CN1148172C - 含有激素和结晶抑制剂的透皮治疗系统 - Google Patents
含有激素和结晶抑制剂的透皮治疗系统 Download PDFInfo
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Abstract
本发明是关于一种可受控释放雌二醇和诺塞甾酮醋酸酯的膏药形式的透皮治疗系统,包括一个背层,一个用活性成份过饱和的含雌二醇和诺塞甾酮醋酸酯的贮存层,该贮存层附在背层上并且是用聚丙烯酸酯压敏粘合剂和结晶抑制剂配制而成的,以及一个可剥离的保护层。本发明系统的特征在于,结晶抑制剂是一种含有氨基的聚合物。
Description
本发明是关于一种可将雌二醇与诺塞甾酮醋酸酯(norethisteroneacetate)联合受控释放至人体皮肤的透皮治疗系统(TTS)。
雌二醇和诺塞甾酮醋酸酯的组合,在用于配制透皮治疗系统的助剂中的饱和溶解度通常是非常低的,该助剂例如聚丙烯酸酯粘合剂,增粘剂ifiers),增塑剂和吸收改善剂。因此,将溶解的活性成分载至透皮治疗系统大受限制,和/或在载过饱和溶液的情况下,在储藏期间会发生不需要的结晶。因而导致在基质中溶解的活性成分的比例降低,不利于它们的释放。
对于包含有雌二醇和诺塞甾酮醋酸酯的组合制剂,现已开发出一些用药剂型,其中在一个透皮治疗系统中的几种活性成分含在不同的区域中。但是,制造此类的透皮治疗系统是非常昂贵的。
将干燥剂和透皮治疗系统装在一起能降低再结晶的危险性,但是并不是很容易的。
DE-A 43 36 557中叙述一种以含松香酯压敏粘合剂为基础的活性物质透皮治疗系统。其制备是在100℃和140℃之间的温度下,将几种成分捏合熔融,之后进行涂覆。在如此高的温度下制备药物,其产品可能会发生大量不能被允许的降解。
WO 95/30409中叙述一种局部给药的聚合物释放系统,它是通过一种无推进剂气雾剂将某些活性成分喷雾到局部表面。它的一个突出优点是不使用粘合剂。使用的附加成分包括结晶抑制剂/稳定剂和/或渗透增强剂,例如有取代的环糊精、Transcutol、尿素和异萜烯(isoterpenes);而在该专利中未要求保护雌二醇和诺塞甾酮醋酸酯组合的活性物质。
因此,本发明的一个目的是提供一种稳定的、亦即无再结晶的膏药,其包含雌二醇和诺塞甾酮醋酸酯活性成分。
令人惊奇地发现,本发明的这一目的可通过使用含有氨基的聚合物作为结晶抑制剂而达到,这是本发明要求保护的透皮治疗系统的主要特征。所使用的有效的结晶抑制剂,是以甲基丙烯酸丁酯、甲基丙烯酸2-二甲基氨基乙酯、和甲基丙烯酸甲酯为基础的聚合物,它们的摩尔比优选的是1∶2∶1,聚氨基酰胺、聚氨基咪唑琳、聚醚氨基甲酸乙酯胺(polyetherurethaneamines)、聚胺和聚葡萄糖胺。该结晶抑制剂合适的含量是0.05到30%重量。
在结晶抑制剂的基本基团和雌二醇分子中可迁移的氢原子之间的氢键使雌二醇固定,因而在基质中可自由迁移的雌二醇的浓度降低,就能防止结晶。
压敏粘合剂贮存层含有重量比为1∶2到1∶15,优选1∶3到1∶7的雌二醇和诺塞甾酮醋酸酯,总浓度可高达25%重量。
该贮存层的一种组分可选自老化抑制剂、增塑剂、抗氧化剂和吸收改善剂,增塑剂所使用的浓度为0至5%重量,老化抑制剂所使用的浓度为0.1至2%重量。
合适的老化抑制剂、增塑剂、抗氧化剂和吸收改善剂是本领域技术人员已知的,例如在DE 37 43 949中有叙述。
为了使透皮治疗系统可以使用在皮肤上,此系统必须具有压敏粘合性能。为了使本发明的透皮治疗系统具有这些性能,使用的聚丙烯酸酯压敏粘合剂的有机溶剂溶液,称之谓溶剂基压敏粘合剂。
也可使用水分散液形式的聚丙烯酸酯压敏粘合剂。
同样合适的粘合剂是热熔融的压敏粘合剂。其没有溶剂或分散剂,而是以熔融的形式使用。
紫外光可交联的丙烯酸酯压敏粘合剂同样是合适的。其未使用溶剂,用传统的涂覆技术使用。涂覆后,聚合物链受紫外光照射而交联。为了使压敏粘合剂充分地结合,这是必须的。
透皮治疗系统的贮存层,可由数层相同或不同浓度的活性成份组成。
贮存层的厚度是从0.02mm至0.500mm,但优选的是从0.030mm至0.200mm。
贮存层可以有一个额外的压敏粘合层和/或一个压敏粘合边缘。当贮存层本身的压敏粘着性能不足时,这是必须的。
本发明的透皮治疗系统是用来作为人用的治疗药物。
以下根据实施例说明本发明。
实施例1
将155.08克Durotak 387-2287(National Starch)(聚丙烯酸酯压敏粘合剂(PSA),和4.81克Eudragit E 100(Rohm)(聚丙烯酸酯),与以下这种混悬液一起搅拌均匀,该混悬液为:
2.17克Eutanol G(Caesar und Loretz)(长链脂肪醇),
0.03克乙酰丙酮铝(Merck-Schuchartdt),
1.29克雌二醇半水合物,和
8.33克诺塞甾酮醋酸酯,
将它们溶解在含有27.98克醋酸乙酯和27.97克乙醇的溶剂混合液中。
将所得的粘合剂溶液涂覆到一个Hostaphan RN 100可剥离的保护层上(其两面硅化)得到一个活性物质基质层,其干燥后的涂层重量为96.3g/m2。将一个活生成份不可渗透的背层(0.015mm的厚度的聚酯薄膜)层压在所得的基质层上。之后,冲切出大小为40cm2的透皮治疗系统的贴片。
实施例2至7和比较例
如实施例1所述进行配制,起始材料和用量如在表1中说明。
表1:组成成分(克)
实施例 | 比较例 | 2 | 3 | 4 | 5 | 6 | 7 |
Durotak 387-2287 | 424.31 | 132.84 | 162.25 | 171.50 | 171.50 | 162.25 | 171.50 |
雌二醇半水合物 | 3.37 | 1.34 | 1.34 | 1.34 | 1.34 | 1.34 | 1.34 |
诺塞甾酮醋酸酯 | 21.60 | 8.65 | 8.65 | 8.65 | 8.65 | 8.65 | 8.65 |
Eutanol G | 5.59 | 2.25 | 2.25 | 2.25 | 2.25 | 2.25 | 2.25 |
乙酰丙酮铝 | 1.36 | 0.054 | 0.054 | 0.054 | 0.054 | 0.054 | 0.054 |
醋酸乙酯 | 36.48 | 29.28 | 27.11 | 27.11 | 29.28 | 27.11 | |
乙醇 | 36.48 | 29.28 | 27.11 | 27.11 | 29.28 | 27.11 | |
甲乙酮 | 134.79 | -- | -- | -- | -- | -- | -- |
Euredur 145 | -- | 20.2 | -- | -- | -- | -- | -- |
Euredur 125 | -- | -- | 5.0 | -- | -- | -- | -- |
Euredur 250 | -- | -- | -- | 0.5 | -- | -- | -- |
Euredur 43 | -- | -- | -- | -- | 0.5 | -- | -- |
Euredur 27 | -- | -- | -- | -- | -- | 5.0 | -- |
Euredur 10 | -- | -- | -- | -- | -- | -- | 0.5 |
测试再结晶现象的测试是用穿透光在40倍放大率的显微镜中进行。其结果列于表2中。
表2 再结晶
实施例1 | 在40℃储存3个月之后每40cm3的晶体数 |
比较例 | 154 |
1 | 0 |
2 | 0 |
3 | 0 |
4 | 0 |
5 | 0 |
6 | 0 |
7 | 0 |
表2显示,添加结晶抑制剂使透皮治疗系统免除结晶现象。而相反,比较例(没有添加结晶抑制),三个月后有大量的结晶。
Claims (11)
1.一种受控释放雌二醇和诺塞甾酮醋酸酯的药膏形式的透皮治疗系统,包括一个背层,一个用活性成分过饱和的贮存层,其中含有雌二醇和诺塞甾酮醋酸酯,所述贮存层附在所述背层上并用聚丙烯酸酯压敏粘合剂和结晶抑制剂制备,和一个可剥离的保护层,其特征在于,结晶抑制剂是一种含有氨基的聚合物。
2.根据权利要求1所述的透皮治疗系统,其特征在于,结晶抑制剂选自具体以1∶2∶1的摩尔比的甲基丙烯酸丁酯、甲基丙烯酸2-二甲基氨基乙基酯、和甲基丙烯酸甲酯为基础的聚合物,聚氨基酰胺、聚氨基咪唑啉、聚醚氨基甲酸乙酯胺、聚胺和聚葡萄糖胺。
3.根据权利要求1或2所述的透皮治疗系统,其特征在于,贮存层含有一种或多种结晶抑制剂,含量为0.05至30%重量。
4.根据权利要求1或2的透皮治疗系统,其特征在于,贮存层含有的雌二醇和诺塞甾酮醋酸酯的重量比为1∶2到1∶15,并且其总浓度可高达25%重量。
5.根据权利要求4的透皮治疗系统,其特征在于,贮存层含有的雌二醇和诺塞甾酮醋酸酯的重量比为1∶3到1∶7。
6.根据权利要求1或2的透皮治疗系统,其特征在于,贮存层所含的一种组分选自老化抑制剂、增塑剂、抗氧化剂和吸收改善剂,增塑剂的使用浓度为0至5%重量,老化抑制剂的使用浓度为0.1至2%重量。
7.根据权利要求1或2的透皮治疗系统,其特征在于,压敏粘合剂是溶剂基的粘合剂、分散液粘合剂、热熔粘合剂或紫外线交联的粘合剂。
8.根据权利要求1或2的透皮治疗系统,其特征在于,贮存层是由两层或多层所组成的。
9.根据权利要求1或2的透皮治疗系统,其特征在于,贮存层的厚度是0.02mm至0.500mm。
10.根据权利要求9的透皮治疗系统,其特征在于,贮存层的厚度是0.030mm至0.200mm。
11.根据权利要求1或2的透皮治疗系统,其特征在于,贮存层设置有一个附加的压敏粘合剂层和/或一个压敏粘合剂边缘。
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Application Number | Priority Date | Filing Date | Title |
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DE19828273.7 | 1998-06-25 | ||
DE19828273A DE19828273B4 (de) | 1998-06-25 | 1998-06-25 | Transdermales therapeutisches System, enthaltend Hormone und Kristallisationsinhibitoren |
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CN1148172C true CN1148172C (zh) | 2004-05-05 |
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US (1) | US6899894B1 (zh) |
EP (1) | EP1089719B1 (zh) |
JP (1) | JP2002518430A (zh) |
KR (1) | KR100550888B1 (zh) |
CN (1) | CN1148172C (zh) |
AR (1) | AR019715A1 (zh) |
AT (1) | ATE215819T1 (zh) |
AU (1) | AU768755B2 (zh) |
BR (1) | BR9912210A (zh) |
CA (1) | CA2335582C (zh) |
CZ (1) | CZ300707B6 (zh) |
DE (2) | DE19828273B4 (zh) |
DK (1) | DK1089719T3 (zh) |
ES (1) | ES2177290T3 (zh) |
HU (1) | HUP0102498A3 (zh) |
IL (2) | IL140434A0 (zh) |
NZ (1) | NZ509015A (zh) |
PL (1) | PL193080B1 (zh) |
PT (1) | PT1089719E (zh) |
TR (1) | TR200003839T2 (zh) |
TW (1) | TW533084B (zh) |
WO (1) | WO1999066901A2 (zh) |
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1998
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104027885A (zh) * | 2008-06-19 | 2014-09-10 | 纽帕特公司 | 用于曲坦类化合物离子电渗疗法的多胺增强制剂 |
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CN1310616A (zh) | 2001-08-29 |
US6899894B1 (en) | 2005-05-31 |
CA2335582A1 (en) | 1999-12-29 |
JP2002518430A (ja) | 2002-06-25 |
CZ300707B6 (cs) | 2009-07-22 |
NZ509015A (en) | 2004-01-30 |
AU768755B2 (en) | 2004-01-08 |
WO1999066901A3 (de) | 2000-03-23 |
ATE215819T1 (de) | 2002-04-15 |
CZ20004798A3 (en) | 2001-05-16 |
DE19828273A1 (de) | 1999-12-30 |
DK1089719T3 (da) | 2002-08-05 |
IL140434A0 (en) | 2002-02-10 |
PT1089719E (pt) | 2002-09-30 |
DE19828273B4 (de) | 2005-02-24 |
DE59901202D1 (de) | 2002-05-16 |
KR100550888B1 (ko) | 2006-02-10 |
EP1089719A2 (de) | 2001-04-11 |
IL140434A (en) | 2006-10-05 |
HUP0102498A3 (en) | 2002-01-28 |
TW533084B (en) | 2003-05-21 |
ZA200007751B (en) | 2001-07-18 |
EP1089719B1 (de) | 2002-04-10 |
TR200003839T2 (tr) | 2001-06-21 |
PL193080B1 (pl) | 2007-01-31 |
PL345455A1 (en) | 2001-12-17 |
WO1999066901A2 (de) | 1999-12-29 |
KR20010053132A (ko) | 2001-06-25 |
AU4508699A (en) | 2000-01-10 |
CA2335582C (en) | 2006-04-11 |
ES2177290T3 (es) | 2002-12-01 |
HUP0102498A2 (hu) | 2001-11-28 |
BR9912210A (pt) | 2001-04-10 |
AR019715A1 (es) | 2002-03-13 |
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