CN107847309A - 包含未混合的反应成分的牙科治疗膜 - Google Patents

包含未混合的反应成分的牙科治疗膜 Download PDF

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CN107847309A
CN107847309A CN201680043032.7A CN201680043032A CN107847309A CN 107847309 A CN107847309 A CN 107847309A CN 201680043032 A CN201680043032 A CN 201680043032A CN 107847309 A CN107847309 A CN 107847309A
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史蒂文·D·延森
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Abstract

本发明提供了两部分治疗膜，其可以包括阻挡层、凝胶状组合物层和粘附于所述凝胶状组合物层上的至少一种活性成分。阻挡层可以是不溶于水的柔性膜。在一些实施方案中，所述至少一种活性成分可以是干燥颗粒的形式。在其他实施方案中，所述至少一种活性成分可以是填充有活性成分的微球形式。

Description

包含未混合的反应成分的牙科治疗膜
相关申请的交叉引用
本申请要求于2015年7月22日提交的第62/195,501号美国临时申请的权益，其通过引用整体并入本文。
技术领域
本发明涉及两部分递送模式(modality)以成功递送预期的治疗。
背景技术
通常情况下，递送两部分治疗需要具有单独的室的设备，在该室中化学成分可以彼此远离地存放直到使用时。有些化学物质在混合时不稳定；因此它们没有可评估的保存期限，因此不能被制成可行的商业产品。其他治疗需要在递送时发生化学反应，两部分治疗系统旨在解决这些问题；该系统被设计成使不稳定的组分和反应性组分保持分离直到它们被递送时，于是在需要时这些组分经混合并被放置在治疗位置。
这种装置的实例是具有静止混合尖端的双管注射器。通常，将化学组合物A装入一个管中，并将化学组合物B装入另一个管中。以这种方式，将组合物A和B彼此远离地储存，直到需要输送经混合和递送的组合的化学组合物“C”(A+B＝C)。
通过将递送组分A和B的注射器柱塞向下按压到不动的混合尖端来递送组分，其中所述混合尖端将组分混合在一起得到组合物C，组合物C从尖端喷嘴被递送出来至需要的治疗部位。
双筒注射器已经成为医疗和牙科领域中的常用装置，其有效地输送用于各种治疗的两部分化学组合物。近年来，薄膜或带状产品的发明已经用作向口腔递送一部分化学组合物的手段。薄膜和带状产品包括由薄的不溶性塑料薄片制成的阻挡层和放置在塑料薄片的一个表面上的化学组合物层，从而得到最终产品。在实践中，将化学组合物层放置在牙齿或组织上并粘附到位；阻挡层默认位于在治疗部位的相对侧上，以保护化学组合物不被唾液冲走。薄膜和带状产品是递送均匀组合物系统的高效装置；与旧的注射器递送方法相比，患者更喜欢使用薄膜和条带。对患者而言薄膜和条带更易于使用，也更加方便；这些是重要的因素，因为它鼓励患者遵守强制治疗方案。
发明内容
本发明的实施方案提供了能够通过简单地施加条带/薄膜而将多种/异质化学组合物递送至治疗表面的薄膜和条带。
本发明的实施方案利用由聚合物片材构成的阻挡层。理想的阻挡层可以是薄的、柔韧的并且不溶于水。阻挡层可以构成治疗膜构造中的第一层；在阻挡层的一个表面上可以粘附第二处理层。阻挡层材料的实例包括但不限于：石蜡膜、聚乙烯片、聚丙烯片、PVC片、聚氨酯片、尼龙片、PVA片等。
附图说明
为了描述可以获得本发明的上述和其它优点和特征的方式，通过参考附图中所示的具体示例实施方案对上面简要描述的本发明进行更具体的描述。应理解的是，这些附图仅描绘了本发明的典型实施方案，因此不认为是对本发明范围的限制，使用附图对本发明进行更具体更详细的描述和解释。
图1示出了本发明实施方案的两部分化学组合物条带/薄膜的侧视图。
图2示出了本发明另一实施方案的包括中空微球的两部分化学组合物条带/薄膜的侧视图，所述中空微球填充有包含两部分体系中后半部分的活性成分。
图3示出了本发明其他实施方案的包括中空微球的两部分化学组合物条带/薄膜的侧视图，中空微球经混合并嵌入在另一层中。
具体实施方案
本发明的实施方案使用由聚合物片材构成的阻挡层。理想的阻挡层可以是薄的、柔韧的并且不溶于水。阻挡层可以构成治疗膜构造中的第一层；在阻挡层的一个表面上粘附第二治疗层。阻挡层材料的实例包括但不限于：石蜡膜、聚乙烯片、聚丙烯片、PVC片、聚氨酯片、尼龙片、PVA片等。
本发明的一个实施方案包括三层：
A.阻挡层；
B.凝胶状组合物层；
C.表面粘附的活性成分微粒/颗粒。
图1示出了两部分化学组合物条带/薄膜的实施方案。该薄膜由阻挡层A(第一层)构成。阻挡层A可以由柔韧且不溶于水的薄聚合物片构成。在阻挡层A的一个表面上施加凝胶状组合物层B(第二层)。凝胶状组合物层B可以由与活性成分的一部分均匀混合的水基胶凝剂/增稠剂构成，所述活性成分构成两部分体系的一部分。然后可以将这种均匀的混合凝胶作为薄层施加到阻挡层A上，然后通过将凝胶干燥成凝胶层B而粘附到位。适当干燥时，凝胶层B将具有被称为“蠕虫软糖”的常见糖果的柔性和稠度(consistency)。干燥过程在凝胶层B的表面上产生半脱水层；这种物理现象被称为表面D。表面D是由干燥形成的脱水表层，表面D直接保护在表面之下的组合物中更加含水的部分。活性成分微粒层C的干成分(第三层)粘附/嵌入在表面D内/上。活性成分微粒物理地嵌入表面内或通过表面D的天然粘性而粘附。(在施用活性成分微粒层C之前，可以利用蒸汽或有机润湿剂临时产生或增加表面D的粘性)。活性成分微粒层C的干成分的施用与从盐瓶施用盐相似。活性成分微粒层C的干成分不旨在覆盖凝胶状组合物层B的整个表面，旨在使一部分凝胶状组合物层B未被覆盖，从而使条带/薄膜粘附到牙齿或治疗部位的组织。构成C层的活性成分微粒构成了两部分体系的后半部分。通过设计，表面D中的水不足以完全活化粘附或嵌入其表面内或表面上的干燥的活性成分颗粒。因此，活性成分微粒层C和凝胶状组合物层B包含两部分体系的粘附但分离的组合物。通过设计，当向活性成分微粒层C中引入口腔的水或唾液时，该活性成分微粒层C易于溶解。
当将所得薄膜/条带施加到口腔内的潮湿治疗区时，薄膜/条带被激活。施用时，唾液将活性成分微粒层C的干成分溶解，同时将表面D水合；这使分离的组分在被放置在治疗部位附近之后开始混合。在用手将条带/薄膜施用到牙齿或组织上时，患者可以帮助各层的混合；施加在阻挡层A上的压力会产生将各层挤压在一起的力，从而进一步混合两部分体系。此外，在方案继续进行时，口腔内的作用力，即温度升高至约37℃、温和的咬合力以及脸颊和牙齿之间的连续相互作用，将有助于各层的混合。在混合时，两部分体系被活化，以便利的方式将所需的反应化学物质或储存不稳定的化合物递送到治疗部位。
图2示出了本发明的另一实施方案。图2的条带/薄膜包括与图1相同的层，并且除C层之外的其他层的描述也相同。在图2中，C层是由填充有活性成分的中空微球构成，所述活性成分构成两部分体系的后半部分。微球包括球形空心壳，其通过多种方式递送其内容物。
通过设计，C层的中空壳可以由易溶于水或唾液的材料制成；因此当被放置在湿的治疗表面上时，内部活性成分释放，并且外壳易于溶解。然后释放的化合物与包含在“B”层内的活性成分混合。在混合时，两部分体系被活化，以便利的方式将所需的反应化学物质或储存不稳定的化合物递送到治疗部位。
通过设计，C层的微球可以由具有低压碎强度的材料制成。当将C层放置在治疗部位时，施加的力使微球破裂从而释放其内容物以容易地与“B”层混合。在混合时，两部分体系被活化，以便利的方式将所需的反应化学物质或储存不稳定的化合物递送到治疗部位。
图3示出了本发明的另一实施方案。图3包括图2的所有相同的层，但C层除外。在图3中，图2中C层的空心微球经混合并嵌入B层中。通过设计，混合并嵌入B层内的微球由具有低压碎强度的材料制成。当将B层放置在治疗部位时，施加的力使微球破裂从而释放其内容物以容易地与B层的凝胶部分混合。在混合时，两部分体系被活化，以便利的方式将所需的反应化学物质或储存不稳定的化合物递送到治疗部位。
根据本发明实施方案的实际应用，本专利范围内的许多其他实施方案将变得显而易见。

Claims (6)

1.两部分治疗膜，其包括：
阻挡层；
凝胶状组合物层；和
粘附于所述凝胶状组合物层上的至少一种活性成分。
2.根据权利要求1所述的两部分治疗膜，其中所述阻挡层不溶于水。
3.根据权利要求2所述的两部分治疗膜，其中所述阻挡层包括柔性膜。
4.根据权利要求1所述的两部分治疗膜，其中所述凝胶状组合物层包括脱水的表面。
5.根据权利要求1所述的两部分治疗膜，其中所述至少一种活性成分包括干燥颗粒。
6.根据权利要求1所述的两部分治疗膜，其中所述至少一种活性成分包括填充有活性成分的微球。
CN201680043032.7A 2015-07-22 2016-07-21 包含未混合的反应成分的牙科治疗膜 Pending CN107847309A (zh)

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