根据权利要求1所述的包装件，其中所述覆盖件被声波焊接到所述碗状物。
8.一种接触镜片包装件，所述接触镜片包装件包括：
碗状物，所述碗状物用于保持接触镜片；
大体半透明的覆盖件，所述覆盖件放置在所述碗状物上；和
以及光管理保护***件，所述光管理保护***件附接到所述覆盖件，使得所述***件控制通过所述***件并到达所述覆盖件上的光的类型。
9.根据权利要求8所述的包装件，其中所述覆盖件防止紫外光通过。
10.根据权利要求8所述的包装件，其中所述碗状物为大体半透明的。
11.根据权利要求8所述的包装件，其中所述覆盖件按扣在所述碗状物上。
12.根据权利要求8所述的包装件，其中所述覆盖件被焊接到所述碗状物。
13.根据权利要求8所述的包装件，其中所述覆盖件还包含凸缘，所述凸缘用于由用户的手指抓持。
14.根据权利要求8所述的包装件，其中所述覆盖件被焊接到所述碗状物。
15.组合起来：
一种接触镜片包装件，所述接触镜片包装件包括：
碗状物，所述碗状物用于保持接触镜片；
膜，所述膜接合所述碗状物，以便将接触镜片保持在所述碗状物和所述膜之间；和
以及光管理保护覆盖件，所述光管理保护覆盖件可释放地附接到所述碗状物，使得所述覆盖件控制通过所述覆盖件并到达所述碗状物上的光的类型；和
接触镜片，所述接触镜片保持在所述包装件内。
16.一种覆盖件，所述覆盖件适于放置在形成接触镜片包装件的外侧的碗状物上，所述覆盖件阻挡紫外光进入到所述碗状物中。
17.根据权利要求15所述的包装件，还包括盖材，所述盖材附接到所述碗状物，所述盖材由能够压力成形的箔形成。
18.根据权利要求17所述的包装件，其中所述能够压力成形的箔为层合的聚酯或铝箔复合材料。
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