CN1310614A - 经皮肤使用激素的含有雌二醇的贴片 - Google Patents
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Abstract
一种包含活性物质的贴片,它用以控制释放雌二醇或其医药上可接受衍生物,单独或与助孕素复合至人类或动物的皮肤,该贴片由背垫层,连接其上适合结合活性物质的释放且利用压敏黏合剂制造的包含活性物质的贮存物,及可脱离的保护层所组成,其特征在于该压敏黏合剂包含羊毛蜡或其成分和氧化锌。
Description
本发明涉及一种包含活性物质的贴片,该贴片用以控制雌二醇或其医药上可接受衍生物,单独或与助孕素复合释放至人类或动物的皮肤。
包含雌激素和/或助孕素的贴片已众所周知。然而,它们确有缺点,因为贴片含有乙醇或在使用期间活性物质再结晶的潜在危险。
从DE-OS 32 05 258及EP 0 285 563中已知在一种贴片的配方中同时使用雌二醇和乙醇。然而,制造这种贴片是非常复杂的,以及这种贴片使用后不太舒适,因为它们缺乏柔韧性。
EP 0 285 563描述一种雌激素与助孕素复合使用的经皮肤治疗系统。其中贮存物包含活性物质配方和可选择的一种膜,以及乙醇用作经由皮肤吸收的增强剂。由于活性物质释放主要由膜控制,这种经皮肤治疗系统根本上不同于本发明的活性物质贴片。由此文献所描述的贴片,黏合剂的功能只是固定贴片于皮肤上。控制活性物质的释放非其主要任务,而只是一种可能多余的副作用。这种贴片为所谓的“袋状贴片(pouch patch)”,因其活性物质配方存在于一个袋状物内,由一种不能渗透的背垫层以及具有黏合层的膜所构成。由于其复杂结构的缘故,制造这种贴片需要高费用,因为各个成分必须分别制备,然后在后续的方法步骤中,结合以形成一贴片。
EP 0 275 716描述一种经皮肤的双层系统与本发明的单层系统相比,该系统同时使用一种或多种雌激素,该雌激素溶解或微分散于聚合物层中。于此,压敏层除了包含活性化合物外,还包含会促进经皮肤吸收的物质。该聚合物及压敏层可由聚丙烯酸酯类、硅氧烷类或聚异丁烯类组成。
EP 0328 806描述一种无膜的经皮肤治疗系统,其基质由聚丙烯酸酯黏合剂、溶剂、渗透增强剂、雌激素及其衍生物以及其组合而组成。
WO 87/07138描述一种雌二醇贴片,该贴片包括背垫层、包含活性物质的基质、以及压敏黏合剂,该黏合剂被可除去的保护层覆盖。该基质及压敏黏合剂的生产系根据所应用技术的观点在需要很高费用的方法步骤中进行,即经过均质化、脱气、涂覆、干燥以及分成个别的碎片。在一具体实施方案中,该背垫层必须用压敏黏合剂均匀地涂覆,即意指后续的方法步骤。各个部分的结合在分别的方法步骤中进行。因此贴片的整体生产包括高费用且复杂。
从US 4 624 665中,已知包含在贮存物中的微包覆形式的活性物质的系统。此贮存物被包埋在背垫层及膜之间。此系统的外边缘提供一种压敏黏合剂。该系统的结构和生产是非常复杂,因为活性物质必须被微包覆以均相分布,然后,在后续方法步骤中,必须被包埋于背垫层及膜之间。除此之外,此系统必须提供一种黏合边缘以及涂覆一层保护层。
此外,从EP 0 186 019中已知活性物质贴片,其中向橡胶/粘合树脂物质中加入水可溶胀聚合物,以及从该贴片中可释放出雌二醇。然而,从这些活性物质贴片中释放出来的雌二醇太少且不能符合治疗的需求。
在DE-OS 20 06 696中,描述一种贴片或是一种黏合性绷带,它具有全身性的作用以及其中避孕物质被掺入黏合成分或是黏合薄膜中。此种黏合薄膜可以是一种丙烯酸酯。
因此本发明的目的是避免上述的缺点提供一种稳定的,即无再结晶,包含有雌激素和/或助孕素的贴片,该贴片具有足够的活性物质释放,该释放不受贮存而改变。
令人惊讶地,可由包含雌激素和/或助孕素的压敏黏合剂来达到此目的,该黏合剂包含羊毛蜡或其成分和氧化锌。
因此通过根据主要的权利要求的包含活性物质的贴片可达到上述的目的。该附属权利要求涉及本发明特别优选具体实施方案。
羊毛蜡被认为是一种医药原料且被描述于如药典中。羊毛蜡被使用是因为它对活性物质的释放能力,皮肤对其有良好的忍受度以及其对水分的吸收能力。
氧化锌亦在药典中有描述。氧化锌是作为一种温和的消毒剂及消炎剂,此外其呈弱碱性作用。
根据本发明的活性物质贴片可用于化妆品,及用于人类或兽医治疗目的的医药。
具有足够活性物质释放的含无再结晶雌激素和/或助孕素的贴片包括其贮存物中的雌二醇及其医药上可接受的衍生物,单独或与助孕素复合,其浓度为相对于其贮存物成分总量的1至20%(重量),实际上摩尔比为1∶1至1∶10。
该含雌二醇的贮存物可包含至少一种成分选自防老剂类、增塑剂类、抗氧剂类以及吸收增强剂类。适宜的增塑剂类为本领域内熟练技术人员所熟知的,且已在例如DE 37 43 946中叙述。该含雌二醇贮存物通常包含高达5%(重量)的增塑剂类。
此外,该贮存物包含浓度高达1%(重量)的防老剂类。这些为本领域内熟练技术人员所熟知的,且已在例如DE 37 43 946中叙述。
不可渗透的背垫层以及可脱离的保护层物质亦为本领域内熟练技术人员所熟知。
含雌二醇贮存物可以由溶液、分散液以及熔化物制造。
如果贮存物对皮肤不具有足够的固有黏着性,它可提供附加的无活性物质的压敏黏合剂或提供环绕压敏黏合剂边缘。以这种方式可确保在整个使用期间经皮肤贴片持续黏着在皮肤上。
一种特别优选的含雌二醇经皮肤贴片的结构是一种基质系统,其中,已知此种基质始终控制活性物质释放且依据Higuchi的Vt定律。然而,这并不表示膜系统对于特殊情况没有优点。在膜系统中,控制释放活性物质的膜位于贮存物与压敏黏合层之间。
经皮肤贴片的厚度取决于治疗上的需要而且可相应地调整。通常,其范围是从0.03至0.6毫米。
本发明将通过下列具体实施例来加以说明。
实施例1:
将97.86克的Durotak 387-2287溶液(50.2克的固态物质)、4.0克的羊毛蜡、21.56克的乙醇和10.78克的乙酸乙酯在室温下搅拌均质化2-3个小时,随后加入2.0克雌二醇半水合物及7.0克炔诺酮醋酸酯并搅拌大约1小时。然后加入16.8克氧化锌并搅拌30分钟。
将生成的含活性物质的黏合物质涂覆在可脱离的保护层(HostaphanRN 100,有一面涂覆硅氧烷,利用Hoechst Diafoil)以致使含活性物质贮存物每单位面积的重量大约80克/米2的生成物。这种贮存物上层压不可渗透背垫层(聚酯薄膜,厚度是19微米)。随后冲压出16厘米2的活性物质贴片。
实施例2和3:
按照实施例1的制备方法进行制备,但是原料的数量如表1中所规定(制备配方)。
为了测量人类皮肤的渗透性,皮肤被钳制变成法郎兹细胞(Franzcell)。一种具有1.539厘米2表面的含雌激素和/或助孕素的贴片被黏附于皮肤上,且于37℃下测量活性物质的释放(受体介质:0.9%氯化钠溶液加上0.1%叠氮化钠)。
检测再结晶现象在逆光中进行。
其结果列于表2。
表1:组成物(以克计量)
实施例 | Durotak387-2287固态物质 | 羊毛蜡 | 氧化锌 | 雌二醇半水合物 | 炔诺酮醋酸酯 |
23 | 50.250.2 | 5.62.4 | 15.218.4 | 2.02.0 | 7.07.0 |
表2:分析结果
Es:雌二醇半水合物NeA:炔诺酮醋酸酯
实施例 | 活性物质含量微克/16厘米2Es NeA | 人类皮肤渗透性微克/16厘米2(24-48小时)Es NeA | 再结晶 | ||
123 | 3.2003.2003.200 | 11.20011.20011.200 | 564948 | 907679 | 无无无 |
比较产品EvorelConti | 3.200 | 11.200 | 33 | 46 | 值得注意 |
如表所示,根据本发明的贴片与比较产品相比较,渗透入人类皮肤的含量得到明显的提高。同时可以确定的是按照本发明的实施例没有再结晶现象发生。
Claims (14)
1.一种包含活性物质的贴片,该贴片用以控制雌二醇或其医药上可接受衍生物,单独或与助孕素复合释放至人类或动物的皮肤,该贴片由背垫层,连接其上适合结合活性物质的释放且利用压敏黏合剂制造的包含活性物质的贮存物,以及可脱离的保护层组成,其特征在于该压敏黏合剂包含羊毛蜡或其成分和氧化锌。
2.根据权利要求1的包含活性物质的贴片,其特征在于该贮存物包含1-30%(重量)的羊毛蜡和1-30%(重量)的氧化锌。
3.根据权利要求1的包含活性物质的贴片,其特征在于该贮存物包含雌二醇或是医药上可接受衍生物,单独或与助孕素复合,其量为1-20%(重量),优选为1.5-15%(重量)。
4.根据权利要求1至3任一项的包含活性物质的贴片,其特征在于该贮存物包含雌二醇或其医药上可接受衍生物,单独或与助孕素复合,其摩尔比为1∶1至1∶10。
5.根据权利要求1至4中一项或多项的包含活性物质的贴片,其特征在于该压敏黏合剂包含浓度为1-50%(重量)的增黏树脂。
6.根据权利要求1至5中一项或多项的包含活性物质的贴片,其特征在于该贮存物包含至少一种成分选自防老剂类、抗氧剂类以及吸收增强剂类。
7.根据权利要求1至6项中一项或多项的包含活性物质的贴片,其特征在于该压敏黏合剂是压敏溶液黏合剂、压敏分散液黏合剂或压敏热熔黏合剂。
8.根据权利要求1至7中一项或多项的包含活性物质的贴片,其特征在于该背垫层对于贮存物的成分是不可渗透的。
9.根据权利要求1至8项中一项或多项的包含活性物质的贴片,其特征在于该贮存物由多层组成且提供附加的包含活性物质的压敏黏合剂层。
10.根据权利要求1至9项中一项或多项的包含活性物质的贴片,其特征在于控制释放活性物质的膜设置在贮存物和压敏黏合剂层之间。
11.根据权利要求1至10中一项或多项的包含活性物质的贴片,其特征在于该贮存物被提供环绕压敏黏合剂边缘。
12.根据权利要求1至11中一项或多项的包含活性物质的贴片,其特征在于该包含活性物质的贴片的厚度的范围在0.03至0.6毫米之间。
13.根据权利要求1至12的包含活性物质的贴片,用于化妆品。
14.根据权利要求1至12的包含活性物质的贴片,用于制备人类或兽医治疗目的的医药。
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DE19834007A DE19834007C1 (de) | 1998-07-29 | 1998-07-29 | Estradiolhaltiges Pflaster zur transdermalen Applikation von Hormonen und seine Verwendung |
DE19834007.9 | 1998-07-29 |
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US (1) | US6531149B1 (zh) |
EP (1) | EP1100477B1 (zh) |
JP (1) | JP2002521427A (zh) |
KR (1) | KR100559089B1 (zh) |
CN (1) | CN1172661C (zh) |
AR (1) | AR021459A1 (zh) |
AT (1) | ATE264097T1 (zh) |
AU (1) | AU758107B2 (zh) |
BR (1) | BR9912687A (zh) |
CA (1) | CA2338859C (zh) |
DE (2) | DE19834007C1 (zh) |
ES (1) | ES2220093T3 (zh) |
IL (2) | IL141033A0 (zh) |
PL (1) | PL194102B1 (zh) |
TR (1) | TR200100289T2 (zh) |
TW (1) | TW542726B (zh) |
WO (1) | WO2000006131A1 (zh) |
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DE10304988A1 (de) * | 2003-02-07 | 2004-09-09 | Lts Lohmann Therapie-Systeme Ag | Transdermales Therapeutisches System mit verbessertem Hautklebeverhalten |
US7335735B2 (en) * | 2003-05-07 | 2008-02-26 | Cedars-Sinai Medical Center | Intracellular estradiol binding protein |
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-
1998
- 1998-07-29 DE DE19834007A patent/DE19834007C1/de not_active Expired - Fee Related
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1999
- 1999-07-16 TR TR2001/00289T patent/TR200100289T2/xx unknown
- 1999-07-16 KR KR1020017001313A patent/KR100559089B1/ko not_active IP Right Cessation
- 1999-07-16 US US09/744,711 patent/US6531149B1/en not_active Expired - Fee Related
- 1999-07-16 PL PL99345695A patent/PL194102B1/pl not_active IP Right Cessation
- 1999-07-16 CA CA002338859A patent/CA2338859C/en not_active Expired - Fee Related
- 1999-07-16 CN CNB998088528A patent/CN1172661C/zh not_active Expired - Fee Related
- 1999-07-16 ES ES99936555T patent/ES2220093T3/es not_active Expired - Lifetime
- 1999-07-16 JP JP2000561986A patent/JP2002521427A/ja active Pending
- 1999-07-16 BR BR9912687-7A patent/BR9912687A/pt not_active IP Right Cessation
- 1999-07-16 IL IL14103399A patent/IL141033A0/xx unknown
- 1999-07-16 AU AU51607/99A patent/AU758107B2/en not_active Ceased
- 1999-07-16 EP EP99936555A patent/EP1100477B1/de not_active Expired - Lifetime
- 1999-07-16 DE DE59909189T patent/DE59909189D1/de not_active Expired - Lifetime
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- 1999-07-16 WO PCT/EP1999/005085 patent/WO2000006131A1/de active IP Right Grant
- 1999-07-22 TW TW088112440A patent/TW542726B/zh not_active IP Right Cessation
- 1999-07-28 AR ARP990103732A patent/AR021459A1/es active IP Right Grant
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2001
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IL141033A0 (en) | 2002-02-10 |
CA2338859C (en) | 2007-09-18 |
KR20010079571A (ko) | 2001-08-22 |
WO2000006131A1 (de) | 2000-02-10 |
DE59909189D1 (de) | 2004-05-19 |
PL345695A1 (en) | 2002-01-02 |
TR200100289T2 (tr) | 2001-07-23 |
BR9912687A (pt) | 2001-06-05 |
IL141033A (en) | 2009-06-15 |
ZA200100719B (en) | 2002-06-14 |
TW542726B (en) | 2003-07-21 |
AR021459A1 (es) | 2002-07-24 |
ES2220093T3 (es) | 2004-12-01 |
JP2002521427A (ja) | 2002-07-16 |
EP1100477A1 (de) | 2001-05-23 |
EP1100477B1 (de) | 2004-04-14 |
KR100559089B1 (ko) | 2006-03-13 |
CN1172661C (zh) | 2004-10-27 |
US6531149B1 (en) | 2003-03-11 |
AU5160799A (en) | 2000-02-21 |
CA2338859A1 (en) | 2000-02-10 |
DE19834007C1 (de) | 2000-02-24 |
ATE264097T1 (de) | 2004-04-15 |
AU758107B2 (en) | 2003-03-13 |
PL194102B1 (pl) | 2007-04-30 |
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