CN1179720A - 含皮质甾类的药物组合物 - Google Patents
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Abstract
本发明提供了泡沫药物组合物,其中含有皮质甾类活性物质、快速分解泡沫剂、推进剂和缓冲剂。此快速分解泡沫剂一般含有脂肪醇、水、高级脂肪醇和表面活性剂。本发明组合物可用于治疗多种皮肤病,特别是头皮牛皮癣。
Description
本发明涉及为皮质甾类活性物质给患者皮肤局部用药而改进了的组合物。
皮质甾类,特别是以酯的形式存在的化合物,特别适用于治疗人皮肤病如湿疹、婴儿湿疹、变应性皮炎、疱疹样皮炎、接触性皮炎、脂溢性皮炎、神经性皮炎、牛皮癣及擦烂。含有这类活性物质的制剂通常以醇溶液、洗剂或霜剂的形式用于皮肤患处。但是,这类制剂无效程度较高。洗剂和霜剂通常太粘稠致使活性成分不能有效地穿过表皮,而溶液剂在穿过皮肤前又易挥发。此外,常规的霜剂基质对皮肤有刺激性,特别是对需长期用药的部位,而洗剂的流动性常使用药难以控制。另外,需要用这类制剂擦涂患处以改善活性物质对表皮的穿透性,这种擦涂本身也产生刺激性。
由此,在用皮质甾类治疗皮肤病时迫切需要改进的制剂,它能将最有效的皮质甾类定向施于皮肤,此间活性物质的转运性能有所改进,不便性和刺激性降低,而患者使用起来更容易。
本发明提供了满足这种要求的改进的组合物。
一方面,本发明提供了含有皮质甾类活性物质、快速分解泡沫剂、推进剂和缓冲剂的泡沫性药物组合物。
这类组合物(泡沫后)以泡沫的形式用于皮肤患处,这种泡沫是喜热的(热敏的)快速分解的泡沫。用于皮肤时,该组合物起初是以乳胶冻泡沫的形式。快速分解泡沫慢慢在泡沫温度分解变为液体使醇和活性物质在患处饱和。这样的系统提高了醇和活性物质对表皮的穿透性。由于该组合物是以乳胶冻的形式施用的,其半固体特性使其更易于操作和控制。该泡沫组合物施用时提供了厚球状泡沫,当其分散时容易裂解,使需要治疗的皮肤患处被适当覆盖而溶剂不提前挥发。现已发现,该组合物中含有缓冲剂是很重要的,这能稳定复合泡沫组合物中皮质甾类活性物质的活性异构体,否则在泡沫组合物中复杂的相互作用可能造成活性较强的异构体的不稳定。
本发明中需要使用快速分解的泡沫剂。这些试剂是已知的。适于本发明的快速分解泡沫剂见澳大利亚专利463216和国际专利申请WO85/01876。一般优选快速分解泡沫剂含有脂族醇、水、脂肪醇和表面活性剂。特别优选快速分解泡沫剂中含有下列组份:(a)脂族醇,优选在组合物中的含量为40-90%w/w,更优选55-70%w/w,最优选57-59%w/w;(b)水,优选含量为10-40%w/w;(c)至少一种脂肪醇,优选含量为0.5-10%w/w;(d)表面活性剂,优选乙氧基化脱水山梨醇酯(作为乳化剂),一般含量为0.1-15%w/w。
在快速分解泡沫剂中,脂肪醇选自,例如,鲸蜡醇、硬脂醇、月桂醇、肉豆蔻醇和棕榈醇及其两种或多种醇的混合物。已发现特别优选鲸腊醇和硬脂醇如十八烷基-1-醇的混合物;这两种成分的比例可以调节至在最宽的可能的温度范围内维持泡沫的粘度。在这种情况下,20℃以上时硬脂醇维持粘度而20℃以下时鲸腊醇维持粘度。
脂族醇优选甲醇、乙醇、异丙醇和丁醇及其两种或多种醇的混合物。已发现乙醇是特别优选的。
用于快速分解泡沫剂的表面活性剂优选乙氧基化脱水山梨醇硬脂酸酯、棕榈酸酯、油酸酯、壬基苯酚乙氧基化物和脂肪醇乙氧基化物,及其两种或多种的混合物。于是,例如,已发现特别优选聚山梨酯60(山梨醇的部分硬脂酸酯和其酸酐的混合物与环氧乙烷共聚,每摩尔山梨醇和其酸酐比约20摩尔环氧乙烷)。此表面活性剂提高脂肪醇在系统中的溶解度并提高泡沫的形成。
可使用的推进剂选自常规的气雾推进剂。故可由丙烷、丁烷、二氯二氟甲烷、二氯四氟乙烷、八氟环丁烷及其两种或多种的混合物选择。有必要选择与整个系统最相容的推进剂。特别优选推进剂的含量为3-30%w/w,更优选3-10%w/w,最优选3-5%w/w。推进剂的最大含量为与所用比例的水/脂族醇最易混合的量。除作为推进剂外,推进剂也可作为水/醇系统中的脂肪酸和活性物质溶剂。
也可以使用其它添加剂。故优选加入保湿剂以降低水溶性脂肪醇的干燥作用。这类保湿剂优选含量为0.1-10.0%w/w,更优选0.5-3.0%w/w。特别优选保湿剂是丙二醇,但是也可使用其它保湿剂如甘油、泛醇和山梨醇。
本发明的组合物可以用来转运已用于皮肤病局部治疗的皮质甾类化合物。故,例如,本发明的组合物可用来转运下列具局部作用的皮质甾类及其有药效的混合物:二丙酸别氯米松醋酸环戊酮去炎松 氟二氯松二丙酸氯地米松 肤轻松苯甲酸倍他米松 醋酸肤轻松二丙酸倍他米松 氟考丁酯戊酸倍他米松 氟考龙制剂
醋酸氟甲叉龙丁地去炎松 丙酮缩氟氢羟龙氯氟美松 氯氟松丁酸氯氟美松酮 氢化可地松丙缩羟强龙 醋酸氢化可地松去氧米松 氢化可地松丁酸酯霜醋二氟松 醋酸甲强龙戊酸二氟米松 糠酸莫米松特温度二氟米松 丙炎松
本发明的组合物特别利于倍他米松及其衍生物如苯甲酸倍他米松、二丙酸倍他米松和戊酸倍他米松对病人皮肤的局部给药。特别优选使用戊酸酯,特别是在治疗牛皮癣时。
此皮质甾类活性物质优选的含量为0.01-1.0%w/w,更优选0.05-0.2%w/w。
考虑到组合物的复杂性,出乎意料地发现为了确保组合物中皮质甾类的活性异构体的稳定性并由此确保将具活性得罪异构体转运至表皮,需要用包括适宜缓冲剂的试剂缓冲该组合物。适宜的缓冲剂为乙酸/乙酸钠、枸橼酸/枸橼酸钠和磷酸/磷酸钠,一般需将此组合物缓冲至pH3.0-6.0,优选4.0-5.0,最终缓冲剂优选的含量为0.01-1.0%w/w,更优选0.05-0.2%w/w。当戊酸倍他米松用作活性物质时,特别优选使用枸橼酸缓冲系统,更优选使用无水枸橼酸/枸橼酸钾,将组合物缓冲至pH4.5;在这种情况下,枸橼酸缓冲液对复合组合物中活性较高的17-戊酸酯比活性较低的21-戊酸酯的稳定效果更好,这确保了活性物质中最有效的形式有效地转运至表皮。
可用常规方法制备该组合物,这样在醇/水基质中制得脂肪醇的均匀溶液。按照常规方法脂肪醇、水/脂族醇和推进剂的相对比例便于控制,这样提供了均匀清澈的溶液并形成了适宜的快速分解泡沫。一般来说,脂肪醇、表面活性剂、脂族醇和保湿剂(如果存在)优选与皮质甾类活性物质一起混合来制备“醇相”。“水相”优选由缓冲剂和水混合制备。然后,优选在最终的容器中,以需要的量,将这些相混合。再加压加入推进剂来制备本发明的组合物。
例如,对于戊酸倍他米松,特别优选使用含有作为脂肪醇的鲸腊醇和十八烷基-1-醇,作为表面活性剂的聚山梨酯60、纯水及作为脂族醇的乙醇的组合物。该系统优选用无水枸橼酸/枸橼酸钾缓冲而推进剂优选丁烷/丙烷。一般优选这些组份的比例能使容器中的固定压力达到50-70psi左右。
本发明的组合物可以装于容器中并由该容器中给药,该容器能耐受推进剂气体的压力并具有适当的阀/嘴一以便在加压下以泡沫的形式施用该组合物。如果此容器是金属物质的,在组合物的作用下这些金属易腐蚀,故组合物中可以含有腐蚀抑制剂作为添加剂。由此,如果容器是锡片制成的,则腐蚀抑制剂的存在是必要的。适宜的腐蚀抑制剂包括有机酸盐,优选山梨酸、苯甲酸、苯甲酸钠和山梨酸钠。如果使用,此腐蚀抑制剂的含量可为0.1-15%w/w,优选0.1-3%w/w。在本发明中,特别是当因戊酸倍他米松作为活性物质而使用上述组合物时,铝罐是优选的容器;此时,无腐蚀问题,就不需要加入腐蚀抑制剂。
使用时,此组合物被喷出,产生半固体泡沫(泡沫或乳胶冻),这适于患处(例如头皮,当治疗头皮发生的皮肤病时)的局部给药。给药时,皮肤的热量使乳胶冻变为液体形式,于是释放出能透皮的脂肪醇和皮质甾类活性物质,而留下少量残余物,其残余物的量比用霜剂基质转运活性物质时的量低很多倍。这种给药途径使特定部位的给药更容易,而本发明的组合物提供了方便、可控制并有效的载体来将局部用活性皮质甾类转运至皮肤。与常规局部用皮质甾类制剂相比,这更易控制、减少了对患处的擦涂次数并使醇类载体穿透皮肤将活性物质转运至疗效最大的地方。
本发明的组合物可用于治疗通常用皮质甾类活性物质治疗的皮肤病。由此,此组合物可特别用于治疗湿疹、婴儿湿疹、变应性皮炎、疱疹样皮炎、接触性皮炎、脂溢性皮炎、神经性皮炎、牛皮癣及擦烂。此组合物特别适用于治疗病人头皮患有的牛皮癣。
现通过下列非限制性实施例举例说明本发明。实施例戊酸倍他米松组合物
制备组份如下的戊酸倍他米松制剂:
%w/w戊酸倍他米松 0.12鲸腊醇BP 1.10十八烷基-1-醇BP 0.50聚山梨酯60BP 0.40乙醇 57.79纯水 33.69丙二醇BP 2.00无水枸橼酸BP 0.073枸橼酸钾 0.027丁烷/丙烷
4.30
100.00
将鲸腊醇(HYFATOL 1698,Efkay Chemicals Limited,London)、十八烷基-1-醇(HYFATOL 1898,Efkay Chemicals Limited,London)、聚山梨酯60(CRILLET 3,Croda Chemicals,North Humberside)和乙醇以适当的比例混合并加热至约45℃,连续搅拌至混合物变清澈。将无水倍他米松BP(Roussel Uclaf,Virtolaye,France)缓慢转移至混合物中,再连续搅拌至混合物变清。(醇相)
将纯水分别加热至45℃,将无水枸橼酸BP和枸橼酸钾BP转移至水中,连续搅拌至溶解。(水相)
将醇相和水相分别通过75微米筛过滤并将所需的重量在室温下装入罐(铝,环氧树脂衬里)中。通过阀,将丁烷/丙烷推进剂(推进剂P70)加入罐中的混合物中至所需的重量,并在阀上装致动装置。
此组合物,在由罐中喷在皮肤上时,产生喜热泡沫,这些泡沫吸收皮肤产生的热量而分解并向表皮释放活性物质。枸橼酸缓冲系统的存在稳定戊酸倍他米松17-戊酸酯构型的效果比稳定活性低的21-戊酸酯构型的效果好,由此制备了能将活性物质有效转运至表皮并特别适于治疗牛皮癣(特别是头皮牛皮癣)的组合物。
Claims (33)
1.一种泡沫药物组合物,其中含有皮质甾类活性物质、快速分解泡沫剂、推进剂和缓冲剂。
2.一种泡沫药物组合物,其中含有快速分解泡沫剂、推进剂、缓冲剂和皮质甾类活性物质,该皮质甾类活性物质为一类具有异构现象的物质并具有活性较高的异构体及活性较低的异构体,而缓冲剂的含量能有效地稳定活性较高的异构体使其不异构为活性较低的异构体。
3.权利要求1或2所述的泡沫药物组合物,其特征是被缓冲至pH3.0至6.0。
4.权利要求3所述的泡沫药物组合物,其特征是被缓冲至pH4.0至5.0。
5.上述任意一个权利要求所述的泡沫药物组合物,其中缓冲剂的含量为0.01至1.0%w/w。
6.权利要求5所述的泡沫药物组合物,其中缓冲剂的含量为0.05至0.2%w/w。
7.上述任意一个权利要求所述的泡沫药物组合物,其中缓冲剂选自乙酸/乙酸钠缓冲剂、枸橼酸/枸橼酸钠缓冲剂和磷酸/磷酸钠缓冲剂。
8.上述任意一个权利要求所述的泡沫药物组合物,其中皮质甾类活性物质是选自如下药物的局部有效的皮质甾类及其有药效的混合物:二丙酸别氯米松醋酸环戊酮去炎松 氟二氯松二丙酸氯地米松 肤轻松苯甲酸倍他米松 醋酸肤轻松二丙酸倍他米松 氟考丁酯戊酸倍他米松 氟考龙制剂
醋酸氟甲叉龙丁地去炎松 丙酮缩氟氢羟龙氯氟美松 氯氟松丁酸氯氟美松酮 氢化可地松丙缩羟强龙 醋酸氢化可地松去氧米松 氢化可地松丁酸酯双醋二氟松 醋酸甲强龙戊酸二氟米松 糠酸莫米松特戊酸二氟米松 丙炎松
9.上述任意一个权利要求所述的泡沫药物组合物,其中皮质甾类活性物质是倍他米松或其衍生物。
10.权利要求9所述的泡沫药物组合物,其中皮质甾类活性物质选自苯甲酸倍他米松、二丙酸倍他米松和戊酸倍他米松。
11.权利要求10所述的泡沫药物组合物,其中皮质甾类活性物质是戊酸倍他米松。
12.上述任意一个权利要求所述的泡沫药物组合物,其中皮质甾类活性物质的含量为0.01至1.0%w/w。
13.权利要求12所述的泡沫药物组合物,其中皮质甾类活性物质所含量为0.5至0.2%w/w。
14.上述任意一个权利要求所述的泡沫药物组合物,其中快速分解的泡沫剂含有脂族醇、水、脂肪醇和表面活性剂。
15.权利要求14所述的泡沫药物组合物,其中脂族醇的含量为占组合物重量的40至90%。
16.权利要求15所述的泡沫药物组合物,其中脂族醇的含量为占组合物重量的55至70%。
17.权利要求16所述的泡沫药物组合物,其中脂族醇的含量为占组合物重量的57至59%。
18.权利要求14至17中任一权利要求所述的泡沫药物组合物,其中脂族醇选自甲醇、乙醇、异丙醇、丁醇及其两种或多种的混合物。
19.权利要求18所述的泡沫药物组合物,其中脂族醇是乙醇。
20.权利要求14至19中任一权利要求所述的泡沫药物组合物,其中水的含量为占组合物重量的10至40%。
21.权利要求14至20中任一权利要求所述的泡沫药物组合物,其中脂肪醇的含量为占组合物重量的0.5至10%。
22.权利要求14至21中任一权利要求所述的泡沫药物组合物,其中脂肪醇选自鲸腊醇、硬脂醇、月桂醇、棕榈醇及其两种或多种的混合物。
23.权利要求22所述的泡沫药物组合物,其中脂肪醇是鲸腊醇和硬脂醇的混合物。
24.权利要求14至23中任一权利要求所述的泡沫药物组合物,其中表面活性剂的含量为占组合物的0.1至15%w/w。
25.权利要求14至24中任一权利要求所述的泡沫药物组合物,其中表面活性剂选自乙氧基化的山梨醇硬脂酸酯、棕榈酸酯、油酸酯,壬基苯酚或脂肪醇,及其两种或多种的混合物。
26.权利要求所述25的泡沫药物组合物,其中表面活性剂是山梨醇的部分硬脂酸酯和其酸酐与环氧乙烷以每摩尔山梨醇和其酸酐比20摩尔环氧乙烷的比例共聚的混合物。
27.含有上述任一权利要求所述泡沫药物组合物的药品,其装于能耐受推进剂气体压力的具有阀或嘴的容器中,该阀或嘴用来在加压下将泡沫组合物以泡沫的形式给药。
28.权利要求1所述的泡沫药物组合物,其特征是含有如下组份:
%w/w戊酸倍他米松 0.12鲸腊醇BP 1.10十八烷基-1-醇BP 0.50聚山梨酯60BP 0.40乙醇 57.79纯水 33.69丙二醇BP 2.00无水枸橼酸BP 0.073枸橼酸钾 0.027丁烷/丙烷
4.30
100.00
29.权利要求1至27中任一权利要求所述的泡沫药物组合物,或权利要求28所述的药品,在治疗湿疹、婴儿湿疹、变应性皮炎、疱疹样皮炎、接触性皮炎、脂溢性皮炎、神经性皮炎、牛皮癣及擦烂方面的用途。
30.权利要求29所述的泡沫药物组合物或药品在治疗头皮牛皮癣的用途。
31.治疗可用皮质甾类活性物质治疗的皮肤病的方法,该方法包括给需要的患者局部使用有效量的权利要求1至25中任一权利要求限定的泡沫药物组合物或权利要求27限定的药品。
32.权利要求31所述的方法,其中皮肤病选自湿疹、婴儿湿疹、变应性皮炎、疱疹样皮炎、接触性皮炎、脂溢性皮炎、神经性皮炎、牛皮癣及擦烂。
33.权利要求32所述的方法,用于治疗病人患有的头皮牛皮癣。
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GBGB9504265.1A GB9504265D0 (en) | 1995-03-03 | 1995-03-03 | Corticosteroid-containing pharmaceutical composition |
GB9504265.1 | 1995-03-03 |
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1996
- 1996-03-01 CA CA002214436A patent/CA2214436C/en not_active Expired - Lifetime
- 1996-03-01 BR BR9607687-9A patent/BR9607687A/pt not_active Application Discontinuation
- 1996-03-01 SK SK1190-97A patent/SK283049B6/sk not_active IP Right Cessation
- 1996-03-01 DE DE69630593T patent/DE69630593T2/de not_active Expired - Lifetime
- 1996-03-01 NZ NZ302727A patent/NZ302727A/xx not_active IP Right Cessation
- 1996-03-01 WO PCT/GB1996/000490 patent/WO1996027376A1/en active IP Right Grant
- 1996-03-01 KR KR1019970706110A patent/KR100427492B1/ko not_active IP Right Cessation
- 1996-03-01 EP EP96904935A patent/EP0813413B1/en not_active Expired - Lifetime
- 1996-03-01 PT PT96904935T patent/PT813413E/pt unknown
- 1996-03-01 CN CN96192817A patent/CN1082817C/zh not_active Expired - Lifetime
- 1996-03-01 JP JP52669796A patent/JP4557310B2/ja not_active Expired - Lifetime
- 1996-03-01 HU HU9900801A patent/HU228890B1/hu unknown
- 1996-03-01 ES ES96904935T patent/ES2210349T3/es not_active Expired - Lifetime
- 1996-03-01 US US08/913,144 patent/US6126920A/en not_active Expired - Lifetime
- 1996-03-01 PL PL96322088A patent/PL183730B1/pl unknown
- 1996-03-01 CZ CZ972758A patent/CZ285913B6/cs not_active IP Right Cessation
- 1996-03-01 AU AU48851/96A patent/AU709320B2/en not_active Expired
- 1996-03-01 DK DK96904935T patent/DK0813413T3/da active
- 1996-03-01 AT AT96904935T patent/ATE253367T1/de active
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1997
- 1997-09-03 MX MX9706698A patent/MX9706698A/es unknown
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2002
- 2002-09-27 US US10/256,754 patent/US7078058B2/en not_active Expired - Fee Related
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2006
- 2006-03-30 US US11/394,848 patent/US20060171898A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108601733A (zh) * | 2015-12-15 | 2018-09-28 | 治疗学有限公司 | 卤倍他索泡沫组合物及其使用方法 |
CN108601733B (zh) * | 2015-12-15 | 2021-11-09 | 治疗学有限公司 | 卤倍他索泡沫组合物及其使用方法 |
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