CN1205623A - 生产经皮贴片(tts)的方法 - Google Patents
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Abstract
本发明涉及连续生产经皮贴片的方法。在上述方法中,以条形带(1)形式提供层制品,其包括一面硅化处理的辅助层(3)、含活性成分的自粘层(4)、载体层(9)。含活性成分的部分(4′)是以与带成直角的方向上冲压层(3)和层(4)而得到的,并分段地将含活性成分的部分(4′)传送到第二带(2)上。在两个步骤之间的停止期进行冲加工步骤,并且采用传送装置(11,12),优选以相等的距离实施向第二带的传送。本发明的特征在于:在传送过程中,先从含活性成分的部分(4′)剥离载体层(9),接下来利用自粘性的处理层(5)剥离辅助层部分(3′)。
Description
本发明涉及制造根据权利要求1前序部分的经皮治疗贴片(TTS)的方法。
从DE-PS 32 04 582中已知连续生产和填充带有活性成分的经皮给药的药贴外封的方法。将活性物质按比例以一定距离置于一载体膜上，用金属密封膜部分覆盖，然后再用一间隔层膜，接下来再覆以一面有粘性的弹性胶粘膜，并且其带粘性一面朝向上述的间隔层；其后，将带有周围膜层的活性物质部分冲压成期望的尺寸。这个方法工业损耗相对较大并且浪费了大量的材料。
连续生产经皮治疗贴片的方法也是已知的。首先，用一种可流动的含活性物质的制剂涂覆中间载体膜以制备层压带，然后将其切成预定宽度的带，在接下来的处理步骤中，切割这些带成一定长度的含活性物质的部分；以预定距离将这些部分置于保护膜上，用该保护膜将其各侧都覆盖；最后，垂直带方向在含活性物质的部分之间切割保护膜将其分成单独的贴片。虽然这个方法能最有利地达到基本防止或最小化损失活性物质的目的，但由于其众多的处理步骤，所以相对复杂。
另一个方法描述在DE-OS 41 10027中。在这个连续生产经皮治疗贴片方法中，该贴片具有一个衬底层、一个压敏的粘性活性物质贮存源层和一个可剥离的保护层；在制造过程中活性物质的损失降至最低。在这个方法中，压敏的粘性活性物质贮存源通过分配器棱边转移到保护层上，呈由活性物质压敏粘性层和聚合物膜组成的层制品形式，这一步为后续步骤。但是，这个方法的缺点在于剥离保护膜后最终产品在任何情况下均具有两层聚合物膜，所以得到的整个TTS的硬度在某些情况下会影响贴着舒适感。
因此，本发明的目的是以简单的技术和可靠的方式，将单独的含活性物质部分高速度、高精确度并且没有活性物质损失地从第一基料带以预定的距离挨个地转移到第二基料带上，在第二基料带上优选突出该部分的所有面；在这种方式中，肯定避免了TTS中存在聚合物膜引起的最终产品贴着舒适感。
根据本发明，采用权利要求1的方法达到了这个目的。鉴于专家认为压敏粘性膜只能以具有刚性片材料的层制品形式被转移是技术操作的标准，因此这个解决办法更引人注目。
DE-OS 41 10 027，DE-OS 15 11 873、DE-PS 25 55 910、DE-OS 32 33 546、DE-PS 36 18 542和DE 42 32 279描述了转移方法，但是其中没有提到转移自粘性层制品过程中除去处理膜的可能性。
在制备本发明的贴片时，层数目的多少可根据需要而定，即根据其预期的用途而定，每个单独的层由合适的材料组成，如金属，优选铝，聚合物或纺织织物。根据其各自的目的不同，各层可以是自粘性的或者是防粘的、可渗透活性物质的或者是不可渗透活性物质的、弹性的或者非弹性的。
含活性物质的部分可具有不同的形状，例如矩形、正方形、椭圆形或圆形。但考虑到要避免损失活性物质，优选矩形或正方形。
可能的添加剂根据制备含活性物质层所用的聚合物而定，并且该活性物质包括，例如，增塑剂、增粘剂、稳定剂、载体、扩散和渗透调节添加剂或者填充剂。生理学上可接受的合适物质是本领域内普通技术人员已知的。欲用含活性物质层的自粘性来确保其与皮肤的永久接触。
在使用前除去含活性物质层的保护层，该保护层可由，例如，与生产衬底层时所用的材料相同的材料组成。但是，这些必须是可以被剥离的，例如，通过聚硅氧烷处理。其它可剥离的保护层包括，例如，四氟乙烯、经处理的纸、玻璃纸、聚氯乙烯以及类似的物质。
这个处理层和辅助层可由相同的材料制成。用来生产压敏粘性层的材料为，例如，具有一种基础聚合物和任选的传统添加剂的聚合物基材。合适的材料包括，例如，聚硅氧烷，橡胶，类橡胶的合成均、共或者嵌段聚合物，聚丙烯酸酯和它们的共聚物，以及氢化的松香酯。
基本地，在生产压敏粘合剂中用到的任何聚合物都是合适的，并且是生理上可接受的。特别优选的是基于苯乙烯和1，3-二烯的嵌段共聚物，聚异丁烯，或者是含有丙烯酸酯和／或甲基丙烯酸酯的聚合物和共聚物。在基于苯乙烯和1，3-二烯的嵌段共聚物中优选的是线性苯乙烯-异戊二烯-苯乙烯嵌段共聚物。
把施用于皮肤上的，有或没有吸附介质的，并且产生局部或全身作用的物质作为活性物质。
具有局部效果的物质包括，例如，止汗剂、杀真菌药、杀菌剂、制菌剂。
具有全身效果的物质包括，例如，抗生素、激素、退热药、抗糖尿病剂、冠状血管舒张剂、作用于心脏的葡萄糖甙、解痉剂、低血压的(药物)、影响精神活动的药物、偏头疼的止疼药、皮质激素类、止疼药、避孕剂、抗风湿剂、胆碱能药或抗胆碱能药、sympha ticomimetics或sympha ticolytics、血管舒张药、抗凝血药或抗心律失常药。事实上，还有其它合适的活性物质。
本发明通过实施例显示在附图中，下面将参考附图举例说明本发明。
在图1中，(1)是第一网状层制品或者是第一基料带；其从顶部到底部由一个至少一面硅化处理的膜(3)制成的辅助层，一个含活性物质的压敏粘性层(4)和一个载体层(9)(至少一面经硅化处理)组成。
采用一个切割装置，将膜(3)和含活性物质的层(4)在垂直于基料带方向垂直的切断，因此得到，例如，正方形部分(3′，4′)。不切断硅化处理的载体膜(9)。在夹持进料系统的帮助下，当然也可使用辊进料系统或其它类似系统，在移动过程中，第一基料带(1)被从右边运送到左边，然后被一个夹紧装置固定。在将层(3)和(4)切断后，立即将压敏粘性处理的膜组成的层压层(5)在层(3)一侧层压在网状层层制品(1)。在传输装置的第一配料棱边(11)，将层(4)的含活性物质的压敏的粘性部分(4′)从载体膜(9)上剥离。
通过第二配料棱边(12)，将层(3)的部分(3′)从含活性物质的压敏的粘性部分(4′)上剥离。其后，将部分(4′)粘附到第二基料带(2)上。
所有这些基料带的运动方向都已用箭头指出。
由压敏粘性层(13)(其中没有活性物质)和不透过活性物质的膜(14)(衬底层)的层制品层压在第二带(2)的整个表面上(图2)。通过切割层(13)和(14)、不切割层(2)冲压成单个的贴片。
除去部分(4′)间得到的层(13)和(14)的晶格状切边。通向横向切割(2)得到单独的贴片(图2)。
在厚度为100g／m2的情况下，例如，该含活性物质的压敏的粘性层(4)可包含57％的溶液聚丙烯酸酯、25％的增塑剂、10％的聚甲基丙烯酸酯、和8％的毒扁豆碱。在基料带的宽度为35mm的情况下得到规格为35mm×35mm的正方形贴片。在这种情况下，第二基料带的宽度为大约55mm，并且可由两面都硅化处理的聚酯膜(PET)制得。
Claims (3)
1．一种连续生产经皮治疗贴片的方法，其中首先制备包含至少有一面硅化处理的辅助层(3)、含有活性物质的压敏粘性层(4)和载体层(9)的层制品作为条形第一基料带(1)，把垂直带方向冲压所述的层(3)和(4)得到的含活性物质的部分(4′)立即转移到第二基料带(2)上，冲压步骤发生在两个步骤之间的停止阶段，通过传送装置(11，12)优选以等距离在第二传送带上进行转移过程，其特征在于首先在传送过程中，载体层(9)从含活性物质的部分(4′)上剥离，然后在处理层(5)的帮助下，剥离辅助层的部分(3′)，该层(5)已具有压敏粘合性。
2．根据权利要求1所述的方法，其特征在于条形基料带(1)和第二基料带(2)在不同的运动和停止阶段，和／或以不同的步骤长度，和／或以不同的速率间歇性地传送。
3．根据权利要求1所述的方法，其特征在于在含活性物质的部分(4′)的转移过程中，传输装置在基料带方向上往复运动。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19547691.3 | 1995-12-20 | ||
| DE19547691A DE19547691C1 (de) | 1995-12-20 | 1995-12-20 | Verfahren zur Herstellung transdermaler therapeutischer Pflaster (TTS) |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1205623A true CN1205623A (zh) | 1999-01-20 |
| CN1130172C CN1130172C (zh) | 2003-12-10 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96199114A Expired - Fee Related CN1130172C (zh) | 1995-12-20 | 1996-12-04 | 生产经皮贴片(tts)的方法 |
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| Country | Link |
|---|---|
| US (1) | US6059913A (zh) |
| EP (1) | EP0959834B1 (zh) |
| JP (1) | JP3585128B2 (zh) |
| KR (1) | KR100439921B1 (zh) |
| CN (1) | CN1130172C (zh) |
| AT (1) | ATE213144T1 (zh) |
| AU (1) | AU709517B2 (zh) |
| CA (1) | CA2240416C (zh) |
| CZ (1) | CZ289083B6 (zh) |
| DE (2) | DE19547691C1 (zh) |
| DK (1) | DK0959834T3 (zh) |
| ES (1) | ES2172698T3 (zh) |
| HK (1) | HK1026356A1 (zh) |
| HU (1) | HU225104B1 (zh) |
| IL (1) | IL124618A (zh) |
| MX (1) | MX9804996A (zh) |
| MY (1) | MY113548A (zh) |
| NO (1) | NO311636B1 (zh) |
| NZ (1) | NZ324305A (zh) |
| PL (1) | PL183410B1 (zh) |
| PT (1) | PT959834E (zh) |
| SK (1) | SK282988B6 (zh) |
| WO (1) | WO1997022315A1 (zh) |
| ZA (1) | ZA9610666B (zh) |
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1995
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100425216C (zh) * | 2003-02-13 | 2008-10-15 | 上海东月医疗保健用品有限公司 | 充填式加强型疤痕贴的制备方法 |
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