CN101014315A - 药学上高品质的局部用无水气溶胶泡沫 - Google Patents
药学上高品质的局部用无水气溶胶泡沫 Download PDFInfo
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Abstract
一种局部用药物喷雾泡沫,其包含液体硅酮以提高化妆品品质。虽然液体硅酮本质上是消泡剂,却可产生优质稳定的泡沫。
Description
发明领域
本发明涉及局部用药物组合物。
发明领域
局部用药物组合物理所当然是众所周知的。它们可用作防水剂、防晒剂、皮肤调理剂、唇膏、伤口敷料、润发油等等。无论是哪种具体用途,一般来说,药学上令人满意的局部用活性剂必须在皮肤上保持充分的时间以使活性剂发挥作用;它们应不会刺激皮肤;并且必须让患者觉得在药学上是高品质的,否则患者将不再使用它们。如本领域技术人员所知,“药学上高品质的”表示,患者的皮肤感觉良好。不应该有水分太多或太油的感觉。一些人认为这与乳脂或润滑特性以及“保湿”特性有关。
仍然需要改进局部用载体体系,尤其是亲脂性的载体体系,消费者觉得大多数亲脂性载体体系涂在皮肤上时有太多蜡质或太油腻的感觉。本发明与这种需要有关。
虽然过去已在局部应用方面使用了气溶胶递送亲脂性体系,但是典型的气溶胶体系的问题在于,需要开发一种不会让人感到油腻且在化妆品性质方面表现优异的体系。已知局部应用中不会产生油腻感的非气溶胶组合物可包括液体硅酮如环甲基硅酮、六甲基二硅氧烷和聚二甲基硅氧烷醇。但是,本领域中将这些液体硅酮视作消泡剂。由于其消泡作用,人们不会希望在泡沫是递送体系必需部分的局部用气溶胶组合物中加入消泡剂。但是,意外地发现,在本发明中创造了一种局部用气溶胶泡沫组合物,它含有大量液体硅酮且出乎意料地提供优质泡沫。
本发明提供给使用者许多其它优点,也是所希望达到的目的。泡沫形式的药物递送体系有利于形成局部用药物递送体系的新型但有效的模式。它还有利于连续产品输出,从而方便应用。当以少量分散时,泡沫形式的药物递送体系还可覆盖较大的应用表面积,同时也有利于在该区域提供更佳的产品应用,而常规局部用产品不能产生有效结果。泡沫形式的药物递送体系还有利于使用较低剂量从而尽可能减少副作用。这种泡沫形式递送体系的另一个关键优点是避免了接触空气、光或任何其它形式的污染,因为其在整个产品寿命期间是完全密封的***。因此,具有光和氧化倾向的局部用活性剂可有效保存在气溶胶体系中。无水载体体系还可延长在水基存在下易于降解的局部用活性剂的保存期。
因此,本发明的主要目的是制备一种局部应用或可广泛应用(即可应用于许多药物活性剂)的药物组合物,同时使用者感觉该组合物是药学上是高品质的。
本发明的另一个目的是用尤其适用于亲脂性化合物并且可提供泡沫形式的有效递送的组合物来实现所述主要目的。
又一个目的是提供一种制备局部应用20或泡沫形式药物组合物的方法,以实现各个上述目的和优点。
由以下本发明详细说明,实现本发明各个上述目的以及其它目的的方法和方式将显而易见。
发明概述
一种局部用药物气溶胶泡沫组合物,其包含亲脂性化合物、液体硅酮、起泡剂、推进剂和局部用药物活性剂。该组合物还包含用作泡沫稳定剂的流变改性剂。该组合物具有优异的润肤和擦抹渗入特征。当组合物从雾化容器中喷出时,由大量通常本质为消泡剂的液体硅酮构成的组合物可产生意想不到的优质泡沫。
优选实施方式的具体描述
某些特定术语可适当描述组合物。上文已定义了术语“药学上高品质的”。整篇说明书和所附权利要求书中使用的“药物组合物”应理解为该组合物中各个组分或成分本身是药学上可接受的,例如,它们是局部应用可接受的活性剂的组合物。换句话说,它们是FDA批准的或在GRAS安全列表上。术语“局部用活性药物”表示非限制性地,包括通常局部应用的药物活性剂,例如防水剂、皮肤屏障剂、皮肤调理剂、溶剂、生物粘合剂、痤疮活性剂、镇痛药、麻醉剂、减食欲药、抗组胺药、抗炎药、抗生素、抗真菌剂、抗病毒剂、抗微生物剂、杀芥螨药、杀虱剂、抗肿瘤药、止汗药、止痒药、抗银屑病药、抗皮脂溢剂、收敛剂、生物活性蛋白质和肽、烧伤活性剂、烧灼剂、脱色剂、尿布湿疹药剂、酶、毛发生长活性剂、止血药、角质层分离剂、口疮性溃疡活性剂、唇疱疹活性剂、光敏活性剂、类固醇、晒斑活性剂、防晒剂、***活性剂、疣突活性剂、伤口护理活性剂;以及视黄醇、视黄酸和视黄酸衍生物。它们也可包括处方和非处方(OTC)药物产品。应理解,上述列表只是为了举例而不是为了限制活性剂。术语“药物有效量的局部用活性药物”表示组合物中存在足够量的局部用活性药物以发挥其预期目的。
在本发明中,存在5种必需成分。第一种成分是选自下组的亲脂性化合物或亲脂性化合物的组合,包括但不限于:凡士林、矿物油、植物油、脂肪酸、甘油酯、中链甘油三酯、或它们的组合。亲脂性化合物或亲脂性化合物的组合的量约为组合物总重量的1%-80%。优选地,亲脂性化合物或亲脂性化合物的组合的量约为组合物总重量的5%-65%。存在各种级别的凡士林,其中一种是由Crompton出品的Perfecta级别;一种中链甘油三酯来源是Stepan出品的Neobee1053;并且,一种矿物油来源是Crompton出品的Kaydol White Mineral Oil。中链甘油三酯的一个例子是辛酸/癸酸甘油三酯。
第二种必需成分是液体硅酮或液体硅酮的组合,可用于克服应用于皮肤期间亲脂性化合物的油状/脂状感觉,并提供优良的皮肤感觉和擦抹渗入特征。液体硅酮选自:硅酮、硅酮衍生物、环甲基硅酮、或它们的组合。液体硅酮或液体硅酮的组合的量约为组合物总重量的1%-80%。优选地,液体硅酮或液体硅酮的组合的量约为组合物总重量的5%-35%。优选地,所用的液体硅酮是环甲基硅酮,其中一种来源是Dow Corning出品的ST-环甲基硅酮5-NF。
第三种必需成分是起泡剂,它能使含有上述液体硅酮的产品起泡。所用的起泡剂选自:山梨醇和脂肪酸的单酯、二酯和三酯。起泡剂的用量约为组合物总重量的0.5%-25%。优选地,起泡剂的用量约为组合物总重量的3%-7%。优选使用的起泡剂是脱水山梨糖醇单油酸酯,其中一种来源是Uniqema出品的Span 80V Pharma。
第四种必需成分是药物有效量的局部用活性药物,换句话说即药物活性剂。合适的药物活性剂类型如上所述。具体地说可以是氢化可的松、氧化锌、二氧化碳、视黄醇、杆菌肽锌、硫酸多粘菌素B、硫酸新霉素、维甲酸、水杨酸、利多卡因、丁卡因、磺胺醋酰钠、硼酸、酮康唑、托萘酯、维甲酸、蒽林(Anthralin)、巯氧吡啶锌、薄荷醇、麝香草酚、地索奈德、水杨酸甲酯、樟脑、丙酸氯倍他索、硫酸铝、胰蛋白酶等。通常,存在的药物活性剂的量约为组合物总重量的0.01%-40%。
最后,第五种必需成分是推进剂,用于将组合物从雾化容器中喷出。推进剂选自:碳氢化合物如丁烷、丙烷、戊烷、异戊烷、异丁烷或Aeropres以商品名A-70提供的混合物,以及氢氟碳化合物(hydroflourocarbon)如DuPont的Dymel236fa(1,1,1,3,3,3六氟丙烷)或Dymel227ea/P(1,1,1,2,3,3,3七氟丙烷)或选择推进剂Dymel134a/P(1,1,1,2四氟乙烷)。推进剂的用量约为组合物总重量的1%-30%。优选地,推进剂用量约为组合物总重量的5%-20%。
组合物还包含能够维持泡沫的流变改性剂。如果使用,流变改性剂可选自:聚烃氧基(40)氢化蓖麻油、蜂蜡、石蜡、或其组合。聚烃氧基(40)氢化蓖麻油的来源可以是Lipo Chemicals出品的Lipocol HCO 40或BASF出品的CremophorRH-40。一种蜂蜡来源是Strahl&Pitsch出品的White Wax SP422P NF,一种石蜡来源是Strahl&Pitsch出品的SP-674。组合物中流变改性剂的用量约为组合物总重量的0.05%-15%。优选地,组合物中流变改性剂的用量约为组合物总重量的1%-5%。
因此,本发明的关键在于上述所有五种必需成分的组合以产生所需的药学上高品质的泡沫。当这些成分与本文所述的表面活性剂体系联用时,在其他场合作为消泡剂的物质(即硅酮)的存在下,产生的泡沫稳定且优质。
提供下面的实施例是为了进一步说明,而不是为了限制本发明的方法和组合物。
实施例1:赋形剂
成分
%w/w
辛酸/癸酸甘油三酯 20.00
矿物油 8.00
环甲基硅酮 31.25
脱水山梨糖醇油酸酯 5.00
聚烃氧基(40)氢化蓖麻油 4.00
凡士林 30.00
蜂蜡 0.75
氢化蓖麻油 1.00
将所有成分称量至容器中并加热至70-75℃,充分混合直至均匀。然后冷却至室温并用氢氟碳化合物压缩入喷雾罐中,比例为基础成分:85%、推进剂:15%。
实施例2:用于尿布湿疹的配方
成分
%w/w
辛酸/癸酸甘油三酯 25.50
矿物油 8.00
环甲基硅酮 20.00
蜂蜡 1.50
脱水山梨糖醇单油酸酯 4.50
氢化蓖麻油 0.50
氧化锌 40.00
将除了氧化锌以外的所有成分称量至容器中并加热至70-75℃,充分混合直至均匀。然后冷却至45℃,逐渐加入分散的氧化锌以避免形成团块。然后,冷却至室温并用氢氟碳化合物压缩入铝制喷雾罐中,比例为基础成分:80%、推进剂:20%。
实施例3:止痒配方
成分
%w/w
辛酸/癸酸甘油三酯 24.50
矿物油 10.00
环甲基硅酮 32.00
蜂蜡 1.50
脱水山梨糖醇单油酸酯 6.00
凡士林 25.00
氢化可的松 1.00
将除了氢化可的松以外的所有成分称量至容器中并加热至70-75℃,充分混合直至均匀。然后冷却至35℃,逐渐加入并分散氢化可的松。然后,冷却至室温并用氢氟碳化合物压缩入铝制喷雾罐中,比例为基础成分:90%、推进剂:10%。
测定泡沫特征时,实施例1-3的各产物可产生一流的皮肤感觉,同时具有优良和稳定的泡沫特征,并且认为递送的实现是优异的。
由上述实施例可知,本发明至少实现了所有上文所述的目的。
Claims (19)
1.一种无水局部用药物气溶胶泡沫组合物,所述组合物包含药学上高品质且有效量的以下成分:选自凡士林、矿物油、植物油、脂肪酸、甘油酯、中链甘油三酯的亲脂性化合物或亲脂性化合物的组合;液体硅酮或液体硅酮的组合;起泡剂;局部用活性药物;和推进剂。
2.如权利要求1所述的组合物,其特征在于,所述亲脂性化合物是矿物油。
3.如权利要求1所述的组合物,其特征在于,所述亲脂性化合物是中链甘油三酯。
4.如权利要求1所述的组合物,其特征在于,所述亲脂性化合物是凡士林、矿物油和中链甘油三酯的混合物。
5.如权利要求1所述的组合物,其特征在于,所述液体硅酮选自:硅酮或硅酮衍生物或它们的组合。
6.如权利要求1所述的组合物,其特征在于,所述起泡剂选自:脂肪酸、山梨醇的单酯、二酯和三酯或它们的组合。
7.如权利要求1所述的组合物,其特征在于,所述山梨醇酯选自:脱水山梨糖醇辛酸酯、脱水山梨糖醇二异硬脂酸酯、脱水山梨糖醇二油酸酯、脱水山梨糖醇异硬脂酸酯、脱水山梨糖醇月桂酸酯、脱水山梨糖醇单油酸酯、脱水山梨糖醇三油酸酯、脱水山梨糖醇倍半油酸酯、或它们的组合。
8.如权利要求7所述的组合物,其特征在于,所述起泡剂是脱水山梨糖醇单油酸酯。
9.如权利要求8所述的组合物,其特征在于,所述脱水山梨糖醇单油酸酯的量约为所述无水局部用药物气溶胶泡沫组合物总重量的0.5%-25%。
10.如权利要求1所述的组合物,其特征在于,其还包含流变改性剂。
11.如权利要求10所述的组合物,其特征在于,所述流变改性剂选自:聚烃氧基40氢化蓖麻油、蜂蜡、石蜡、或它们的组合。
12.如权利要求1所述的组合物,其特征在于,所述局部用活性药物选自:痤疮活性剂、镇痛药、麻醉剂、减食欲剂、抗组胺药、抗炎药、抗生素、抗真菌剂、抗病毒剂、抗微生物剂、杀芥螨药、杀虱剂、抗肿瘤药、止汗药、止痒药、抗银屑病药、抗皮脂溢剂、收敛剂、生物活性蛋白质和肽、烧伤活性剂、烧灼剂、脱色剂、尿布湿疹药剂、酶、毛发生长活性剂、止血药、角质层分离剂、口疮性溃疡活性剂、唇疱疹活性剂、牙科活性剂、唾液活性剂、光敏活性剂、皮肤保护剂/屏障剂、类固醇、晒斑活性剂、防晒剂、***活性剂、疣突活性剂、伤口护理活性剂;以及视黄醇、视黄酸或视黄酸衍生物。
13.如权利要求1所述的组合物,其特征在于,所述推进剂是碳氢化合物。
14.如权利要求1所述的组合物,其特征在于,所述推进剂是氢氟碳化合物。
15.如权利要求5所述的组合物,其特征在于,所述液体硅酮是环甲基硅酮。
16.如权利要求1所述的组合物,其特征在于,所述液体硅酮或液体硅酮的组合的量约为所述无水局部用药物气溶胶泡沫组合物总重量的1%-80%。
17.如权利要求13所述的组合物,其特征在于,所述碳氢化合物选自:丁烷、丁烷的异构体、丙烷、丙烷的异构体、戊烷、戊烷的异构体、或它们的组合。
18.如权利要求14所述的组合物,其特征在于,所述氢氟碳化合物选自:1,1,1,2四氟乙烷和1,1,1,2,3,3,3七氟丙烷。
19.如权利要求1所述的组合物,其特征在于,所述亲脂性化合物或亲脂性化合物的组合的量约为所述无水局部用药物气溶胶泡沫组合物总重量的1%-80%。
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US10/875,470 | 2004-06-24 | ||
US10/875,470 US8211449B2 (en) | 2004-06-24 | 2004-06-24 | Pharmaceutically elegant, topical anhydrous aerosol foam |
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US (1) | US8211449B2 (zh) |
EP (1) | EP1765286B1 (zh) |
JP (1) | JP2008504259A (zh) |
KR (1) | KR20070050040A (zh) |
CN (1) | CN101014315A (zh) |
AU (1) | AU2005285441B2 (zh) |
BR (1) | BRPI0512574B8 (zh) |
CA (1) | CA2570450C (zh) |
WO (1) | WO2006031271A2 (zh) |
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-
2004
- 2004-06-24 US US10/875,470 patent/US8211449B2/en active Active
-
2005
- 2005-06-16 BR BRPI0512574A patent/BRPI0512574B8/pt not_active IP Right Cessation
- 2005-06-16 EP EP05821068A patent/EP1765286B1/en not_active Not-in-force
- 2005-06-16 WO PCT/US2005/021229 patent/WO2006031271A2/en active Application Filing
- 2005-06-16 CN CNA2005800210969A patent/CN101014315A/zh active Pending
- 2005-06-16 AU AU2005285441A patent/AU2005285441B2/en not_active Ceased
- 2005-06-16 JP JP2007518125A patent/JP2008504259A/ja not_active Withdrawn
- 2005-06-16 CA CA2570450A patent/CA2570450C/en not_active Expired - Fee Related
- 2005-06-16 KR KR1020077001681A patent/KR20070050040A/ko not_active Application Discontinuation
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103552188A (zh) * | 2013-10-25 | 2014-02-05 | 佳木斯大学 | 口腔医用材料分离剂及其制备方法 |
CN103552188B (zh) * | 2013-10-25 | 2016-01-20 | 佳木斯大学 | 口腔医用材料分离剂及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
KR20070050040A (ko) | 2007-05-14 |
AU2005285441A1 (en) | 2006-03-23 |
BRPI0512574A (pt) | 2008-03-25 |
JP2008504259A (ja) | 2008-02-14 |
AU2005285441B2 (en) | 2010-04-29 |
WO2006031271A2 (en) | 2006-03-23 |
CA2570450C (en) | 2013-02-19 |
CA2570450A1 (en) | 2006-03-23 |
EP1765286B1 (en) | 2012-09-05 |
EP1765286A2 (en) | 2007-03-28 |
WO2006031271A3 (en) | 2006-06-01 |
BRPI0512574B1 (pt) | 2018-06-26 |
US8211449B2 (en) | 2012-07-03 |
BRPI0512574B8 (pt) | 2021-05-25 |
US20050287081A1 (en) | 2005-12-29 |
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