CN102438590B - 局部泡沫组合物 - Google Patents
局部泡沫组合物 Download PDFInfo
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- CN102438590B CN102438590B CN2010800181257A CN201080018125A CN102438590B CN 102438590 B CN102438590 B CN 102438590B CN 2010800181257 A CN2010800181257 A CN 2010800181257A CN 201080018125 A CN201080018125 A CN 201080018125A CN 102438590 B CN102438590 B CN 102438590B
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Abstract
本发明涉及新的包含活性剂的水包油型乳液泡沫气雾剂组合物,其用于治疗各种慢性和急性皮肤病症,特别是痤疮和牛皮癣;且涉及制备该乳液泡沫气雾剂组合物的方法。特别是,本发明涉及在油相中包含类维生素A的水包油型乳液泡沫气雾剂组合物。
Description
技术领域
本发明涉及新的泡沫气雾剂组合物,其包含用于治疗皮肤疾病的药物活性剂。
背景技术
在局部药物递送方面有许多挑战。该局部组合物应递送活性剂至治疗部位,具有理想的感觉特征,不在皮肤表面残留令人不快的残余物,且不引起刺激或不适。已知泡沫气雾剂(aerosol foam)适合于该目的。
Callaghan等人的美国专利No.7,387,807公开了局部组合物,其包含野甘菊提取物、药物赋形剂,化妆试剂,和其它生物活性物质,如类维生素A。该组合物可以是乳液如乳膏或洗剂的形式。
Angel等人的美国专利No.7,326,408公开了局部治疗痤疮的组合物,其包含一种或多种遮光剂和抗细菌药物,其中该组合物可以是凝胶、喷雾剂、泡沫、洗剂的形式或其它适合施用于皮肤的形式。该组合物可进一步包括其他抗痤疮药物,如类维生素A(例如维甲酸,阿达帕林或他扎罗汀)。
Abram的美国专利No.6,730,288描述了泡沫气雾剂组合物,其包含有效量的药物活性成分、闭塞剂、水性溶剂、有机共溶剂,所述药物活性成分在水和闭塞剂中都不溶,且闭塞剂存在的量足以在使用时在皮肤上形成闭塞层。
Abram等人的美国公开的申请No.2006/0292080描述了水包油型泡沫乳液(emulsion foam),包含:溶于水相的维生素或其类似物和溶于油相的稳定剂、乳化剂、闭塞剂、和有机共溶剂,且没有描述油相的颗粒尺寸。
Larm等人的美国公开的申请No.2006/0057168描述了制备水包油型微乳液或亚微乳液组合物,特别是水包油型微乳液或亚微乳液泡沫组合物的方法。这些亚微乳液或微乳液泡沫具有较高的油含量且需要亲水性和疏水性表面活性剂两者。
本发明涉及低油和低表面活性剂的包含药物活性剂的亚微乳液或微乳液泡沫气雾剂,其为化妆优异的、化学和物理稳定的、良好耐受的,容易配制的,和适合施用于脸的。
发明内容
本发明涉及具有油相和水相的水包油型乳液泡沫气雾剂组合物(aerosolfoam composition),所述组合物包含药物活性剂、水、油、油可混溶的有机溶剂、表面活性剂和推进剂。本发明提供在水包油型乳液泡沫气雾剂组合物中的低油和低表面活性剂含量。
在一个实施方案中,本发明提供包含油相和水相的水包油型乳液泡沫气雾剂组合物,所述组合物包含:
药物活性剂,
水,
油,其存在量少于约10重量%,
油可混溶的有机溶剂,
包含亲水性表面活性剂的表面活性剂成分,其量为约0.1%至约10重量%,和
推进剂;且其中所述药物活性剂溶解于该组合物的油相中,且其中油相的颗粒尺寸小于约1000nm。
根据另一实施方案,本发明提供制备水包油型亚微乳液或微乳液泡沫气雾剂组合物的方法,该组合物包含药物活性剂、水、存在量少于约10重量%的油、油可混溶的有机溶剂、约0.1%至约10重量%的包含亲水性表面活性剂的表面活性剂成分,和推进剂,该方法包括:
a)混合该药物活性剂、第一等分部分的水、油、油可混溶的有机溶剂和表面活性剂成分以形成水包油型乳液,
b)加热步骤(a)的水包油型乳液至相转变温度,其中该水包油型乳液形成油包水型乳液,
c)冷却该油包水型乳液至低于相转变温度以形成亚微或微水包油型乳液,
d)添加第二等分部分的水以冷却亚微或微水包油型乳液,
e)用推进剂推进亚微或微水包油型乳液的样品以形成水包油型亚微乳液或微乳液泡沫气雾剂。
根据一个实施方案,本发明提供通过该方法制备的产物。
根据另一实施方案,本发明提供治疗皮肤疾病、障碍或病症的方法,包括向需要该治疗的患者皮肤给药有效量的本发明的组合物。
根据另一实施方案,本发明涉及本文所述的组合物在制备用于治疗皮肤疾病、障碍或病症的药物中的用途。
附图简述
图1为说明本发明一个优选实施方案的示意流程图,其中制备低油和低表面活性剂含量的水包油型亚微乳液或微乳液泡沫气雾剂组合物(730/2/1)。该方法详细描述于实施例1。
图4说明高HLB的乙氧基化脂肪醇醚表面活性剂与他扎罗汀的相容性(他扎罗汀稳定性)。与各种低HLB表面活性剂进行比较。
图5说明高HLB的乙氧基化脂肪醇醚表面活性剂与他扎罗汀的相容性(他扎罗汀亚砜(sulfoxide)形成)。与各种低HLB表面活性剂进行比较。
图6说明本发明亚微乳液或微乳液的油相的颗粒尺寸分布(730/2/1)。
发明详述
本发明涉及具有油相和水相的水包油型乳液泡沫气雾剂组合物,所述组合物包含药物活性剂、水、油、油可混溶的有机溶剂、表面活性剂、和推进剂。在一个实施方案中,本发明提供低油和低表面活性剂含量的水包油型乳液泡沫气雾剂组合物。根据另一实施方案,该组合物配制成亚微乳液或微乳液。
因此,根据一个实施方案,本发明提供包含油相和水相的水包油型乳液泡沫气雾剂组合物,所述组合物包含:
药物活性剂,
水,
油,其存在量少于约10重量%,
油可混溶的有机溶剂,
包含亲水性表面活性剂的表面活性剂成分,其量为约0.1%至约10重量%,和
推进剂;且其中所述药物活性剂溶解于组合物的油相中,且其中油相的颗粒尺寸小于约1000nm。
该油和油可混溶的有机溶剂以及任何油可混溶的赋形剂一起构成组合物的油相。
根据一个实施方案,油相的平均颗粒尺寸为约100nm。
在一个实施方案中,本发明的组合物基本上不含或不含水可混溶的有机溶剂,如丙二醇。
在一个可选实施方案中,所述药物活性剂溶解于组合物的水相中。
油颗粒递送药物活性剂穿过皮肤屏障的特征总结于下表1:
表1
油成分
适当地,油在组合物中存在的量为约1%至约9重量%。在另一实施方案中,油的存在量为约3%至约8重量%,如约3%,4%,5%,6%,7%或8重量%。
所述油在水包油型乳液体系的不连续相中。在一个实施方案中,所述油为烃。适当地,所述烃选自芳族化合物,或直链、支链的或环状烷烃或烯烃,或其混合物。
根据一个实施方案,所述芳族化合物选自甘菊环,菊薁和环亚己基-二苯基甲烷,及其混合物。
根据另一实施方案,该直链、支链的或环状烷烃或烯烃选自异链烷烃(isoparaffin),二癸烯,二乙基己基环己烷,二十烷,异十二烷,异二十烷,异十六烷,长叶烯,矿物油,石蜡(paraffin),五氢角鲨烯,矿脂,角鲨烷,角鲨烯,十四烯,其衍生物,及其混合物.
根据一个实施方案,所述油为矿物油。在一个实施方案中,矿物油的存在量为约1%至约9重量%。在另一实施方案中,矿物油的存在量为约3%至约8重量%,如约3%,4%,5%,6%,7%或8重量%。
在另一实施方案中,所述油为植物油。适当地,该植物油选自棕榈油,大豆油,菜籽油,向日葵油,花生油,玉米油,橄榄油,椰子油,棉子油,亚麻子油,葡萄子油,榛子油或芝麻油,及其混合物。
表面活性剂成分
本发明的局部泡沫组合物包含表面活性剂成分。适当地,该表面活性剂在组合物中存在的量为约1%至约8重量%。在另一实施方案中,该表面活性剂的存在量为约2%至约6重量%,如约2%,3%,4%,5%或6重量%。
表面活性剂的亲水性/亲油性平衡(HLB)描述表面活性剂对水或油的亲和力。HLB标度范围为1(完全亲脂的)至20(完全亲水的),且10表示两个特征的均衡。亲油性表面活性剂倾向于形成油包水型(w/o)乳液,且亲水性表面活性剂倾向于形成水包油型(o/w)乳液。两种表面活性剂的混合物的HLB等于表面活性剂A的重量分数乘其HLB值加上表面活性剂B的重量分数乘其HLB值(加权平均值)。
在一个实施方案中,该表面活性剂成分包含亲水性表面活性剂。在另一实施方案中,该表面活性剂成分由单一亲水性表面活性剂组成,且在另一实施方案中,该表面活性剂成分包含多于一种表面活性剂且它们HLB值的加权平均值为约10至约20。在另一实施方案中,该表面活性剂成分由非离子表面活性剂组成。
合适的非离子表面活性剂包括但不限于乙氧基化脂肪醇醚,PEG衍生物,乙氧基化脂肪酸,丙二醇酯,脂肪醇,甘油酯和衍生物,聚醚和脱水山梨醇酯,及其混合物。
示例性乙氧基化脂肪醇醚包括硬脂醇聚氧乙烯醚-2,硬脂醇聚氧乙烯醚-10,硬脂醇聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-2,鲸蜡硬脂醇聚氧乙烯醚-3,鲸蜡硬脂醇聚氧乙烯醚-5,鲸蜡硬脂醇聚氧乙烯醚-6,鲸蜡硬脂醇聚氧乙烯醚-10,鲸蜡硬脂醇聚氧乙烯醚-12,鲸蜡硬脂醇聚氧乙烯醚-15,鲸蜡硬脂醇聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-21,鲸蜡硬脂醇聚氧乙烯醚-22,鲸蜡硬脂醇聚氧乙烯醚-25,鲸蜡硬脂醇聚氧乙烯醚-30,鲸蜡硬脂醇聚氧乙烯醚-31,鲸蜡硬脂醇聚氧乙烯醚-32,鲸蜡硬脂醇聚氧乙烯醚-33,月桂基聚氧乙烯醚-3,月桂基聚氧乙烯醚-4,月桂基聚氧乙烯醚-5,月桂基聚氧乙烯醚-9,月桂基聚氧乙烯醚-10,月桂基聚氧乙烯醚-12,月桂基聚氧乙烯醚-15,月桂基聚氧乙烯醚-20,月桂基聚氧乙烯醚-21,月桂基聚氧乙烯醚-22,月桂基聚氧乙烯醚-23,壬基酚聚氧乙烯醚-9,油基聚氧乙烯醚-2,油基聚氧乙烯醚-5,油基聚氧乙烯醚-10和油基聚氧乙烯醚-20。
在一个实施方案中,所述亲水性乙氧基化脂肪醇醚选自硬脂醇聚氧乙烯醚-10,硬脂醇聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-10,鲸蜡硬脂醇聚氧乙烯醚-12,鲸蜡硬脂醇聚氧乙烯醚-15,鲸蜡硬脂醇聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-21,鲸蜡硬脂醇聚氧乙烯醚-22,鲸蜡硬脂醇聚氧乙烯醚-25,鲸蜡硬脂醇聚氧乙烯醚-30,鲸蜡硬脂醇聚氧乙烯醚-31,鲸蜡硬脂醇聚氧乙烯醚-32,鲸蜡硬脂醇聚氧乙烯醚-33,鲸蜡硬脂醇聚氧乙烯醚-6,月桂基聚氧乙烯醚-5,月桂基聚氧乙烯醚-9,月桂基聚氧乙烯醚-10,月桂基聚氧乙烯醚-12,月桂基聚氧乙烯醚-15,月桂基聚氧乙烯醚-20,月桂基聚氧乙烯醚-21,月桂基聚氧乙烯醚-22,月桂基聚氧乙烯醚-23,壬基酚聚氧乙烯醚-9,油基聚氧乙烯醚-10和油基聚氧乙烯醚-20。
在另一实施方案中,其中所述亲水性乙氧基化脂肪醇醚为聚乙二醇鲸蜡硬脂基醚12(鲸蜡硬脂醇聚氧乙烯醚-12)。在一个实施方案中,该聚乙二醇鲸蜡硬脂基醚12在组合物中存在的量为约1%至约8重量%。在另一实施方案中,该聚乙二醇鲸蜡硬脂基醚12的存在量为约2%至约6重量%,如约2%,3%,4%,5%或6重量%。
示例性PEG(聚氧乙烯)衍生物包括PEG-7氢化蓖麻油,PEG-25氢化蓖麻油,PEG-30蓖麻油,PEG-31蓖麻油,PEG-32蓖麻油,PEG-33蓖麻油,PEG-34蓖麻油,PEG-35蓖麻油,PEG-40氢化蓖麻油,PEG-50蓖麻油和PEG-60氢化蓖麻油。
示例性乙氧基化脂肪酸包括PEG-5油酸酯,PEG-6油酸酯,PEG-10油酸酯,PEG-6硬脂酸酯,PEG-8硬脂酸酯和PEG-9硬脂酸酯,PEG-20硬脂酸酯,PEG-40硬脂酸酯,PEG-41硬脂酸酯,PEG-42硬脂酸酯,PEG-43硬脂酸酯,PEG-44硬脂酸酯,PEG-45硬脂酸酯,PEG-46硬脂酸酯,PEG-47硬脂酸酯,PEG-48硬脂酸酯,PEG-49硬脂酸酯,PEG-50硬脂酸酯和PEG-100硬脂酸酯。
示例性丙二醇酯包括丙二醇棕榈酸酯和丙二醇硬脂酸酯。
示例性脂肪醇包括鲸蜡醇和硬脂醇。
示例性甘油基酯和衍生物包括甘油山嵛酸酯,甘油二山嵛酸酯,甘油二油酸酯,甘油二硬脂酸酯,甘油亚油酸酯,甘油油酸酯,甘油硬脂酸酯,PEG-23甘油醚椰油酸酯,PEG-6辛酸/癸酸甘油酯,PEG-7甘油醚椰油酸酯,聚甘油-10二异硬脂酸酯,聚甘油-2二异硬脂酸酯,聚甘油-3二异硬脂酸酯和聚甘油-6二异硬脂酸酯,
示例性聚醚包括泊洛沙姆124,泊洛沙姆182,泊洛沙姆184,泊洛沙姆188,泊洛沙姆237,泊洛沙姆331,泊洛沙姆338和泊洛沙姆407。
示例性脱水山梨醇衍生物包括脱水山梨醇聚氧乙烯(20)醚月桂酸酯,脱水山梨醇聚氧乙烯(20)醚棕榈酸酯,脱水山梨醇聚氧乙烯(20)醚硬脂酸酯,聚山梨酯80,脱水山梨醇月桂酸酯,脱水山梨醇油酸酯,脱水山梨醇棕榈酸酯,脱水山梨醇倍半油酸酯,脱水山梨醇硬脂酸酯和脱水山梨醇三油酸酯。
在一个实施方案中,该表面活性剂成分包含一种或多种亲水性非离子表面活性剂且基本上不含,或不含亲油性表面活性剂。根据一个实施方案,该表面活性剂成分基本上不含,或不含脂肪醇。
在一个实施方案中,该表面活性剂成分包含亲水性乙氧基化脂肪醇醚。在另一实施方案中,所述表面活性剂成分包含亲水性乙氧基化脂肪醇醚,且基本上不含,或不含亲油性表面活性剂。
药物活性剂
适当地,用于本文的组合物的药物可接受的活性剂选自类维生素A,视黄酸代谢阻滞剂(RAMBAs),免疫应答调节化合物,维生素D类似物,皮质类固醇,抗组胺剂,抗细菌剂,抗真菌剂,抗病毒剂,细胞毒素剂,补骨脂素,抗脱发剂,抗雄激素,止痒剂,角质层分离剂,焦油,地蒽酚,防腐剂,遮光剂,麻醉剂,镇痛剂,皮肤调节剂和营养剂,其盐,其衍生物及其混合物。在一个实施方案中,该组合物可包含多于一种药物活性剂,其盐或衍生物。药物活性剂的合适的浓度范围为约0.001%至约30重量%,取决于活性剂或活性剂组合的性质。
在一个实施方案中,该药物活性剂为类维生素A。合适的类维生素A的实例包括,但不限于,他扎罗汀,维甲酸,异维甲酸,阿维A,阿维A酯,阿达帕林,贝沙罗汀,阿利维A酸,维生素A,视黄醛,棕榈酸视黄基酯,乙酸视黄基酯,丙酸视黄基酯,亚油酸视黄基酯,5-(2-(4,4-二甲基硫代色满-6-基)乙炔基)噻吩-2-羧酸乙酯,6-(2-4,4-二甲基硫代色满-6-基)-乙炔基)-3-吡啶基甲醇和6-(2-(4,4-二甲基硫代色满-6-基)-乙炔基)吡啶-3-甲醛,其盐,其衍生物及其混合物。在一个实施方案中,所述类维生素A为他扎罗汀。在一个可选实施方案中,所述类维生素A为维甲酸。在另一实施方案中,该组合物包含类维生素A与第二药物活性剂的组合。在一个实施方案中,该组合为他扎罗汀和第二药物活性剂。在另一实施方案中,该组合为维甲酸和第二药物活性剂。
适当地,类维生素A的一个组合为与皮质类固醇的组合,如丙酸氯倍他索;或与维生素D类似物如卡泊三烯的组合;或与抗细菌剂如克林霉素或其药物可接受的盐(例如磷酸克林霉素)的组合。或者,在一个实施方案中,本发明的组合物包含维甲酸与抗细菌剂,如克林霉素或其药物可接受的盐(例如磷酸克林霉素)的组合。
组合物中类维生素A的合适的浓度范围包括,例如,约0.001%至约5重量%。在一个实施方案中,所述类维生素A的存在量为约0.01%至约1%。在另一实施方案中,所述类维生素A的存在量为约0.025%至约0.5%。在一个实施方案中,当所述类维生素A为他扎罗汀时,其存在量为约0.05%或0.1重量%。在另一实施方案中,当所述类维生素A为维甲酸时,其存在量为约0.025%,0.05%或0.1%。
本文使用的作为药物可接受的活性剂的合适视黄酸代谢阻滞剂(RAMBAs)为rambazole。
本文使用的合适的免疫应答调节化合物,免疫抑制剂,免疫调节剂和免疫调控剂包括修饰免疫应答或免疫系统功能的化学或生物衍生的试剂(通过刺激抗体形成或抑制白细胞活性)。示例性试剂或化合物包括,但不限于环肽(如环孢菌素),他克莫司,曲培莫司,吡美莫司,西罗莫司(sirolimius)(雷帕霉素),维罗莫司(verolimus),拉氟莫司,拉喹莫德,麦考酚酸,和咪唑并喹啉胺如咪喹莫特,其盐,其衍生物,及其混合物。
合适的维生素D类似物包括,但不限于,骨化二醇,骨化三醇,卡泊三烯,帕立骨化醇,22-氧杂骨化三醇,双氢速甾醇,维生素D2,其盐,其衍生物,及其混合物。
合适的皮质类固醇包括,但不限于,二丙酸阿氯米松,安西奈德,二丙酸倍氯米松,苯甲酸倍他米松,二丙酸倍他米松,戊酸倍他米松,布地奈德,丙酸氯倍他索,丁酸氯倍他松,醋酸可的松,地奈德,去羟米松,二醋酸二氟拉松,戊酸二氟可龙,氟氯奈德,新戊酸氟地塞米松,氟西奈德,醋酸氟轻松,氟考丁酯,氟可龙,醋酸氟泼尼定,氟氢缩松,氟羟可舒松,丙酸氟替卡松,哈西奈德,丙酸卤倍他索,氢化可的松,醋酸氢化可的松,丁酸氢化可的松,丙酸氢化可的松,戊酸氢化可的松,醋酸甲基泼尼松龙,糠酸莫米松,盐酸丙吗卡因,醋酸泼尼松,戊酸泼尼松,曲安奈德,泼尼卡酯,其盐,其衍生物,及其混合物。
合适的抗组胺剂包括,但不限于,西替利嗪,伐匹他定,苯海拉明,曲普利啶,美吡拉敏,氯环力嗪,异丙嗪,卡比沙明,曲吡那敏,溴苯那敏,羟嗪,特非那定,氯苯那敏,其盐,其衍生物,及其混合物。
合适的抗细菌剂包括,但不限于,庆大霉素,新霉素,链霉素,头孢泊肟酯,克林霉素,林可霉素,红霉素,杆菌肽,短杆菌肽,万古霉素,多西环素,米诺环素,土霉素,四环素,磷霉素,夫西地酸,莫匹罗星,磺胺醋酰,甲硝唑和氨苯砜,其盐,其衍生物,及其混合物。
合适的抗真菌剂包括,但不限于,选自以下的那些:棘球白素如anidulafunin,卡泊芬净和米卡芬净;多烯类如两性霉素B,克念菌素,非律平,制霉色基素,曲古霉素,哈霉素,鲁斯霉素,美帕曲星,那他霉素,制霉菌素,培西洛星,表霉素;烯丙基胺类如布替萘芬,萘替芬和特比萘芬;咪唑类如联苯苄唑,布康唑,氯米达唑,氯康唑,克霉唑,益康唑,恩康唑,芬替康唑,氟曲马唑,异康唑,酮康唑,拉诺康唑,咪康唑,奈康唑,奥莫康唑,硝酸奥昔康唑,舍他康唑,硫康唑和噻康唑;硫代氨基甲酸酯类如利拉萘酯,托西拉酯,托林达酯和托萘酯;三唑类如阿巴康唑,氟康唑,伊曲康唑,泊沙康唑,雷夫康唑,沙康唑,特康唑和伏立康唑;和其它抗真菌剂如吖啶琐辛,阿莫罗芬,苯柳胺酯,溴柳氯苯胺,丁氯柳胺,丙酸钙,氯苯甘醚,环吡酮,氯羟喹,科帕腊芬内特,依沙酰胺,氟胞嘧啶,卤普罗近,海克替啶,氯氟卡班,硝呋太尔,碘化钾,丙酸,巯氧吡啶,水杨苯胺,丙酸钠,舒苯汀,替诺尼唑,甘油三乙酸酯,十一碳烯酸,丙酸锌,灰黄霉素,寡霉素,吡咯尼群,西卡宁,绿毛霉素(viridian),其盐,其衍生物,及其混合物。
合适的抗病毒剂包括,但不限于,阿昔洛韦,地昔洛韦,卡波佛,泛昔洛韦,膦甲酸钠,更昔洛韦,干扰素,喷昔洛韦,伐昔洛韦,其盐,其衍生物,及其混合物。
合适的细胞毒素剂包括,但不限于,硫唑嘌呤,环磷酰胺,环孢菌素,甲氨蝶呤,羟基脲,沙利度胺,博来霉素,氟尿嘧啶,其盐,其衍生物,及其混合物。
示例性补骨脂素为甲氧沙林。
合适的抗雄激素包括,但不限于,螺内酯,环丙孕酮,氟他胺,非那雄胺,其盐,其衍生物,及其混合物。
示例性抗脱发剂为米诺地尔。
合适的止痒剂包括,但不限于,炉甘石,樟脑和薄荷醇,其盐,其衍生物,及其混合物。
合适的角质层分离剂包括,但不限于,过氧化苯甲酰,水杨酸,脲,间苯二酚,硫,其盐,其衍生物,及其混合物。
合适的焦油包括,但不限于,煤焦油,松焦油,木焦油,其盐,其衍生物,及其混合物。
合适的防腐剂包括,但不限于,过氧化氢,氯己定,西曲溴铵,聚乙烯吡咯酮碘,三氯生,其盐,其衍生物,及其混合物。
合适的遮光剂包括,但不限于,氨基苯甲酸,阿伏苯宗,贝曲嗪诺,比索曲唑,β-胡萝卜素,西诺沙酯,4-(二甲基氨基)苯甲酸,二羟苯宗,甲酚曲唑,依莰舒,恩索利唑,乙基己基三嗪酮,胡莫柳酯,指甲花醌,邻氨基苯甲酸薄荷基酯,4-甲基亚苄基樟脑,美克西酮,奥他苯酮,奥克立林,甲氧肉桂酸辛酯,水杨酸辛酯,羟甲氧苯酮,舒利苯酮,氧化锌,二氧化钛,其盐,其衍生物,及其混合物。
合适的麻醉剂和镇痛剂包括,但不限于,苯佐卡因,利多卡因,丙胺卡因和水杨酸胆碱,其盐,其衍生物,及其混合物。
合适的皮肤调节剂包括,但不限于,烃油和蜡,聚硅氧烷,脂肪酸衍生物,胆固醇,甘油二酸酯和甘油三酸酯,植物油,乙酰甘油酯,烷基酯,链烯基酯,羊毛脂,牛乳甘油三酯,蜡酯,蜂蜡,固醇,磷脂,其衍生物,及其混合物。
示例性营养剂包括维生素,必需氨基酸,必需脂肪,抗氧化剂,其盐,其衍生物,及其混合物。
水相
本发明的局部泡沫组合物还包含水。水形成乳液系统的连续相。在一个实施方案中,该泡沫组合物包含水的量为约65%至约90重量%。在另一实施方案中,水的存在量为约70%至约85重量%。在另一实施方案中,水的存在量为约77重量%。
油可混溶的有机溶剂
本发明的局部泡沫组合物包含油可混溶的有机溶剂以促进活性剂在油中的溶解。该油可混溶的有机溶剂和油一起构成组合物的油相。
该油可混溶的有机溶剂在组合物中存在的量为约1%至约20重量%。在一个实施方案中,该油可混溶的有机溶剂的存在量为约3%至约15重量%。在另一实施方案中,该油可混溶的有机溶剂的存在量为约5重量%。
合适地,油可混溶的有机溶剂的非限制性实例包括醇如辛醇,癸醇,十二烷基十六醇,十二烷基十四醇,己醇,己基癸醇,己基癸基十八醇,异鲸蜡醇,异硬脂醇,月桂醇,肉豆蔻醇,辛基癸醇,辛基十二烷醇,油醇,十三醇;酯,如硬脂酸丁基酯,苯甲酸C12-15烷基酯,乳酸C12-15烷基酯,甘油三辛酸/癸酸酯,乙基己酸鲸蜡硬脂基酯,异壬酸鲸蜡硬脂基酯,辛酸鲸蜡基酯,棕榈酸鲸蜡基酯,椰油-辛酸酯/癸酸酯,椰油甘油酯,油酸癸基酯,己二酸二丁基酯,碳酸二辛基酯,己二酸二乙基己基酯,琥珀酸二乙基己基酯,己二酸二异丙基酯,苹果酸二辛基酯,二-PPG-2肉豆蔻醇聚氧乙烯醚-10己二酸酯,二-PPG-3肉豆蔻基醚己二酸酯,油酸乙酯,椰油酸乙基己基酯,羟基硬脂酸乙基己基酯,棕榈酸乙基己基酯,壬酸乙基己基酯,硬脂酸乙基己基酯,月桂酸己基酯,月桂酸己基癸基酯,硬脂酸己基癸基酯,硬脂酸异鲸蜡基酯,硬脂酸异鲸蜡基硬脂基酯,油酸异癸基酯,肉豆蔻酸异丙酯,棕榈酸异丙基酯,新戊酸异硬脂基酯,异壬酸异十三烷基酯,乳酸月桂基酯,乳酸肉豆蔻基酯,肉豆蔻酸肉豆蔻基酯,硬脂酰硬脂酸辛基十二烷基酯,芥酸油烯基酯,油酸油烯基酯,季戊四醇四辛酸酯/四癸酸酯,季戊四醇四异硬脂酸酯,PPG-2肉豆蔻基醚丙酸酯,丙二醇二辛酸酯/二癸酸酯,丙二醇异硬脂酸酯,辛酸丙基庚基酯,辛酸硬脂基酯;醚如二辛基醚,PPG-10鲸蜡基醚,PPG-11硬脂基醚,PPG-14丁基醚,PPG-15硬脂基醚,PPG-3氢化蓖麻油,PPG-3肉豆蔻基醚;羧酸如C10-40羟基烷基酸,C10-40异烷基酸,C32-36异烷基酸,癸酸,己酸,辛酸,椰子酸,月桂酸,亚油酸,亚麻酸,亚麻子酸,肉豆蔻酸,油酸,蓖麻油酸和羊毛脂。
根据一个实施方案,该油可混溶的有机溶剂选自己二酸二异丙基酯,肉豆蔻酸异丙酯,十二烷醇和辛酸/癸酸甘油三酯。
在一个实施方案中,油可混溶的有机溶剂为己二酸二异丙基酯(在此也称为DIPA)。在一个实施方案中,DIPA在组合物中存在的量为约1%至约20重量%。在另一实施方案中,DIPA的存在量为约3%至约15重量%。在另一实施方案中,DIPA的存在量为约5重量%。
根据另一实施方案,本发明的组合物包含第二药物可接受的活性剂。在一个实施方案中,该第二活性剂溶解于水相(即连续相)。这可通过以下实现:将该第二活性剂溶于等分部分的水或等分部分的水可混溶的有机溶剂,随后将该等分部分溶于组合物中。
根据一个实施方案,该水可混溶的有机溶剂的存在量为约1%至约20重量%。根据另一实施方案,该水可混溶的有机溶剂的存在量为约10重量%。
适当地,水可混溶的有机溶剂包括,但不限于,醇,包括戊醇,苄醇,环己烷二甲醇,二丙酮醇,乙醇,己醇,异丁醇,异丙醇,甲醇,正丁醇,丙醇,叔丁基醇,四氢糠醇;羧酸,包括乙酸;二醇,包括1,2-己二醇,丁二醇,二甘醇,二丙二醇,乙基己二醇,乙二醇,己二醇,戊二醇,丙二醇,四甘醇,三甘醇,三聚丙二醇;和多元醇,包括聚乙二醇,丁烷三醇,甘油和1,2,6-己三醇。
在一个实施方案中,该水可混溶的有机溶剂为丙二醇。
推进剂
认识到本发明的局部泡沫组合物必须使用推进剂以在使用时产生泡沫。推进剂可为任何合适的液化气体或其混合物,如烃,氯氟碳化合物,二甲基醚,氢氟碳化合物及其混合物。
其它合适的推进剂包括压缩气体如氮,二氧化碳,一氧化二氮和空气。在一个实施方案中,该推进剂为烃的混合物。在另一优选实施方案中,烃的混合物为丙烷、正丁烷和异丁烷的混合物。
推进剂的存在量为约1%至约20重量%,或约3%至约15重量%。在一个实施方案中,推进剂的存在量为约5%至约10重量%,如约5%,6%,7%,8%,9%或10重量%。该推进剂可在填充时加入组合物中,使用压力容器如标准气雾剂分配器。
当该组合物从压力容器释放时,该组合物为泡沫气雾剂(也已知为摩丝)。根据一个实施方案,该泡沫气雾剂为均匀的。在另一实施方案中,该泡沫气雾剂用剪切力,如轻微机械作用例如涂搽或喷散可轻易破碎。
在另一实施方案中,该推进剂不存在于组合物中。根据该实施方案,该组合物可通过机械手段,如通过在容器上的泵作用或挤压作用从其容器中挤出。
本文使用的合适的压力容器包括铝、锡板和玻璃容器。
在一个实施方案中,该压力容器为整体的铝容器,其中内表面衬有化学惰性的衬里。本文使用的一个合适的内表面衬里为聚酰胺-酰亚胺(PAM),如Exal Corporation,of Youngstown,Ohio提供的。该容器可安装直立使用或颠倒使用的阀和常规泡沫喷射致动器。或者,该容器可安装定量的阀。
皮肤病学可接受的赋形剂
根据一个实施方案,该组合物可进一步包含一种或多种皮肤病学可接受的赋形剂。该皮肤病学可接受的赋形剂的非限制性实例包括稀释剂,悬浮剂,佐剂,防腐剂,着色剂,润滑剂,pH调节剂(包括缓冲剂),增稠剂,润湿剂,芳香剂,稳定剂,螯合剂,抗结块剂,粘度增加剂,增溶剂,增塑剂,渗透促进剂,成膜剂,抗氧化剂,湿润剂,泡沫促进剂或任何这些成分的混合物。
在一个实施方案中,该一种或多种皮肤病学可接受的赋形剂包括防腐剂、抗氧化剂和pH调节剂。
防腐剂
本发明的局部泡沫气雾剂组合物可另外包含防腐剂。防腐剂在组合物中存在的量为约0.01%至约2重量%。在一个实施方案中,防腐剂的存在量为约0.1%至约1重量%。在另一实施方案中,防腐剂的存在量为约0.3重量%。
合适的防腐剂包括,但不限于苄醇,重氮烷基脲,对羟苯甲酸甲酯,对羟基苯甲酸乙酯,对羟苯甲酸丙酯,对羟苯甲酸丁酯,苯氧基乙醇,山梨酸和其盐如山梨酸钾,苯甲酸和其盐如苯甲酸钠,及其混合物。
根据一个实施方案,该防腐剂为山梨酸和山梨酸钾的混合物。
抗氧化剂
本发明的局部泡沫气雾剂组合物可进一步包含抗氧化剂。该抗氧化剂在组合物中存在的量为约0.001%至约1重量%。在一个实施方案中,该抗氧化剂的存在量为约0.05%至约0.5重量%。在另一实施方案中,该抗氧化剂的存在量为约0.1重量%。
合适的抗氧化剂包括,但不限于,丁化羟基甲苯(BHT),丁化羟基苯甲醚,生育酚,没食子酸丙基酯,维生素E TPGS,其衍生物,及其混合物。在一个实施方案中,该抗氧化剂为BHT。
pH调节剂
本发明的局部泡沫气雾剂组合物可进一步包含pH调节剂以帮助稳定该活性剂。根据一个实施方案,pH调节剂的存在量为约0.01%至约10重量%。在一个实施方案中,pH调节剂为碱。合适的pH调节碱包括但不限于碳酸氢盐,碳酸盐和氢氧化物(如碱金属或碱土金属氢氧化物,以及过渡金属氢氧化物)。pH调节剂也可为酸,酸式盐,或其混合物。pH调节剂也可为缓冲剂。合适的缓冲剂包括,但不限于柠檬酸盐/柠檬酸,乙酸盐/乙酸,磷酸盐/磷酸,甲酸盐/甲酸,丙酸盐/丙酸,乳酸盐/乳酸,碳酸盐/碳酸,铵/氨,依地酸盐/依地酸,其衍生物,及混合物。根据一个实施方案,该pH调节剂为柠檬酸盐/柠檬酸缓冲剂。根据一个实施方案,该柠檬酸盐/柠檬酸缓冲剂的存在量为约0.02%至约2重量%。
在另一实施方案中,本发明涉及水包油型乳液泡沫气雾剂组合物,其包含:他扎罗汀,水,约3%至约8重量%的油,油可混溶的有机溶剂,约2%至约6重量%的包含非离子亲水性表面活性剂的表面活性剂成分,和烃推进剂,其中他扎罗汀溶解于组合物的油相且其中油相的颗粒尺寸小于约1000nm。
根据一个实施方案,他扎罗汀泡沫气雾剂的油相的平均颗粒尺寸为约100nm。
这些实施方案示例的他扎罗汀泡沫制剂特别适合于施用于脸部小区域以治疗痤疮。在一个实施方案中,该他扎罗汀泡沫气雾剂制剂从计量剂量的致动器分配。在另一实施方案中,该他扎罗汀泡沫气雾剂组合物配制成大粒乳液(即油相的颗粒尺寸大于1000nm)。
在另一实施方案中,第二药物活性剂溶解于该组合物。在另一实施方案中,第二药物活性剂溶解于组合物的水相。这可通过以下实现:将该另一药物活性剂溶于等分部分的水,然后将其溶解于组合物中。
另一方面,第二药物活性剂溶于等分部分的水可混溶的有机溶剂,然后将其溶解于组合物中。在另一实施方案中,第二药物活性剂在包含类维生素A他扎罗汀的组合物中。
定义
如本文所使用的,术语″给药(administering)″和“给药(administered)”是指以所述方式向受治疗者递送组合物以提供治疗效果的任何方法。
如本文所使用的,术语“其衍生物”是指药物活性剂的前药,溶剂化物,水合物,酯和酸。
如本文所使用的,术语“有效量″的活性剂或成分,或药物活性剂或成分(其在此处为同义的),是指给药后足以具有治疗效果的药物活性剂的量。有效量的活性剂可能,将会或预期能缓解症状。有效量的活性剂将根据治疗的具体疾病或疾病、疾病严重性、治疗持续时间、和使用的组合物的具体成分而改变。
如本文所使用的,术语“脂肪醇”是指具有约9至约22个碳原子长度的脂肪链的醇。
如本文所使用的,“乳液”是指两种或更多种不混溶的(不可混合的)液体的混合物,其中分散相(即在水包油型乳液情况中的油)的颗粒尺寸小于约10,000nm。
如本文所使用的,“亚微乳液”是指两种或更多种不混溶的(不可混合的)液体的混合物,其中分散相(即在水包油型乳液情况中的油)的颗粒尺寸范围为约100nm至约1000nm。
如本文所使用的,“微乳液”是指两种或更多种不混溶的(不可混合的)液体的混合物,其中分散相(即在水包油型乳液情况中的油)的颗粒尺寸范围为约10nm至约100nm。
如本文所使用的,“纳米乳液”是指两种或更多种不混溶的(不可混合的)液体的混合物,其中分散相(即在水包油型乳液情况中的油)的颗粒尺寸范围为约1nm至100nm。
如本文所使用的,术语“相转变温度”是指水包油型乳液转变成油包水型乳液(或反过来)的温度。
如本文所使用的,″pH调节剂″是指添加至组合物中的特定pH调节剂,包括但不限于,缓冲剂、碱或酸,其盐及其混合物。
本文使用的术语″皮肤病学可接受的赋形剂″是指本文所述组合物中存在的任何非活性成分。
如本文所使用的,术语“药物可接受的盐”是指药物可接受且具有母体化合物所需的药理活性的盐。所述盐包括:(1)与酸形成的酸加成盐,所述酸例如,乙酸,苯甲酸,柠檬酸,葡糖酸,谷氨酸,戊二酸,乙醇酸,盐酸,乳酸,马来酸,苹果酸,丙二酸,扁桃酸,磷酸,丙酸,山梨酸,琥珀酸,硫酸,酒石酸,天然和合成衍生的氨基酸,及其混合物;或(2)通过以下形成的盐:当母体化合物中存在的酸性质子时,(i)被金属离子例如碱金属离子,碱土金属离子,或铝离子代替;或(ii)使有机碱,例如,乙醇胺,二乙醇胺,三乙醇胺,缓血酸胺和N-甲基葡糖胺质子化。
如本文所使用的,″受治疗者″、″个体″或″患者″是指任何受治疗者,特别是需要治疗的人。
如本文所使用的,“治疗(treatment)”或“治疗(treating)”疾病、障碍或病症包括减轻其至少一种症状,减少其严重性,或延迟、预防或抑制其进展。治疗不需要意味着疾病、障碍或病症被完全治愈。本文所述的有用的组合物仅需要减少疾病、障碍或病症的严重性,减少与其相关的症状严重性,改善患者的生活质量,或延迟、预防或抑制疾病、障碍或病症的发生。
本文所述的任何浓度范围,百分比范围或比例范围应理解为包括在其范围和部分内的任何整体的浓度、百分比或比例,如整体的十分之一和百分之一,除非另有所述。
应理解上文和本文其它地方使用的术语″一个″和″一种″是指″一个(种)或多个(种)″列举的成分。本领域技术人员清楚地是,使用的单数包括复数,除非另有说明。因此,术语″一个″、″一种″和“至少一个(种)”在本申请中可互换使用。
在整个申请中,各个实施方案的描述使用术语“包括”,然而,在一些具体情况下,一个实施方案可替代地用术语“基本上由......组成”或“由......组成”描述。
为了更好地理解本发明的教导且不以任何方式限制其范围,除非另有说明,所有表示量、百分比或比例的数值,以及说明书和权利要求书中使用的其它数值,应理解为在所有情况下通过术语“约”限制。
如本文所使用的,术语“基本上不含”特定成分是指组合物具有少于约1%的特定成分。
本文使用的其它术语应由其本领域公知的含义所定义。
制备方法
在一个实施方案中,本发明提供制备水包油型亚微乳液或微乳液泡沫气雾剂组合物的方法,该组合物包含药物活性剂、水、少于约10重量%的油,油可混溶的有机溶剂、约0.1%至约10重量%的包含亲水性表面活性剂的表面活性剂成分、和推进剂,该方法包括:
a)混合该药物活性剂、第一等分部分的水、油、油可混溶的有机溶剂和表面活性剂成分以形成水包油型乳液,
b)加热步骤(a)的水包油型乳液至相转变温度,其中该水包油型乳液形成油包水型乳液,
c)冷却该油包水型乳液至低于相转变温度以形成亚微或微水包油型乳液,
d)添加第二等分部分的水以冷却亚微或微水包油型乳液,
e)用推进剂推进亚微或微水包油型乳液的样品以形成水包油型亚微乳液或微乳液泡沫气雾剂(aerosol foam)。
根据一个实施方案,第一等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约10%至约40重量%且第二等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约90%至约60重量%。
根据一个实施方案,第一等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约10%至约40重量%且第二等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约90%至约60重量%。
根据另一个实施方案,第一等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约15%至约35%且第二等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约85%至约65%。
根据另一个实施方案,第一等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约20%至约30%且第二等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约80%至约70%。根据另一实施方案,第一等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约25%且第二等分部分的水占亚微或微水包油型乳液泡沫气雾剂的总水含量的约75%。
本文描述的方法提供低油和低表面活性剂亚微乳液或微乳液泡沫气雾剂的制备,其中制备浓亚微乳液或微乳液(包含第一等分部分的水)且随后稀释(用第二等分部分的水)至最终得到所需的低油和低表面活性剂亚微乳液或微乳液。通过初始制备浓亚微乳液或微乳液,足够浓度的表面活性剂存在于组合物中以稳定亚微米或微米尺寸的油相。然后稀释步骤提供所需的低油和低表面活性剂亚微乳液或微乳液。认为添加第二等分部分的水(其温度显著低于相转变温度)用来固定组合物的亚微乳液或微乳液结构,且当然,稀释该组合物以提供低油和低表面活性剂组合物。
根据一个实施方案,第二药物活性剂溶解于组合物的水相。这可通过以下实现:将第二药物活性剂溶解于等分部分的水或水可混溶的有机溶剂,然后溶解(solubilize)于组合物中。
在一个实施方案中,将溶于等分部分的水或水可混溶的有机溶剂的第二药物活性剂在步骤(d)后添加至亚微或微水包油型乳液中)。即,在形成亚微乳液或微乳液后将第二药物活性剂溶解于组合物的水相中。
本发明另一方面为该方法制备的产物。
治疗方法
本发明的乳液泡沫气雾剂组合物为化妆方面优异的且适用于涂覆至脸上以治疗皮肤疾病或病症。该组合物容易涂布、不油腻、不干燥且在皮肤上残留最少的残余物。
本发明提供治疗皮肤疾病、障碍或病症的方法,包括向需要该治疗的患者皮肤给药有效量的本发明的组合物。在一个实施方案中,该皮肤疾病、障碍或病症为痤疮。在另一实施方案中,该皮肤疾病、障碍或病症为牛皮癣。
本发明还涉及本文所述的组合物在制备用于治疗皮肤疾病、障碍或病症的药物中的用途。
本发明还涉及治疗皮肤疾病、障碍或病症的方法,通过向需要该治疗的患者皮肤给药有效量的本发明的组合物。
可通过本发明的组合物治疗的示例的,非限制性的皮肤疾病、障碍或病症包括痤疮,酒渣鼻,皮炎,牛皮癣和真菌病。根据一个实施方案,该皮肤疾病、障碍或病症为痤疮。根据另一实施方案,该皮肤疾病、障碍或病症为牛皮癣。
在一个实施方案中,本发明的组合物与合适的其它药物剂型组合使用。该其它药物剂型在本文所述的组合物之前、同时或之后给药。
在一个实施方案中,关于这一点,本发明组合物和其它药物剂型同时给药于患者。在另一个可选实施方案中,本发明的组合物和其它药物剂型之一在早晨给药而另一个在晚上给药。
在另一个实施方案中,该其它药物剂型可为合适的口服药物。在这方面,本发明组合物可在摄入口服药物之前、同时或之后施用至患者的目标区域。
根据一个实施方案,本发明组合物包含类维生素A且口服药物剂型包含选自抗生素、避孕药、类维生素A如异维甲酸,和营养剂的药物活性剂。
而且,本发明的泡沫组合物可与其它辅助疗法和治疗一起使用,如用肥皂或清洗剂预先洗涤。然而,痤疮在这方面是需要的,因为抗细菌皂和磨蚀皂可增加刺激。
实施例
以下实施例为优选实施方案的说明,且不是解释为限制本发明。所有百分比基于最终制备的递送系统或制剂的重量百分比,除非另有说明,且所有总量等于100重量%。
表2a,2b,2c和2d
水包油型亚微/微泡沫乳液制剂-他扎罗汀(0.1%)
706/8/2(表2a)-不存在推进剂*
706/8/3(表2b)-不存在推进剂*
*在每100克气雾剂基质添加约7至8克AP70推进剂后,表2a和2b所述的制剂以泡沫分配。
730/2/1(表2c)
SFW0260-02(表2d)
实施例1
制备亚微/微泡沫乳液制剂-他扎罗汀的方法
方法:气雾剂基质制备(730/2/1):
相1(油相):BHT,鲸蜡硬脂醇聚氧乙烯醚-12,矿物油和山梨酸
相2(活性相):他扎罗汀溶于己二酸二异丙基酯(DIPA)
相3(缓冲剂相):去离子水(占气雾剂基质的总水含量的约22.8%),柠檬酸,柠檬酸钾和山梨酸钾
相4(水相):去离子水(占气雾剂基质的总水含量的约77.2%)
1.在环境温度下在合适的不锈钢容器中将他扎罗汀溶解于己二酸二异丙基酯中(相2)。
2.在环境温度下在不锈钢容器中制备缓冲溶液(相3)。
3.将油相成分添加至主批料容器中(相1)。
4.在主批料容器中混合相1、相2和相3。开始在搅拌下低温加热。继续加热至70℃至80℃的相转变温度范围直到油包水型乳液出现。
5.开始冷却至低于相转变温度。当乳液变成水包油型亚微/微乳液时,在环境温度下以适中速率添加相4去离子水。搅拌直到均匀。在25℃-30℃下保持变成批料。
6.测试气雾剂基质的pH。
7.用1N氢氧化钾溶液或10%柠檬酸溶液调节pH至4.70至5.50的范围。
8.用去离子水调节至100%(补偿蒸发的水损失)。
上述方法在图1中以图解形式表示。
另一个可选方法-气雾剂基质制备(SFW0260-02):
在环境温度,在次要容器中将他扎罗汀溶解于己二酸二异丙基酯,同时搅拌。
添加矿物油和BHT至次要容器中,同时搅拌直到溶液均匀。
在环境温度下,添加去离子水(占气雾剂基质总水含量的约28.8%),柠檬酸和柠檬酸钾至主批料容器中,同时搅拌直到所有成分完全溶解。
添加山梨酸钾至主批料容器中,同时搅拌直到山梨酸钾完全溶解。
继续搅拌主批料容器的内含物且添加次要容器的内含物(他扎罗汀,DIPA,矿物油和BHT)至主批料容器中,然后添加山梨酸和鲸蜡硬脂醇聚氧乙烯醚-12。
开始加热且继续加热直到达到相转变温度,即其中水包油型乳液转变成油包水型乳液(通过传导性或目视观察测量)。相转变温度范围为约70℃至约80℃。
冷却主批料容器至低于相转变温度(约69℃)以促进水包油型亚微/微乳液的形成。
在环境温度下添加去离子水(占气雾剂基质总水含量的约71.2%)。继续搅拌且保持主批料容器在约25℃-30℃。
测试pH且按需要调节至4.70至5.50的范围。用去离子水调节以补偿蒸发的水损失。
气雾剂填充和卷曲(Crimping)
将气雾剂基质填充入合适的铝气雾剂容器中,插入合适的阀,真空卷曲且用合适的推进剂充气。
表3
亚微/微泡沫乳液-他扎罗汀(0.1%)和卡泊三烯(0.005%)
实施例2
制备亚微/微泡沫乳液-他扎罗汀(0.1%)和卡泊三烯(0.005%)的方法气雾剂基质:
1.添加BHT(项目3),鲸蜡硬脂醇聚氧乙烯醚-12(项目4),矿物油(项目5)和生育酚(项目6)至主混合容器中。
2.通过将己二酸二异丙基酯(项目1)和他扎罗汀(项目2)添加至小混合容器中制备第一活性相,且混合直到他扎罗汀溶解。
3.将第一活性相溶液(项目1和2)添加至主混合容器中。
4.通过向单独的混合容器中添加水(项目7)制备第一水相.。
5.开始搅拌第一水相并将EDTA、Na2(项目8)和磷酸二钠(项目9)添加至水中且混合直到溶解。
6.添加第一水相(项目7至9)至主混合容器中。
7.当监测主混合容器内含物(项目1至9)的传导性时,开始加热至约80℃,并开始搅拌。
8.随着温度增加,混合物从水包油型乳液转变成油包水型乳液,且观察到传导性的相应降低。
9.当温度达到约80℃时,停止加热且开始缓慢冷却主混合容器中的内含物,同时保持搅拌。
10.在约70℃,该混合物从油包水型乳液转变成水包油型乳液,且观察到传导性的相应增加。混合物的外观也从不透明变为半透明。
11.在该温度,当混合物为半透明时,将第二水相(项目10)在环境温度下添加至主混合容器中,且继续搅拌。添加第二水相后混合物的温度将降低至约40℃。
12.当搅拌混合物时,继续冷却直到温度范围降低至约25℃至30℃。
13.通过将丙二醇(项目11)和卡泊三烯(项目12)添加至小混合容器中制备第二活性相,且混合直到卡泊三烯溶解。
14.将第二活性相(项目11和2)转移至主混合容器中且搅拌直到混合物均匀。
成品:
1.添加气雾剂基质(项目1至12)至空的气雾剂容器中。
2.将在气雾剂容器上的气雾剂阀关紧。
3.添加推进剂(项目13)至气雾剂容器中。
4.测试该气雾剂容器以证实没有泄漏。
5.将致动器安置在气雾剂阀上。
6.在室温,散布前摇动气雾剂容器。
表4
亚微/微泡沫乳液-磷酸克林霉素(1%)和维甲酸(0.05%)
实施例3
制备亚微/微泡沫乳液制剂-磷酸克林霉素(1%)和维甲酸(0.05%)的方法
气雾剂基质:
1.添加BHT(项目3),鲸蜡硬脂醇聚氧乙烯醚-12(项目4)和矿物油(项目5)至主混合容器中。
2.通过将(项目1)和维甲酸(项目2)添加至小混合容器中制备第一活性相,且混合直到溶解。
3.将第一活性相溶液(项目1和2)添加至主混合容器中。
4.通过向单独的混合容器中添加水(项目6)制备第一水相。
5.开始搅拌第一水相并将无水柠檬酸(项目7)和柠檬酸钾一水合物(项目8)添加至水中且混合直到溶解。
6.添加第一水相(项目6至8)至主混合容器中。
7.当监测主混合容器内含物(项目1至8)的传导性时,开始加热至约80℃,并开始搅拌。
8.随着温度增加,混合物从水包油型乳液转变成油包水型乳液,且观察到传导性的相应降低。
9.混合物从水包油型乳液转变成油包水型乳液后,停止加热且开始缓慢冷却主混合容器的内含物,同时保持搅拌。
10.在冷却下,该混合物从油包水型乳液转变回为水包油型乳液,且观察到传导性的相应增加。混合物的外观也从不透明变为半透明。
11.在该温度,当混合物为半透明时,在环境温度添加第二水相(项目9)至主混合容器中,且继续搅拌。添加第二水相后混合物的温度将降低。
12.当搅拌该混合物时,持续冷却直到温度范围降低至约25℃至30℃。
13.通过将水(项目10)和磷酸克林霉素(项目11)添加至小混合容器中制备第二活性相,且混合直到磷酸克林霉素溶解。
14.将第二活性相(项目10和11)转移至主混合容器中,且搅拌直到混合物均匀。
15.通过将丙二醇(项目12)和苄醇(项目13)添加至小混合容器中制备防腐剂相,且混合直到均匀。
16.将防腐剂相(项目12和13)转移至主混合容器中且搅拌直到混合物均匀。
成品:
1.添加气雾剂基质(项目1至13)至空的气雾剂容器中。
2.将在气雾剂容器上的气雾剂阀关紧。
3.添加推进剂(项目14)至气雾剂容器中。
4.测试该气雾剂容器以证实没有泄漏。
5.将致动器安置在气雾剂阀上。
6.在室温,散布前摇动气雾剂容器。
表5至9中所述的制剂为本发明的进一步说明。
表5
亚微/微泡沫乳液-他扎罗汀(0.1%)和丙酸氯倍他索(0.05%)
表6
亚微/微泡沫乳液-维生素D3(0.02%)
表7
亚微/微泡沫乳液-水杨酸(2%)
表8
亚微/微泡沫乳液-阿达帕林0.1%
表9
亚微/微泡沫乳液-丙酸氯倍他索(0.05%)
实施例4
皮肤渗透研究
进行皮肤渗透研究,使用体外皮肤分布测试比较实施例2a和2b的他扎罗汀亚微/微泡沫乳液(基质)制剂与TAZORACTM乳膏和凝胶制剂的局部递送。
分层厚皮(split-thickness skin)(~0.50mm)切片安置在流通扩散池中,且测试试剂以15.63mg/cm2的限定剂量涂覆于3个皮肤供体上,每个重复5次。
在不同时间点(t=0,2,6hrs)收集组织,洗涤,带剥离(tape stripped),且分裂为表皮和真皮。他扎罗汀在表皮、真皮以及洗液中的分布用50pg/mLLOQ通过LC/MS/MS确定。
实施例5
表面活性剂与他扎罗汀的相容性
在50℃进行加速的稳定性研究(使用HPLC)以测量他扎罗汀与各种表面活性剂的相容性。图4和5显示他扎罗汀在亲水性乙氧基化脂肪醇醚表面活性剂,如鲸蜡硬脂醇聚氧乙烯醚-12中最稳定,与各种亲油性表面活性剂相反。
实施例6
颗粒尺寸分布的测量
使用Malvern Mastersizer 2000仪器测量本发明的亚微/微乳液(泡沫气雾剂基质)的油相的颗粒尺寸分布。图6说明优选制剂(730/2/1)的油相的颗粒尺寸分布。平均颗粒尺寸为0.097μm,即,约0.1μm(即约100nm)。
Claims (19)
1.水包油型乳液泡沫气雾剂组合物,其包含油相和水相,所述组合物包含:
i)他扎罗汀,
ii)水,其量为65%至90重量%,
iii)油,其存在量少于10重量%,
iv)油可混溶的有机溶剂,
v)包含亲水性表面活性剂的表面活性剂成分,其量为0.1%至10重量%,和
vi)推进剂;且其中
所述他扎罗汀溶解于该组合物的油相中,且其中油相的颗粒尺寸小于1000nm。
2.根据权利要求1的泡沫气雾剂组合物,其中所述组合物包含70%至85重量%的水。
3.根据权利要求1或2的泡沫气雾剂组合物,其中所述油选自甘菊环,菊薁,异链烷烃,直链α烯烃,亚环己基二苯基甲烷,二癸烯,二乙基己基环己烷,二十烷,异十二烷,异二十烷,异十六烷,长叶烯,矿物油,石蜡,五氢角鲨烯,矿脂,角鲨烷,角鲨烯,十四烯,及其混合物。
4.根据权利要求3的泡沫气雾剂组合物,其中所述油为矿物油。
5.根据权利要求1的泡沫气雾剂组合物,其中所述油的存在量为1%至9重量%。
6.根据权利要求5的泡沫气雾剂组合物,其中所述油的存在量为3%至8重量%。
7.根据权利要求1的泡沫气雾剂组合物,其中该油可混溶的有机溶剂选自己二酸二异丙基酯,肉豆蔻酸异丙酯,辛基十二烷醇和甘油三辛酸/癸酸酯,及其混合物。
8.根据权利要求1的泡沫气雾剂组合物,其中所述表面活性剂成分包含亲水性乙氧基化脂肪醇醚。
9.根据权利要求8的泡沫气雾剂组合物,其中所述表面活性剂成分包含亲水性乙氧基化脂肪醇醚,且基本上不含,或不含亲油性表面活性剂。
10.根据权利要求8或9的泡沫气雾剂组合物,其中所述亲水性乙氧基化脂肪醇醚选自硬脂基聚氧乙烯醚-10,硬脂基聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-6,鲸蜡硬脂醇聚氧乙烯醚-10,鲸蜡硬脂醇聚氧乙烯醚-12,鲸蜡硬脂醇聚氧乙烯醚-15,鲸蜡硬脂醇聚氧乙烯醚-20,鲸蜡硬脂醇聚氧乙烯醚-21,鲸蜡硬脂醇聚氧乙烯醚-22,鲸蜡硬脂醇聚氧乙烯醚-25,鲸蜡硬脂醇聚氧乙烯醚-30,鲸蜡硬脂醇聚氧乙烯醚-31,鲸蜡硬脂醇聚氧乙烯醚-32,鲸蜡硬脂醇聚氧乙烯醚-33,月桂基聚氧乙烯醚-5,月桂基聚氧乙烯醚-9,月桂基聚氧乙烯醚-10,月桂基聚氧乙烯醚-12,月桂基聚氧乙烯醚-15,月桂基聚氧乙烯醚-20,月桂基聚氧乙烯醚-21,月桂基聚氧乙烯醚-22,月桂基聚氧乙烯醚-23,壬基酚聚氧乙烯醚-9,油基聚氧乙烯醚-10,油基聚氧乙烯醚-20,及其混合物。
11.根据权利要求10的泡沫气雾剂组合物,其中所述亲水性乙氧基化脂肪醇醚为鲸蜡硬脂醇聚氧乙烯醚-12。
12.根据权利要求1的泡沫气雾剂组合物,其中所述表面活性剂成分的存在量为1%至8重量%。
13.根据权利要求12的泡沫气雾剂组合物,其中所述表面活性剂成分的存在量为2%至6重量%。
14.根据权利要求1的泡沫气雾剂组合物,其中所述推进剂包括一种或多种烃推进剂。
15.水包油型乳液泡沫气雾剂组合物,其包含油相和水相,所述组合物包含:
i)他扎罗汀;
ii)水,其量为70%至85重量%;
iii)油,其存在量为3%至8重量%;
iv)油可混溶的有机溶剂;
v)包含亲水性表面活性剂的表面活性剂成分,其量为2%至6重量%;
和
vi)烃推进剂;和
其中所述他扎罗汀溶解于组合物的油相中,且其中油相的颗粒尺寸小于1000nm。
16.根据权利要求1至15任一项的组合物在制备用于治疗皮肤疾病、障碍或病症的药物中的用途。
17.制备水包油型亚微乳液或微乳液泡沫气雾剂组合物的方法,所述组合物包含他扎罗汀、其量为65%至90重量%的水、存在量少于10重量%的油、油可混溶的有机溶剂、0.1%至10重量%的包含亲水性表面活性剂的表面活性剂成分、和推进剂,该方法包括:
a)混合所述他扎罗汀、第一等分部分的水、油、油可混溶的有机溶剂和表面活性剂成分以形成水包油型乳液,
b)加热步骤(a)的水包油型乳液至相转变温度,其中该水包油型乳液形成油包水型乳液,
c)冷却该油包水型乳液至低于相转变温度以形成亚微或微水包油型乳液,
d)添加第二等分部分的水以冷却亚微或微水包油型乳液,
e)用推进剂推进亚微或微水包油型乳液的样品以形成水包油型亚微乳液或微乳液泡沫气雾剂。
18.根据权利要求17的方法,其中所述第一等分部分的水占亚微乳液或微乳液泡沫气雾剂的总水含量的10%至40重量%,且所述第二等分部分的水占亚微乳液或微乳液泡沫气雾剂的总水含量的90%至60重量%。
19.通过根据权利要求17或18的方法制备的产物。
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