CN1331586A - 透明的透皮烟碱输送装置 - Google Patents

透明的透皮烟碱输送装置 Download PDF

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CN1331586A
CN1331586A CN99814719A CN99814719A CN1331586A CN 1331586 A CN1331586 A CN 1331586A CN 99814719 A CN99814719 A CN 99814719A CN 99814719 A CN99814719 A CN 99814719A CN 1331586 A CN1331586 A CN 1331586A
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R·M·盖尔
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Abstract

一种用于输送烟碱的透明的透皮输送装置,它的不透明指数低于48.6%。

Description

透明的透皮烟碱输送装置
                            要求优先权
本发明者要求了临时申请No.60/112,730；60/124,679和60/126,798的申请日作为优先权日。
                             发明领域
本发明涉及用于给予烟碱来进行戒烟治疗的透皮输送装置。具体地说，本发明涉及透明的透皮烟碱输送装置。
                             发明背景
肠胃外输送药物的透皮途径提供了优于其它给药途径的优点。用于输送各种药物或其它有益制剂的透皮系统在例如下列美国专利中有所描述：3,598,122；3,598,123；3,731,683；3,797,494；4,031,894；4,144,317；4,201,211；4,286,592；4,314,557；4,379,454；4,435,180；4,559,222；4,568,343；4,573,995；4,588,580；4,645,502；4,698,062；4,704,282；4,725,272；4,781,924；4,788,062；4,816,258；4,849,226；4,904,475；4,908,027；4,917,895；4,938,759；4,943,435；5,004,610；5,071,656；5,122,382；5,141,750；5,284,660；5,314,694；5,342,623；5,411,740和5,635,203,这些专利均全部纳入本文作为参考。
通过颊、鼻和透皮途径给予烟碱来帮助希望戒烟的患者在临床上已经证实能有效地减少复吸。烟碱口香糖和透皮烟碱是目前最广泛使用的烟碱替代治疗的两种形式。用于输送烟碱的透皮装置例如公开在下列美国专利中：4,597,961；4,758,434；4,764,382；4,839,174；4,908,213；4,915,950；4,943,435；4,946,853；5,004,610；5,016,652；5,077,104；5,230,896；5,411,739；5,462,745；5,508,038；5,599,554；5,603,947和5,726,190，这些专利均全部纳入本文作为参考。
现有技术中的大多数透皮输药装置利用了在装置远离皮肤面上的不能渗透的被衬来保护装置免受破坏和防止活性剂丧失。为了提高使用者的满意程度，这些被衬层的颜色通常与皮肤颜色相似。然而，很容易理解，要提供接近所有皮肤颜色的着色的被衬层显然在商业上是不实用的。
已经采取的另一种方法是提供透明的透皮系统，系统中所有形成装置的元件均透明得足以通过该装置看见天然的肤色。采用该方法的市售的产品包括Alora和Climara雌激素替换贴片和Duragesic透皮芬太奴输送系统。当将这些装置施加到皮肤上后，可通过贴片看到患者天然肤色，从而使贴片的存在不令人注意。政府规定需要这些产品有鉴别标记，但是标记可以浅色或白墨水形式印在这些装置上，它们在几英尺距离外不明显，但是仔细观察时仍能辨认。
已经发现有不挥发性药物(如芬太尼和激素替换类固醇)的这些透明贴片是有用的，但是对于烟碱的输送还没有这样的透明产品。
烟碱是一种液态生物减，它无色，有挥发性，有强碱性，易氧化，暴露在光下后会分解，有高度的渗透性，不仅能渗透通过人皮肤，而且还能通过常规用于制造透皮产品被衬层和包装材料的许多聚合物(例如参见美国专利5,077,104)。因此，目前的烟碱透皮输送装置的被衬层采用了不透明的皮肤颜色的多层膜，该膜通常含有金属层(如铝)。
不仅市售的烟碱透皮贴片采用不透明的被衬，而且由于操作和加工烟碱的复杂性，这些装置中有许多还含有不透明的其它组件。例如，最初的Prostep透皮烟碱产品采用了不透明白色凝胶形式的药物贮层，它通过不透明的粘合剂覆盖层来固定。Habitrol和Nieotrol烟碱贴片的药物贮层中掺入了其中吸收了烟碱的吸收剂垫片。
还有人提出，将烟碱和其它改善烟碱停吸治疗的物质一起给予。例如参见，上述专利4,908,213；5,599,554和5,726,190以及WO97/33581。
                              发明概述
本发明涉及用于单独或与其它药剂联合来透皮给予烟碱的透明的透皮输送装置。
这些装置应足够得透明，当其置于皮肤上时，对象的皮肤可通过该装置清楚地看见。可用浅色或白墨水形式将识别标记印在该装置上，使得标记在近距离内不明显但仔细检查后可以发现。
                              发明详述
本发明的较佳装置利用透明的聚合膜作为被衬层，该膜对烟碱的渗透性低于1微克/平方厘米小时(较佳的是低于0.5微克/平方厘米·小时)，烟碱溶解度低于1％(重量)(较佳的低于0.1％)。这些膜的厚度宜小于约6密耳，最佳的约为2-4密耳。这些膜与透皮装置的一种或多种常规元件(除了可除去的剥离衬里外)结合使用，这些元件例如是药物贮层、粘合剂和速度控制膜，这些元件必须也具有足够的透明度，从而使得组装的装置在放到皮肤上后可透过该装置清楚地看到天然的皮肤颜色。成品的不透明指数小于大约48.6％，较佳的小于大约35.11％，更佳的小于20％。
除了是透明的且足以使烟碱不可渗透外，该被衬层还必须具有足够的机械强度和物理完整性，以便在预期的给药期间(通常是18-24小时)内保持系统完整，而且，被衬层必须提供与相邻层(如透皮装置的药物贮层或粘合剂层)稳定的界面。这些性质的组合不一定能在一种材料上找到，因此用于本发明装置上的透明的被衬层可以是多层膜。除了具有对烟碱的低渗透性外，被衬层还必须有低的烟碱溶解度。这是因为烟碱是有毒的，例如，如果被衬层含有大量溶解的烟碱，则儿童舔该被衬层将是危险的。
具有本发明所需性质的合适的聚合物材料包括Scotchpak1220(它是由3MCompany，Minneapolis，Minnesota出售的聚对苯二甲酸乙二醇酯/乙烯乙酸乙烯酯(PETEVA)双层膜)以及Saranex2057(它是购自Dow Chemical Company，Midland，Michigan的高密度聚乙烯(HDPE)/乙烯丙烯酸(EAA)/尼龙/EAA多层材料)。还可采用上述美国专利5,077,104中描述的市售的Braex膜(丁腈橡胶与丙烯腈和丙烯酸甲酯的接枝共聚物)。
这些膜是较佳的被衬材料，其中包括从大约73-77％丙烯腈和大约23-27％丙烯酸甲酯在含有约70％重量的衍生自丁二烯的聚合物单元的大约8-10重量份的丁二烯/丙烯腈共聚物存在下共聚形成的接枝共聚物。
本发明的透明的透皮输送装置可以是上述专利中描述的任何一种形式。然而，较佳的形式包含被衬层、烟碱贮层的层压物，其中烟碱贮层含有溶解在载体中的烟碱，其浓度低于烟碱在该载体中的饱和浓度。如果药物贮层组件本身具有粘合性，则可使用简单的单片装置。然而，在许多情况下希望包括额外的组件，如在上述美国专利5,004,610和5,342,623中描述的速度控制膜以及用于将装置维持在皮肤上的另外的粘合剂层。除烟碱外，还考虑到装置还可含有在戒烟、吸烟替换或吸烟取代治疗中与烟碱协作或增强烟碱作用的其它药物或其它活性物质。对于所有这些装置，在用于将装置固定在皮肤上的贴片粘合剂表面上通常还施加了可除去的剥离衬里，该剥离衬里可在使用前除去。
适用于制造各个组件的各种材料是本领域中已知的，它们公开在上述专利中。
粘合剂组件宜为压敏粘合剂，其包括但不局限于，聚硅氧烷类、聚丙烯酸酯类、聚氨酯类、丙烯酸类粘合剂(包括交联或不交联的丙烯酸共聚物)、乙酸乙烯酯粘合剂、乙烯乙酸乙烯酯共聚物、以及天然的或合成的橡胶，包括聚丁二烯、聚异戊二烯和聚异丁烯粘合剂，以及它们的混合物和接枝共聚物。装置还可有本领域已知的亲水性吸水聚合物，如单独或组合的聚乙烯醇和聚乙烯吡咯烷酮。粘合剂可用来形成单片输送装置，其中烟碱溶解在粘合剂中形成了自粘性的药物贮层。或者，粘合剂可以施加在无粘性的溶解有烟碱的贮层表面上，形成多层装置。在烟碱贮层和粘合剂之间还可有速度控制膜，为本领域已知的那样。
烟碱可以和另一药剂组合给予，该试剂可包括抗焦虑药、抗高血压药、抗抑郁药和食欲抑制剂，如氟西汀、咖啡因、丁螺环酮、苯丙醇胺、可乐定、帕罗西汀、西酞普兰和舍曲林。
装置中的烟碱在贮层中处于亚饱和条件下(即低于单位活性)，因此贮层中没有不溶解的烟碱。如果装置中有其它药剂，它们宜是完全溶解的，但是也可以不溶解的形式存在，只要最终的产品表现出合适的透明度即可。
在本发明中，烟碱以及其它任选的待共同给药的药剂通过皮肤或其它体表面以治疗有效的速度输送预定的时间(对于烟碱而言，宜为16-24小时)。
本发明的透皮治疗装置可用本领域已知的方法来制备，例如在本文上述透皮装置专利中描述的那些方法。
提供下列实施例是为了描述本发明的实施，而绝不是限制本发明。
                                实施例1
对各种市售的透皮贴片进行测试，测定它们的透明度并与本发明的透明烟碱贴片比较。如美国专利5,004,610中实施例Ⅳ所述的那样制得烟碱贴片，用PET/EVA(Scotchpak1220，3M，Minneapolis，MN)或Saranex(Dow ChemicalCompany，Midland，MI)被衬代替Scotchpak1006被衬。用Macbeth 1500/Plus颜色测定系统(Kollmorgem Instruments Corp.，Newburgh，NY)测定透射通过各系统的光。表1显示了不透明指数，它是各测试系统在入射光通过装置时被吸收的百分数。
              表1贴片不透明性
             贴片    不透明指数
           Minitran     48.6％
           Alora     20.21％
           FemPatch     35.11％
           Climara     19.33％
    实施例1-烟碱和Saranex被衬     17.04％
    实施例1-烟碱和PET/EVA被衬     19.66％
Minitran甘油三硝酸酯系统在大约5英尺的距离内清楚可见，而FerPatch明显较不引人注意。然而，Alora、Climara和Nicoderm贴片是难以让人察觉的。因此，本发明的透皮装置应具有低于48.6％(较佳的低于35.11％、更佳的低于20％)的不透光指数。
在大致描述了本发明及其较佳实施方案后，本领域技术人员显然能作各种改动和替换。这些改动和替换可在不脱离仅由下列权利要求确定的本发明范围下作出。

Claims (9)

1.一种用于透皮给予烟碱的装置，该装置包含被衬层、由所述被衬层支持的含烟碱药物贮层，以及用于使该装置维持与皮肤呈烟碱传输关系的部件，其中该装置是足够透明的，使待施加该装置处的对象皮肤可通过所述装置看到。
2.根据权利要求1所述的装置，其中所述被衬的烟碱渗透性低于1.0微克/平方厘米·小时。
3.根据权利要求1所述的装置，其中所述被衬的烟碱渗透性低于0.5微克/平方厘米·小时。
4.根据权利要求2所述的装置，其中被衬的烟碱溶解度低于1％(重量)。
5.根据权利要求3所述的装置，其中被衬的烟碱溶解度低于0.1％(重量)。
6.根据权利要求4所述的装置，其中该装置的不透明指数低于48.6％。
7.根据权利要求6所述的装置，其中该装置的不透明指数低于35.11％。
8.根据权利要求6所述的装置，其中该装置的不透明指数低于20％。
9.根据权利要求1所述的装置，其中所述被衬从选自下列的材料制成：PET/EVA层压物、HDPE/EAA/尼龙/EAA多层层压物、以及包含从73-77％丙烯腈和23-27％丙烯酸甲酯共聚形成的接枝共聚物的膜，该共聚在含70％重量衍生自丁二烯的聚合物单元的8-10重量份丁二烯/丙烯腈共聚物存在下进行。
CN99814719A 1998-12-18 1999-12-14 透明的透皮烟碱输送装置 Pending CN1331586A (zh)

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