CN102740891B - 载体组合物 - Google Patents
载体组合物 Download PDFInfo
- Publication number
- CN102740891B CN102740891B CN201180008172.8A CN201180008172A CN102740891B CN 102740891 B CN102740891 B CN 102740891B CN 201180008172 A CN201180008172 A CN 201180008172A CN 102740891 B CN102740891 B CN 102740891B
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- Prior art keywords
- phenolic group
- carrier compositions
- phosphate
- list
- fertility phenolic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
本发明涉及载体组合物,该载体组合物包含电子转移剂的磷酸化合物和极性非质子溶剂。用所述载体组合物配制的生物活性化合物显示出具有改善的特性。
Description
技术领域
本发明涉及用于递送生物活性化合物的载体组合物。
背景技术
在本说明书引用或讨论知识的文件、法令或条款的情况下,该引用或讨论并不等于认可该知识的文件、法令或条款或其任意组合在优先权日时是公共可用的、公众已知的、普通常识的一部分;或已知与试图解决本说明书所涉及任何问题相关。
药物递送是指在人和动物中施用药物化合物以实现治疗效果的方法或过程。
已开发药物递送技术以改善药物化合物的生物利用度、安全性、持续时间、起效或释放。
在开发药物递送技术时,可能遇到的问题包括药物递送系统与药物化合物的相容性、维持足够的和有效的持续时间、潜在的副作用、以及满足患者的便利性和依从性。因此,许多药物递送技术达不到期望的改善和需求。
因此,仍然需要有效递送药物的替代性药物递送系统。
发明内容
出乎意料地发现,包含电子转移剂的磷酸化合物和溶剂的载体组合物可有效递送生物活性化合物。
根据第一方面,提供了一种用于递送生物活性化合物的载体组合物,其包含电子转移剂的磷酸化合物和溶剂,所述电子转移剂的磷酸化合物选自:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐、单-(生育酚基)磷酸酯二钠盐、二-(生育酚基)磷酸酯、二-(生育酚基)磷酸酯单钠盐或其混合物,所述溶剂选自:N,N-二甲基甲酰胺(DMF)、N-甲基-2-吡咯烷酮(NMP)、二甲亚砜(DMSO)、N,N-二甲基乙酰胺(DMAC)、二甲基亚砜、二氧六环六甲基磷酰三胺(dioxane hexamethylphosphorotriamide)、碳酸丙烯酯、γ-丁内酯、单甲基醚乙酸酯、乳酸乙酯、1,3二甲基-2-咪唑啉酮(异山梨醇二甲醚,或DMI)、肉豆蔻酸异丙酯、蓖麻醇酸丙二醇酯、异壬酸异壬酯和脂肪酸的蔗糖酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、异硬脂酸异丙酯、己二酸二异丙酯、二聚酸二异丙酯(diisopropyl dimerate)、马来酸大豆油、棕榈酸辛酯、乳酸十六烷基酯、甘油、辛二醇(caprylylglycol)、角鲨烯、红没药醇(Bisabolol)、苯甲醇、蓖麻醇酸十六烷基酯、醋酸十六烷基酯、小麦胚芽甘油酯(wheat germ glycerides)、乳酸肉豆蔻酯、油酸癸酯、羊毛脂酸异丙酯(isopropyl lanolate)、四硬脂酸季戊四醇酯、二辛酸/二癸酸新戊二醇酯、异壬酸异壬酯、异壬酸异十三烷基酯、肉豆蔻酸肉豆蔻酯、辛基十二烷醇和羟基硬脂酸辛酯,其中所述溶剂的浓度为所述载体组合物总浓度的约0.05%w/w至最高约30%w/w。
还提供了电子转移剂的磷酸化合物和溶剂在制备用于递送生物活性化合物的载体组合物中的用途。
还提供了一种制备用于递送生物活性化合物的载体组合物的方法,其包括将所述电子转移剂的磷酸化合物和所述溶剂组合的步骤。
当载体组合物包含单-(生育酚基)磷酸酯与二-(生育酚基)磷酸酯的混合物时,其比例可以是至少2∶1、约4∶1至约1∶4或约6∶4至约8∶2。在一些实施方案中,所述比例是约6∶4或约8∶2。
载体组合物包含下述量的电子转移剂的磷酸化合物:载体组合物总浓度的约0.01%w/w至约20%w/w、约0.01%w/w至约10%w/w、约0.01%w/w至约5%w/w或约0.05%w/w至约2%w/w。在一些实施方案中,所述载体组合物包含下述量的电子转移剂的磷酸化合物:载体组合物总浓度的约0.1%w/w、约1%w/w或约5%w/w。
载体组合物可具有下述浓度(基于上述选定的溶剂组)的溶剂:约0.05%w/w至最高约50%w/w、至最高约40%w/w、至最高约30%w/w、至最高约20%w/w、至最高约10%w/w、至最高约5%w/w、至最高约3%w/w、至最高约2%w/w或至最高约1%w/w。
在第二方面中,提供了包含所述载体组合物和生物活性化合物的制剂。
还提供了制备所述制剂的方法,其包括将生物活性化合物添加到所述载体组合物的步骤。
所述生物活性化合物可以是药物或其可药用的衍生物、保健营养品(nutraceurical)或其可用于保健营养品的衍生物或者药妆品(cosmeceutical)或其可用于药妆品的衍生物。
生物活性化合物可以以下述量存在:载体组合物总浓度的约0.001%w/w至约15%w/w、至约10%w/w、至约5%w/w、至约2%w/w或至约1%w/w,或者0.001%w/w至约0.05%w/w、至约1%w/w、至约2%w/w或至约5%w/w。
在第三方面中,提供了一种所述载体组合物的用于改善递送生物活性化合物的用途。所述载体组合物可改善和/或能够递送生物活性化合物,尤其经由肠内或胃肠外的施用途径。
所述载体组合物还可改善生物活性化合物在对象中的生物利用度。
本发明的载体组合物还可被用于治疗对象的病症的方法,所述方法包括在所述载体组合物中施用有效量的生物活性化合物。所述病症包括可用与载体组合物一起配制的生物活性化合物治疗的那些病症。
在第四方面中,提供了溶剂尤其在载体组合物中增加电子转移剂的磷酸化合物之溶解性和/或稳定性的用途。
发明详述
本发明涉及载体组合物,包含电子转移剂的磷酸化合物和溶剂。已显示了与所述载体组合物一起配制的生物活性化合物具有改善的特性。电子转移剂的磷酸化合物
术语“电子转移剂”意指可磷酸化的化合物,并且所述化合物在非磷酸化形式时可接受电子而产生相对稳定的分子基团或者可接受两个电子使得化合物可参与可逆的氧化还原系统。电子转移剂的实例包括抗氧化剂及其衍生物。
术语“抗氧化剂”意指能够减缓或防止其它分子氧化的分子。氧化是一种将电子从物质转移到氧化剂的化学反应。氧化反应可以产生启动损害细胞的链式反应的自由基。抗氧化剂通过移除自由基中间体终止这些链式反应,并且通过自身氧化抑制其它氧化反应。因此,抗氧化剂常常是还原剂。
抗氧化剂大体上分为两大类,这取决于它们是否可溶于水(亲水的)或油脂(疏水的)。抗坏血酸(维生素C)是水溶性抗氧化剂的实例。胡萝卜素、生育酚(维生素E)、视黄醇(维生素A)、泛醇(辅酶Q的还原形式)和钙化醇(维生素D)是脂溶性抗氧化剂的实例。
胡萝卜素(carotene)是不含氧的类胡萝卜素。类胡萝卜素基于胡萝卜素其中一个或更多个氢原子被羟基取代和/或一些氢原子对被氧原子取代。术语“羟基类胡萝卜素”是指用一个或更多个羟基取代的胡萝卜素。隐黄素(cryptoxanthin)是羟基类胡萝卜素的实例:它与β-胡萝卜素密切相关,只是增加了羟基。
维生素E以八种不同的形式存在,即四种生育酚和四种生育三烯酚。所有形式均以色满环为特征,该色满环带有可提供氢原子以还原自由基的羟基和使其渗透进入生物膜的疏水侧链。维生素E的这些衍生物可归类为“羟基色满”(“hydroxy chromans”)。生育酚和生育三烯酚均存在α、β、γ和δ形式,这由色满环上甲基的数量和位置决定。不同于类似的生育酚,生育三烯酚在疏水侧链中存在三个双键。维生素E的不同形式如式(I)所示:
视黄醇(retinol)属于被称为类视黄醇(retinoid)的化合物家族。有三代类视黄醇。第一代类视黄醇包括视黄醇、视黄醛、维甲酸(tretinoin)(视黄酸,全反式维甲酸)、异维甲酸和阿利维甲酸(alitretinoin)。第二代类视黄醇包括依曲替酯(etretinate)和其代谢物阿曲汀(acitretin)。第三代类视黄醇包括他扎罗汀、贝沙罗汀和阿达帕林(adapalene)。
泛醇是苯并醌醇并且是泛醌(辅酶Q10)的还原形式。
钙化醇(维生素D)有几种形式。两种主要形式是维生素D2(例如麦角钙化醇)和维生素D3(例如骨化三醇、胆钙化醇)。其它形式包括维生素D1(麦角钙化醇与光甾醇(lumisterol)1∶1的分子复合物)、维生素D4(22-二氢麦角钙化醇)和维生素D5(谷钙化醇,由7-脱氢谷甾醇制得)。
本文描述的任何抗氧化剂或其衍生物适合于本发明。优选的抗氧化剂及其衍生物选自类胡萝卜素、羟基色满、类胡萝卜素、类视黄醇、苯并醌醇和钙三醇。优选羟基色满。最优选任何形式的母育酚(例如生育酚)。
术语“磷酸化合物”指磷酸化的化合物,在化合物的氧原子(通常来自于羟基)与磷酸基(PO4)的磷原子之间形成共价键:本文中,所述化合物是电子转移剂。
磷酸化合物可以是磷酸单酯、磷酸二酯、磷酸三酯、焦磷酸单酯、焦磷酸二酯、或其盐或衍生物、或其混合物。二酯和三酯可包含相同的电子转移剂或不同的电子转移剂。
“盐”包括金属盐,如碱金属盐或碱土金属盐,例如钠盐、镁盐、钾盐和钙盐。优选钠盐和钾盐。
“衍生物”包括一个或更多个磷酸质子被取代基取代的磷酸化合物。衍生物的一些非限制性实例包括用氨基-烷基基团取代磷酸质子的磷脂酰衍生物、用糖(如葡萄糖)取代磷酸质子的糖衍生物。
术语“氨基-烷基基团”是指包含氨基(-NH2)和烷基的基团。术语“烷基”是指具有1至8个碳原子的直链、支链或环状烃基。实例包括甲基、乙基、丙基、异丙基、丁基、异丁基、仲丁基、叔丁基、戊基、己基、环己基、庚基和辛基。最优选磷脂酰胆碱衍生物。
当所述电子转移剂是生育酚时,生育酚的磷酸化合物的实例包括但不限于:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐、单-(生育酚基)磷酸酯二钠盐、二-(生育酚基)磷酸酯、二-(生育酚基)磷酸酯单钠盐或其混合物。这些磷酸化合物可以衍生自生育酚的α、β、γ或δ形式或者其组合。
在一些实施方案中,尤其对于递送营养活性物和药妆品活性物而言,可期望使用生育酚的磷酸化合物的非中和形式。非中和生育酚基磷酸酯的pH可以为约2至约4或约2至约3。在一些实施方案中,非中和生育酚基磷酸酯的pH为约2或约3。
当载体组合物包括单-磷酸酯与二-磷酸酯(例如单-(生育酚基)磷酸酯和二-(生育酚基)磷酸酯)的混合物(本文称为“TPM”)时,其比例可以是至少2∶1、约4∶1至约1∶4或者约6∶4至约8∶2。在一些实施方案中,该比例可以是约6∶4或约8∶2。
载体组合物包含下述量的电子转移剂的磷酸化合物:载体组合物总浓度的约0.01%w/w至约20%w/w、约0.01%w/w至约10%w/w、约0.01%w/w至约5%w/w或约0.05%w/w至约2%w/w。在一些实施方案中,载体组合物包含下述量的电子转移剂的磷酸化合物:载体组合物总浓度的约0.1%w/w、约1%w/w或约5%w/w。
溶剂
在化学中,按照极性增加排序,溶剂可以分为非极性非质子溶剂、极性非质子溶剂和极性质子溶剂。溶剂的极性确定了化合物(能够溶解另一些溶剂或液体化合物或者与其混溶)的类型。通常,极性溶剂最佳溶解极性化合物以及非极性溶剂最佳溶解非极性溶剂,即“相似相容”。
载体组合物包含溶剂,选自N,N-二甲基甲酰胺(DMF)、N-甲基-2-吡咯烷酮(NMP)、二甲亚砜(DMSO)、N,N-二甲基乙酰胺(DMAC)、二甲基亚砜、二氧六环六甲基磷酰三胺、碳酸丙烯酯、γ-丁内酯、单甲基醚乙酸酯、乳酸乙酯、1,3二甲基-2-咪唑啉酮(异山梨醇二甲醚,或DMI)、肉豆蔻酸异丙酯、蓖麻醇酸丙二醇酯、异壬酸异壬酯和脂肪酸的蔗糖酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、异硬脂酸异丙酯、己二酸二异丙酯、二聚酸二异丙酯、马来酸大豆油、棕榈酸辛酯、乳酸十六烷基酯、甘油、辛二醇、角鲨烯、红没药醇、苯甲醇、蓖麻醇酸十六烷基酯、醋酸十六烷基酯、小麦胚芽甘油酯、乳酸肉豆蔻酯、油酸癸酯、羊毛脂酸异丙酯、四硬脂酸季戊四醇酯、二辛酸/二癸酸新戊二醇酯、异壬酸异壬酯、异壬酸异十三烷基酯、肉豆蔻酸肉豆蔻酯、辛基十二烷醇和羟基硬脂酸辛酯。
载体组合物可以仅包含一种如上限定的溶剂;但是,也可以使用这些溶剂的混合物或组合。为了避免任何疑问,应注意的是本文中所使用的单数形式应视为包括复数形式,除非上下文中另做明确说明。
在一些优选的实施方案中,溶剂可具有相对高水平的疏水性,但仍然可混溶于水。在含水的环境中,尤其优选能够增加脂溶性分子(如,生育酚基磷酸酯)溶解性的那些溶剂。
溶剂在载体组合物中的浓度(基于上述选定的溶剂组)的改变将取决于使用的溶剂和/或待与载体组合物一起配制的生物活性化合物,出乎意料地发现,只有相对少量的溶剂是实现期望结果所必需的。在一些实施方案中,载体组合物可具有的溶剂浓度(基于上述选定的溶剂组)为:约0.05%w/w至最高约30%w/w、至最高约20%w/w、至最高约10%w/w、至最高约5%w/w、至最高约3%w/w、至最高约2%w/w或至最高约1%w/w。
生物活性化合物
术语“生物活性化合物”是指在人或动物中针对医学、治疗、美容或兽医学目的的具有生物学作用的任何化学物质,并且包括涵盖药、药妆品(cosmeceutical)、保健营养品(nutraceutical)和营养剂在内的药物。应理解,某些生物活性化合物可分类在一个以上的这些类别中。
多种多样的生物活性化合物可以用本发明的载体组合物来递送。实例包括但不仅限于心血管药,特别是抗高血压剂(例如钙通道阻滞剂或钙拮抗剂)和抗心律失常药;充血性心力衰竭药物;肌肉收缩药;血管扩张剂;血管紧张素转化酶(ACE)抑制剂;利尿剂;碳酸酐酶抑制剂;强心苷;磷酸二酯酶抑制剂;α阻滞剂;β-阻滞剂;钠通道阻滞剂;钾通道阻滞剂;β-肾上腺素能激动剂;血小板抑制剂;血管紧张素II拮抗剂;抗凝血剂;溶栓剂;出血治疗物;贫血治疗物;凝血酶抑制剂;抗寄生虫药;抗菌剂;胰岛素;人类生长激素和肽;疫苗;抗炎药,特别是非甾体抗炎药(NSAID),更特别地是COX-2抑制剂;甾体抗炎药;预防性抗炎药;抗青光眼药;肥大细胞稳定剂;散瞳药;影响呼吸系统的药;过敏性鼻炎药物;α-肾上腺素能激动剂;皮质类固醇;慢性阻塞性肺病药物;黄嘌呤氧化酶抑制剂;抗关节炎药;痛风治疗物药;内分泌物及内分泌物拮抗剂;抗分枝杆菌药;抗真菌药;抗原虫药;抗蠕虫药;特别针对呼吸道、疱疹病毒、巨细胞病毒、人类免疫缺陷病毒和肝炎感染的抗病毒剂;白血病和卡波西肉瘤的治疗剂;疼痛治疗药,特别是麻醉剂和止痛剂,阿片类药物,包括阿片受体激动剂、阿片受体局部激动剂、阿片类拮抗剂或阿片受体混合激动-拮抗剂;精神抑制药;拟交感神经药;肾上腺素能激动剂;影响神经递质摄取或释放的药物;抗胆碱能药;抗痔疮药;预防或治疗放射或化疗作用的药物;产生脂肪药(liopgenisis drug);脂肪减少治疗剂;抗肥胖肽;减肥药如脂肪酶抑制剂;拟交感神经药;胃溃疡和炎症治疗剂,如质子泵抑制剂;前列腺素;VEGF抑制剂;降血脂药物,特别是他汀类;影响中枢神经系统(CNS)的药物,如抗精神病药、抗癫痫药和抗惊厥药、精神活性药物、兴奋剂、抗焦虑药和安眠药、抗抑郁药;抗帕金森药;激素及其片段,如性激素;生长激素拮抗剂;促性腺激素释放激素及其类似物;甾体激素及其拮抗剂;选择性雌激素调节剂;生长因子;抗糖尿病药,如胰岛素、胰岛素片段、胰岛素类似物、胰高血糖素样肽和降血糖药;H1、H2、H3和H4抗组胺药;肽、蛋白质、多肽、核酸和寡核苷酸药物;天然蛋白质、多肽、寡核苷酸和核酸等化合物的类似物、片段和变体;用于治疗偏头痛的药;哮喘药;胆碱能拮抗剂;糖皮质激素;雄激素;抗雄激素;肾上腺皮质激素生物合成抑制剂;骨质疏松治疗剂,如双磷酸盐类(biphosphonates);抗甲状腺药;防晒霜(suncreens),太阳防护剂(sunprotectants)和滤光剂(filter);细胞因子激动剂;细胞因子拮抗剂;抗肿瘤药;抗老年痴呆症药;HMGCoA还原酶抑制剂;贝特类(fibrates);胆固醇吸收抑制剂;HDL胆固醇升高药;降甘油三酯药;抗衰老或抗皱纹药;产生激素的前体分子;蛋白质,如胶原蛋白和弹性蛋白;抗菌药;祛痘药(antiacne agent);抗氧化剂;毛发处理剂和皮肤美白剂;防晒霜,太阳防护剂和滤光剂;人载脂蛋白的变体;产生激素的前体分子;蛋白质及其肽;氨基酸;植物提取物,如葡萄籽提取物;DHEA;异黄酮;营养药,包括维生素、植物甾醇和环烯醚萜苷、倍半萜内酯、萜、酚苷、三萜、氢醌衍生物、苯基酮(phenylalkanone);抗氧化剂,如视黄醇和其它类视色素,包括视黄酸和辅酶Q10;Ω-3-脂肪酸;葡萄糖胺;核酸、寡核苷酸、反义药物;酶;细胞因子;细胞因子类似物;细胞因子激动剂;细胞因子拮抗剂;免疫球蛋白;抗体;抗体药物;基因治疗剂;脂蛋白;促红细胞生成素;疫苗;用于治疗或预防人和动物疾病的小分子和大分子治疗药,如过敏/哮喘、关节炎、癌症、糖尿病、生长障碍、心血管疾病、炎症、免疫系统障碍、脱发、疼痛、眼科疾病、癫痫、妇科障碍、CNS疾病、病毒感染、细菌感染、寄生虫感染、胃肠道(GI)疾病、肥胖和血液疾病。
合适的生物活性化合物的一些具体的非限制性实例包括:
麻醉剂:
包括氨基-酯和氨基-酰胺麻醉剂,如苯佐卡因、氯普鲁卡因、可卡因、利血平、胍乙啶、环美卡因、二甲卡因/拉罗卡因、丙氧卡因、普鲁卡因/奴佛卡因、丙美卡因、丁卡因/阿美所卡因、阿替卡因、布比卡因、卡替卡因、辛可卡因/二丁卡因、依替卡因、左布比卡因、利多卡因/利诺卡因、甲哌卡因、哌罗卡因、丙胺卡因、罗哌卡因、三甲卡因、异丙酚、氟烷、安氟醚巴比妥类药物、苯并二氮
类药物、新斯的明和克他命。
烷化剂:
包括卡莫司汀、环磷酰胺、异环磷酰胺、链脲霉素和氮芥。
钙通道阻滞剂:
包括氨氯地平、阿雷地平、阿折地平、巴尼地平、贝尼地平、西尼地平、氯维地平、氯硝地平、达罗地平、右尼古地平、依福地平、依那地平、依高地平、非洛地平、氟地平、呋尼地平、伊加地平、伊拉地平、拉西地平、来米地平、乐卡地平、马尼地平、美舒地平(mesuldipine)、尼卡地平、硝苯地平、尼鲁地平、尼伐地平、尼莫地平、尼索地平、尼群地平、奥拉地平、奥索地平、帕洛地平、普拉地平、沙更地平、索尼地平、替鲁地平、tiaDMIpine、trombodipine、沃他地平(watanidipine)、维拉帕米、加洛帕米、苯并硫氮杂
地尔硫
米贝拉地尔、苯普地尔、氟司必林和芬地林。
抗心律失常药和抗心绞痛药:
包括胺碘酮、丙吡胺、醋酸氟卡尼、硫酸奎尼丁、硝酸甘油、雷诺嗪、胺碘酮、异山梨醇和阿替普酶。
抗菌药、抗生素和祛痘药
包括阿莫西林、氨苯青霉素、阿奇霉素、苯明青霉素、博来霉素、过氧化苯甲酰、西诺沙星、氯霉素、道诺霉素、普卡霉素、氟喹诺酮、环丙沙星、克拉霉素、克林霉素、clindesse、氯法齐明、葡糖酸氯己定、氯洒西林、地美环素、强力霉素、红霉素、乙硫异烟胺、亚胺培南、吲哚美辛、赖甲环素、米诺环素、萘啶酸、呋喃妥因、青霉素、利福平、螺旋霉素、磺胺醋酰钠、磺胺苯酰、周效磺胺、磺胺甲基嘧啶、磺胺醋酰、磺胺嘧啶、磺胺异噁唑、磺胺甲基异噁唑、磺胺吡啶、四环素、头孢氨苄、头孢地尼、三氯生、氧氟沙星、vancoin、格列本脲(glyburide)、莫匹罗星、头孢丙烯、头孢呋辛酯、诺氟沙星、异烟肼、蛇麻酮、D-青霉胺、左氧氟沙星、加替沙星和甲氧苄氨嘧啶。
抗癌药:
包括阿霉素、6-硫鸟嘌呤、紫杉醇、多西他赛、喜树碱、醋酸甲地孕酮、诺维本(navelbine)、阿糖胞苷、氟达拉滨、6-巯基嘌呤、5-氟尿嘧啶、替尼泊苷、长春碱、长春新碱、顺铂、秋水仙碱、卡铂、甲苄肼和依托泊苷。
抗抑郁药、抗精神病药和抗焦虑药:
包括阿普唑仑、阿莫沙平、苯他西泮、溴西泮、氯氮
(clorazipine)、氯巴占、氯噻西泮、地西泮、劳拉西泮、氟硝西泮、氟西泮、氯甲西泮、美达西泮、硝西泮、奥沙西泮、替马西泮、马普替林、米安色林、去甲替林、利培酮、舍曲林、曲唑酮、baloperidol、马来酸三甲丙咪嗪氟西汀、昂丹司琼、咪达唑仑、氯丙嗪、氟哌啶醇、三唑仑、氯氮平、三氟丙嗪、氟非那嗪癸酸酯、氟阿尼酮、奋乃静、匹莫齐特(pimozide)、普鲁氯嗪、舒必利、硫醚嗪、帕罗西汀、西酞普兰、丁氨苯丙酮、苯乙肼、奥氮平、双丙戊酸钠和文拉法辛。
阿片类药物:
包括阿片受体激动剂和拮抗剂,表现出混合激动剂/拮抗剂活性的化合物和表现出部分激动剂活性的化合物,包括吗啡、迪普吗啡(depomorphine)、埃托啡、二乙酰吗啡、氢吗啡酮、羟吗啡酮、左啡诺、美沙酮、左醋美沙朵(levomethadyl)、哌替啶、芬太尼、舒芬太尼、阿芬太尼、可待因、氢可酮、羟考酮、蒂巴因、地索吗啡、尼可吗啡、二丙酰吗啡、苄吗啡、乙基吗啡、哌替啶、美沙酮、曲马多、右旋丙氧吩、纳洛酮和纳曲酮、丁丙诺啡、纳布啡、布托啡诺、喷他佐辛和乙基酮基环唑星(ethylketocyclazocine)。
三环类药:
包括硫唑嘌呤、阿米替林、法莫替丁、异丙嗪、帕罗西汀、奥卡西平(oxcarbazapine)和米氮平(mertazapine)。
抗糖尿病药:
包括乙酰苯磺酰环己脲(acetohexamide)、氯磺丙脲、格列本脲(glibenclaraide)、格列齐特、格列吡嗪、二甲双胍、妥拉磺脲、格列本脲、格列美脲和甲苯磺丁脲。
抗癫痫药:
包括贝克拉胺、卡马西平、加巴喷丁、噻加宾、氨己烯酸(vigabatrin)、托吡酯、氯硝西泮、乙苯妥英、美芬妥英、甲琥胺、甲基苯巴比妥、奥卡西平、甲乙双酮、苯乙酰脲、苯巴比妥、苯妥英、苯琥胺、扑米酮、舒噻嗪、苯妥英钠、呋喃妥因一水合物、加巴喷丁、拉莫三嗪、唑尼沙胺、乙琥胺和丙戊酸。
安眠药/镇静剂和肌肉松弛剂
包括酒石酸唑吡坦、异戊巴比妥、巴比妥、丁巴比妥、戊巴比妥、溴替唑仑、卡溴脲、利眠宁、氯美噻唑、安眠酮(methaqualome)、眠尔通、安眠酮(methaqualome)、环苯普林(cyclobenzaprene)、环苯扎林、替扎尼定、巴氯芬、布他比妥、佐匹克隆、阿曲库铵、筒箭毒碱和苯巴比妥。抗真菌药、抗原虫药和抗寄生虫药:
包括两性霉素、硝酸布康唑、克霉唑、硝酸益康唑、氟康唑、氟胞嘧啶、灰黄霉素、伊曲康唑、酮康唑、咪康唑、纳他霉素、制霉菌素、硝酸硫康唑、特康唑、噻康唑和十一烯酸,苄硝唑、氯碘羟喹、癸氧喹酯、二碘羟基喹啉、二氯尼特、二硝托胺、呋喃唑酮(fuzolidone)、甲硝哒唑、尼莫拉唑、呋喃西林、奥硝唑、特比萘芬、克霉唑、氯喹、甲氟喹、伊曲康唑、乙胺嘧啶、吡喹酮、奎纳克林、甲苯达唑和替硝唑。
抗高血压药和心脏治疗药
包括坎地沙坦、肼苯哒嗪、可乐定、氨苯蝶啶、非洛地平、吉非罗齐、非诺贝特、硝苯地平(nifedical)、哌唑嗪、梅坎米胺、多沙唑嗪、多巴酚丁胺和西来替昔酯(cilexetil)。
抗偏头痛药:
包括甲磺酸双氢麦角胺、酒石酸麦角胺、马来酸美西麦角、马来酸苯噻啶(pizotifen maleate)和琥珀酸舒马曲坦。
抗毒蕈碱剂:
包括阿托品、苯海索、比哌立登、乙丙嗪(ethopropazine)、莨菪碱、溴美喷酯、奥昔布宁、奥苯昔明(oxyphencylcimine)和托吡卡胺。抗肿瘤剂(或免疫抑制剂)
包括氨鲁米特、安吖啶、硫唑嘌呤、白消安、苯丁酸氮芥、环孢菌素、达卡巴嗪、雌莫司汀、依托泊苷、洛莫司汀、美法仑、巯嘌呤、甲氨蝶呤、丝裂霉素、米托坦、米托蒽醌、甲基苄肼、枸橼酸他莫西芬、睾内酯、他克莫司、巯嘌呤和西罗莫司。
抗帕金森病药:
包括甲磺酸溴麦角环肽、左旋多巴、托卡朋、罗匹尼罗、溴麦角环肽、降血糖药如磺酰脲类、双胍类、α-葡糖苷酶抑制剂、噻唑烷二酮类、卡麦角林、卡比多巴和马来酸麦角乙脲(lysuride maleate)。
抗甲状腺药:
包括卡比马唑(carbimazole)和丙硫氧嘧啶。
抗病毒药:
包括金刚烷胺、瑞替诺韦(retinovir)、西多福韦、阿昔洛韦、泛昔洛韦、利巴韦林、安普那韦、茚地那韦(indinavirm)、金刚乙胺(rimantadine)和依法韦仑、喷昔洛韦、更昔洛韦、阿糖腺苷、阿巴卡韦、阿德福韦、阿普那韦(apmrenavir)、地拉韦啶、地达诺新、司他夫定、扎西他宾、齐多夫定、恩夫韦地和干扰素。
心脏收缩药:
包括氨力农、米力农、洋地黄毒苷、地高辛、依诺昔酮、毛花洋地黄苷C和甲地高辛。
调血脂药(hypo an d hyper lipidemic agents):
包括非诺贝特、氯贝丁酯、普罗布考、依折麦布(ezetimibe)和托彻普(torcetrapib)。
抗炎药:
包括美昔康(meoxicam)、曲安奈德、色甘酸(cromolyn)、奈多罗米、羟化氯喹、孟鲁司特、齐留通、扎鲁斯特和美洛昔康。
抗组胺药:
包括非索非那定、水合氯醛、羟嗪、异丙嗪、西替利嗪、西咪替丁、赛克利嗪(clyclizine)、美克洛嗪、乘晕宁、氯雷他定、尼扎替丁(nizatadine)和异丙嗪。
抗溃疡药:
包括奥美拉唑、兰索拉唑、泮托拉唑和雷尼替丁。
利尿剂:
包括氢氯噻嗪、阿米洛利、乙酰唑胺、呋塞米和托拉塞米。
NSAID:
包括芳基烷酸亚族,其包括双氯芬酸、醋氯芬酸、阿西美辛、阿氯酚酸、溴芬酸、依托度酸、吲哚美辛、吲哚美辛法尼酯、萘丁美酮、奥沙美辛、丙谷美辛、舒林酸和托美丁;2-芳基丙酸(洛芬类)亚族,包括阿明洛芬、苯恶洛芬、卡洛芬、右布洛芬、右酮洛芬、芬布芬、非诺洛芬、氟诺洛芬、氟比洛芬、布洛芬、异丁普生、吲哚洛芬、酮洛芬、酮咯酸、洛索洛芬、咪洛芬、萘普生、奥沙普嗪、吡洛芬、舒洛芬、他氟比尔(tarenflurbil)和噻洛芬酸;以及N-芳基邻氨基苯甲酸(芬那酸)亚族,包括氟芬那酸、甲氯芬那酸、甲芬那酸和托芬那酸;氨丁三醇、塞来昔布、奈帕芬胺、阿司匹林、罗非昔布、萘普生、舒林酸、吡罗昔康、保泰松(pheylbutazone)、托美丁、吲哚美辛、对乙酰氨基酚(acetominophen)(扑热息痛)、曲马多和丙氧芬。
类视黄素:
包括第一代类视黄素,如视黄醇、视黄醛、维甲酸(视黄酸、全反式维甲酸)、异维甲酸和阿利维甲酸;第二代类视黄素,如依曲替酯及其代谢物阿曲汀;第三代类视黄素,如他扎罗汀、贝沙罗丁和阿达帕林激素和类固醇:
包括促肾上腺皮质激素(ACTH)、抗利尿激素(加压素)、心房利钠因子(ANF)、心房利钠肽(ANP)、倍氯米松、可的松、东莨菪碱、多巴胺、肾上腺素、儿茶酚胺类、胆囊收缩素、柠檬酸克罗米酚、达那唑、地塞米松、己烯雌酚(DES)、炔雌醇、氟氢可的松、非那雄胺、促卵泡激素、胃泌素、羟孕酮、生长激素、胰岛素、瘦蛋白(leptin)、黄体生成素、醋酸甲羟孕酮、美雌醇(mestranol)、炔雌醚、甲基睾酮、诺龙、炔诺酮(norethindrone)、炔诺酮(norethisterone)、炔诺孕酮、雌二醇、缀合雌激素、氧雄龙、催产素、强的松、孕酮、催乳素、protogalndins、生长抑素、康力龙、己烯雌酚、甲状腺素、磷酸泼尼松龙、曲安西龙、丙酮米非司酮、布地奈德、左甲状腺素、睾酮、环戊丙酸睾酮、氟甲睾酮、氟他胺、糠酸莫米松、环丙孕酮、氟米隆(fluromethalone)、戈舍瑞林、亮丙瑞林、降钙素、卤贝他索、氢化可的松和替勃龙。
他汀类及衍生物:
包括阿托伐他汀、氟伐他汀、洛伐他汀、制霉菌素、瑞舒伐他汀、普伐他汀、奥利司他和辛伐他汀。
兴奋剂:
包括安非他明、芬特明、酪胺、麻黄碱、间羟胺、苯肾上腺素、右旋安非他命、右芬氟拉明、芬氟拉明、尼古丁、咖啡因和马吲哚。
血管收缩剂:
包括去氨加压素。
血管扩张剂(vasodilitor):
包括卡维地洛、特拉唑嗪、酚妥拉明和薄荷脑。
抗阿尔茨海默病药物:
包括左乙拉西坦、levitiracetam和多奈哌齐。
ACE抑制剂:
包括苯那普利、依那普利、雷米普利、福辛普利钠、赖诺普利、米诺地尔、异山梨酯、rampril和喹那普利。
β肾上腺素受体拮抗剂:
包括阿替洛尔、噻吗洛尔、吲哚洛尔、盐酸普萘洛尔、比索洛尔、艾司洛尔、琥珀酸美托洛尔、美托洛尔和酒石酸美托洛尔。
血管紧张素II拮抗剂:
包括氯沙坦。
血小板抑制剂:
包括阿昔单抗、氯吡格雷、替罗非班和阿司匹林。
醇类和酚类:
包括曲马多、盐酸曲马多、别嘌呤醇、骨化三醇、西洛他唑、索他洛尔、乌索二醇(urasodiol)、溴哌利多、氟哌利多、三氟噻吨癸酸酯、沙丁胺醇、硫酸沙丁胺醇、卡立普多、氯倍他索、罗匹尼罗、拉贝洛尔和美索巴莫。
酮类和酯类:
包括胺碘酮、氟替卡松、螺内酯、强的松、曲唑酮、去羟米松、甲基强的松、苯佐那酯、萘丁美酮和丁螺环酮。
止吐药:
包括甲氧氯普胺。
眼治疗剂:
包括多佐胺、溴莫尼定、奥洛他定、环喷托酯、毛果芸香碱和乙膦硫胆碱。
抗凝剂和抗血栓剂:
包括华法林、依诺肝素(enoxaparin)和来匹卢定。
痛风治疗剂:
包括丙磺舒和磺吡酮(sulfinpyrazone)。
COPD和哮喘治疗剂:
包括异丙托溴铵(ipratropium)。
骨质疏松治疗剂:
包括雷洛昔芬、帕米膦酸盐和利塞膦酸盐。
美容肽:
包括乙酰基六肽-3、乙酰基六肽-8、乙酰基八肽和l-肌肽。
疫苗:
包括含有类毒素(失活的有毒化合物)的疫苗;蛋白质,蛋白质亚基和多肽;多核苷酸,如DNA和RNA;缀合物;辅助剂,如皂苷、病毒体、无机和有机辅助剂,如zostavax。
营养保健品活性剂和药妆品活性剂:
包括辅酶Q10(或泛醌)、泛醇或白藜芦醇;类胡萝卜素,如α、β或γ-胡萝卜素、番茄红素、叶黄素、玉米黄质和虾青素;植物营养素,如番茄红素、叶黄素和玉米黄质;不饱和脂肪酸,如亚油酸,共轭亚油酸,亚麻酸,Ω-3脂肪酸,包括但不限于二十二碳六烯酸(DHA)和二十碳五烯酸(EPA)及其甘油酯;脂溶性维生素,包括维生素D(D2、D3及其衍生物)、维生素E(α、β、γ、δ-生育酚,或α、β、γ、δ-生育三烯酚)、维生素A(视黄醇、视黄醛、视黄酸及衍生物)、维生素K(K1、K2、K3及其衍生物)、癸酸/辛酸甘油三酯、叶酸、铁、烟酸、亚油酸甘油酯、Ω6脂肪酸、维生素F、硒、氰钴胺素、芦荟(aloe vera)、β-葡聚糖、红没药醇、茶(camellia thea)(绿茶)提取物、癸酸/辛酸甘油三酯、积雪草(centellaasiatica)(gotu cola)提取物、十六/十八醇橄榄油酸酯、叶绿素、橙(citrussinensis)(橘)油、椰油基脯氨酸、二辛醚、月桂亚氨基二丙酸生育酚磷酸酯二钠盐(维生素E磷酸酯)、甘油、油酸甘油酯、光果甘草(glycyrrhizaglabra)(甘草)根提取物、北美金缕梅(hamamelis virgiana)(金缕梅)提取物、乳酸、卵磷脂、叶黄素、澳洲坚果(macadamia integrifolia)(澳洲胡桃)籽油、母菊(matricaria chamomilla)(春黄菊)提取物、月见草(oenothera biennis)(月见草)油、木樨榄(olea europaea)(橄榄)叶提取物、米糠油、鳄梨(persea gratissima)(鳄梨)油、何首乌(polygonummultiflorum)提取物、石榴甾醇、白藜芦醇、多花蔷薇(rosa eglanteria)(野玫瑰果)油、澳洲檀香(santalum spicatum)(檀香)油、二氧化钛、叶酸、甘油、甘油亚油酸酯(Ω-6脂肪酸维生素F)、维生素A棕榈酸酯、葡萄(vitis vinifera)(葡萄籽)油、卤倍他索(halobetasol)、腺苷、三磷酸腺苷、α羟基酸、尿囊素、透明质酸及衍生物、isolutrol、凝血酸、乙醇酸、精氨酸、葡萄糖胺抗坏血酸酯、棕榈酸抗坏血酸酯、水杨酸、鼠尾草酸、α硫辛酸、γ亚麻酸(GLA)、泛醇、丙酸视黄酯、棕榈酸视黄酯、糠基腺嘌呤、视黄醛、铜肽、艾地苯醌、二甲基氨基乙醇(DMAE)、烟酰胺、β-葡聚糖、棕榈酰五肽-4、棕榈酰低聚肽/四肽-7、易色新(ethocyn)、神经酰胺、苯丙氨酸、葡糖醛酸内酯、L-肉毒碱、hydroxylapetite、棕榈酰三肽-3、弗司扣林(forskolin)、氧化锌、α-红没药醇、丁子香酚、水飞蓟素、大豆异黄酮、桃叶珊瑚苷、梓醇、来自卡密松山金车(Arnica chamissonis)的伪愈创内酯(pseudoguaianolide)、迷迭香酸、迷迭香酚、水杨酸类(如水杨苷、水杨醇和水杨酸)、毒甾醇(taxasterol)、α-山莴苣醇、异山莴苣醇、蒲公英苷(taraxacoside、ceremide)、熊果苷、姜醇、姜烯酚(shagaol)、金丝桃素(hypercin)、弹性蛋白、胶原及其肽。
特别优选的生物活性化合物,包括利多卡因、双氯芬酸、酮咯酸、丙胺卡因、卤倍他索、氢化可的松及其组合。
应理解生物活性化合物的可药用、可用于保健营养品或可用于药妆品的衍生物包含在本发明的范围内。
术语“可药用、可用于保健营养品或可用于药妆品的衍生物”包括但不限于可药用、可用于保健营养品或可用于药妆品的盐、酯、这些酯的盐、醚或包括前药和代谢物的任何其它衍生物,当向所需要的对象(例如,患者、人或动物)施用时,所述衍生物能够直接或间接地提供如本文中所述的生物活性化合物。
本文中使用的术语“可药用、可用于保健营养品或可用于药妆品的盐”是指在合理医学判断的范围内,适用于与人或低等动物的组织接触而没有过度毒性、刺激性、过敏反应等,并且与合理的效益/风险比相称的那些盐。可药用、可用于保健营养品或可用于药妆品的盐是本领域中所熟知的。例如,S.M.Berge等在J.Pharmaceutical Sciences,66:1-19,1977中详细描述了可药用、可用于保健营养品或可用于药妆品的盐。可药用、可用于保健营养品或可用于药妆品的无毒酸加成盐的实例是氨基与无机酸或有机酸形成的盐,所述无机酸例如为盐酸、氢溴酸、磷酸、硫酸和高氯酸,所述有机酸例如为乙酸、草酸、马来酸、酒石酸、柠檬酸、琥珀酸或丙二酸,或者是通过利用本领域中使用的其它方法(例如离子交换)而形成的盐。其它的可药用盐包括己二酸盐、藻酸盐、抗坏血酸盐、天冬氨酸盐、苯磺酸盐、苯甲酸盐、硫酸氢盐、硼酸盐、丁酸盐、樟脑酸盐(camphorate)、樟脑磺酸盐、柠檬酸盐、环戊烷丙酸盐、二葡萄糖酸盐、十二烷基硫酸盐、乙磺酸盐、甲酸盐、富马酸盐、葡庚糖酸盐、甘油磷酸盐、葡糖酸盐、半硫酸盐(hernisulfate)、庚酸盐、己酸盐、氢碘酸盐、2-羟基-乙磺酸盐、乳糖酸盐、乳酸盐、月桂酸盐、十二烷基硫酸盐、苹果酸盐、马来酸盐、丙二酸盐、甲磺酸盐、2-萘磺酸盐、烟酸盐、硝酸盐、油酸盐、草酸盐、棕榈酸盐、帕莫酸盐、果胶酸盐(pectinate)、过硫酸盐、3-苯基丙酸盐、磷酸盐、苦味酸盐、新戊酸盐、丙酸盐、硬脂酸盐、琥珀酸盐、硫酸盐、酒石酸盐、硫氰酸盐、对甲苯磺酸盐、十一烷酸盐、戊酸盐等。代表性的碱金属盐或碱土金属盐包括钠、锂、钾、钙、镁等。适当时其它可药用盐还包括无毒的铵盐、季铵盐和使用抗衡离子(如卤离子、氢氧根、羧酸根、硫酸根、磷酸根、硝酸根、低级烷基磺酸根和芳基磺酸根)形成的胺阳离子。
术语“可药用、可用于保健营养品或可用于药妆品的酯”是指在体内水解的酯类,并且包括容易在人体内分解留下母体化合物或其盐的那些酯类。合适的酯基包括例如衍生自可药用、可用于保健营养品或可用于药妆品的脂肪族羧酸的那些酯基,特别是链烷酸、链烯酸、环烷酸和链烷二酸,其中每个烷基或烯基部分有利地具有不多于6个碳原子。具体的酯的实例包括甲酸酯、醋酸酯、丙酸酯、丁酸酯、丙烯酸酯和乙基琥珀酸酯。
本文中所使用的术语“可药用、可用于保健营养品或可用于药妆品的前药”指生物活性化合物的那些前药,在合理医学判断的范围内,其适于与对象的组织接触而没有过度毒性、刺激性、过敏反应等,与合理的效益/风险比相称,并可有效用于其预期用途,还可包括本发明化合物的两性离子形式。术语“前药”是指在体内迅速转化释放上面分子式的母体化合物的化合物,例如通过在血液中水解。T.Higuchi和V.Stella,Pro-drugsas Novel Delivery Systems,A.C.S.Symposium Series第14卷,以及Edward B.Roche编,Bioreversible Carriers in Drug Design,AmericanPharmaceutical Association and Pergamon Press,1987中提供了深入的讨论。
生物活性化合物可以实现期望的生物效果的任何必须量存在。典型地,生物活性化合物以下述量存在:载体组合物总浓度的约0.001%w/w至最高约15%w/w、至最高约10%w/w、至最高约5%w/w、至最高约2%w/w、至最高约1%w/w,或者约0.001%w/w至最高约0.05%w/w、至最高约0.1%w/w、至最高约1%w/w、至最高约2%w/w、至最高约5%w/w,或者约1%w/w、约2%w/w或约5%w/w。
优势
出乎意料地发现,与包含所述电子转移剂的磷酸化合物和另一些种类的溶剂(如,乙醇或表面活性剂(具有明确的极性和非极性区域))的载体组合物相比,选自下述的溶剂的存在可增加电子转移剂的磷酸化合物的溶解性:N,N-二甲基甲酰胺(DMF)、N-甲基-2-吡咯烷酮(NMP)、二甲亚砜(DMSO)、N,N-二甲基乙酰胺(DMAC)、二甲基亚砜、二氧六环六甲基磷酰三胺、碳酸丙烯酯、γ-丁内酯、单甲基醚乙酸酯、乳酸乙酯、1,3二甲基-2-咪唑啉酮(异山梨醇二甲醚,或DMI)、肉豆蔻酸异丙酯、蓖麻醇酸丙二醇酯、异壬酸异壬酯和脂肪酸的蔗糖酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、异硬脂酸异丙酯、己二酸二异丙酯、二聚酸二异丙酯、马来酸大豆油、棕榈酸辛酯、乳酸十六烷基酯、甘油、辛二醇、角鲨烯、红没药醇、苯甲醇、蓖麻醇酸十六烷基酯、醋酸十六烷基酯、小麦胚芽甘油酯、乳酸肉豆蔻酯、油酸癸酯、羊毛脂酸异丙酯、四硬脂酸季戊四醇酯、二辛酸/二癸酸新戊二醇酯、异壬酸异壬酯、异壬酸异十三烷基酯、肉豆蔻酸肉豆蔻酯、辛基十二烷醇和羟基硬脂酸辛酯。
还发现,尤其当溶剂作为载体组合物用于生物活性化合物时,可增加电子转移剂的磷酸化合物的稳定性。
因此,本发明的载体组合物能有效地:
(a)在必要时增加电子转移剂的磷酸化合物的含量。电子转移剂的磷酸化合物的增加量可增加生物活性化合物的有效渗透。
(b)相对于水相使溶剂浓度(基于上述选定的溶剂组)降低。这有益于亲水分子(如蛋白质)的结构保真度,这些分子在有机溶剂存在时可发生变性和/或沉淀。在水相中相对的增加还能够增加生物活性化合物的浓度,这些化合物是亲水的,相反在比较例乙醇制剂中具有较差的溶解性。
(c)潜在地更安全和更简单的工作环境,这是因为所述溶剂是不可燃的。
(d)更加稳定的溶剂溶液用于贮藏电子转移剂的磷酸化合物。
因此,本发明的载体组合物可改善生物活性化合物的递送,尤其是经由肠内或胃肠外的途径施用的那些。所述载体组合物还可经由肠内或胃肠外的施用途径递送生物活性化合物,之前这可能不是那么容易。
本发明的载体组合物还可以改善生物活性化合物在对象中的生物利用度。
本发明的载体组合物还可以用在治疗对象的病症的方法中,所述方法包括在本发明载体组合物中施用有效量的生物活性化合物。所述载体组合物还可用于递送生物活性化合物以治疗对象中的病症。所述病症包括可以通过与所述载体组合物一起配制的生物活性化合物来治疗的那些病症。
通常,术语“治疗”意指影响对象、组织或细胞以获得期望的药理学的和/或生理学的效果,其包括:(a)抑制感染或疾病,如通过阻止其发展或进一步发展;(b)缓解或减轻感染或疾病的影响,如通过引起感染或疾病的影响的消退;(c)降低感染或疾病的发生率或者(d)预防来自存在于易患感染或疾病或者处于其危险中的对象、组织或细胞的感染或疾病,但是还未被诊断为保护性药理学的和/或生理学的效果,所以感染或疾病没有在对象、组织或细胞中发展或出现。
术语“对象”指任何动物,尤其是哺乳动物,如人,所述对象患有需要用式(I)的化合物治疗的疾病。
术语“施用”应被理解为向遭受待治疗或预防的疾病或病症或者处于其危险中的对象提供本发明的化合物或药物组合物。
术语“治疗有效量”指能引起对象、组织或细胞的生物学或医学反应的式(I)之化合物的量,该反应为研究者、兽医、医师、或其它临床医生所寻找的。
施用途径
生物活性化合物可通过任何施用途径进行递送。
施用途径可根据效果粗略分为三种类型,即“表面”(“topical”),其期望效果是局部的,因此物质直接施用到其所期望起作用处;“肠内”,其期望效果是全身的(非局部的),因此物质通过消化道提供;以及“胃肠外”,其期望效果是全身的,因此物质通过除消化道以外的途径提供。
美国食品和药物管理局承认111种不同的施用途径。以下是施用途径的实例的非限制性清单。
具有局部效果的表面施用途径的实例包括表皮(到皮肤上)和玻璃体内(到眼睛上)。
具有全身(非局部)效果的肠内施用途径的实例包括涉及胃肠道任何部分的任何施用形式,例如口服(到口内)、鼻内(到鼻内)、直肠(到直肠内)和阴道(到阴道内)。
通过注射、输注或扩散的具有全身效果的肠胃外施用途径的实例包括静脉内(到静脉内)、动脉内(到动脉内)、肌内(到肌肉中)、心脏内(到心脏内)、皮下(到皮肤下)、经皮(通过针-穿刺到皮肤内)、皮内(到皮肤自身内)、囊内(到椎管内)、腹膜内(输注或注射到腹膜内)、膀胱内输注(输注到膀胱内)、硬膜内(注射或输注到硬膜外空间内)、透皮(通过完整皮肤扩散)、透粘膜(通过粘膜扩散)、吹入法(通过鼻扩散)、吸入(通过口扩散)、舌下(舌下)、以及口含(通过牙龈附近面颊吸收)。
由于所述溶剂的存在可增加电子转移剂的磷酸化合物的溶解性,继而可有效地增加生物活性化合物的渗透,所以优选胃肠外施用途径。但是,本发明的载体还可适合于肠内施用。
根据本发明的制剂可以是任何合适的施用形式(例如,参见Pharmaceutics and Pharmacy Practice,J.B.Lippincott Company,Philadelphia,Pa.,Banker和Chalmers编,第238-250页(1982))。制剂可以由制药领域熟知的任何方法制备,如Remington J.P.,The Scienceand Practice of Pharmacy,A.R.Gennaro编,第20版,Lippincott,Williams and Wilkins Baltimore,Md.(2000)中所描述的。这些方法包括将生物活性化合物与载体组合,然后使制剂成形为所期望产品(如果需要)的步骤。
剂型
包含载体组合物和生物活性化合物的制剂可被制备成任何合适的剂型用于肠内和胃肠外施用。
本领域技术人员将很容易理解哪种合适的剂型用于肠内和胃肠外施用。
用于肠内施用的合适的剂型包括但不限于胶囊、片剂、丸剂或特定片剂(如,含片、舌下片、咀嚼片或口腔崩解片)。另一个合适的剂型的实例是可食用的薄膜。
用于肠内施用的另一些合适的剂型包括液体溶液或悬液。合适的液体溶液或悬液可以是饮料形式的剂型,如含有电解质(例如,gatorade)或糖浆和酏剂的运动饮料。其它合适的液体溶液或悬液剂型包括鼻腔递送溶液和口服悬液。
用于肠内施用的剂型还可以是粉末或固体晶体,在施用前可溶解于或悬浮于液体中。可替换地,所述粉末可被直接消耗或者添加到食物或饮料产品中消耗。
在另一个实施例中,用于肠内施用的剂型可以是食物(在消耗该食物前将组合物加入其中)。例如,食物产品可以是威化(bar)(如健康威化)、谷类、面包(如强化面包)、糕点、膏(如黄油)、乳制品(如奶酪或牛奶)或者任何其它合适的食物产品。
当组合物具有不愉快的味道时,为了掩饰糟糕的味道可将添加剂与足够的香料添加到剂型中(例如掩蔽剂)。
用于胃肠外施用的合适之剂型的例子包括但不限于可注射物(即溶液、悬液乳剂和用于重建的干粉)、乳房内的浸剂、阴道内的递送系统、储库和其它贴片和插入物。
制备载体组合物
本发明的载体组合物可由多种技术制备。
制备载体组合物的一个方法包括将电子转移剂的磷酸化合物与溶剂组合并再加入水。根据生物活性化合物的溶解性和稳定性,可将其溶于水相或溶剂相中。通常,使溶剂加热至30℃或更高,然后将电子转移剂的磷酸化合物溶解于该溶剂。如果生物活性化合物在该极性非质子溶剂中可溶,则在将电子转移剂的磷酸化合物与极性非质子溶剂组合时,将生物活性化合物加入,制剂余量由水组成。
所述载体组合物还可任选包含一种或更多种赋形剂。本领域技术人员理解可以包含在本发明载体组合物或制剂中的合适的赋形剂。其它赋形剂的选择将取决于生物活性化合物的特性和所用的施用形式。其它赋形剂的实例包括水、增稠剂或胶凝剂、表面活性剂、缓冲液、缓和剂(有机溶剂)、甜味剂、崩解剂、调味剂(flavour)、着色剂、芳香剂(fragrance)、电解质、pH调节剂、外观改良剂、薄膜发泡聚合物等。合适的崩解剂包括玉米淀粉、甲基纤维素、聚乙烯吡咯烷酮、黄原胶、膨润土、藻酸或琼脂。合适的调味剂包括薄荷油,冬青油,樱桃、桔子或覆盆子香料。相对高浓度的有机溶剂可避免进一步添加防腐剂的需要;但是,如果认为必要时,可添加本领域人员技术人员已知的任何合适防腐剂,包括但不限于苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯和亚硫酸氢钠。赋形剂可以在制备过程的任何步骤期间被加入,通常是在加入水之后。
一种或更多种赋形剂以下述量存在:载体组合物总浓度的0%w/w至最高约10%w/w、至最高约5%w/w、至最高约3%w/w,或者约3%w/w至约5%w/w。
附图说明
参照以下附图对实施例进行描述,其中:
图1为提供与实施例1的比较研究相关的结果的图;
图2为提供与实施例2相关的结果的图;
图3为提供与实施例2相关的结果的图;和
图4为提供与实施例3相关的结果的图。
实施例
现在将参照以下非限制性实施例对本发明的多种实施方案/方面进行描述。
实施例1
与包含生育酚基磷酸酯(TPM)和多种溶剂的载体组合物一起配制的辅酶Q10(CoQ10)的皮肤吸收的研究
方法
确定Nivea
(对照)包含0.05w/w%CoQ10。
基于此,测试了根据上述方法制备的下列三种制剂。比较例乙醇制剂(pH4.5)
制剂(A)(pH4.5)
制剂(B)(pH4.5)
使用Franz扩散池体外测试制剂
由腹壁形成术手术获得全厚度人皮肤以用于12ml立式Franz扩散池(Permegear,PA)。除去全部下层脂肪和结缔组织。皮肤平铺在铝箔片之间冷冻并贮藏在-20℃直到实验当天早晨。
Franz池使用PBS作为接受体溶液(12ml),表面面积为1.77cm2。在实验期间,池维持在32℃。使用的每个制剂的限定剂量(每池40μl)来模拟体内所使用的大剂量。使用24个池,每个处理组n=4~5池。对接收溶液定期采样4小时以测定CoQ10的经皮吸收。在4小时的时期结束时,将皮肤从Franz池中移出并将表面剩余的未吸收药物小心地洗掉。然后,使用1-丙醇从该皮肤中提取吸收的CoQ10。将来自扩散池的时间点所对应的皮肤提取物加载到UPLC板上使用经过验证的方法定量CoQ10含量。
表1
结果
与未处理的皮肤样品内的内源水平相比,比较例乙醇制剂和本发明的制剂(A)和(B)增加了在皮肤中所检测的CoQ10的量(参见图1)。这些增加量为106%~238%(见下表1)并且全都是统计学上显著的(p<0.005)。相比之下,经Nivea
处理后的CoQ10的平均水平仅增加了~10%,认为不显著。比较例乙醇制剂和本发明的制剂(A)和(B)比Nivea
显著(p<0.002)增加了CoQ递送至皮肤的量。这些增加量为190%~310%。
结论
本实施例表明包含TPM和本发明的溶剂的载体组合物提供了针对包含TPM和乙醇的载体组合物的有效且更稳定的替代物。
实施例2
与TPM和乳酸乙酯一起配制的胰岛素的药效学研究
方法
阴性对照——KY胶冻剂
用于监测由在大鼠上擦拭表面制剂的物理过程而引起的血糖降低。压力可引起血糖大范围波动。
阳性对照——使用乙醇作为溶剂的TPM/胰岛素
由Phosphagenics创造的标准TPM/胰岛素制剂用于疗效的I期和II期临床试验。该制剂可重现地降低了STZ大鼠模型的血糖。该制剂在水中包含2.26mg/ml胰岛素、30%乙醇作为溶剂、2%TPM(2∶1)和1%羟丙基纤维素H。
TPM/胰岛素EL 1~3
测试包含乳酸乙酯(作为乙醇的替代物)的三种不同的TPM/胰岛素制剂。这些制剂(pH都为7)包含:
IN#1:在水中的12mg/ml胰岛素、4%乳酸乙酯、4%TPM(2∶1)和1%羟丙基纤维素H。
IN#2:在水中的12mg/ml胰岛素、15%乳酸乙酯、2%TPM(2∶1)和1%羟丙基纤维素H。
IN#3:在水中的2.26mg/ml胰岛素、4%乳酸乙酯、4%TPM(2∶1)和1%羟丙基纤维素H。
治疗应用
本研究被设计用于测试新的TPM/胰岛素制剂(包含乳酸乙酯)对经链脲霉素处理的糖尿病大鼠的葡萄糖稳态的影响,从而确定最佳剂量。动物(n=15)为雄性且10~12周龄。所有的动物重量>300g,并且在禁食状态下循环葡萄糖浓度>10mmol/L(平均禁食葡萄糖浓度为22.20±2.96mmol/L)。本研究的关键终点是5小时胰岛素耐量试验期间血糖的水平(如下述指导进行)。
施用链脲霉素
在使用前即刻将链脲霉素(STZ)(Sigma chemicals)溶于柠檬酸钠缓冲液(0.1mol/L,pH 4.5)中,通过以50mg/kg的量单一腹腔内注射STZ诱导糖尿病。STZ注射后24小时,如果大鼠血糖大于16mmol/L,则它们被认为患有糖尿病且包含在本研究中。在全部组中,通过从尾部采血获得局部样品进行血糖测量。在测试前,将动物放置5天,然后施用STZ。
应用凝胶
应用该制剂前24小时,将动物麻醉并从背部刮下~30cm2的皮,为了加强制剂的吸收,避免对皮肤的任何损伤。以12mg/cm2的剂量施用TPM/胰岛素通过刮过的区域。除去皮后24小时进行胰岛素耐量试验。在每个处理后和下一个处理之前,使动物恢复3天。
ITT(胰岛素耐量试验)
在应用胰岛素或对照制剂之前,将动物禁食2小时。在制剂施用后0、30、60、90、120、180、240和300分钟自尾部取局部血液样品。使用葡萄糖棒(glucose stick)(AccuChek,Roche Diagnostics)在同一时间点测定血糖水平。
结果
所有的TPM/胰岛素制剂都在糖尿病小鼠中引起了血糖浓度的显著降低(参见图2)。施用后30分钟,血糖从起始值显著降低(p<0.05),并且在整个实验期间保持降低。本文所测试的制剂之间在降低血糖上没有差别,如曲线下面积所证明的(参见图3)。因此,低至4%浓度的乳酸乙酯与30%浓度的乙醇看上去一样有效。增加的乳酸乙酯制剂的亲水相还使得增加了蛋白质浓度,但是在这个特定的制剂中,增加的胰岛素含量没有转化成增加的疗效。
结论
乳酸乙酯能够替换TPM/胰岛素制剂中的乙醇而不削弱经皮递送。有意义的是,可使用低至2%或4%浓度的乳酸乙酯来替换30%乙醇,这潜在地允许亲水性药物更高的浓度和更多水环境以确保不稳定分子(如蛋白质)的保真度(fidelity)。
实施例3
与TPM和乳酸乙酯一起配制的双氯芬酸的经皮递送研究
测试包含TPM和乳酸乙酯的四种不同的双氯芬酸制剂。使用了双氯芬酸二乙胺(D)和钠盐(DNa)两种形式。制剂如下:
DICLO#1:在水中的5%双氯芬酸二乙胺、1%TPM(6∶4)、2%乳酸乙酯、1%羟丙基纤维素H。
DICLO#2:在水中的5%双氯芬酸钠盐、1%TPM(6∶4)、12%乳酸乙酯、1%羟丙基纤维素H。
DICLO#3:在水中的5%双氯芬酸钠盐、1%TPM(6∶4)、22%乳酸乙酯、1%羟丙基纤维素H。
DICLO#4:在水中的5%双氯芬酸二乙胺、1%TPM(6∶4)、12%乳酸乙酯、1%羟丙基纤维素H。
使用Franz扩散池体外测试制剂
由Monash University School of Biological Sciences伦理委员会批准同意动物实验(方案号BAM/B/2006/31)。在12ml立式Franz扩散池(Permegear,PA)中使用全厚度大鼠腹部皮肤。通过使用CO2气体窒息处死大鼠,将腹部区域小心地刮毛并切除。除去全部下层脂肪和结缔组织。将皮肤平铺在铝箔片之间冷冻并贮藏在-20℃直到实验当天早晨。
Franz池使用PBS作为接受体溶液(12ml),表面面积为1.77cm2。在实验期间,池维持在32℃。使用的每个制剂的限定剂量(每池40μl)模拟体内所使用的大剂量。使用24个池,每个处理组n=4~5池。对接收溶液定期采样4小时以测定双氯芬酸的经皮吸收。将来自扩散池的时间点所对应的皮肤提取物加载到UPLC板上使用经过验证的方法定量双氯芬酸含量。
结果
包含乳酸乙酯的制剂能够诱导的双氯芬酸经皮递送。该分子的二乙胺和钠两种形式能够通过皮肤。有意思的是,具有最低乳酸乙酯浓度(2%)的制剂能够产生最佳的经皮递送。
实施例4:制剂实施例
下列为三种制剂实施例。
1.日霜
水(纯化水)
乙酰八肽-3
甲氧基肉桂酸乙基己基酯
甘油
C12~15烷基苯甲酸酯
鲸蜡硬脂醇(和)鲸蜡硬脂醇醚-20(cetearyl alcohol and ceteareth-20)2-羟基-4-甲氧基二苯甲酮(Benzophenone-3)
水杨酸辛酯
丙二醇
d-α-生育酚磷酸酯(单磷酸酯和二磷酸酯混合物)
硬脂酸甘油酯(和)PEG-100硬脂酸酯
聚二甲基硅氧烷
辛二醇
苯氧乙醇
生育酚
黄原胶
羟乙基纤维素
甜橙(Citrus Aurantium Dulcis)(橘)油
肌肽
视黄醇
聚山梨酯20
茶(Camellia Sinensis)(绿茶)提取物
檀香(Santalum Album)(檀香)油
EDTA二钠
泛琨
d-苧烯
金合欢醇
沉香醇
2.晚霜
水(纯化水)
甘油
C12~15烷基苯甲酸酯
鲸蜡硬脂醇(和)鲸蜡硬脂醇醚-20
辛酸/癸酸甘油三酯
乙酰八肽-3
聚二甲基硅氧烷
d-α-生育酚磷酸酯(单磷酸酯和二磷酸酯混合物)
十六醇
辛二醇
生育酚
视黄醇
聚山梨酯20
肌肽
羟乙基纤维素
三乙醇胺
黄原胶
硅酸镁铝
泛醌
苯氧乙醇
EDTA二钠
3.抗皱冰凝(Wrinkle freeze)
水
库拉索芦荟(Aloe barbardensis)[芦荟(aloe vera)]鲸蜡硬脂醇橄榄油酸酯
油酸甘油酯
Decyl cuvate
d-α-生育酚磷酸酯(单磷酸酯和二磷酸酯混合物)
角鲨烯[橄榄]
月桂亚氨基二丙酸生育酚磷酸酯二钠盐
生育酚[α、δ、γ、β天然维生素E]
支链淀粉
稻(Oryza Sativa)(米)糠油(和)生育三烯酚
β-胡萝卜素[维生素A]
亚油酸甘油酯[Ω6脂肪酸维生素F]
氨基丁酸
单硬脂酸甘油酯
红没药醇
白藜芦醇
维生素A棕榈酸酯
胆骨化醇[维生素D3]
鹿角菜胶
甲萘醌[维生素K]
抗坏血酸棕榈酸酯[维生素C]
乳酸
苯氧乙醇
苯甲醇
脱氢乙酸
本说明书中,除非上下文另有要求,否则词语“包含”和“含有”意指“包括”,即当将本发明描述或定义为包含指定的特征时,相同发明的不同实施方案还可以包括另外的特征。
尽管本发明通过实施例和其有关可能的实施方案已被描述,但应理解,可对其进行修饰和改良,而不背离本发明的范围。
Claims (43)
1.一种用于递送生物活性化合物的载体组合物,其包含单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物和溶剂,其中所述单-(生育酚基)磷酸化合物和所述二-(生育酚基)磷酸化合物的比例按重量计在4:1至1:4的范围内,所述单-(生育酚基)磷酸化合物选自:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐或单-(生育酚基)磷酸酯二钠盐,并且所述二-(生育酚基)磷酸化合物选自:二-(生育酚基)磷酸酯或二-(生育酚基)磷酸酯单钠盐,所述溶剂选自:N-甲基-2-吡咯烷酮、乳酸乙酯和1,3二甲基-2-咪唑啉酮,其中所述溶剂的浓度为所述载体组合物总浓度的0.05%w/w至最高30%w/w。
2.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物和/或所述二-(生育酚基)磷酸化合物是非中和的形式。
3.根据权利要求2所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的pH为2至4。
4.根据权利要求2所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的pH为2至3。
5.根据权利要求2所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的pH为2。
6.根据权利要求2所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的pH为3。
7.根据权利要求1所述的载体组合物,其中所述载体组合物中包含的单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的比例按重量计为6:4至8:2。
8.根据权利要求1所述的载体组合物,其中所述载体组合物中包含的单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的比例按重量计为6:4。
9.根据权利要求1所述的载体组合物,其中所述载体组合物中包含的单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的比例按重量计为8:2。
10.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为所述载体组合物总浓度的0.01%w/w至20%w/w。
11.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为所述载体组合物总浓度的0.01%w/w至10%w/w。
12.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为所述载体组合物总浓度的0.01%w/w至5%w/w。
13.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为所述载体组合物总浓度的0.05%w/w至2%w/w。
14.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为载体组合物总浓度的0.1%w/w。
15.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为载体组合物总浓度的1%w/w。
16.根据权利要求1所述的载体组合物,其中所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的量为载体组合物总浓度的5%w/w。
17.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高20%w/w。
18.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高10%w/w。
19.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高5%w/w。
20.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高3%w/w。
21.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高2%w/w。
22.根据权利要求1所述的载体组合物,其中所述溶剂的浓度为0.05%w/w至最高1%w/w。
23.单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物和溶剂在制备用于递送生物活性化合物的载体组合物中的用途,所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的比例按重量比计在4:1至1:4的范围内,所述单-(生育酚基)磷酸化合物选自:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐或单-(生育酚基)磷酸酯二钠盐,并且所述二-(生育酚基)磷酸化合物选自:二-(生育酚基)磷酸酯或二-(生育酚基)磷酸酯单钠盐,所述溶剂选自:N-甲基-2-吡咯烷酮、乳酸乙酯和1,3二甲基-2-咪唑啉酮,其中所述溶剂的浓度为所述载体组合物总浓度的0.05%w/w至最高30%w/w。
24.一种制备用于递送生物活性化合物的载体组合物的方法,其包括将单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物和溶剂组合的步骤,所述单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的比例按重量比计在4:1至1:4的范围内,所述单-(生育酚基)磷酸化合物选自:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐或单-(生育酚基)磷酸酯二钠盐,并且所述二-(生育酚基)磷酸化合物选自:二-(生育酚基)磷酸酯或二-(生育酚基)磷酸酯单钠盐,所述溶剂选自:N-甲基-2-吡咯烷酮、乳酸乙酯和1,3二甲基-2-咪唑啉酮,其中所述溶剂的浓度为所述载体组合物总浓度的0.05%w/w至最高30%w/w。
25.一种包含根据权利要求1所述的载体组合物和生物活性化合物的制剂。
26.根据权利要求25所述的制剂,其中所述生物活性化合物是药物、保健营养品或者药妆品。
27.根据权利要求25所述的制剂,其中所述生物活性化合物是利多卡因、双氯芬酸、酮咯酸、丙胺卡因、卤倍他索、氢化可的松或其组合。
28.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高15%w/w。
29.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高10%w/w。
30.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高5%w/w。
31.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高2%w/w。
32.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高1%w/w。
33.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高0.05%w/w。
34.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的0.001%w/w至最高0.1%w/w。
35.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的1%w/w。
36.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的2%w/w。
37.根据权利要求25所述的制剂,其中所述生物活性化合物的量为所述载体组合物总浓度的5%w/w。
38.一种制备根据权利要求25所述的制剂的方法,其包括将生物活性化合物添加到权利要求1的载体组合物的步骤。
39.根据权利要求1所述的载体组合物在制造用于治疗对象病症的药物中的用途,其中所述药物配制为在根据权利要求1所述的载体组合物中施用有效量的生物活性化合物。
40.根据权利要求1所述的载体组合物在制造用于递送生物活性化合物以治疗对象病症的药物中的用途。
41.根据权利要求1所述的载体组合物在制造用于改善生物活性化合物的递送和/或生物利用度的药物中的用途。
42.根据权利要求41所述的用途,其中所述递送是肠内或胃肠外施用途径。
43.选自以下的溶剂用于增加单-(生育酚基)磷酸化合物与二-(生育酚基)磷酸化合物的混合物的溶解性和/或稳定性的用途:N-甲基-2-吡咯烷酮、乳酸乙酯和1,3二甲基-2-咪唑啉酮,其量为0.05%w/w至最高30%w/w,其中所述单-(生育酚基)磷酸化合物和所述二-(生育酚基)磷酸化合物的比例按重量计在4:1至1:4的范围内,所述单-(生育酚基)磷酸化合物选自:单-(生育酚基)磷酸酯、单-(生育酚基)磷酸酯单钠盐或者单-(生育酚基)磷酸酯二钠盐,并且所述二-(生育酚基)磷酸化合物选自:二-(生育酚基)磷酸酯或二-(生育酚基)磷酸酯单钠盐。
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EP2531047A4 (en) | 2010-02-05 | 2014-03-19 | Phosphagenics Ltd | CARRIER WITH AN UNINUTRALIZED TOCOPHERYL PHOSPHATE |
MX2012011355A (es) | 2010-03-30 | 2012-11-30 | Phosphagenics Ltd | Parche de suministro transdermico. |
US9561243B2 (en) * | 2011-03-15 | 2017-02-07 | Phosphagenics Limited | Composition comprising non-neutralised tocol phosphate and a vitamin A compound |
CN104042502B (zh) * | 2014-06-10 | 2016-04-27 | 刘佰岭 | 一种深层渗透吸收并促进新陈代谢延缓衰老的护肤组合物 |
MA41688A (fr) * | 2014-10-16 | 2017-08-22 | Honeywell Int Inc | Procédé de séparation de fluorure d'hydrogène de mélanges fluorure d'hydrogène/hydrocarbures halogénés au moyen de liquides ioniques |
CA3007587C (en) | 2015-12-09 | 2023-12-05 | Phosphagenics Limited | Pharmaceutical formulation |
WO2017214497A1 (en) | 2016-06-10 | 2017-12-14 | Clarity Cosmetics Inc. | Non-comedogenic hair and scalp care formulations and method for use |
JP7198754B2 (ja) | 2016-12-21 | 2023-01-04 | アベーチョ バイオテクノロジー リミテッド | 方法 |
WO2019148087A1 (en) * | 2018-01-29 | 2019-08-01 | Duke University | Compositions and methods of enhancing 5-hydroxytryptophan bioavailability |
CN115916183A (zh) * | 2020-01-10 | 2023-04-04 | 布里奥里生物技术公司 | 含有罗非昔布的局部用组合物及其制备和使用方法 |
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CN1684709A (zh) * | 2002-08-09 | 2005-10-19 | 生命健康科学有限公司 | 局部用的药物学载体 |
WO2008034178A1 (en) * | 2006-09-21 | 2008-03-27 | Salvatore Iemma | Topical depilating composition |
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US20190298834A1 (en) | 2019-10-03 |
AU2011213484A1 (en) | 2012-08-23 |
JP5859981B2 (ja) | 2016-02-16 |
EP2531219A1 (en) | 2012-12-12 |
WO2011094822A1 (en) | 2011-08-11 |
ZA201205832B (en) | 2013-05-29 |
EP2531219A4 (en) | 2015-01-14 |
CA2788675C (en) | 2018-01-16 |
CN102740891A (zh) | 2012-10-17 |
JP2017141294A (ja) | 2017-08-17 |
AU2011213484B2 (en) | 2015-07-09 |
CA2788675A1 (en) | 2011-08-11 |
IL221185A (en) | 2017-12-31 |
KR20120115991A (ko) | 2012-10-19 |
NZ601528A (en) | 2015-04-24 |
RU2012133467A (ru) | 2014-02-10 |
US20120283233A1 (en) | 2012-11-08 |
JP2015193640A (ja) | 2015-11-05 |
SG182836A1 (en) | 2012-09-27 |
US20160375136A1 (en) | 2016-12-29 |
JP2013518822A (ja) | 2013-05-23 |
MX2012009068A (es) | 2012-09-07 |
BR112012019508A2 (pt) | 2018-03-13 |
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