CN112955124A - 具有精确的活性物溶出谱的口腔膜组合物和剂型 - Google Patents
具有精确的活性物溶出谱的口腔膜组合物和剂型 Download PDFInfo
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- CN112955124A CN112955124A CN201980073077.2A CN201980073077A CN112955124A CN 112955124 A CN112955124 A CN 112955124A CN 201980073077 A CN201980073077 A CN 201980073077A CN 112955124 A CN112955124 A CN 112955124A
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Abstract
本文中公开了用于递送一种或更多种活性物的单独单位剂量的口腔膜,所述膜具有精确计算和受控的活性物溶出谱。可使用广泛多种活性物,包括例如氯巴占、地西泮或利鲁唑。还公开了通过施用本文中公开的口腔膜来治疗多种疾病和病症例如癫痫和癫痫发作的方法。
Description
技术领域
本公开内容涉及用于递送平均颗粒尺寸D90小于约160微米的一种或更多种活性物例如氯巴占的单独单位剂量的口腔膜(oral film),其中所述口腔膜具有精确的、受控的活性物溶出速率,以及通过向有此需要的患者施用所述口腔膜来治疗包括癫痫和癫痫发作的多种疾病的方法。
背景技术
可将活性成分例如药物(drug)或药品(pharmaceutical)制备成片剂形式以允许准确和一致的给药。然而,这种制备和分配药物的形式具有许多缺点,包括必须添加大比例的辅料以获得能够处理的尺寸、较大的药物形式需要额外的储存空间、以及分配包括对片剂进行计数,其具有不准确的趋势。此外,估计多达人口的28%的许多人难以吞咽片剂。尽管作为克服吞咽困难的方式,可将片剂打碎成较小的片或者甚至压碎,但是对于许多片剂或丸剂形式,这不是合适的解决方案。例如,单独或与食物混合压碎或破坏片剂或丸剂形式以促进摄取也可破坏控释特性。
作为片剂和丸剂的替代物,可使用膜来承载例如药物、药品等的活性成分。然而,历史上膜以及利用该剂型制备药物递送系统的过程二者都在制剂、加工和药代动力学领域呈现了一些独特的挑战。特别地,膜和从中切割的口腔剂量单元具有许多不利的特性,使得它们无法在实践中使用,直到近年来进步使得膜成为高度期望的剂型为止。
与传统的片剂和丸剂一样,以口腔膜形式施用的药物的吸收取决于许多因素,包括药物物质从膜中的释放、药物物质在生理条件下的溶出和增溶。在一种方式中,体外溶出度是体内性能的相关预测因子。立即释放口腔剂型的体外溶出测试用于评估批次之间药物产品的品质;指导新制剂的开发;以及随着产品发生变化确保持续的产品品质、生物等效性和性能。
由于口腔膜溶解快速,因此对于这些快速溶解的产品,需要在置于液体中之后并且以非常小的时间间隔时几乎立即能够进行精确测量的改善的溶出测试。
发明内容
公开了用于以单独单位剂量递送期望量的平均颗粒尺寸D90小于约160微米的活性物的口腔膜。所述膜包含:水溶性聚合物基质、水溶胀性聚合物基质、或水溶性且水溶胀性聚合物基质;以及添加剂。所述活性物可选自广泛多种活性物,例如本文所公开的那些,包括氯巴占、利鲁唑、地西泮、或其任意组合。所述添加剂可选自:甜味剂、矫味剂、味道增强剂、填充剂、增塑剂、染料、色素、渗透增强剂、缓冲剂、防腐剂、二氧化硅、抗黏剂、及其任意组合。在将膜置于介质中后,在约3分钟之后多于约2%的活性物溶于介质中。
活性物的平均颗粒尺寸D90小于约160微米、小于约120微米、小于约100微米、小于约80微米、小于约50微米、小于约20微米、小于约10微米,或者D90为约8微米。任选地,活性物的平均颗粒尺寸D50还小于约30、小于约20、小于约10、小于约4,或者D50为约3,和/或平均颗粒尺寸D10小于约10、小于约5、小于约2,或者D10为约1。
当活性物为氯巴占时,单独单位剂量可包含约2mg至约20mg、约5mg、或约20mg的氯巴占。任选地,口腔膜中少于约10%的活性物溶出。在某些实施方案中,在将膜置于介质中后,在约3分钟之后多于约20%的活性物溶出,在约3分钟之后约30%的活性物溶出,在约1分钟之后约30%的活性物溶出,在约1分钟之后多于约50%的活性物溶出,在约2.5分钟之后多于约95%的活性物溶出,在约3.5分钟之后多于约40%的活性物溶出,在约5分钟之后多于约55%的活性物溶出,在约5分钟之后多于约75%的活性物溶出,在约6.5分钟之后多于约85%的活性物溶出,或者在约10分钟之后多于约95%的活性物溶于介质中。在其某些实施方案中,在将膜储存在约20℃至约60℃、和/或高至约75%的相对湿度(RH)、或约60%RH下超过0个月至约36个月之后测量活性物的溶出度。
口腔膜可包含选自以下的甜味剂:三氯蔗糖、甜菊、乙酰磺胺酸钾、糖精、果糖、阿斯巴甜、及其任意组合,任选地以按组合物的重量计约0.5%至约5%存在。口腔膜可包含浆果矫味剂,任选地以按组合物的重量计约0.1%至约15%存在。
还公开了通过向有此需要的人以单独单位剂量施用包含活性物的口腔膜来治疗癫痫和癫痫发作的方法。
附图说明
图1和图2是用于PION技术的系统的示例性配置。
图3是示出包含5mg经研磨的氯巴占(D90=106微米)和5mg氯巴占(D90=8.3微米)的口腔膜以及包含氯巴占的口腔片剂中活性物的溶出度的图。
图4是通过传统溶出法测得的包含5mg和15mg地西泮的口腔膜的平均活性物溶出谱的图。
图5是通过PION技术测得的包含5mg和15mg地西泮的口腔膜的平均活性物溶出谱的图。
图6是通过传统溶出法测得的包含50mg利鲁唑的口腔膜的平均活性物溶出谱的图。
图7是通过PION技术测得的包含50mg利鲁唑的口腔膜的平均活性物溶出谱的图。
图8是示出通过传统溶出法测得的包含5mg氯巴占的口腔膜在约25℃和约40℃下60RH储存约24个月之后的平均活性物溶出谱的图。
图9是包含5mg和20mg氯巴占的口腔膜在约25℃和约40℃下储存之后通过PION技术测得的平均活性物溶出谱的图。
图10是图9的图的增强视角,其示出了包含5mg和20mg氯巴占的口腔膜在约25℃和约40℃下储存之后1分钟至10分钟的活性物溶出谱的曲线。
图11是包含5mg氯巴占的口腔膜的图9的结果的二阶导数值和拐点的图。
图12是包含5mg和20mg氯巴占的口腔膜的图9结果的二阶导数值和拐点的图。
图13和图14是包含5mg、10mg和20mg氯巴占的口腔膜在约25℃和约40℃下60RH储存约24个月之后的平均活性物溶出谱的图。
图15是图13的活性物溶出谱的一阶导数图。
图16是通过PION技术测得的包含5mg、10mg和20mg氯巴占的口腔膜在约25℃下60RH储存约24个月之后,以及在约40℃下60RH储存约24个月之后活性物溶出谱的图。
图17是图16的活性物溶出谱的一阶导数图。
图18是通过PION技术测得的包含5mg、10mg和20mg氯巴占的口腔膜在约25℃下60RH储存约24个月之后,以及在制造之后(即未进行储存)的活性物溶出谱的图。
图19是图18的活性物溶出谱的一阶导数图。
图20是通过PION技术测得的包含5mg、10mg和20mg氯巴占的口腔膜在不同介质中的活性物溶出谱的图。
图21是图20的活性物溶出谱的一阶导数图。
图22是通过PION技术测得的包含氯巴占的液体混合物、包含5mg氯巴占的口腔膜、以及安慰剂的活性物溶出谱的图。
图23是图22的活性物溶出谱的一阶导数图。
具体实施方式
建立药物产品(包括口腔膜)和活性物的溶出谱,并且更具体地,溶出速率,以确保批次之间的一致性,并识别关于药物活性物的生物利用度的任何潜在问题。使用光纤UV监测系统PION技术开发了用于更精确和准确地测试溶出谱的出乎意料的新方式。
本文中公开了用于以单独单位剂量递送期望量的平均颗粒尺寸D90小于约160微米的活性物的口腔膜,与目前已知的关于膜剂型的现有溶出测试和溶出谱相比,所述口腔膜的活性物溶出谱具有改善的精确度、更多的采样点和增强的变化评价速率。
本文中公开的单独单位剂量(即剂量单元)的口腔膜包含:水溶性聚合物基质、水溶胀性聚合物基质、或水溶性且水溶胀性聚合物基质;任选地微粉化活性物;和一种或更多种添加剂。膜是自支撑的,并且活性物基本均一地分布在膜内。基本均一的分布通过变化不超过活性物期望量的10%的基本相等尺寸的单独单位剂量来测量。包含活性物的膜可通过例如美国专利7,666,337;8,603,514;8,765,167;9,855,221;和9,931,305中所描述的流延法(casting method)来制造,然后被切成单独单位剂量(剂量单元),所述专利全部通过引用整体并入本文。或者,单独单位剂量可被制成单独的腔(well)或条带,例如美国专利8,956,685;美国专利8,936,825;和美国公开US2012/0263865中所公开的那样,其全部通过引用整体并入本文。
术语“膜”可包括呈任何形状的膜和片,包括矩形、正方形或其他期望的形状。膜可为任何期望的厚度和尺寸。在一个实施方案中,膜可具有使得其可例如通过放置到口腔中而向患者施用的厚度和尺寸。膜可以是相对薄的,从约0.0025mm至约0.250mm,或者膜可以是稍厚的,从约0.250mm至约1.0mm。一些膜甚至可更厚,例如大于约1.0mm,或者更薄,例如小于约0.0025mm。膜可为单层或者膜可为多层,包括层合膜或多层流延膜。当为多层时,活性物可存在于一层中、存在于多于一层但非所有层中或存在于所有层中。活性物可存在于黏膜接触层中。活性物可与一种或更多种添加剂在单层中组合、各自包含在分开的层中、或者可各自另外包含在同一剂型的离散区域中。
活性物
可对膜进行处理以确保任何活性物都基本均一地分布在整个膜中。例如,当将膜例如流延膜切成基本相同尺寸的单独单位剂量时,可非常准确地知道单位剂量中活性物的量。当活性物为药物(medicament),即药物(drug)时,剂量的准确性是特别有利的,并且实际上是例如美国FDA的政府监管机构所要求的。
可并入本发明的膜中的活性物包括而不限于药品和化妆品活性物、药物(drug)、药物(medicament)、抗原或变应原(例如豚草花粉)、孢子、包括细菌的微生物、种子、漱口剂组分(例如氯酸盐或亚氯酸盐)、矫味剂、香料(fragrance)、酶、防腐剂、甜味剂、着色剂、香料(spice)、维生素及其组合。
如本领域普通技术人员容易理解的那样,膜中活性物的量取决于许多因素,包括例如所选择的活性物、期望的治疗强度、膜的层数和所选择的制剂。药物活性物占按膜组合物的重量计约0.001%至约99%、约0.003%至约75%、或约0.005%至约50%,包括大于约0.005%、大于约0.05%、大于约0.5%、大于约1%、大于约5%、大于约10%、大于约15%、大于约20%、大于约30%、约50%、大于约50%、小于约50%、小于约30%、小于约20%、小于约15%、小于约10%、小于约5%、小于约1%、小于约0.5%、小于约0.05%、或小于约0.005%。其他组分的量可根据活性物和其他组分而变化,但是通常这些组分占膜组合物的按总重量计不超过约50%、不超过约30%、或不超过约15%。
适用于本文中的膜的活性物包括但不限于以下治疗剂类别:ace抑制剂;肾上腺素能剂;肾上腺皮质类固醇;肾上腺皮质抑制剂;醛固酮拮抗剂;生物碱;氨基酸;同化剂;强壮剂(analeptic);镇痛剂;麻醉剂;厌食剂;抗痤疮剂;抗肾上腺素能剂;抗变态反应剂;抗阿米巴剂;抗贫血剂;抗心绞痛剂;抗焦虑剂;抗关节炎剂;抗心律失常剂;平喘剂;抗动脉粥样硬化剂;抗胆甾醇血剂(anti-cholesterolemic);抗细菌剂;抗生素;抗胆碱能剂;抗凝剂;抗惊厥剂;抗抑郁剂;抗糖尿病剂;止泻剂;抗利尿剂;解毒剂;止吐剂;抗癫痫剂;抗纤维蛋白溶解剂;抗真菌剂;抗出血剂;抗组胺剂;抗高血脂剂;抗高血压剂;抗低血压剂;抗感染剂(全身和非全身性的二者);抗炎剂;抗脂质剂;抗躁狂剂;抗微生物剂;抗偏头痛剂;抗有丝分裂剂;抗霉菌剂;止恶心剂;抗肿瘤剂;抗中性白细胞减少剂;抗肥胖剂;抗寄生虫剂;抗帕金森剂;抗增殖剂;抗精神病剂;解热剂;抗风湿剂;抗皮脂溢剂;抗分泌剂;镇痉剂;抗卒中剂;抗血栓形成剂;抗甲状腺剂;抗肿瘤剂;镇咳剂;抗溃疡剂;抗尿毒症剂;抗病毒剂;食欲抑制剂;食欲刺激剂;生物学响应调节剂;血糖调节剂;血液凋节剂;血液代谢调节剂;骨再吸收抑制剂;支气管扩张剂;心血管剂;中枢神经系统兴奋剂;脑舒张剂;避孕剂;冠状动脉扩张剂;胆碱能剂;咳嗽抑制剂;减充血剂;镇静剂;诊断助剂;膳食补充剂;利尿剂;多巴胺能剂;酶;雌激素受体激动剂;子宫内膜异位症控制剂;祛痰剂;勃起功能障碍治疗剂;红细胞生成剂;溶纤剂(ibrinolytic);生育剂;荧光剂;游离氧自由基清除剂;胃酸抑制剂;胃肠蠕动效应剂;遗传修饰剂(genetic modifier);糖皮质激素;毛发生长促进剂;止血剂;组胺H2受体拮抗剂;顺势治疗剂;激素;血钙过多控制剂;血钙过少控制剂;降胆固醇剂;降血糖剂;降血脂剂;降血压剂;离子交换树脂;成像剂;免疫接种剂;免疫调节剂(immunomodulator);免疫调节剂(immunoregulator);免疫刺激剂;免疫抑制剂;角质软化剂;轻泻剂;LHRH激动剂;心情调节剂;晕动病制剂;黏液溶解剂;肌肉松弛剂;散瞳剂;鼻减充血剂;神经肌肉阻断剂;神经保护剂;NMDA拮抗剂;非激素固醇衍生物;骨质疏松治疗剂;阵痛促进剂;抗副交感神经剂;拟副交感神经剂;纤溶酶原激活剂;血小板激活因子拮抗剂;血小板聚集抑制剂;前列腺素;精神治疗剂;精神药物;放射性剂;呼吸道剂;灭疥疮剂;致硬化剂;镇静剂;镇静催眠剂;选择性腺苷A1拮抗剂;5-羟色胺拮抗剂;5-羟色胺抑制剂;5-羟色胺受体拮抗剂;戒烟治疗剂;类固醇;刺激剂;交感神经阻滞剂;子宫松弛剂(terinerelaxant);甲状腺激素;甲状腺抑制剂;拟甲状腺素剂;镇定剂;震颤治疗剂(tremortherapy);肌萎缩性侧索硬化剂;脑缺血剂;佩吉特病剂;不稳定心绞痛剂;血管收缩剂;血管扩张剂;体重管理剂;创伤愈合剂;黄嘌呤氧化酶抑制剂;及其组合。
适合用于本文的活性物的实例包括抗酸剂、H2-拮抗剂和镇痛剂。例如,抗酸剂剂量可使用单独或与氢氧化镁和/或氢氧化铝组合的碳酸钙的成分来制备。此外,抗酸剂可与H2-拮抗剂组合使用。
镇痛剂包括阿片类(opiates)和阿片衍生物,例如羟考酮(可作为商购);布洛芬(可作为MotrinMotrinAdvilMotrinMotrin Midol CrampMotrin Migraine和商购)、阿司匹林(可作为 Genuine和商购)、对乙酰氨基酚(可作为SilapapSilapapTylenolTylenolExtraTylenol Infants’TylenolTylenol 阳商购)及其组合,其可任选地包含咖啡因。可用于本发明的另一些疼痛缓解剂包括盐酸哌替啶(可作为商购)、辣椒素(可作为商购)、硫酸吗啡和盐酸纳曲酮(可作为商购)、盐酸氢吗啡酮(可作为商购)、萘磺酸丙氧芬和对乙酰氨基酚(可作为商购)、芬太尼(可作为和商购)、透明质酸钠(可作为商购)、阿达木单抗(可作为商购)、琥珀酸舒马曲坦(可作为商购)、离子渗透型芬太尼(fentanyl iontophoretic)(可作为商购)、柠檬酸邻甲苯海明(orphenadrine citrate)(可作为商购)、四水合水杨酸镁(可作为商购)、盐酸羟吗啡酮(可作为Opana商购)、美索巴莫(methocarbamol)(可作为商购)、卡利普多(carisoprodol)(可作为商购)、盐酸曲马朵(可作为和商购)、硫酸吗啡(可作为MS商购)、美他沙酮(可作为商购)、盐酸羟考酮(可作为商购)、对乙酰氨基酚/盐酸羟考酮(可作为商购)、羟考酮/阿司匹林(可作为商购)、重酒石酸羟考酮/对乙酰氨基酚(可作为商购)、重酒石酸羟考酮/布洛芬(可作为商购)、奈帕芬胺(nepafenac)(可作为商购)和普瑞巴林(可作为商购)。
本文中公开的膜还可包含例如NSAID的药剂,包括依托度酸(可作为商购)、酮洛酸氨丁三醇(可作为或商购)、萘普生钠(可作为商购)、氟比洛芬(可作为商购)、双氯芬酸钠/米索前列醇(可作为商购)、塞来昔布(可作为商购)、舒林酸(可作为商购)、奥沙普秦(可作为商购)、吡罗昔康(可作为商购)、吲哚美辛(可作为商购)、美洛昔康(可作为商购)、甲芬那酸(可作为商购)、托美丁钠(可作为商购)、三水杨酸胆碱镁(可作为商购)、双氯芬酸钠(可作为商购)、双氯芬酸钾(可作为或商购)和米索前列醇(可作为商购)。阿片激动剂和拮抗剂(例如丁丙诺啡和纳洛酮)为用于本发明的药物的另一些实例。
用于本文的另一些活性物的另一些药物包括止泻剂(例如洛哌丁胺(loperamide)(可作为Imodium QCHealth Care AmericaLeader和商购)、硝唑尼特(可作为商购)和盐酸地芬诺酯/硫酸阿托品(可作为商购))、抗组胺剂、镇咳药、减充血剂、维生素和呼吸清新剂(breathffeshener)。用于感冒、疼痛、发烧、咳嗽、充血、流鼻涕和变态反应的单独或组合使用的常见药物可包含在本发明的膜组合物中,所述药物例如对乙酰氨基酚、布洛芬、马来酸氯苯吡胺、右美沙芬、右美沙芬HBr、去氧肾上腺素HCl、伪麻黄碱HCl、苯海拉明及其组合(例如右美沙芬HBr和去氧肾上腺素HCl(可作为商购))。
另一些可用于本文的活性物包括但不限于:酒精依赖的治疗药,例如阿坎酸钙(可作为商购);变态反应治疗药物,例如盐酸异丙嗪(可作为商购)、苯磺酸贝他斯汀(可作为商购)、氢可酮磺化二乙烯苯-乙烯苯共聚物(hydrocodone polistirex)/氯苯吡胺磺化二乙烯苯-乙烯苯共聚物(可作为商购)、盐酸西替利嗪(可作为商购)、盐酸西替利嗪/盐酸伪麻黄碱(可作为商购)、盐酸异丙嗪/磷酸可待因(可作为商购,含可待因)、吡嘧司特(可作为商购)、盐酸非索非那丁(可作为商购)、盐酸美克洛嗪(meclizine hydrochloride)(可作为商购)、盐酸氮斯汀(azelastine hydrochloride)(可作为商购)、尼扎替丁(可作为商购)、地洛他定(可作为商购)、色甘酸钠(可作为商购)、盐酸依匹斯汀(可作为商购)、盐酸氮斯汀(可作为商购)、泼尼松龙磷酸钠(可作为Orapred商购)、盐酸奥洛他定(可作为商购)、富马酸酮替芬(可作为商购)和孟鲁司特钠(可作为商购);以及抗组胺剂,例如苯海拉明HCl(可作为商购)、氯雷他定(可作为商购)、阿斯咪唑(可作为商购)、萘丁美酮(可作为商购)、苯海拉明HCL(可作为商购)和氯马斯汀(可作为商购)。
本公开内容的膜还可包含阿尔茨海默病治疗药物,例如盐酸他克林(可作为商购)、加兰他敏(可作为商购)、盐酸多奈哌齐(可作为商购)、酒石酸卡巴拉汀(可作为商购)、辛炔(可作为商购)和美金刚(可作为商购);贫血症药物,例如氰钴维生素(可作为商购)和菲立莫妥(ferumoxytol)(可作为商购);麻醉药,例如具有苯佐卡因的安替比林(可作为和商购);心绞痛药物,例如苯磺酸氨氯地平(可作为商购)、硝酸甘油(可作为 商购)、单硝酸异山梨醇(可作为商购)和二硝酸异山梨醇(可作为商购);镇咳药,例如愈创木酚甘油醚(guaifensin);抗阿尔茨海默剂,例如尼麦角林;以及CaH-拮抗剂,例如硝苯地平(可作为和商购)。
可用于本公开内容的活性物还可包括平喘剂,例如硫酸沙丁胺醇(可作为商购)、异丙托溴铵(可作为商购)、昔萘酸沙美特罗(salmeterolxinafoate)(可作为商购)、扎鲁司特(可作为商购)、氟尼缩松(可作为商购)、硫酸奥西那林(可作为商购)、沙丁胺醇吸入剂(可作为商购)、硫酸特布他林(可作为商购)、福莫特罗(可作为商购)、色甘酸钠(可作为商购)、盐酸左旋沙丁胺醇(可作为商购)、齐留通(可作为商购)、丙酸氟替卡松/沙美特罗(可作为商购)、硫酸沙丁胺醇/曲安奈德(可作为商购)、二甲黄嘌呤(可作为商购)和倍氯米松(可作为 商购);血管性水肿药物,例如C1酯酶抑制剂(人)(可作为商购)和艾卡拉肽(可作为商购);以及抗菌药物,例如甲氧苄啶/磺胺甲唑(可作为商购)、莫匹罗星(可作为商购)、甲硝唑(可作为商购)、乙酰磺胺异唑(可作为商购)、次水杨酸铋和甲硝唑/盐酸四环素(可作为Helidac商购)、呋喃妥因(可作为商购)、诺氟沙星(可作为商购)、琥乙红霉素/乙酰磺胺异唑(可作为商购)和左氧氟沙星(可作为商购)。
本公开内容的膜还可包含一种或更多种抗生素,包括阿莫西林(可作为商购)、氨苄青霉素(可作为和商购)、阿莫西林/克拉维酸钾(可作为商购)、盐酸莫西沙星(可作为商购)、贝西沙星(可作为商购)、克拉霉素(可作为商购)、头孢布坦(可作为商购)、头孢呋辛酯(可作为商购)、头孢丙烯(可作为商购)、盐酸环丙沙星(可作为和商购)、磷酸克林霉素(可作为Cleocin商购)、盐酸多西环素(可作为商购)、地红霉素(可作为商购)、红霉素(可作为 阳商购)、局部用红霉素(可作为 商购)、吉米沙星(可作为商购)、氧氟沙星(市场上已知为商购)、泰利霉素(可作为商购)、盐酸洛美沙星(可作为商购)、盐酸米诺环素(可作为商购)、磷霉素氨丁三醇(fosfomycin tromethamine)(可作为商购)、具钾青霉素(penicillin withpotassium)(可作为Penicillin商购)、甲氧苄啶(可作为商购)、盐酸环丙沙星(可作为Proquin商购)、利福平、异烟肼和吡嗪酰胺(可作为商购)、头孢托仑(可作为商购)、头孢克肟(可作为商购)、四环素(可作为Achromycin和商购)、妥布霉素(可作为商购)、利福昔明(可作为商购)、阿奇霉素(可作为商购)、阿奇霉素混悬剂(可作为商购)、利奈唑胺(可作为商购)、过氧化苯甲酰和克林霉素(可作为商购)、红霉素和过氧化苯甲酰(可作为商购)、地塞米松(可作为商购)、环丙沙星和地塞米松(可作为商购)、硫酸多黏菌素B/硫酸新霉素/氢化可的松(可作为商购)、硫酸黏杆菌素/硫酸新霉素/醋酸氢化可的松/通佐溴胺(可作为Cortisporin-TC商购)、盐酸头孢氨苄(可作为商购)、头孢地尼(可作为商购)和加替沙星(可作为商购)。
另一些可用的活性物包括癌症治疗药物,包括环磷酰胺(可作为商购)、甲氨蝶呤(可作为和商购)、柠檬酸他莫昔芬(可作为商购)、贝伐单抗(可作为商购)、依维莫司(可作为商购)、帕唑帕尼(可作为商购)和阿那曲唑(可作为商购);白血病治疗剂,例如奥法木单抗(可作为商购);抗血栓药,例如抗凝血酶重组冻干粉(可作为商购)、普拉格雷(可作为商购);抗凝剂,例如具有持续释放双嘧达莫的阿司匹林(可作为商购)、华法林钠(可作为商购)、双嘧达莫(可作为商购)、达肝素(可作为商购)、达那肝素(可作为商购)、依诺肝素(可作为商购)、肝素(可作为Hep-Lock、Hep-Pak、Hep-Pak CVC、Heparin Lock Flush商购)、亭扎肝素(可作为商购)和硫酸氢氯吡格雷(可作为商购);止吐药,例如盐酸格拉司琼(可作为商购)和大麻隆(可作为商购)、盐酸曲美苄胺(可作为商购)和盐酸昂丹司琼(可作为商购);抗真菌治疗剂,例如酮康唑(可作为商购)、泊沙康唑(可作为商购)、环吡酮(可作为商购)、灰黄霉素(可作为商购)、硝酸奥昔康唑(可作为商购)、氟康唑(可作为商购)、硝酸舍他康唑(可作为商购)、盐酸特比萘芬(可作为商购)、环吡酮(可作为商购)、制霉菌素/曲安奈德(可作为商购)、硝酸益康唑(可作为商购)、伊曲康唑(可作为商购)和特康唑(可作为商购)。
活性物还可包括抗炎药物,例如硫酸羟氯喹(可作为商购)、丙酸氟替卡松(可作为商购)、康纳单抗(可作为商购)、安西奈德(可作为商购)、甲泼尼龙(可作为商购)、布地奈德(可作为Entocort商购)、阿那白滞素(可作为商购)、二醋酸双氟拉松(可作为商购)和依那西普(可作为商购);解痉药,例如苯巴比妥/硫酸莨菪碱/硫酸阿托品/氢溴酸东莨菪碱(可作为商购);抗病毒治疗剂,例如磷酸奥司他韦(可作为商购);抗寄生虫药物,包括替硝唑(可作为商购);食欲治疗药物,例如醋酸甲地孕酮(可作为Megace商购)、盐酸芬特明(可作为商购)和盐酸二乙胺苯丙酮(可作为商购);关节炎药物,包括来氟米特(可作为商购)、赛妥珠单抗(可作为商购)、双氯芬酸钠(可作为商购)、戈利木单抗(可作为商购)和托珠单抗(可作为商购);膀胱控制药物,例如曲司氯铵(可作为商购)、醋酸去氨加压素(可作为商购)、酒石酸托特罗定(可作为商购)、氯化奥昔布宁(可作为或商购)、达非那新(可作为商购)和琥珀酸索非那新(可作为商购);血管收缩药物,例如马来酸甲麦角新碱(可作为商购);血浆尿酸控制剂,例如拉布立酶(可作为商购);缺铁性贫血药物,例如菲立莫妥(可作为商购);淋巴瘤药物,例如普拉曲沙(可作为商购)、罗米地辛(可作为商购);疟疾药物,例如蒿甲醚/苯芴醇(可作为商购);低钠血症药物,例如托伐普坦(可作为商购);用于治疗血管性血友病(vonWillebrand disease)的药物(可作为商购);抗高血压药物,例如曲前列环素(可作为商购)、他达拉非(可作为商购);降胆固醇药物,包括帕立骨化醇(可作为商购)、匹伐他汀(可作为商购)、洛伐他汀、烟酸(可作为商购)、盐酸考来替泊(可作为商购)、瑞舒伐他汀钙(可作为商购)、氟伐他汀钠(可作为商购)、阿托伐他汀钙(可作为商购)、洛伐他汀(可作为商购)、烟酸(可作为商购)、普伐他汀钠(可作为商购)、具缓冲型阿司匹林的普伐他汀钠(可作为Pravigard商购)、消胆胺(可作为商购)、辛伐他汀和烟酸(可作为商购)、阿替洛尔、氯噻酮(可作为商购)、阿替洛尔(可作为商购)、非诺贝特(可作为商购)、非诺贝特(可作为商购)、依折麦布/辛伐他汀(可作为商购)、考来维仑(可作为商购)、富马酸比索洛尔(可作为商购)、依折麦布(可作为商购)、富马酸比索洛尔/氢氯噻嗪(可作为商购)和辛伐他汀(可作为商购)。
本文中包括的活性物还可包括慢性肾病药物,例如帕立骨化醇(可作为商购);避孕剂,包括依托孕烯(可作为商购)、醋酸炔诺酮、炔雌醇(可作为Loestrin 24商购)、炔雌醇、诺孕曲明(可作为Ortho商购)、左炔诺孕酮(可作为Plan商购)、左炔诺孕酮和炔雌醇(可作为商购)、左炔诺孕酮、炔雌醇(可作为商购)和醋酸甲羟孕酮(可作为商购);COPD药物,例如酒石酸阿福特罗(可作为商购)和异丙托溴铵、硫酸沙丁胺醇(可作为商购);咳嗽抑制剂,包括苯佐那酯(可作为商购)、愈创甘油醚、磷酸可待因(可作为Tussi-Organidin商购)以及对乙酰氨基酚、磷酸可待因(可作为Tylenol with商购);用于治疗糖尿病的药物,包括盐酸吡格列酮、盐酸二甲双胍(可作为ACTOplus商购)、甲磺酸溴隐亭(可作为商购)、利拉鲁肽(可作为商购)、沙格列汀(可作为商购)、盐酸吡格列酮(可作为商购)、格列美脲(可作为商购)、马来酸罗格列酮、盐酸二甲双胍(可作为商购),马来酸罗格列酮(可作为商购),马来酸罗格列酮(可作为商购)、艾塞那肽(可作为商购)、艾塞那肽(可作为商购)、氯磺丙脲(可作为商购)、盐酸比格列酮、格列美脲(可作为商购)、盐酸二甲双胍(可作为商购)、格列吡嗪(可作为商购)、格列本脲、二甲双胍(可作为和商购)、盐酸二甲双弧(可作为商购)、西他列汀(可作为商购)、地特胰岛素(detemir)(可作为商购)、格列吡嗪、盐酸二甲双胍(可作为商购)、格列本脲(可作为商购)、瑞格列奈(可作为萄购)、阿卡波糖(可作为商购)、那格列奈(可作为商购)、醋酸普兰林肽(可作为商购)、卡格列净(可作为商购)、利格列汀(可作为商购)、达格列净(可作为商购)、甘精胰岛素(可作为或商购)、门冬胰岛素(可作为商购)、赖脯胰岛素、恩格列净(可作为商购)和妥拉磺脲(可作为商购)。
其他可用的活性物可包括消化剂,例如柳氮磺胺吡啶(可作为商购)、雷贝拉唑钠(可作为商购)、鲁比前列酮(可作为商购)、盐酸双环胺(可作为商购)、硫糖铝(可作为商购)、乳果糖(可作为商购)、多库酯(可作为商购)、巴柳氮二钠(可作为商购)、氯沙坦钾(可作为商购)、奥沙拉嗪钠(可作为商购)、盐酸氯氮克利溴铵(可作为商购)、艾美拉唑镁(可作为商购)、法莫替丁(可作为商购)、兰索拉唑(可作为商购)、兰索拉唑和萘普生(可作为Prevacid商购)、阿莫西林/克拉霉素/兰索拉唑(可作为商购)、奥美拉唑(可作为商购)、泮托拉唑钠(可作为商购)、盐酸甲氧氯普胺(可作为或商购)、西咪替丁(可作为商购)、盐酸雷尼替丁(可作为商购)和奥美拉唑、碳酸氢钠(可作为商购);利尿剂,包括螺内酯、氢氯噻嗪(可作为商购)、螺内酯(可作为商购)、布美他尼(可作为商购)、托拉基米(torsemide)(可作为商购)、氯噻嗪(可作为商购)、呋塞米(可作为商购)、美托拉宗(可作为商购)和氢氯噻嗪、氨苯蝶啶(可作为商购)。
本文中可用的活性物还可包括用于气肿(emphysema)的治疗剂,例如噻托溴铵(可作为商购);纤维肌痛药物,例如盐酸米那普仑(可作为商购);用于治疗痛风的药物,例如秋水仙碱(可作为商购)和非布索坦(可作为商购);灌肠治疗剂,包括氨基水杨酸(可作为和商购);癫痫药物,包括丙戊酸(可作为商购)、非尔氨酯(可作为商购)、拉莫三嗪(可作为商购)、普里米酮(可作为商购)、奥卡西平(可作为商购)、唑尼沙胺(可作为商购)、左乙拉西坦(可作为商购)和苯妥英钠(可作为商购)。
本文中可用的活性物还可包括眼用药物和治疗剂,例如盐酸地匹福林(可作为商购)、缬更昔洛韦(可作为商购)、更昔洛韦眼用凝胶(可作为商购);苯磺酸贝他斯汀(可作为商购)、贝西沙星(可作为商购)、溴芬酸(可作为商购)、氟米龙(可作为商购)、盐酸毛果芸香碱(可作为商购)、环孢素(可作为商购)、酒石酸溴莫尼定(可作为Alphagan商购)、盐酸多佐胺/马来酸噻吗洛尔(可作为商购)、比马前列素(可作为商购)、马来酸噻吗洛尔(可作为商购)、曲伏前列素(可作为商购)、拉坦前列素(可作为商购)、碘化二乙氧膦酰硫胆碱(可作为Phospholine商购)和兰尼单抗(ranibizumab)(可作为商购);流体控制剂,例如乙酰唑胺(可作为商购);胆结石药物,包括熊去氧胆酸(ursodiol)(可作为商购);用于治疗龈炎的药物,包括葡萄糖酸氯已定(可作为商购);头痛药物,包括布他比妥/磷酸可待因/阿司匹林/咖啡因(可作为商购,含可待因)、盐酸那拉曲坦(可作为商购)、阿莫曲普坦(可作为商购)、酒石酸麦角胺/咖啡因(可作为商购)、布他比妥/对乙酰氨基酚/咖啡因(可作为商购)、布他比妥/阿司匹林/咖啡因(可作为商购)、琥珀酸夫罗曲坦(可作为商购)、苯甲酸利扎曲坦(可作为商购)、黏酸异美汀/氯醛比林/对乙酰氨基酚(可作为商购)、甲磺酸双氢麦角胺(可作为商购)、氢溴酸依拉曲坦(可作为商购)和佐米曲坦(可作为商购);流感药物,例如嗜血杆菌b结合疫苗;破伤风类毒素缀合物(可作为商购);和心脏治疗剂,包括硫酸奎尼丁、二硝酸异山梨醇/盐酸肼屈嗪(可作为商购)、地高辛(可作为商购)、醋酸氟卡尼(可作为商购)、盐酸美西律(可作为商购)、磷酸丙吡胺(可作为商购)、盐酸普鲁卡因胺(可作为商购)和普罗帕酮(可作为商购)。
其他可用的活性物包括肝炎治疗剂,包括恩替卡韦(可作为商购)、乙肝免疫球蛋白(可作为HepaGam商购)和利巴韦林(copegus/rebetol/ribasphere/Vilona/virazole)(可作为商购);疱疹治疗剂,包括盐酸伐昔洛韦(可作为商购)、喷昔洛韦(可作为商购)、阿昔洛韦(可作为商购)和泛昔洛韦(可作为商购);用于高血压的治疗剂,包括依那普利拉(可作为商购)、卡托普利(可作为商购)和赖诺普利(可作为商购)、盐酸维拉帕米(可作为商购)、雷米普利(可作为商购)、奥美沙坦酯(可作为商购)、氨氯地平/阿托伐他汀(可作为商购)、盐酸尼卡地平(可作为商购)、盐酸地尔硫(可作为商购)、盐酸喹那普利(可作为商购)、盐酸喹那普利/氢氯噻嗪(可作为商购)、培哚普利(可作为商购)、坎地沙坦酯(可作为商购)、坎地沙坦酯/氢氯噻嗪(可作为Atacand商购)、厄贝沙坦/氢氯噻嗪(可作为商购)、厄贝沙坦(可作为商购)、苯磺酸氨氯地平/奥美沙坦酯(可作为商购)、盐酸左布诺洛尔(可作为商购)、盐酸倍他洛尔(可作为商购)、奈必洛尔(可作为商购)、卡托普利/氢氯噻嗪(可作为商购)、甲磺酸多沙唑嗪(可作为商购)、盐酸可乐定(可作为商购)、卡维地洛(可作为商购)、纳多洛尔(可作为商购)、纳多洛尔/苄氟噻嗪(可作为商购)、缬沙坦(可作为商购)、伊拉地平(可作为商购)、醋酸胍那苄(可作为商购)、盐酸胍法辛(可作为或商购)、氯沙坦钾/氢氯噻嗪(可作为商购)、盐酸普萘洛尔(可作为商购)、盐酸普萘洛尔/氢氯噻嗪(可作为商购)、依普利酮(可作为商购)、安倍生坦(可作为商购)、马来酸依那普利/非洛地平(可作为商购)、酒石酸美托洛尔(可作为商购)、盐酸贝那普利(可作为商购)、盐酸贝那普利/氢氯噻嗪(可作为Lotensin商购)、氨氯地平/盐酸贝那普利(可作为商购)、吲达帕胺(可作为商购)、群多普利(可作为商购)、替米沙坦(可作为商购)、替米沙坦/氢氯噻嗪(可作为Micardis商购)、盐酸哌唑嗪(可作为商购)、阿米洛利、氢氯噻嗪(可作为商购)、福辛普利钠(可作为ZZXT商购)、福辛普利钠/氢氯噻嗪(可作为商购)、吲哚洛尔(可作为商购)、非洛地平(可作为商购)、柠檬酸西地那非(可作为商购)、尼索地平(可作为商购)、群多普利/盐酸维拉帕米(可作为商购)、阿利克仑(可作为商购)、甲磺酸依普沙坦(可作为商购)、甲磺酸依普沙坦/氢氯噻嗪(可作为Teveten商购)、盐酸莫西普利/氢氯噻嗪(可作为商购)、盐酸莫西普利(可作为商购)、马来酸依那普利/氢氯噻嗪(可作为商购)和赖诺普利/氢氯噻嗪(可作为商购)。
本公开内容的膜可包括可用于治疗HIV/AIDS的药物的活性物,例如安普那韦(可作为商购)、替普那韦(可作为商购)、依法韦仑/恩曲他滨/泰诺福韦(可作为商购)、拉米夫定/齐多夫定(可作为商购)、硫酸茚地那韦(可作为萄购)、拉米夫定(可作为商购)、沙奎那韦(可作为商购)、扎西他滨(可作为商购)、洛匹那韦/利托那韦(可作为商购)、福沙那韦钙(可作为商购)、利托那韦(可作为商购)、齐多夫定(可作为商购)、硫酸阿扎那韦(可作为商购)、依法韦仑(可作为商购)、阿巴卡韦/拉米夫定/齐多夫定(可作为商购)、地达诺新(可作为商购)、甲磺酸奈非那韦(可作为商购)、奈韦拉平(可作为商购)、富马酸替诺福韦酯(可作为商购)、司他夫定(可作为商购)和硫酸阿巴卡韦(可作为商购);同型半胱氨酸去除剂,包括无水甜菜碱(可作为商购);药物,例如胰岛素(可作为 和商购);和HPV治疗剂,例如人乳头瘤病毒疫苗(可作为商购)或二价人乳头瘤病毒(human papillomavirusbivalent)(可作为商购);免疫抑制剂,包括环孢素(可作为和商购)。
可用于本公开内容的活性物还可包括催乳激素抑制剂,例如甲磺酸溴隐亭(可作为商购);有助于压力测试的药物,例如瑞加德松(可作为商购);秃顶药物,包括非那雄胺(可作为和商购);胰腺炎治疗剂,例如吉非贝齐(可作为商购);激素药物,例如醋酸炔诺酮/炔雌醇(可作为商购)、醋酸戈舍瑞林(可作为商购)、黄体酮凝胶(可作为商购)、黄体酮(可作为商购)、鲑鱼降钙素(可作为商购)、骨化三醇(可作为商购)、左甲状腺素钠(synthroid)(可作为商购)、睾酮(可作为 和商购);绝经期药物,例如雌二醇/醋酸炔诺酮(可作为商购)、屈螺酮/雌二醇(可作为商购)、雌二醇/左炔诺孕酮(可作为Climara商购)、雌二醇/醋酸炔诺酮(可作为商购)、雌二醇(可作为和商购)、酯化雌激素和甲睾酮(可作为商购)、雌激素(可作为商购)、雌酮硫酸酯哌嗪(estropipate)(可作为商购)、缀合雌激素(可作为商购)和醋酸甲羟孕酮(可作为商购);月经药物,包括醋酸亮丙瑞林(可作为Lupron Depot商购)、凝血酸(可作为商购)和醋酸炔诺酮(可作为商购);以及肌肉松弛药,包括盐酸环苯扎林(可作为商购)、替扎尼定(可作为商购)和硫酸茛菪碱(可作为商购)。
本文中可用的活性物还可包括骨质疏松症药物,包括伊班膦酸钠(可作为商购)、利塞膦酸(可作为商购)、盐酸雷洛昔芬(可作为商购)和阿仑膦酸钠(可作为商购);排卵增强剂,包括柠檬酸克罗米酚(可作为 商购);佩吉特病(Paget’s disease)治疗剂,例如依替膦酸二钠(可作为商购);胰酶缺乏症药物,例如胰脂肪酶(可作为或商购);用于治疗帕金森病的药物,例如二盐酸普拉克索(可作为商购)、盐酸罗匹尼罗(可作为商购)、卡比多巴/左旋多巴(可作为Sinemet商购)、卡比多E/左旋多E/恩他卡朋(可作为商购)、盐酸司来吉兰(可作为商购)、雷沙吉兰(可作为商购)、恩他卡朋(可作为商购)和盐酸司来吉兰(可作为商购);多发性硬化药物,例如达伐吡啶(可作为商购)和干扰素β-I b(可作为商购);前列腺药物,包括氟他胺(可作为商购)、尼鲁米特(可作为商购)、度他雄胺(可作为商购)、盐酸坦索罗辛(可作为商购)、盐酸特拉唑嗪(可作为商购)和盐酸阿夫唑嗪(可作为商购)。
本公开内容的膜还可包含精神病药物,包括阿普唑仑(可作为获得)、氯氮平(可作为获得)、氟哌啶醇(可作为获得)、盐酸氟西汀(可作为获得)、盐酸舍曲林(可作为获得)、阿塞那平(可作为商购)、伊潘立酮(可作为商购)、盐酸帕罗西汀(可作为获得)、阿立哌唑(可作为商购)、胍法辛(可作为商购)、苯丙胺和甲基苯丙胺(可作为和商购)、盐酸氯米帕明(可作为商购)、盐酸丁螺环酮(可作为商购)、氢溴酸西酞普兰(可作为商购)、盐酸度洛西汀(可作为商购)、哌甲酯(可作为Ritalin、商购)、双丙戊酸钠(丙戊酸)(可作为商购)、硫酸右苯丙胺(可作为商购)、盐酸文拉法辛(可作为商购)、司来吉兰(可作为商购)、卡马西平(可作为商购)、碳酸锂(可作为商购)、马来酸氟伏沙明/盐酸右哌甲酯(可作为商购)、盐酸齐拉西酮(可作为商购)、甲磺酸双氢麦角碱(可作为商购)、草酸依他普仑(可作为商购)、氯氮(可作为商购)、盐酸吗茚酮(可作为商购)、硫酸苯乙肼(可作为商购)、替沃噻吨(可作为商购)、盐酸地昔帕明(可作为商购)、苯二氮类(例如可作为获得的那些)、盐酸去甲替林(可作为商购)、硫酸反苯环丙胺(可作为商购)、丙氯拉嗪、米氮平(可作为商购)、利培酮(可作为商购)、富马酸喹硫平(可作为商购)、盐酸多塞平(可作为商购)盐酸托莫西汀(可作为商购)、马来酸三甲丙咪嗪(可作为商购)、奥氮平/盐酸氟西汀(可作为商购)、盐酸丙咪嗪(可作为商购)、盐酸普罗替林(可作为商购)、盐酸安非他酮(可作为Wellbutrin印Wellbutrin商购)和奥氮平(可作为商购)。
本文中可用的活性物还可包括降尿酸治疗剂,包括别嘌醇(可作为商购);癫痫发作(seizure)药物,包括加巴喷丁(可作为商购)、乙苯妥英(可作为商购)、氨己烯酸(可作为商购)和托吡酯(可作为商购);用于带状疱疹的治疗剂,例如带状疱疹活疫苗(可作为商购);皮肤护理药物,包括卡西波曲(可作为商购)、优特克单抗(可作为商购)、特拉万星(可作为商购)、异维A酸(可作为商购)、氢化可的松/双碘喹啉(可作为商购)、磺胺醋酰钠/硫(可作为商购)、壬二酸(可作为商购)、过氧化苯甲酰(可作为商购)、阿达帕林(可作为商购)、氟尿嘧啶(可作为商购)、吡美莫司(可作为商购)、局部用红霉素(可作为商购)、氢化可的松(可作为商购)、甲硝唑(可作为商购)、多西环素(可作为商购)、维甲酸(可作为和商购)、对甲氧酚/维甲酸(可作为商购)、维生素A酸(可作为商购)、卡泊三醇水合物/二丙酸倍他米松(可作为商购)、他扎罗汀(可作为商购)、醋酸氟轻松(可作为商购)、地索奈德(可作为商购)、硝酸咪康唑/氧化锌(可作为商购)、酮康唑(可作为商购)和依法珠单抗(可作为商购)。
本文中可用的其他活性物可包括睡眠障碍药物,包括扎来普隆(可作为商购)、艾司佐匹克隆(可作为商购)、酒石酸唑吡坦(可作为Ambien商购)、劳拉西泮(可作为商购)、盐酸氟西泮(可作为商购)、三唑仑(可作为商购)、氯硝西泮(可作为商购)、巴比妥类,例如)、莫达非尼(可作为商购)、替马西泮(可作为商购)、雷美替胺(可作为商购)、氯骏二钾(可作为商购)、地西泮(可作为商购)、夸西泮(可作为商购)和艾司唑仑(可作为商购);戒烟药物,例如瓦伦尼克林(可作为商购)、烟碱如和盐酸安非他酮(可作为商购);以及类固醇类,包括二丙酸阿氯米松(可作为商购)、二丙酸倍他米松(可作为商购)、糠酸莫美他松(可作为商购)、氟替卡松(可作为FloventFlovent商购)、醋酸氟轻松(可作为商购)、糠酸莫美他松一水合物(可作为商购)、去羟米松(可作为商购)、克霉唑/二丙酸倍他米松(可作为商购)、醋酸泼尼松龙(可作为PredBudesonideRhinocort商购)、泼尼松龙磷酸钠(可作为商购)、地索奈德(可作为商购)和丙酸卤倍他索(可作为商购)。
本发明的膜还可包含可用于甲状腺疾病治疗的活性物,例如激素TC和TD(可作为Armour 商购);钾缺乏症治疗剂,包括氯化钾(可作为商购);甘油三酯调节剂,包括ω-3-酸乙酯(可作为商购);泌尿系统药物,例如盐酸非那吡啶(可作为商购)和乌洛托品、亚甲基蓝/水杨酸苯酯/苯甲酸/硫酸阿托品/莨菪碱(可作为商购);产前维生素(可作为AdvancedPrenate商购);体重控制药物,包括奥利司他(可作为商购)和盐酸西布曲明(可作为商购)。
预期用于本文中的常用H2-拮抗剂包括西咪替丁、盐酸雷尼替丁、法莫替丁、尼扎替丁、乙溴替丁、咪芬替丁(mifentidine)、罗沙替丁、皮沙替丁(pisatidine)和哌芳替丁(aceroxatidine)。
活性抗酸剂成分包括但不限于以下:氢氧化铝、氨基乙酸二羟基铝、氨基乙酸、磷酸铝、碳酸二羟基铝钠、碳酸氢盐、铝酸铋、碳酸铋、次碳酸铋(bismuth subcarbonate)、次没食子酸铋、次硝酸铋、次水杨酸铋、碳酸钙、磷酸钙、柠檬酸离子(酸或盐)、氨基乙酸、水合硫酸镁铝、氢氧化镁铝(magaldrate)、硅铝酸镁、碳酸镁、甘氨酸镁、氢氧化镁、氧化镁、三硅酸镁、乳固形物(milk solid)、磷酸铝二氢钙或磷酸铝氢钙(aluminum mono-ordibasiccalcium phosphate)、磷酸三钙、碳酸氢钾、酒石酸钠、碳酸氢钠、硅铝酸镁、酒石酸和盐。
本发明中所使用的药物活性剂可包含变应原或抗原,例如但不限于:植物花粉,其来自草(grass)、树木(tree)或豚草(ragweed);动物皮屑,其为猫和其他有毛动物皮肤和毛发脱落的小鳞屑(tiny scale);昆虫,例如屋尘螨、蜜蜂和黄蜂(wasp);以及药品,例如青霉素。
具体的活性物的实例包括但不限于16-α氟雌二醇(16-alpha fluorocstradiol)、16-α-吉妥辛(16-alpha-gitoxin)、16-表雌三醇(16-epiestriol)、17α-二氢马萘雌酮(17alpha dihydroequilenin)、17α-雌二醇(17 alpha estradiol)、17β-雌二醇(17 betaestradiol)、17羟基孕酮(17hydroxy progesterone)、1α-羟基维生素D2(lalpha-hydroxyyitamin D2)、1-十二吡咯烷酮(1-dodecpyrrolidinone)、20-差向异构体-1,25二羟基维生素D3(20-epi-1,25dihydroxyvitamin D3)、22-骨化三醇(22-oxacalcitriol)、2CVV、2’-失碳-cGMP、3-异丁基GABA、5-乙炔基尿嘧啶、6-FUDCA、7-甲氧基他克林(7-methoxytacrine)、阿巴美丁(Abamectin)、阿巴诺喹(abanoquil)、阿贝卡尔(abecarnil)、阿比特龙(abiraterone)、阿鲁司特(Ablukast)、阿鲁司特钠(Ablukast Sodium)、阿卡地辛(Acadesine)、阿坎酸(acamprosate)、阿卡波糖(Acarbose)、醋丁洛尔(Acebutolol)、盐酸胺酰醋苯(Acecainide Hydrochloride)、醋克利定(Aceclidine)、醋氯芬酸(aceclofenae)、醋氨苯砜(Acedapsone)、醋谷胺铝(Aceglutamide Aluminum)、醋孟南(Acemannan)、醋氨酚、乙酰唑胺、乙酰苯磺酰环己脲(Acetohexamide)、醋羟胺酸(Acetohydroxamic Acid)、acetomepregenol、马来酸醋奋乃静(AcetophenazineMaleate)、磺胺苯砜钠(Acetosulfone Sodium)、氯化乙酰胆碱(AcetylcholineChloride)、乙酰半胱氨酸(Acetylcysteine)、乙酰基-L-肉碱、乙酰美沙醇、阿西呋喃(Acifran)、阿昔莫司(acipimox)、阿昔替酯(acitemate)、阿维A、阿西维辛(Acivicin)、阿柔比星(Aclarubicin)、乙乳胆铵(aclatonium)、盐酸阿考达唑(AcodazoleHydrochloride)、阿考烟肼(aconiazide)、吖啶琐辛(Acrisorcin)、阿伐斯汀(Acrivastine)、阿克罗宁(Acronine)、阿克索胺(Actisomide)、阿托地近(Actodigin)、阿昔洛韦(Acyclovir)、酰基富烯(acylfulvene)、金刚芬酯(Adafenoxate)、阿达帕林(Adapalene)、阿达帕林(Adapalene)、阿达色林(Adatanserin)、盐酸阿达色林(Adatanserin Hydrochloride)、腺环戊醇(adecypenol)、腺环戊醇(adecypenol)、阿德福韦(Adefovir)、阿地米屈(Adelmidrol)、腺苷蛋氨酸(Ademetionine)、腺苷(Adenosine)、阿地唑仑(Adinazolam)、盐酸阿地芬宁(Adipheinine Hydrochloride)、肥胖菌素(adiposin)、阿多来新(Adozelesin)、阿屈非尼(Adrafinil)、肾上腺酮(Adrenalone)、阿布他明(airbutamine)、阿拉普利(Alacepril)、阿来霉素(Alamecin)、丙氨酸、阿拉丙酯(Alaproclate)、阿莱肽(alaptide)、阿苯达唑(Albendazole)、白唇竹叶青素(albolabrin)、沙丁胺醇(Albuterol)、阿布妥因(Albutoin)、烯氯苯乙酸(Alclofenae)、阿氯米松二丙酸酯(Alclometasone Dipropionate)、铝克洛沙(Alcloxa)、aldecalmycin、阿地白介素(Aldesleukin)、尿囊素铝(Aldioxa)、阿仑膦酸钠(Alendronate Sodium)、阿仑磷酸(Alendronic Acid)、阿仑替莫(Alentemol)、阿仑替莫氢溴酸盐(AlentemolHydrobromide)、盐酸烯丙他明、烯丙苯乙胺氯化物(Aleuronium Chloride)、阿来西定、阿法骨化醇、盐酸阿芬太尼、阿夫唑嗪、丙缩阿尔孕酮、阿糖脑苷酶、阿列氟烷、阿利那斯汀(alinastine)、阿利帕胺、尿囊素、阿洛巴比妥(Allobarbital)、别嘌醇、ALL-TK拮抗剂、阿格列汀(Alogliptin)、阿洛米酮、阿洛司琼、盐酸阿洛司琼、阿洛夫定、阿尔哌汀、α淀粉酶、αidosone、阿吡坦、阿普唑仑、盐酸阿普洛尔、盐酸阿普诺辛(Alprenoxime Hydrochloride)、前列地尔(Alprostadil)、阿司他丁钠、酒石酸阿坦色林、阿替普酶、阿尔噻嗪(Althiazide)、六甲蜜胺、阿托霉素B(altromycin B)、柠檬酸阿尔维林(AlverincCitrate)、阿韦舒托(Alvircept Sudotox)、醋酸阿马地酮、盐酸金刚烷胺、氨莫司汀、安波霉素(Ambomycin)、安布替星、安布茶碱(Ambuphylline)、安布赛特、安西法尔、安西奈德、氮脒青霉素(Amdinocillin)、氮苄脒青霉素双酯(Amdinocillin Pivoxil)、盐酸氨甲达林、阿洛米松、氨托利、安麦角、醋酸阿美蒽醌、甲硫阿美铵(amezinium metilsulfate)、安非他酮(amfebutamone)、氨芬酸钠、氨氟替唑、阿米环素、甲磺酸阿米福林、磺胺异唑(amidox)、氨氟沙星、氨磷汀、阿米卡星、盐酸阿米洛利、盐酸氨吖啶、氨基苯甲酸钾、氨基苯甲酸钠、氨基己酸、氨鲁米特、氨基马尿酸钠(Aminohippurate Sodium)、氨基乙酰丙酸、氨茶碱、阿米雷司(Aminorex)、氨基水杨酸钠(Aminosalicylate sodium)、氨基水杨酸、胺碘酮、盐酸氨普立糖、盐酸氨喹新、氨磺必利、阿米曲士、盐酸阿米替林、氨来呫诺、氨氯地平、异戊巴比妥钠、阿莫地喹、盐酸阿莫地喹、阿莫罗芬、阿莫沙平、阿莫西林(Amoxicillin)、安非氯醛(Amphecloral)、硫酸安非他命、安福霉素、两性霉素B(Amphotericin B)、氨苄青霉素、安吡昔康、二甲胺嗪硫酸酯、氨喹酯、氨力农、氨力农、氨柔比星、安吖啶、胰淀素、淀硫霉素(amythiamicin)、醋酸阿那孕酮、阿那格雷、阿那白滞素、ananain、阿那立肽、阿那立肽醋酸酯、阿那曲唑、阿那佐林钠(Anazolene Sodium)、安克洛酶、穿心莲内酯、雄烯二酮、血管生成抑制剂、血管紧张素酰胺(Angiotensin Amide)、阿尼多昔、阿尼利定、盐酸阿尼洛泮、茴拉西坦、阿尼罗酸、辛托品甲基溴化物(Anisotropine Methylbromide)、阿尼普酶、阿尼扎芬、双炔失碳酯(anordrin)、拮抗剂D、拮抗剂G、安雷利克斯(antarelix)、磷酸安他唑啉、抗蠕霉素(Anthelmycin)、地蒽酚、安曲霉素、抗雄激素(antiandrogen)、二乙酰氨苯砜(Acedapsone)、非尔氨酯、抗雌激素(antiestrogen)、抗瘤酮(antineoplaston)、安替比林、反义寡核苷酸、阿帕多林(apadoline)、阿帕泛、阿帕西林钠、阿帕茶碱、阿扎丙宗(apazone)、阿非迪霉素甘氨酸(aphidicolin glycinate)、Apixifylline、盐酸阿扑吗啡、阿可乐定(apraclonidine)、盐酸阿可乐定(Apraclonidine Hydrochloride)、安普霉素、阿普林定、盐酸阿普林定、阿普硫钠(aprosulate sodium)、抑肽酶(aprotinin)、马来酸阿普氮平、阿替加奈、无嘌呤酸(apurinic acid)、无嘌呤酸(apurinic acid)、阿雷地平、阿拉诺丁、阿巴前列素、阿贝卡星(arbekicin)、阿比朵尔(Arbidol)、盐酸阿布他明、阿氯非林(Arclofenin)、阿地肝素钠(Ardeparin Sodium)、阿加曲班、精氨酸、单宁酸精氨加压素、阿立酮、阿立哌唑(aripiprazol)、阿罗洛尔(arotinolol)、阿普西特(Arpinocid)、阿替夫林、富马酸阿替利特、阿西马朵林、aspalatone、门冬酰胺酶、天门冬氨酸(Asparic Acid)、门冬托星、asperfuran、阿司匹林、阿扑西林、曲林菌素(Asprelin)、阿司咪唑、硫酸阿司米星、asulacrine、阿他美坦、阿替洛尔、阿替韦啶、阿替美唑、阿替丙嗪马来酸盐、阿托利特、阿托伐他汀钙、阿托西班、阿托伐醌、抗癣青霉素B(atpenin B)、苯磺酸阿曲库铵(AtracuriumBesylate)、阿莫司汀、阿曲肌醇、阿托品、金诺芬、短梗霉素A(aureobasidin A)、金硫葡糖、阿维霉素、阿伏帕星、阿夫立定、尼扎替丁(Axid)、axinastatin1、axinastatin 2、axinastatin 3、阿扎苯胺、阿扎胞苷(Azacitidinie)、盐酸氮氯嗪、阿扎康唑、印楝素(azadirachtine)、阿扎兰司他二盐酸盐、富马酸阿扎克生、马来酸阿扎那托、阿扎硝唑、阿扎哌隆、阿扎立平、重氮丝氨酸、阿扎司琼、马来酸阿扎他定、硫唑嘌呤、硫唑嘌呤钠、阿扎毒素(azatoxin)、重氮酪氨酸(azatyrosine)、壬二酸、氮革斯汀(azelastine)、阿折地平、氮革吲哚(Azepindole)、阿扎替派、阿齐利特、阿奇霉素、阿洛西林、阿佐利明、阿佐寒米、阿佐霉素(Ambomycin)、氨曲南、阿珠莫林钠、盐酸巴氨西林(Bacampicillin Hydrochloride)、浆果赤霉素III(baccatin III)、杆菌肽、巴氯芬、假马齿苋皂素A(bacoside A)、假马齿苋皂素B(bacoside B)、bactobolamine、balanol、巴拉齐朋、balhimycin、巴洛沙星、巴柳氮、班贝霉素(Bambermycins)、班布特罗、硫酸巴美生、盐酸巴米茶碱、班硝唑(Bamidazole)、宝藿苷1(baohuoside 1)、巴马斯汀、巴尼地平、巴西芬净、盐酸巴他必利、巴布司特、马来酸巴氮平、巴马司他、白僵菌素(beauvericin)、盐酸贝恩酮、贝卡普勒明、贝康唑、二丙酸倍氯米松(Beclomethasone Dipropionate)、贝氟沙通、苄丝肼(Beinserazide)、贝磷地尔、颠茄(Belladonna)、贝洛酰胺、贝美司琼、贝米曲啶、贝莫拉旦、盐酸贝那利秦、盐酸贝那普利、贝那普利(Benazeprilat)、甲磺酸苯达洛尔、苄达酸、苄氟噻嗪(Bendroflumethiazide)、苯芴醇、贝尼地平、贝诺睾酮、苯洛芬、苯洛芬、盐酸奥布卡因(BenoxinateHydrochloride)、苯哌利多、苯他西泮、苯替酪胺、贝奴司他、苯溴马隆、苄索氯铵(Benzethonium Chloride)、盐酸苄替米特、苯咯溴铵溴化物(Benzilonium Bromide)、盐酸苄吲吡林、苯异唑、苯佐卡因(Benzocaine)、苯并二氢卟酚(benzochlorins)、盐酸苯佐他明、苯佐替派、benzoidazoxan、苯佐那酯、过氧化苯甲酰、苯沙酸钙(Benzoylpas Calcium)、苯甲酰星形孢菌素(benzoylstaurosporine)、苯喹胺、苄噻嗪、苯扎托品、甲磺酸苯扎托品、盐酸苄达明、青霉噻唑酰多聚赖氨酸(Benzylpenicilloyl Polylysine)、苄普地尔、盐酸苄普地尔、贝拉克坦(Beractant)、贝前列素、贝瑞福林、柏拉非农、柏托沙米、B红霉素、贝西吡啶、β-alethine、亚阿克拉霉素(betaclamycin B)、倍他米松、倍他米隆、倍他洛尔、盐酸倍他洛尔、氯贝胆碱(Bethanechol Chloride)、硫酸苄二甲胍(Bethanidine Sulfate)、桦木酸、贝凡洛尔、盐酸贝凡洛尔、苯扎贝特、bFGF抑制剂、盐酸比拉米可、比阿培南、比卡鲁胺、盐酸比西发定、盐酸二氯地尔、比地索胺、二苯美伦、联苯苄唑、比卡林、bimithil、宾达利、比尼霉素、比螺酮、bioxalomycinα2、盐酸比培那醇、比哌立登、盐酸珍尼柳酯、比立哌隆、比生群、比沙雷米、bisaziridinylspermine、双-苯并咪唑A、双-苯并咪唑B、双奈法德、乳酸比索布啉、比索洛尔、硫酸镁双巯氧吡啶(Bispyrithione Magsulfex)、bistramide D、bistramide K、bistratene A、硫氯酚钠、比托特罗甲磺酸盐、比伐卢定、比折来新、硫酸博来霉素、勃雄二醇二丙酸盐、勃拉军酮、勃地酮十一碳烯酸、波尔定碱(boldine)、勃来诺、勃金刚酯、波吲洛尔、波生坦、波克昔定、布雷菲尔德菌素(brefeldin)、breflate、布喹那钠、溴他西尼、溴苄胺对甲苯磺酸(Bretylium Tosylate)、盐酸布芬太尼、溴莫尼定、纤维蛋白酶、溴克立新、溴克利那、溴伏克辛(Brofoxine)、马来酸溴朵林、溴西泮、溴氯唑酮、菠萝蛋白酶、溴芬酸、Brominidione、溴隐亭、盐酸溴苯海拉明、溴沙尼特(Bromoxamide)、溴哌利多、溴哌利多癸酸盐、马来酸溴苯那敏(Brompheniramine Maleate)、溴哌莫、溴匹立明、溴替唑仑、马来酸布卡尼盐、布新洛尔、盐酸布克力嗪、布色酮、布地奈德、布地品、布度钛、丁福明、布美他尼(Bumetamide)、布那司特、布那唑嗪、盐酸布诺洛尔、丁吡考胺、盐酸布比卡因、盐酸丁丙诺啡、盐酸安非他酮(Bupropion Hydrochloride)、布拉氨酯、醋酸布舍瑞林、盐酸丁螺环酮、白消安、仲丁巴比妥(Butabarbital)、布他西丁、盐酸布他拉莫、布他比妥、氨苯丁酯、柠檬酸布他米酯(Butamirate Citrate)、布他哌嗪、布他前列素、布替膦酸四钠(Butedronate Tetrasodium)、布替萘芬、布替利嗪、丁硫氨酸亚砜亚胺(buthioninesulfoximine)、布替卡星、丁苯宁、硫酸布替罗星、布替西雷、丙酸布替可特、硝酸布康唑、布托酯、布托巴胺、盐酸布托丙茚、布托啡诺、盐酸布他沙明、盐酸布替林、放线菌素C(Cactinomycin)、卡地姆碘、咖啡因、胡桐素A、骨化二醇、卡泊三醇(Calcipotriene)、卡泊三醇、降钙素、骨化三醇、十一碳烯酸钙(Calcium Undecylenate)、钙感光蛋白(calphostinC)、卡普睾酮、坎苯达唑(Cambendazole)、卡莫格雷、喜树碱衍生物、坎格列净(canagliflozin)、金丝雀痘IL-2、坎地沙坦、杀念菌素、坎沙曲、坎沙曲拉(candoxatrilat)、卡格列波糖(Caniglibose)、坎利酸钾(Canrenoate Potassium)、坎利酮、卡培他滨、克冠酸钠(CapobenateSodium)、卡泊酸(Capobenic Acid)、硫酸卷曲霉素、卡罗单抗、辣椒素、卡托普利、卡普脲、卡醋胺、卡巴胆碱、卡巴多司、卡马西平、过氧化脲(Carbamide Peroxide)、十二烷基硫酸卡班太尔(Carbantel Lauryl Sulfate)、卡巴匹林钙(Carbaspirin Calcium)、卡巴折伦、咔唑霉素C(carbazomycin C)、羧苄青霉素钾、甘珀酸钠(Carbenoxolone Sodium)、卡贝替姆、卡贝缩宫素、卡比多巴、卡比多巴-左旋多巴、马来酸卡比沙明、盐酸卡比芬、卡波氯醛、羧甲半胱氨酸(Carbocysteine)、石炭酸品红、卡铂、卡前列素、卡巴韦(carbovir)、甲酰胺-氨基-叠氮基-le、羧酰胺基三唑、羧酰胺基三唑β-1,3-葡聚糖、盐酸卡布特罗、CaRest M3、柠檬酸卡芬太尼、卡立普多、卡金刚酸、卡莫司汀、CARN 700、卡硝唑(Camidazole)、卡罗沙酮、卡培立肽、马来酸卡奋乃静(CarphenazineMaleate)、卡洛芬、琥珀酸卡沙群、卡他唑酯(Cartazolate)、卡替洛尔、盐酸卡替洛尔、软骨衍生抑制剂(cartilage derived inhibitor)、盐酸卡柔比星、卡芦莫南钠、卡维地洛、卡伏曲林、盐酸卡伏曲林、卡折来新、酪蛋白激酶抑制剂(casein kinase inhibitors)(ICOS)、栗树精胺(castanospermine)、卡芦莫南(caurumonam)、西巴西坦、天蚕素B、西地芬戈、头孢克洛、头孢羟氨苄、头孢孟多(Cefamandole)、头孢帕罗、头孢曲秦、头孢氮氟钠、头孢唑啉(Cefazolin)、头孢拉宗、头孢卡品酯(cefcapene pivoxil)、头孢达肟喷替特甲苯磺酸盐(cefdaloxime pentexil tosilate)、头孢地尼、头孢妥仑匹酯(cefditoren pivoxil)、头孢吡肟、头孢他美、头孢替考、头孢克肟、头孢瑞南、盐酸头孢甲肟(CefinenoximeHydrochloride)、头孢美唑(Cefinetazole)、头孢雷特(cefminlox)、头孢地嗪、头孢尼西钠、头孢哌酮钠、头孢雷特(Ceforamide)、头孢噻利、头孢噻肟钠、头孢替坦、头孢替安、头孢西丁、头孢唑兰、头孢咪唑、头孢匹胺、头孢匹罗、头孢泊肟酯、头孢丙烯、头孢沙定、头孢磺啶、头孢他啶、头孢特仑、头孢布烯、头孢唑肟钠、头孢曲松、头孢呋辛、雷公藤红素(celastrol)、celikalim、塞利洛尔、cepacidiine A、头孢乙腈钠、头孢氨苄(cephalexin)、头孢来星、头孢噻啶(Cephaloridine)、头孢噻吩钠、头孢匹林钠、头孢拉定(Cephradine)、西文氯胺、西立伐他汀、西罗普利、舍托肝素钠、蓝肽、西他苯钠、西他氯铵、盐酸塞他洛尔、西替地尔、西替利嗪、乙酰氯霉素、盐酸西曲酸酯、西曲瑞克、氯化十六烷基吡啶、鹅去氧胆酸、盐酸氯苯达诺、氯醛甜菜碱、苯丁酸氮芥、氯霉素、氯登妥因(Chlordantoin)、氯氮革(Chlordiazepoxide)、氯己定葡糖酸盐、二氢卟酚(chlorins)、醋酸氯地孕酮、氯东方菌素A(chloroorienticin A)、盐酸氯普鲁卡因、氯磺丙脲(Chloropropamide)、氯喹、氯喹磺酰胺(chloroquinoxaline sulfonamide)、氯噻嗪、氯烯雌醚、氯喔星(Chloroxine)、氯二甲酚、氯苯甘油氨酯、马来酸氯苯那敏(Chlorpheniramine Maleate)、氯丙嗪、氯磺丙脲、氯普噻吨、金霉素硫酸氢盐、氯噻酮(Chlorthalidone)、氯唑沙宗、消胆胺树脂、盐酸卡波罗孟、西苯唑啉、西卡前列素、盐酸环拉福林、氢苯嘧吲哚(Ciclazindol)、环索奈德、西氯他宁、环吡酮、环洛芬、环丙洛尔、西多福韦、盐酸西多塞平、西苯唑啉(Cifenline)、环格列酮、盐酸西拉多巴、西兰司琼、西司他丁钠、西拉普利、西尼地平、甲磺酸西洛巴明、西洛雷定、西洛芬净、西洛他唑、西马特罗、西眯替丁、西托溴铵(cimetropium bromide)、西那司特、盐酸辛那色林、马来酸桂哌酯、环桂氟胺、烯孕醇、西尼必利、桂美君、桂利嗪、西诺西泮、西诺沙星、桂哌林、桂溴胺、辛喷他宗、辛曲胺、塞奥罗奈、西潘茶碱、琥珀酸环丙法朵、环丙奈德、环丙贝特、环丙沙星、西前列烯、西拉马朵、西罗霉素、西沙必利、苯磺顺阿曲库胺(cisatracuriumbesilate)、顺康唑、顺铂、顺-卟啉、西替克新、西酞普兰、西替酰胺、胞磷胆碱、柠檬小单孢菌抗生素类α(citreamicinα)、克拉屈滨、盐酸氯胺羟喹(Clamoxyquin Hydrochloride)、克拉霉素、黄皮酰胺(clausenamide)、克拉维酸钾(Clavulanate Potassium)、克拉唑仑、氯佐利明(Clazolimine)、氯波必利、氯马斯汀、马来酸克仑硫卓(Clentiazem Maleate)、克利溴铵(Clidinium Bromide)、克林沙星、克林霉素、氯碘羟喹、氯碘沙尼(Clioxamide)、克利洛芬、氯巴占、丙酸氯倍他索、丁酸氯倍他松、醋酸氯可托龙、氯达洛能(Clodanolene)、盐酸氯达酮、氯膦酸(clodronic acid)、氯法齐明、氯贝丁酯、磷酸氯非铵(ClofiliumPhosphate)、醋酸氯孕酮、磷酸氯马克仑(Clomacran Phosphate)、醋酸氯美孕酮、氯甲孕酮、氯美噻唑、氯米芬(clomifene)类似物、氯氨雷司、克罗米酚、盐酸氯米帕明、氯硝西泮、可乐定、氯硝甘油、氯尼塞利、氯尼辛、氯帕胺、氯哌噻吨、盐酸氯哌喹酮(CloperidoneHydrochloride)、氯吡格雷、氯哌莫齐、甲磺酸氯哌帕生、氯吡酸、氯泼尼醇、氯前列醇钠、二钾氯氮革(Clorazepate Dipotassium)、氯乙双酯、氯索隆、盐酸氯哌隆、盐酸氯丙那林、氯舒隆、盐酸邻氯苯丁胺、氯氰碘柳胺、乙酰甘氨酸氯西拉敏(Closiramine Aceturate)、氯噻平、马来酸氯噻吨胺(Clothixamide Maleate)、丙酸氯硫卡松、克霉唑、苄星氯唑西林(Cloxacillin Benzathine)、氯羟喹啉、氯氮平、可卡因、球孢菌素、可待因、可多克辛、秋水仙碱、考来替兰(colestimide)、盐酸考来替泊、考来酮、考福新、棕榈酸考福西利(Colfosceril Palmitate)、黏菌素甲烷磺酸钠(Colistimethate Sodium)、硫酸黏杆菌素(Colistin Sulfate)、collismycin A、collismycin B、甲磺酸可尔特罗、康普瑞汀A4(combretastatin A4)、康普瑞汀(combretastatin)类似物、补体结合抑制素(complestatin)、conagenin、盐酸考诺封(Conorphone Hydrochloride)、考替特罗(contignasterol)、蛇毒解聚素(contortrostatin)、醋酸三氟米松(CormethasoneAcetate)、可的瑞林绵羊Triflutate、促肾上腺皮质激素(Corticotropin)、醋酸可的松、可的伐唑、可托多松、cosalane、costatolide、替可克肽(Cosyntropin)、可替宁、香豆素(Coumadin)、库马霉素、crambescidin 816、克伐他汀、克立那托(crisnatol)、克罗米腈钠、色甘酸钠、克罗米通、念珠藻素8(cryptophycin 8)、cucumariosid、铜迈星、curacin A、硫酸可德兰(curdlan sulfate)、curiosin、环青霉素(Cyclacillin)、环佐辛、cyclazosin、环HPMPC、胺氢咔唑(Cyclindole)、马来酸赛利拉敏、赛克力嗪、环苯达唑(Cyclobendazole)、环苯扎林、环丁基甲酸A、环丁基甲酸G、氨甲环酸(cyclocapron)、环氯胍双羟萘酸盐(Cycloguanil Pamoate)、环己酰亚胺、环戊蒽醌(cyclopentanthraquinones)、环戊噻嗪、盐酸环喷托酯、盐酸环丙奋乃静、环磷酰胺、环铂(cycloplatam)、环丙烷、环丝氨酸、地诺前列素(cyclosin)、环孢菌素(Cyclosporine)、环噻唑烷(cyclothialidine)、环噻嗪、环噻唑霉素(cyclothiazomycin)、环庚米特、赛普霉素(cypemycin)、盐酸苯环戊胺、环丙西泮、盐酸赛庚啶、盐酸环丙利多、环丙孕酮、环丙米特、半胱胺、盐酸半胱氨酸、胱氨酸、阿糖胞苷、盐酸阿糖胞苷、阿糖胞苷十八烷基磷酸盐(cytarabine ocfosfate)、细胞松弛素B(cytochalasin B)、溶细胞因子(cytolytic factor)、磷酸己烷雌酚(cytostatin)、达卡巴嗪、达昔单抗、达地米星(dactimicin)、放线菌素(Dactinomycin)、黄豆苷元、甲苯磺酸达来达林、达福普汀、达肝素钠、达曲班、达伐他汀、达那肝素(danaparoid)、达那唑、丹曲林、达格列净(dapagliflozin)、daphlnodorin A、达哌唑、达匹坦、盐酸达泊西汀、氨苯砜、达托霉素、达格列酮钠、达非那新、darlucin A、达罗地平、达西多明、盐酸柔红霉素、马来酸达才促醇(Dazadrol Maleate)、盐酸氮革尼尔(Dazepinil Hydrochloride)、达美格雷、富马酸达佐必利、盐酸达唑氧苯、硫酸异喹胍(Debrisoquin Sulfate)、地西他滨、去铁酮、地夫可特、去氢胆酸(Dehydrocholic Acid)、dehydrodidemnin B、脱氢表雄酮(Dehydroepiandrosterone)、地拉普利、盐酸地拉普利、甲磺酸地拉韦啶、地来夸明、地发哌嗪、醋酸地马孕酮、地莫匹醇、花翠素(delphinidin)、地美溴铵(Demecarium Bromide)、地美环素、去甲环素、地莫西泮、地奴真菌素(Denofungin)、脱氧吡啶诺林(deoxypyridinoline)、丙戊酸钠(Depakote)、地泼罗酮、地前列素、酯肽霉素(depsidomycin)、德伦环烷、硫酸皮肤素(dermatan sulfate)、地昔洛韦、地西龙缩丙酮、地氟烷、盐酸地昔帕明、地西卢定、去乙酰毛花苷、德舍瑞林、去氨加压素、去氧孕烯、地奈德、去羟米松、desoxoamiodarone、醋酸去氧皮质酮(Desoxycorticosterone Acetate)、地他铵重酒石酸盐(detajmium bitartrate)、盐酸地特诺、醋酸地肽瑞里、地伐西匹、地塞米松、右旋米唑、马来酸右溴苯那敏(Dexbrompheniramine Maleate)、马来酸右氯苯那敏、盐酸代克拉莫(Dexclamol Hydrochloride)、右苄替米特、盐酸右芬氟拉明(DexfenfluramineHydrochloride)、右异环磷酰胺、苯双咪唑(Deximafen)、地昔卡因、右酮洛芬、右氯谷胺、右美托咪定、右奥马铂、右奥沙屈盐酸盐、右泛醇、右培美酸、盐酸右普萘洛尔、右雷佐生、右索他洛尔、糊精2-硫酸盐、右旋安非他命(Dextroamphetamine)、右美沙芬、盐酸右啡烷、右甲状腺素钠、右维拉帕米、地扎胍宁、地秦胺、地佐辛、盐酸二醋洛尔、环己氨磺酸二胺卡因、硫米齐特(Diapamide)、泛影葡胺(Diatrizoate Meglumine)、泛影酸(Diatrizoic Acid)、二氨藜芦啶、地西泮、地吖醌、二氮嗪、盐酸二苯西平、二苯并噻吩、地布卡因、敌敌畏(Dichliorvos)、氯醛比林、双氯非那胺、地西利酮、双氯芬酸钠、双氯西林、dicranin、双香豆素(Dicumarol)、盐酸双环维林、去羟肌苷、膜海鞘素B(didemnin B)、迪多克斯(didox)、双烯雌酚(Dienestrol)、地诺孕素、柠檬酸乙胺嗪、diethylhomospermine、二乙基去甲精胺(diethylnorspermine)、盐酸安非拉酮、己烯雌酚(Diethylstilbestrol)、盐酸地芬腈酰胺(Difenoximide Hydrochloride)、地芬诺辛、醋酸双氟拉松(Diflorasone Diacetate)、盐酸二氟沙星、盐酸二氟嗪(Difluanine Hydrochloride)、二氟可龙、二氟米酮钠、二氟尼柳、二氟泼尼酯、地弗他酮、洋地黄(Digitalis)、洋地黄毒苷、地高辛、盐酸双己维林、二羟西汀(dihVdrexidine)、二氢-5-氮杂胞苷、酒石酸二氢可待因(DihVdrocodeine Bitartrate)、二氢麦角胺甲磺酸盐、二氢睾酮(Dihydroestosterone)、硫酸二氢链霉素、双氢速甾醇、二氢紫杉醇、9-、狄兰汀(Dilantin)、盐酸地来洛尔、盐酸地尔硫卓、二甲法登、盐酸二甲弗林、茶苯海明、二巯丙醇、二甲双酮、马来酸二甲茚定、地美炔酮、二甲基前列腺素A1、二甲基亚砜、二甲基高精胺(dimethylhomospermine)、地来西坦、盐酸地莫沙明(DimoxamineHydrochloride)、地诺前列素、地诺前列酮、盐酸地奥沙屈、二霉素(dioxamycin)、柠檬酸苯海拉明、地芬尼多、盐酸地芬诺酯、二苯基螺莫司汀、盐酸地匹福林(DipivefinHydrochloride)、地匹福林(Dipivefrin)、dipliencyprone、地丙苯酮、dipropylnorspermine、双嘧达莫、双吡硫翁、安乃近、地红霉素、圆皮海绵内酯(discodermolide)、地索布胺、地索苯宁、丙吡胺、二沙利、双硫仑、地特吉仑(Ditekiren)、双丙戊酸钠(Divalproex Sodium)、马来酸地佐环平、多巴酚丁胺、多卡巴胺、多西苯醌、多西他赛、多康唑、二十二烷醇(docosanol)、多非利特、多拉司琼、依巴斯汀、依比拉肽、乙溴替丁、依布硒、依卡派特、依卡倍特、依卡曲尔、ecdisteron、echicetin、蛇毒锯鳞蝰素(echistatin)、依可碘酯(Echothiophate Iodide)、依氯那明马来酸盐、乙唑司特、依考莫司汀、益康唑、海鞘素722(ecteinascidin 722)、依达拉奉、依达曲沙、依地福新、醋酸依地福龙、埃巴单抗、依度尿苷、依决洛单抗、氯化腾喜龙(Edrophonium Chloride)、醋酸edroxyprogesteone、依非加群、依氟鸟氨酸、依福地平、egualcen、依兰群、依降钙素(eleatonin)、榄香烯(elemene)、依来曲普坦、依高地平、依利罗地、依沙芦星、eltenae、依鲁卡因、emalkalim、依美斯汀、盐酸依米丁、乙格列酯、甲苯磺酸依米铵(EmiliumTosylate)、乙嘧替氟、依莫白介素、恩格列净(empagliflozin)、盐酸依那朵林、依那普利、依那普利拉、依那吉仑、依那扎群、恩环丙酯、恩屈嗪甲磺酸盐、恩甲羟松(Endrysone)、恩氟烷、恩格列酮、恩康唑、依尼前列素、恩莫单抗、恩洛铂、乙诺司特、依诺利康钠、依诺沙星、依诺沙星、依诺肝素钠、依诺肝素钠、依诺昔酮、磷酸恩哌罗林、恩丙茶碱、恩普氨酯、恩他卡朋、肠抑肽(enterostatin)、恩韦拉登、恩韦肟、麻黄碱、依匹西林、表美雌醇、肾上腺素、环硼肾上腺素(Epinephryl Borate)、依匹哌啶、依匹唑、表柔比星、盐酸差向四环素(Epitetracycline Hydrochloride)、依匹噻嗪、阿法依泊汀(Epoetin Alfa)、倍他依泊汀(Epoetin Beta)、依前列醇、依前列醇钠、依普利酮(epoxymexrenone)、依立雄胺、依普罗沙坦、依斯的明、马萘雌酮(equilenin)、马烯雌酮(Equilin)、厄布洛唑、厄多司坦、甲磺酸双氢麦角碱(Ergoloid Mesylates)、马来酸麦角新碱、酒石酸麦角胺、艾生利特、厄索夫明、赤藓糖醇(erythritol)、赤癣四硝酸酯(Erythrityl Tetranitrate)、红霉素、盐酸艾司洛尔、盐酸依索比星、盐酸乙硫酰丙喹(Esproquin Hydrochloride)、艾司唑仑、雌二醇、雌莫司汀、雌莫司汀类似物、雌秦醇氢溴酸盐、雌三醇、雌呋酯、雌激素激动剂(estrogenagonists)、雌激素拮抗剂(estrogen antagonists)、雌激素(Estrogens)、缀合雌激素(Conjugated Estrogens)、酯化雌酮、雌酮硫酸酯哌嗪(Estropipate)、乙磺普隆、盐酸乙基麻黄碱、依他硝唑、依坦特罗、依他洛汀(Etarotene)、依他唑酯盐酸盐、依特比妥、乙沙西嗪(ethacizin)、依他尼酸钠、依他尼酸、盐酸乙胺丁醇、香草二乙胺、油酸氨基乙醇(Ethanolamine Oleate)、乙氯戊烯炔醇(Ethehlorvynol)、乙醚、乙炔雌二醇、乙碘油(Ethiodized Oil)、乙硫异烟胺、依托南硝酸盐、普罗吩胺盐酸盐(EthopropazineHydrochloride)、乙琥胺、乙苯妥英、依托沙秦盐酸盐(Ethoxazene Hydrochloride)、乙苯托品(Ethybenztropine)、乙基氯、地布酸乙酯(Ethyl Dibunate)、乙雌烯醇、Ethyndiol、氯炔诺酮(Ethynerone)、双醋炔诺酮(Ethynodiol Diacetate)、依苯达唑、依替卡因、依替膦酸二钠(Etidronate Disodium)、依替膦酸(Etidronic Acid)、依替菲宁、依汀替丁盐酸盐、依替唑仑、依托度酸、依托芬那酯、依托福明盐酸盐、依托咪酯、依托孕烯、盐酸依托哌酮、依托泊苷、艾托卜宁(Etoprine)、盐酸乙苯啶盐、依托唑啉、依曲巴明、依曲替酯(Etretinate)、醋酸乙色胺、盐酸优卡托品(Eucatropine Hydrochloride)、丁香油酚、盐酸尤普罗辛、扁枝衣霉素(eveminomicin)、依沙美肟、艾沙瑞林、盐酸已丙洛尔、依西美坦、法倔唑、faeriefungin、泛昔洛韦、法莫替丁、氨吡啶、泛托法隆、盐酸泛曲酮、法罗培南、法西多曲、法舒地尔、法扎拉滨、非多托秦、非尔氨酯、联苯乙酸、非洛地平、苯赖加压素、非那拉胺、非那莫、芬苯达唑、芬布芬、芬西布醇、芬氯酸、芬克洛宁、苯克洛酸、芬度柳、芬雌酸、盐酸芬乙茶碱、盐酸芬氟拉明、酚加宾、非尼米特、非尼雷司、盐酸芬美托唑(FenmetozoleHydrochloride)、苯甲吗啉酮、非诺班、硫酸苯辛替明、非诺贝特、非诺多泮、非诺洛芬、非诺特罗、奋匹帕隆(Fenpipalone)、盐酸苯呤司特、芬前列林、芬喹唑、芬尼替尼(fenretinide)、芬司匹利、柠檬酸芬太尼、芬替酸、芬替克洛、芬替康唑、盐酸非尼啶醇、非普地醇、吡磷铁钠、铁利司坦(ferristene)、ferrixan、干燥硫酸亚铁、菲立磁(Ferumoxides)、非莫西尔(ferumoxsil)、盐酸非托西酯、非索非那定、富马酸非唑拉明(Fezolamine Fumarate)、非西他滨、非阿尿苷、纤维蛋白原1125、非格司亭、菲律宾菌素、非那雄胺、黄酮地洛马来酸盐、夫拉平度(flavopiridol)、盐酸黄酮哌酯、夫拉扎酮、氟卡尼、氟丁特罗、氟罗沙星、氟辛克生、硫酸氟司洛尔、氟乙西泮、氟卓斯汀(flezelastine)、氟罗布芬(flobufen)、夫洛非宁、氟氧头孢、氟地平、氟苯尼考、氟非宁、氟沙地尔、氟司喹南、氟氯西林、氟尿苷、氟拉睾酮(fluasterone)、氟扎可特、盐酸氟巴尼酯、氟苯达唑(Flubendazole)、氟西吲哚、氟氯奈德、氟康唑、氟胞嘧啶、氟氘丙氨酸、磷酸氟达拉滨、氟氯达唑(Fludazonium Chloride)、氟代脱氧葡糖F18、氟多雷司、醋酸氟氢可的松、氟灭酸(Flufenamic Acid)、氟苯柳、氟马西尼、氟美西诺、氟甲喹、氟美立酮、氟米松(Flumethasone)、氟美吗酮、氟甲氮平、氟氨雷司、芬氟咪唑、氟莫奈德、氟桂利嗪、氟硝唑、氟尼缩松、氟硝西泮、氟尼辛、氟骨化三醇(fluocalcitriol)、醋酸氟轻松(FluocinoloneAcetonide)、醋酸氟轻松(Fluocinolone)、氟考丁酯(Fluocortin Butyl)、氟可龙、荧光素、盐酸氟柔红霉素(fluorodaunorunicin hydrochloride)、氟多巴F18、氟米龙、氟尿嘧啶、盐酸氟曲辛、氟西汀、氟甲睾酮、氟洛克生、氟哌醇胺、醋酸氟培龙、氟非那嗪癸酸酯(Fluphenazine Decanoate)、氟吡汀(flupirtine)、氟泼尼龙、氟丙喹宗、氟前列醇钠、氟喹宗、盐酸氟朵林、氟氢缩松(Flurandrenolide)、盐酸氟西泮、氟比洛芬、氟瑞托芬、氟红霉素、氟西他滨、氟法胺、醋酸氟孕酮、六氟二乙酯(Flurothyl)、氟乙烯醚、氟司哌隆、氟司必林、丙酸氟替卡松、氟曲马唑、氟曲林、氟伐他汀、氟伐他汀钠、氟伏沙明、氟齐胺、叶酸、卵泡调节蛋白(Follicle regulatory protein)、卵泡抑素(Folliculostatin)、甲吡唑、二甲替嗪甲磺酸盐、福拉沙坦、福酚美克、forfenirmex、福美坦、福莫可他、福莫特罗、磷利酯、膦西泮、膦甲酸钠、磷霉素、膦乙醇钠、福辛普利、福辛普利拉(Fosinoprilat)、磷苯妥英(fosphenyloin)、磷喹酮、福司地尔、福司曲星、福莫司汀、碱性品红、呋莫西林、培里霉素(Fungimycin)、呋喃洛芬、呋喃唑酮、呋唑氯铵(Furazolium Chloride)、呋格雷酸钠、呋罗布芬、呋罗达唑、呋塞米、夫西地酸钠、夫西地酸、加巴喷丁、钆贝葡胺(GadobenateDimeglumine)、钆贝酸(gadobenic acid)、钆布醇、钆双胺、钆特沙弗林、钆喷酸葡胺、钆特酸(gadoteric acid)、钆特醇、钆弗塞胺、加兰他敏、加丹司琼、盐酸加丹司琼、三碘季胺酚(Gallamine Triethiodide)、硝酸镓、戈洛帕米、加洛他滨、更非辛、gamolenic acid、更昔洛韦、加尼瑞克、白明胶酶抑制剂、四甲癸二醇(Gemcadiol)、吉西他滨、吉美前列素、吉非贝齐、硫酸庆大霉素、龙胆紫(Gentian Violet)、吉哌隆、孕氯酮、孕二烯酮、孕诺酮己酸酯、孕三烯酮、盐酸吉伏曲林、吉立索泮、格拉莫德(glaspimod)、蓝萼甲素(glaucocalyxin A)、格来色林、格列胺脲、格列波脲、格列他尼钠、格列氟胺、格列美脲、格列吡嗪、格洛莫南、胰高血糖素、glutapyrone、谷胱甘肽抑制剂、格鲁米特、格列本脲、glycopine、glycopril、格隆溴铵(Glycopyrrolate)、格列己脲、格列嘧啶钠、格列辛脲、格列帕脲、金Au 198、Gonadoctrinins、戈那瑞林、促性腺激素(Gonadotropins)、戈舍瑞林、短杆菌肽、格拉司琼、格帕沙星、灰黄霉素、哌苯四醚、愈甘醚茶碱(Guaithylline)、胍那苄、醋酸胍那苄、硫酸胍那决尔、胍西定、胍乙啶单硫酸盐、盐酸胍法辛、硫酸胍尼索喹、硫酸胍氯酚、盐酸胍诺克汀、胍诺沙苄、硫酸胍生、硫酸胍诺西芬、胍立莫司三盐酸化物、哈拉西泮、哈西奈德、软海绵素B(halichondrin B)、丙酸卤倍他索(Halobetasol Propionate)、卤泛群、盐酸卤泛群、卤芬酯、卤夫酮氢溴酸盐、海乐萌(halomon)、卤培米特、氟哌啶醇、卤泼尼松、卤孕酮、卤普罗近、氟烷、哈喹诺、哈霉素、Han memopausal促性腺激素、鸠麻霉素(hatomamicin)、hatomarubigin A、hatomarubigin B、hatomarubigin C、hatomarubigin D、肝素钠、hepsulfam、调蛋白(heregulin)、海他西林、海特溴铵(Heteronium Bromide)、六氯酚、过氧化氢、己芴溴铵(Hexafluorenium Bromide)、六亚甲基二乙酰胺、海克西定、海索苯定、硫酸海索那林、己雷琐辛、磷酸组胺、组氨酸、组织胞浆菌素、组氨瑞林、氢溴酸后马托品(Homatropine Hydrobromide)、盐酸胡喹嗪、人绒毛膜促性腺激素(Human chorionicgonadotropin)、海恩酮、盐酸肼屈嗪、肼苯哒嗪乙烯苯共聚物(Hydralazine Polistirex)、氢氯噻嗪、氢可酮酒石酸氢盐、氢化可的松、氢氟甲噻嗪、盐酸氢吗啡酮、氢溴酸羟苯丙胺、硫酸羟基氯喹、奥芬氨酯(Hydroxyphenamate)、己酸羟孕酮(HydroxyprogesteroneCaproate)、羟基脲(Hydroxyurca)、盐酸羟嗪、羟甲香豆素、莨菪碱、金丝桃素(hypericin)、依巴沙星、伊班膦酸(ibandronic acid)、伊博格碱、异波帕胺、异丁司特、异丁芬酸、布洛芬、富马酸伊布利特、醋酸艾替班特、鱼石脂、亚可替定(Icotidine)、伊达比星、艾多昔芬、碘苷、伊决孟酮、Iemefloxacin、Iesopitron、伊非曲班、异环磷酰胺、Ilepeimide、illimaquinone、伊莫福新、伊洛马司他、伊洛达普、伊潘立酮、伊洛前列素、盐酸伊马芬(Imafen Hydrochloride)、盐酸伊马唑旦、咪达普利、米达西尼(imidazenil)、咪唑并吖啶酮(imidazoacridones)、咪癸碘(Imidecyl Iodine)、盐酸咪多卡、盐酸咪多林、咪脲(Imidurea)、盐酸咪洛克生、亚胺培南、盐酸丙咪嗪、咪喹莫特、免疫促进剂多肽、盐酸英普咪定、茚达立酮、吲达帕胺、盐酸英地卡尼、盐酸茚洛秦、靛胭脂、茚地那韦、吲哚氰绿(Indocyanine Green)、盐酸吲哚普利、吲哚利旦、吲哚美辛、吲哚美辛钠、吲哚洛芬、吲哚拉明、吲哚瑞酯盐酸盐、吲哚克索、盐酸茚屈林、伊诺特隆、伊诺加群、伊诺莫单抗、烟酸肌醇酯(Inositol Niacinate)、胰岛素、干扰素、白介素、吲四唑、盐酸英曲替林、碘苄胍、碘苯扎酸(Iobenzamic Acid)、碘比醇、碘卡酸葡甲胺(Iocarmate Meglumine)、碘卡酸(IocarmicAcid)、碘西他酸(Iocetamic Acid)、碘达胺、碘、胆影酸葡甲胺、碘克沙醇、iodoamiloride、碘安替比林I 131(Iodoantipyrine I 131)、碘胆甾醇I 131、碘多柔比星、碘马尿酸钠I131、碘奥酮I 125、双碘喹啉、碘沙酸葡甲胺、Iodoxamie Acid、碘格利酸(Ioglicic Acid)、碘非他胺盐酸盐I 123、碘拉醇、碘葡醇、碘葡胺、碘甘卡酸(Ioglycamic Acid)、Iogulamide、碘海醇、碘美普尔、Iomethin I 125、碘帕醇、碘泛酸(Iopanoic Acid)、碘喷托、碘苯酯、碘普西酸(Ioprocemic Acid)、碘普胺、碘普罗酸(Iopronic Acid)、碘吡多、碘吡酮、iopyrol、碘西法酸(Iosefamic Acid)、碘丝酸(Ioseric Acid)、碘磺拉胺葡甲胺、碘琥酸(Iosumetic Acid)、碘酞硫、碘替酸(Iotetric Acid)、碘酞酸钠、碘他拉酸(Iothalamic Acid)、碘赛特、碘曲仑、碘曲西酸(Iotroxic Acid)、Iotyrosine I 131、碘佛醇、碘克酸钠(Ioxagiate Sodium)、碘克酸葡甲胺(Ioxaglate Meglumine)、碘克沙酸(Ioxaglic Acid)、碘昔兰、羟泛影酸(Ioxotrizoic Acid)、依帕利特、伊培沙宗、伊匹达克林、碘泊酸钙(Ipodate Calcium)、甘薯苦醇(ipomeanol)、4-、异丙托溴铵(IpratropiumBromide)、依普黄酮、伊普吲哚、异丙苯甘酸(Iprofenin)、异丙硝唑(Ipronidazole)、异丙铂、盐酸异丙沙明、伊沙匹隆、厄贝沙坦、伊立替康、伊洛沙星、伊罗普拉、伊索拉定、伊替马唑、伊沙司坦、依沙莫可苏(Isamoxole)、伊波格雷、异帕米星、isobengazole、异氨苯丁酯、异卡波肼、异康唑、异他林(Isoetharine)、isofloxythepin、醋酸异氟泼尼龙、异氟烷、异氟磷、isohomohalicondrin B、异亮氨酸、盐酸伊索马唑、盐酸异戊拉明、异烟肼、异丙碘铵、异丙醇、异丙基乌诺前列酮、异丙肾上腺素盐酸盐、异山梨醇、异山梨醇一硝酸盐、依索喹胺、异维甲酸(Isotretinoin)、伊索克酸、伊索昔康、盐酸异克舒令、伊拉地平、伊他美林、伊他司琼、伊他格雷、伊托必利、伊曲康唑、伊维菌素、茉莉素(jasplakinolide)、交沙霉素、kahalalide F、卡拉芬净、硫酸卡那霉素、盐酸氯胺酮、酮色林、酮佐辛、凯他唑仑、乙氧二羟丁酮(Kethoxal)、富马酸氧丙咪嗪(Ketipramine Fumarate)、酮康唑、酮洛芬、酮啡诺、酮咯酸、富马酸酮替芬、吉他霉素、盐酸拉贝洛尔、拉西地平、拉西地平、拉克替醇、拉替维辛(lactivicin)、莱乃康(laennec)、拉呋替丁、三醋酸片螺素-N(lamellarin-Ntriacetate)、拉米非班、拉米夫定、拉莫三嗪、拉诺康唑、拉诺辛(Lanoxin)、兰吡立松、兰瑞肽、兰索拉唑、拉坦前列素、砖红镰孢菌素(lateritin)、月桂氮酮(laurocapram)、月桂基异喹啉氮溴化物、琥珀酸拉伏替丁(Lavoltidine Succinate)、拉扎贝胺、来西贝特、雷拉霉素(leinamycin)、来米地平、来明拉唑、来那西普、来尼喹新、来格司亭、仑哌隆、硫酸香菇多糖(lentinan sulfate)、瘦素(leptin)、leptolstatin、乐卡地平、麦角腈、来立司琼、盐酸来替米特、来曲珠利、来曲唑、亮氨酸、leucomyzin、醋酸亮丙瑞林(Leuprolide Acetate)、亮丙瑞林+雌激素+黄体酮、亮丙瑞林、琥珀酸左旋苯丙胺(Levamfetamine Succinate)、左旋咪唑、乳糖酸左旋多巴酚丁胺(Levdobutamine Lactobionate)、D-克罗卡林(Leveromakalim)、左乙拉西坦、左环丝氨酸(Leveycloserine)、左倍他洛尔、左布诺洛尔、左布比卡因、左卡巴斯汀、左卡尼汀、左旋多巴、左羟丙哌嗪、左氧氟沙星、左呋喃他酮、左亚叶酸钙(Levoleucovorin Calcium)、左醋美沙朵、盐酸左醋美沙朵(Levomethadyl AcetateHydrochloride)、左莫普洛尔、盐酸左南曲朵、左旋异肾上腺素、左炔诺孕酮、左丙氧芬萘磺酸(Levopropoxyphene Napsylate)、左普皮西林钾(Levopropylcillin Potassium)、左美洛昔芬、左啡诺酒石酸(LevorphanolTartrate)、左西孟旦、左舒必利、左甲状腺素钠、盐酸左沙屈尔、来昔帕泛、来红霉素、利阿唑、赖苯普利、盐酸利达脒、利多卡因、利多苯宁、利多氟嗪、利法利嗪、利贝特、利非贝罗、林那罗汀、林可霉素、线性多胺类似物、利诺格列、利诺吡啶、利诺曲班、林西多明、林替曲特、林托必利、碘塞罗宁I 125、碘塞罗宁钠、复方甲状腺素(Liotrix)、利沙必利、赖诺普利、lissoclinamide 7、硫酸利沙齐农、洛铂、氯苯扎利钠、洛布卡韦、氯德拉苯、洛度沙胺(Iodoxamide)、盐酸洛非咪唑、草酸洛芬太尼、盐酸洛非帕明、盐酸洛非西定、蚯蚓磷脂(lombricine)、洛美沙星、洛美利嗪、盐酸洛美曲林、洛美曲索、洛蒙真菌素(Lomofungin)、氯诺昔康(Lomoxicam)、洛莫司汀、氯萘帕林、氯那唑酸、氯尼达明、盐酸洛哌丁胺、氯碳头孢、盐酸劳拉义明、氯雷他定、劳拉西泮、劳氨酯、盐酸劳卡尼、氯瑞唑、Loreinadol、氯戊米特、氯甲西泮、氯诺昔康、氯诺昔康、氯他拉明、氯扎封、氯沙坦、氯西加酮、洛索蒽醌、盐酸洛硫嗪、氯替泼诺、洛伐他汀、洛韦胺、洛沙平、洛索立宾、芦贝鲁唑、盐酸硫蒽酮、鲁非罗尼、甲磺酸卢罗司、勒托替康、促黄体激素(luteinizing hormone)、鲁拉西酮(Lurasidone)、镥、醋酸黄体瑞林、褪黑素受体拮抗剂(luzindole)、阿朴酸钠(Lyapolate Sodium)、氨棕己胺(Lycetamine)、lydicamycin、利迪霉素(Lydimycin)、利奈孕酮、赖氨加压素、赖氨酸、利索茶碱(lysofylline)、溶葡萄球菌素、裂解肽、马度米星、磺胺米隆、抗菌肽2酰胺、水杨酸镁、硫酸镁、厚朴酚(magnolol)、美坦新、马来他姆(Malethamer)、野梧桐色烯(mallotochromene)、mallotojaponin、马洛替酯、马洛替酯、锰福地吡、马尼地平、maniwamycin A、甘露醇、制甘糖酶素A、手霉素E、手霉素F、马哌斯汀、马普替林、马立马司他、马提克8708(Martek 8708)、马提克92211(Martek 92211)、马索罗酚、乳腺丝氨酸蛋白酶抑制剂(maspin)、massetolide、基质溶解因子抑制剂(matrilysininhibitor)、美登素(Maytansine)、琥珀酸马扎哌汀、马吲哚、甲苯达唑、盐酸美贝维林、甲溴菲宁、美布氨酯、盐酸美卡拉明、盐酸氮芥、甲氯环素、甲氯灭酸钠、甲氯喹酮、二丁酸甲氯松、盐酸美达西泮、美多力农、美屈孕酮、美沙洛尔、甲羟孕酮、甲羟松、盐酸美克洛嗪(Meelizine Hydrochloride)、甲芬那酸、甲苯地尔、盐酸美芬雷司、美非沙胺、盐酸甲氟喹、美夫西特、巨霉素磷酸二氢钾、醋酸甲地孕酮、葡甲胺、美格鲁托、醋酸美仑孕酮、盐酸美利曲辛、美法仑、盐酸美莫汀、盐酸美大麻坦、美诺克酮、美诺立尔、尿促性素、硫酸甲氧苯汀、美帕曲星、溴美喷酯、盐酸哌替啶、硫酸美芬丁胺、甲苯妥应(Mephenyloin)、甲苯巴比妥、盐酸甲哌卡因、甲丙氨酯、盐酸美普他酚、美喹多司、汞林钠、美巴龙(merbarone)、巯嘌呤、氯汞苯酚(Mercufenol Chloride)、氯化氨汞、汞Hg197丙醇、美罗培南、美沙拉嗪、美西拉宗、美索达嗪、美睾酮、美雌醇、盐酸美舒令、盐酸美他洛尔、聚苯烯奥西那林、重酒石酸间羟胺(Metaraminol Bitartrate)、美他沙酮、甲烯前列素、美替瑞林(meterelin)、二甲双胍、氯醋甲胆碱、美他环素、盐酸美沙酮、左醋美沙朵、美沙噻嗪、盐酸脱氧麻黄碱(Methamphetamine Hydrochloride)、甲喹酮、醋甲唑胺、甲地嗪、乌洛托品、醋酸美替诺龙、美替妥英、甲氧西林钠、甲巯咪唑、甲硫氨酸酶(methioninase)、甲硫氨酸、美替沙腙、盐酸美噻吨、美索巴莫、美索比妥钠、甲氧夫啉、甲氨蝶呤、左美丙嗪、甲苯酮(methoxatone)、甲氧氟烷、甲琥胺、甲氯噻嗪、帕莫酸甲酯(Methy1 Palmoxirate)、甲硝阿托品、甲苄索氯铵、甲基多巴、盐酸甲基多巴乙酯、亚甲基蓝、马来酸甲麦角新碱、甲基组胺、R-α、甲基肌苷单磷酸盐、盐酸哌甲酯、甲基泼尼松龙、甲睾酮、双醋甲异炔诺醇(MethynodiolDiacelate)、美西麦角、马来酸美西麦角、甲硫米特、甲硫平、美替普林、甲硫咪胺(metipamide)、美替洛尔、盐酸美替唑啉、醋酸美克法胺(Metkephamid Acetate)、甲氧氯普胺、碘二甲箭毒(Metocurine Iodide)、16,16-二甲诺龙(Metogest)、美托拉宗、美托哌丙嗪、氯苯氨啶、美托洛尔、美托喹嗪、美曲磷酯、甲泛葡胺、甲泛影钠、甲硝唑、美妥替哌、美替拉酮、甲酪氨酸、盐酸美西律、美利酸钾、美洛西林、mfonelic Acid、盐酸米安色林、米贝拉地尔、二盐酸米贝拉地尔、米勃酮、米歇尔胺B(michellamine B)、咪康唑、microcolin A、氟咪胺、盐酸咪达唑仑、米多君、米非司酮、米福贝特、米格列醇、米拉醋胺、米拉美林、米屈肼、咪仑哌隆、米利哌汀、米那普仑、米力农、米替福新、盐酸米姆本、米那普林(minaprine)、米那索龙、米诺罗米、米诺环素、米诺地尔、盐酸米氟嗪、米奥卡霉素(miokamycin)、米普拉苷、米芬太尼、米立司亭、盐酸米林霉素、马来酸米立司琼、米氮平、错配的双链RNA、米索硝唑、米索前列醇、米丁度胺、米托卡星(Mitocarcin)、丝裂红素(Mitocromin)、米托洁林、米托胍腙、二溴卫矛醇、米托马星、丝裂霉素、米托萘胺、米托司培、米托坦、米托蒽醌、米库氯铵、米伐折醇、mixanpril、米克昔定、咪唑斯汀、咪唑立宾、吗氯贝胺、莫达非尼、硫酸莫达林、莫地卡尼、莫昔普利、莫法罗汀、盐酸莫非吉兰、莫苯唑酸、莫拉司亭、吗啉那宗、盐酸吗茚酮、吗多明、莫米松、马来酸莫那匹尔、莫能菌素、甘油辛酸酯和甘油癸酸酯混合物(Monoctanoin)、孟鲁司特钠、孟替瑞林、莫哌达醇、莫雷西嗪(Moracizine)、酒石酸莫仑太尔、莫雷西嗪(Moricizine)、吗尼氟酯、硫酸吗啡、鱼肝油酸钠、莫沙帕明、莫沙必利、动能内酯(motilide)、莫维A胺、拉氧头孢二钠、莫沙佐辛、莫昔普令、吗硝唑、莫索尼定、腮腺炎皮肤试验抗原、芥抗癌剂、莫唑胺、印度洋海绵(mycaperoxide)B、麦考酚酸、myriaporone、大麻折尼、大麻隆、盐酸大麻坦、盐酸大麻克酯、萘丁美酮、N-乙酰基地那林、辅酶I、那氟沙星、纳多洛尔、那屈肝素钙、那法道曲(nafadotride)、萘莫司他、那法瑞林、萘夫西林钠、萘酚平、盐酸萘咪酮、萘非可特、苹果酸萘甲羟胺、盐酸萘福昔定、草酸萘呋胺、盐酸萘替芬、萘哌地尔、那格列钒、nagrestip、盐酸纳布啡、Naldemedine、萘啶酮酸钠、萘啶酮酸、纳美芬、盐酸纳美酮、纳洛酮+喷他佐辛、纳曲酮、纳莫雷特、苯丙酸诺龙、盐酸南曲朵、盐酸萘帕他定、萘二磺酸盐、盐酸萘帕咪唑、napaviin、盐酸萘甲唑林、萘萜二醇(naphterpin)、萘普生、萘普索、奈沙加群、盐酸萘拉诺、甲基盐霉素(Narasin)、那拉曲坦、那托司亭、那沙普酶、纳他霉素、那替普酶、盐酸那高利特、奈必洛尔、尼拉霉素、奈达铂、奈多罗米、盐酸奈法唑酮、盐酸萘氟齐特、盐酸奈福泮、马来酸奈来扎林、盐酸奈马唑啉、奈莫柔比星、棕榈酸新霉素、溴新斯的明、奈立膦酸、硫酸奈替米星、中性内肽酶、中性霉素、奈韦拉平、盐酸奈西利定、烟酸、硝溴生、盐酸尼卡地平、尼麦角林、氯硝柳胺、尼可地尔、烟醇、硝苯地平、Nifirmerone、氟蚁灵(Nifluridide)、硝呋拉定、硝呋地腙、硝呋太尔、硝呋隆、硝呋达齐、硝呋米特、硝呋吡醇、硝呋奎唑、硝呋噻唑、尼鲁米特、尼伐地平、尼马宗、尼莫地平、尼培替丁、尼拉伏林、尼立达唑、nisamycin、甲磺酸尼司特罗、乳酸链球菌素、尼索氨酯、尼索地平、尼索西汀、醋酸尼司特林、硝苯胂酸、硝唑尼特(nitazoxamide)、硝替卡朋、盐酸硝呋坦、盐酸硝拉明、盐酸硝拉咪唑、硝西泮、尼群地平、硝环素、硝丹宁、呋喃妥因、呋喃西林、硝酸甘油、硝甲酚汞、硝米特、柠檬酸硝米芬、氧化亚氮、氮氧化物抗氧化剂、nitrullyn、尼伐可醇、尼维美酮钠、尼扎替丁、诺柏斯汀、诺考达唑、诺拉霉素、诺利溴铵、马来酸诺米芬辛、盐酸诺美沙朵、诺勃酮、重酒石酸去甲肾上腺素、炔诺酮、异炔诺酮、诺氟沙星、诺氟烷、诺孕酯、诺孕美特、炔诺孕酮、盐酸去甲替林、诺司卡品、新生霉素钠、N-取代benzaimides、奴芬克索、尼尔雌醇(Nylestriol)、制霉菌素、O6-苄基鸟嘌呤、双复磷、奥卡哌酮、盐酸奥芬太尼、奥西普隆、辛酸、奥他酰胺、盐酸奥替尼啶、奥托君、奥曲肽、磷酸奥克替林、氧氟沙星、奥福宁(Oformine)、okicenone、奥氮平、寡核苷酸、奥洛他定、奥普力农、奥沙拉秦、奥沙拉嗪钠、奥伐尼、奥美拉唑、奥那司酮、昂丹司琼、昂唑司特、卵母细胞成熟抑制剂、盐酸奥匹哌醇、oracin、硝酸奥康唑、奥古蛋白、奥利司他(Orlislat)、奥马铂、奥美普林、奥硝唑、奥帕诺辛、柠檬酸奥芬那君、奥沙特隆、奥腾折帕、苯唑西林钠(Oxacillin Sodium)、氧格雷酯、奥沙利铂、盐酸奥沙香豆素、奥沙米索、奥沙尼喹、氧雄龙、双羟萘酸甲嘧烯酚、盐酸羟丙替林、奥沙普秦、奥沙巴唑、奥沙米特、oxaunomycin、奥沙西泮、奥卡西平、奥生多龙、奥昔卡因、富马酸奥昔托隆、奥芬达唑、羟苯甘氨酸、奥苯达唑、奥昔康唑、羟多巴胺、奥昔磷酸、盐酸奥昔芬净、奥昔啡烷、肟莫南、肟莫南钠、奥哌咪酮、奥拉西坦、奥昔拉米、奥昔舒仑、盐酸奥美替丁、奥索地平、苯丙酸奥索孕酮、喹酸、盐酸氧烯洛尔、胆茶碱、氯化奥昔布宁(Oxybutynin Chloride)、奥昔氯生、羟考酮、盐酸羟甲唑啉、羟甲烯龙、盐酸羟吗啡酮、奥昔哌汀、羟基保泰松、羟嘌呤醇、氧四环素、催产素、奥扎格雷、奥唑林酮、紫杉醇、palauamine、帕地霉素、帕利那韦、棕榈酰根霉素(palmitoylrhizoxin)、帕莫酸钠、帕马苷、硫酸帕马洛尔、帕米格雷、帕米膦酸二钠、帕米膦酸、帕那普隆、帕那美新、人参炔三醇(panaxytriol)、泮考必利、泮库溴铵、帕尼培南、pannorin、帕诺米芬、泛硫乙胺、泮托拉唑、盐酸罂粟碱、副球菌素(parabactin)、对乙酰氨基酚、三聚乙醛、醋酸帕拉米松、盐酸瑞尼托林、溴帕拉喷酯、双羟萘酸副品红(Pararosaniline Pamoate)、帕苯咪唑(Parbendazole)、盐酸帕康唑、复方樟脑酊(Paregoric)、硫酸帕立太特、盐酸帕吉林、帕肝素钠、硫酸巴龙霉素、帕罗西汀、欧苷菊、帕曲星、保洛霉素、帕折普汀、帕秦克隆、帕佐昔特、帕珠沙星、培氟沙星、培门冬酶、培戈汀、盐酸培兰色林、培得星(peldesine)、培利霉素、培维A、盐酸培力农、培美酸、硝酸哌美立特、吡嘧司特、匹莫林、培那西林、硫酸喷布洛尔、喷昔洛韦、五氟利多、苄星青霉素G、青霉素G钾、普鲁卡因青霉素、青霉素G钠、青霉素V、苄星青霉素V、海巴青霉素V、青霉素V钾、喷他氨酯、季戊四醇四硝酸酯、喷他夫西(pentafuside)、喷他脒、戊吗酮、戊氮芥、甲硫戊哌铵(Pentapiperium Methylsulfate)、喷他佐辛、喷替酸、马来酸喷硫平、喷替吉肽、喷替米星、戊胺唑酮钠、戊巴比妥、喷托孟、喷托普利、戊聚糖、喷司他丁、己酮可可碱、戊硝醇、戊四氮(pentrozole)、硫酸培洛霉素、胃酶抑素、全氟溴烷、perfofamide、培磷酰胺、培高利特、马来酸哌克昔林、紫苏子醇、培哚普利、培哚普利拉、哌拉平、扑灭司林、哌罗匹隆、奋乃静、苯乙酰脲、苯乙利定(phenaridine)、苯连氮霉素(phenazinomycin)、盐酸非那吡啶、保泰松甘油酸钠、芬卡米特(Phencarbamide)、盐酸苯环利定、酒石酸苯甲曲秦、硫酸苯乙肼、盐酸苯甲吗啉、苯巴比妥、盐酸酚苄明、苯丙香豆素、苯羟基丙氨酸(phenserine)、phensuccinal、苯琥胺、芬特明、盐酸芬特明、甲磺酸酚妥拉明、Phentoxifylline、对氨基水杨酸苯酯、乙酸苯酯、苯丙氨酸、苯丙氨酰基酮康唑、保泰松、盐酸去氧肾上腺素、盐酸苯丙醇胺、苯丙醇胺磺化二乙烯苯-乙烯苯共聚物(Phenylpropanolamine Polistirex)、盐酸非尼拉朵、苯妥英(Phenyloin)、磷酸酶抑制剂、毒扁豆碱、哌西那朵、溶链菌(picibanil)、匹可曲林二乙醇胺、胡黄连活素、吡库特罗、匹多莫德、哌法宁(Pifamine)、毛果芸香碱、吡西卡尼、匹马吉定、盐酸匹美汀、匹米前列素、匹莫苯、匹莫齐特、吡那地尔、匹那朵林、吲哚洛尔、吡美诺(pinnenol)、匹诺塞林(pinocebrin)、盐酸哌氧平、吡格列酮、匹泮哌隆、匹哌氮酯、哌库溴铵、哌西他嗪、哌拉西林钠、马来酸哌拉酰胺、哌嗪、哌泊溴烷、哌泊舒凡、棕榈酸哌泊噻嗪、盐酸哌泊索仑、哌普唑啉、盐酸匹喹酮、盐酸哌喹齐尔、吡拉西坦、盐酸吡喃达明、吡柔比星、吡拉莫南钠、吡拉唑酸、吡苄青霉素钠、醋酸吡布特罗、匹仑哌隆、盐酸哌仑西平、吡咯他尼(piretamide)、吡非尼酮、吡地西林钠、吡膦酸钠、吡前列素、吡曲克辛、盐酸吡利霉素、吡吲哚、吡吗格雷、盐酸吡美诺、吡大麻(Pirnabine)、吡罗克酮、吡罗达韦、吡咯司特、酒石酸吡咯格列、匹罗酯、吡拉酰胺、盐酸吡罗蒽醌、吡罗昔康、匹罗昔酮、吡洛芬、吡喹诺唑、哌多明、普尼拉明、垂体后(Pituitary,Posterior)、盐酸匹氨苄青霉素、匹伏普利、苯噻啶、胎盘浸膏A(placetinA)、铂化合物、铂-三胺配合物、普卡霉素、普洛美坦、泊比司特乙二胺、普达非洛、毒葛提取物、甲基硫酸波定(Poldine Methylsulfate)、聚氨葡糖、木质素磺酸钠、硫酸多黏菌素B、泊利噻嗪、泊那司他、卟吩姆钠、泊非霉素、氯化钾、碘化钾、高锰酸钾、聚维酮碘、普拉洛尔、氯解磷定(Pralidoxime Chloride)、盐酸普拉西坦、盐酸普莫卡因、普拉氯铵、马来酸普拉朵林、普伐他汀(Pravastatin/Pravachol)、普拉西泮、哌唑嗪、盐酸哌唑嗪、泼那扎特、泼尼卡酯、泼尼莫司汀、泼尼松龙、泼尼松、泼尼松龙戊酸酯(Prednival)、琥珀酸孕烯诺龙、盐酸普瑞特罗、盐酸普立地芬、普立非酮、盐酸丙胺卡因(PrilocalneHydrochloride)、洛赛克(Prilosec)、磷酸伯氨喹、普米洛尔、扑米酮、赖诺普利(Prinivil)、普林米特氨丁三醇、普啉索旦、盐酸普齐地洛、盐酸普罗地芬、丙磺舒、安克罗米钙、普罗布考、盐酸普鲁卡因胺、盐酸普鲁卡因、盐酸丙卡巴肼、盐酸丙卡特罗、丙氯拉嗪、普西奈德、丙氯诺、盐酸丙环定、盐酸普地利定、普罗度酸、盐酸普罗法朵、普罗加比(Progabide)、黄体酮、丙谷胺、人胰岛素原、脯氨酸、盐酸普罗林坦、盐酸丙嗪、盐酸异丙嗪、盐酸普罗帕酮、丙帕锗、丙泮尼地、溴丙胺太林、盐酸丙美卡因、丙帕硝酯、丙戊茶碱、盐酸奥昔利平、普匹卡星、丙酰马嗪、丙酸、丙酰肉碱、丙酰左旋肉碱、丙吡胺、丙吡胺+扑热息痛、丙哌维林、丙泊酚、盐酸丙氧卡因、盐酸右丙氧芬、盐酸普萘洛尔、西沙必利(Propulsid)、丙基双-吖啶酮、丙己君、丙碘酮、丙硫氧嘧啶、普罗喹宗、丙利酸钾、盐酸普罗克生、海葱次苷、前列他林、酪氨酸激酶抑制剂(prostratin)、硫酸鱼精蛋白、内源性抗微生物多肽(protegrin)、普罗瑞林、妥舒沙星、盐酸普罗替林、普罗沙唑、柠檬酸普罗沙唑、普昔罗米、酒石酸普罗啡烷、普卢利沙星、盐酸伪麻黄碱、嘌罗霉素、红紫素(purpurins)、吡拉布隆、扑酸噻嘧啶、吡嗪酰胺、吡唑呋喃菌素(Pyrazofurin)、吡唑啉吖啶(pyrazoloacridine)、溴吡斯的明、马来酸美吡拉敏、乙胺嘧啶、吡诺林、吡啶硫酮钠、吡啶硫酮锌、盐酸吡咯戊酮、马来酸吡咯沙敏、吡咯卡因、盐酸吡咯利芬、吡咯尼群、恩波吡维铵、甲磺酸夸达佐辛、夸西泮、喹齐酮、夸唑定、喹唑司特、喹硫平、喹夫拉朋、喹高利特、喹那定蓝、喹那普利、喹那普利拉、盐酸喹唑嗪、奎勃龙、Quinctolate、醋酸喹地卡明、喹度溴铵、盐酸喹洛雷、炔雌醚、喹法米特、醋酸奎孕醇、奎孕酮、葡萄糖酸奎尼丁、盐酸喹洛雷、硫酸奎宁、盐酸喹吡罗、硫酸喹丙那林、奎纽溴铵、奎奴普丁、马来酸喹哌嗪、雷贝拉唑钠、消旋甲砜霉素(Racephenicol)、消旋肾上腺素、raf拮抗剂、雷复尼特(Rafoxamide)、雷利托林、雷洛昔芬、雷替曲塞、雷马曲班、雷米普利、雷莫拉宁、雷莫司琼、雷奈酸、雷尼霉素、雷尼替丁、雷诺嗪、萝芙木提取物(RauwolfiaSerpentina)、瑞卡南、盐酸瑞卡南、瑞氯西泮、瑞加韦单抗、瑞拉司亭、松弛素、雷洛霉素、盐酸瑞马酰胺、盐酸瑞芬太尼、瑞前列醇、瑞莫必利、瑞吡司特、瑞普米星、盐酸瑞普特罗、利舍平、辣椒辣素(resinferatoxin)、间苯二酚、脱甲基化瑞替普汀、网状蛋白(reticulon)、瑞肝素钠、瑞维齐农、铼Re 186依替膦酸盐、根瘤菌素(rhizoxin)、利巴米诺、利巴韦林、利波腺苷、核酶、利卡司琼、利多格雷、利福布汀、利福美坦、利福克昔、利福米特、利福平、利福喷汀、利福昔明、RII retinamide、利洛吡司、利鲁唑、金刚乙胺、盐酸林卡唑、利美索龙、利米特罗氢溴酸盐、利莫罗近、利奥地平、利奥前列素、利帕西泮、利匹沙坦、利塞膦酸钠、利塞膦酸、利索卡因、盐酸利索利特、利喷西平、维思通(Risperdal)、利培酮、利坦色林、利替培南、利托君、利托司特、利托那韦、苯甲酸利扎曲普坦、盐酸柔卡斯啶、罗库溴铵、罗多卡因、罗氟烷、罗谷亚胺(Rogletimide)、罗希吐碱、罗他霉素、Roletamicide、罗加米定、罗利普令(Rolicyprine)、咯利普兰、罗利环素、罗咯定、氯马扎利、罗莫肽、罗硝唑、罗匹尼罗、盐酸罗匹妥英、罗哌卡因、罗匹嗪、罗喹美克、罗沙米星、罗格列酮、罗索沙星、罗托沙敏、roxaitidine、洛克沙肿、罗克吲哚、罗红霉素、鲁必金醇B1、ruboxyl、芦氟沙星、卢帕他定(rupatidine)、芦他霉素、卢扎朵仑、沙贝鲁唑、沙芬戈、沙非罗尼、saintopin、沙丁胺醇、R-柳胆来司、马来酸沙乙酰胺、水杨醇、水杨酰胺、水杨酸葡甲胺、水杨酸、沙美特罗、沙那西定(Salnacediin)、双水杨酯、沙美利定、山帕曲拉、山环素、山费培南、血根氯铵、沙康唑、沙普立沙坦、沙丙蝶呤、沙奎那韦、盐酸沙氟沙星、醋酸沙拉新、SarCNU、肌肉叶绿醇(sarcophytol)A、沙格司亭、沙莫西林、沙匹西林、沙格雷酯、沙芦普酶、沙特力农、沙替格雷、沙妥莫单抗喷地肽、锡克试验对照品、司可芬净、氢溴酸东莨菪碱、盐酸Scrazaipine、Sdi 1模拟物、司骨化醇、司可巴比妥、Seelzone、醋酸司格列肽、司来吉兰、盐酸司来吉兰、硫化硒、硒代甲硫氨酸Se 75、塞福太、司美利特、生度米星、司莫地尔、司莫司汀、有义寡核苷酸、氯化三苯唑(Sepazonium Chloride)、盐酸氯氟哌醇、司普立糖、盐酸塞罗西汀、醋酸丝拉克肽、马来酸麦角克索、丝氨酸、丝美辛、醋酸舍莫瑞林、舍他康唑、舍吲哚、舍曲林、司普替林、司托哌隆、司韦单抗、七氟烷、司佐胺、西波吡啶、盐酸西布曲明、信号转导抑制剂、硅雄酮、西立匹特、西替普酶、硝酸银、西孟旦、辛曲秦、辛伐他汀、辛卡利特、西奈芬净、西硝地尔、sinnabidol、西帕曲近、西罗莫司、西索米星、西托糖苷、西佐喃、索布佐生、淀粉硫酸钠、碘化钠I 123、硝普钠、羟丁酸钠、苯乙酸钠、水杨酸钠、solverol、酒石酸索立哌汀、猪丙氨生长素、盐酸索金刚胺、生长介素B、生长介素C、人蛋氨生长素、生长激素、猪诺生长素、牛度生长素、索纳明、索比尼尔、索立夫定、索他洛尔、盐酸索特瑞醇、司帕沙星、磷乙酰天冬氨酸钠、磷乙酰天冬氨酸、司帕霉素、硫酸司巴丁、盐酸大观霉素、穗霉素(spicamycin)D、螺哌隆、甲磺酸螺朵林、螺旋霉素、盐酸螺普利、螺普利拉、盐酸锗螺胺、螺莫司汀、螺内酯、螺铂、螺沙宗、斯耐潘定(splenopentin)、海绵抑制素1(spongistatin 1)、镝双胺、角鲨胺、盐酸司他霉素、焦磷酸亚锡、亚锡硫胶体、司坦唑醇、维司托隆、星孢菌素(staurosporine)、司他夫定司替霉素、醋酸司腾勃龙、司替罗宁、司替碘铵、司洛碘铵、stipiamide、司替戊醇、斯哚巴丁、硫酸链霉素、链霉素异烟肼(Streptonicozid)、链黑菌素、链脲霉素、基质溶素抑制剂、氯化锶Sr 89、succibun、二巯丁二酸、氯化琥珀酰胆碱、硫糖铝、硫糖酯钾、舒多昔康、舒芬太尼、舒福替丁、硫西泮、舒巴坦匹酯、硝酸硫康唑、磺胺苯、磺胺苯酰、磺胺醋酰、磺胺西汀、磺胺嘧啶、磺胺多辛、磺胺林、磺胺甲嘧啶、磺胺对甲氧嘧啶、磺胺二甲嘧啶、磺胺甲二唑、磺胺甲唑、磺胺间甲氧嘧啶、磺胺二甲唑、氨苯磺酸锌、磺胺硝苯、柳氮磺吡啶、磺胺异噻唑、磺胺吡唑、盐酸硫氧洛尔、sulfinosine、磺吡酮、磺胺异唑、磺黏菌素、盐酸磺酰特罗、砜亚胺(sulfoxamine)、舒林酸(Sulinldac)、硫马林、舒硝唑、舒洛地尔、磺氯苯脲、硫培南、草酸舒洛昔芬、舒必利、硫前列酮、舒他西林、舒噻嗪(Sulthiame)、舒托必利、硫鲁司特、舒马罗汀、舒马普坦、磺氨苄青霉素钠、舒普罗酮、舒洛芬、suradista、舒拉明、舒福姆、马来酸舒立卡尼、舒立托唑、马来酸舒罗吖啶、硫酸琥甲哌酯、苦马豆素(swainsonine)、司马卡林(symakalim)、氯氧三嗪、盐酸昔美汀、合成糖胺聚糖、盐酸Taciamine、盐酸他克林、他克莫司、盐酸酞氨西林、玉米赤霉醇(Taleranol)、他利霉素、他莫司汀、他美辛、他尼氟酯、盐酸他洛普仑、他洛柳酯、盐酸他美曲林、他莫昔芬、富马酸坦帕明、盐酸坦洛新、盐酸坦达明、坦度螺酮、tapgen、他前列烯、他索沙坦、牛磺莫司汀、紫杉烷(Taxane)、紫杉烷(Taxoid)、琥珀酸他扎朵林、他扎司特、他扎罗汀、盐酸他齐茶碱、三唑巴坦、他唑非隆、盐酸他佐洛尔、特丁非隆、替布喹、比西酸锝Tc 99m、替克洛占、替可加兰钠、Teecleukin、替氟烷、替加氟(Tegafur)、得理多(Tegretol)、替考拉宁、替仑西平、tellurapyrylium、替美司坦、替米沙坦、端粒酶抑制剂、盐酸替洛蒽醌、盐酸替鲁地平、盐酸替马沙星、甲硫托铵(Tematropium Methyl sulfate)、替马西泮、替美斯汀、替莫普利、替莫西林、替莫泊芬、替莫唑胺、替尼达普、替尼泊苷、替诺柳、替诺昔康、替吡吲哚、替泊沙林、替普罗肽、特拉唑嗪、特比萘芬、硫酸特布他林、特康唑、特非那定、特拉伏沙、特麦角脲、醋酸特立帕肽、特拉吉仑、特利加压素、特罗地林、盐酸特罗扎林、替罗昔隆、特他洛尔、替昔康、替昔米德(Tesimide)、睾内酪、睾酮、丁卡因、tetrachlorodecaoxide、四环素、盐酸四氢唑啉、盐酸四咪唑、四唑司特葡甲胺、tetrazomine、替曲膦、四羟醌、四氧普林、四氢甲吲胺、松草碱(thaliblastine)、沙利度胺、羟乙茶碱安妥明(Theofibrate)、茶碱、噻苯达唑、硫咪嘌呤、甲砜霉素、硫戊巴比妥、盐酸硫西新、噻丙铵氯(Thiazinamium Chloride)、硫乙哌丙嗪(Thiethylperazine)、硫汞苯磺钠、硫柳汞、噻可拉林(thiocoraline)、thiofedrine、硫鸟嘌呤、thiomarinol、硫喷妥钠、噻普酰胺(thioperamide)、硫利达嗪、噻替哌、替沃噻吨、盐酸替芬那米、替芬西林鉀(Thiphencillin Potassium)、塞仑、托扎啉酮、苏氨酸、凝血酶、血小板生成素、血小板生成素模拟物、胸腺法新、胸腺生成素受体激动剂、胸腺曲南、盐酸甲状米登、甲状腺素I 125、甲状腺素I 131、硫克司特、硫克司特钠、噻加宾、噻美尼定(Tiamenidine)、噻奈普汀、tiapafant、盐酸噻帕米、盐酸噻拉米特、噻唑呋林、硫苯司特钠、替勃龙、替贝酸、丙酸替卡贝松、替卡波定、替卡西林甲苯酯钠、替克拉酮、噻氯匹定、替尼酸、替诺洛尔、替呋酸钠、二胆碱替吉莫南、替孕醇、盐酸替来他明、盐酸替利定、替利洛尔、替洛芬阿酯、盐酸替洛隆、替鲁膦酸二钠、替鲁膦酸、替美呋酮、醋酸替莫贝松、噻吗洛尔、tin ethyl etiopurpurin、替大麻酚、替硝唑(Timidazole)、亭扎肝素钠、噻康唑、硫达唑嗪、碘氯化物、盐酸硫哌立酮、硫平酸、盐酸替螺酮、硫替丁、噻托溴铵、噻昔达唑、盐酸噻戊托辛、替泼尼旦、盐酸替普洛尔、替普司特葡甲胺、盐酸替普地尔、替奎安、盐酸替喹胺、提莱菌素(tirandalydigin)、替拉扎明、替拉扎特(tirilazad)、替罗非班、替罗酰胺(tiropramide)、二氯二茂钛、替呫诺、新戊酸替可的松、盐酸替扎尼定、妥布霉素、妥卡尼、托莰非、盐酸托芬那辛、妥拉洛尔、妥拉磺脲、盐酸妥拉唑林、甲苯磺丁脲、托卡朋、托西拉酯、托法胺、托加比特、拉莫三嗪、托利咪酮、托林达酯、托美丁、托萘酯、托泊酮I 131、甲苯磺吡胺、托瑞司他、托鲁司特、盐酸托莫西汀、甲磺酸托那佐辛、托吡酯、托泊替康、盐酸托泊替康、topsentin、托普雄酮、托喹嗪、托拉塞米、托瑞米芬、托拉塞米、托西芬、托氟沙星、全能干细胞因子、曲卡唑酯、曲弗明、曲洛奈德、盐酸曲马多、盐酸曲马唑啉、群多普利、氨甲环酸、曲尼司特、群司卡尼、转录抑制剂、曲呫诺、盐酸曲唑酮、曲唑酮-HCl、盐酸曲苯佐明、盐酸曲芬太尼、曲洛酯、马来酸曲匹泮、醋酸曲托龙、维A酸、三醋酸甘油酯、三乙酰尿苷(triacetyluridine)、三嗪芬净、曲安西龙、硫酸曲安吡嗪、氨苯蝶啶、三唑仑、三苄糖苷、甘油三辛酸酯(tricaprilin)、三甲氧苯醋酰胺(Tricetamide)、三氯噻嗪、毛透明蛋白(trichohyalin)、曲西立滨、三柠檬酸盐(Tricitrates)、三氯酚哌嗪、三氯福司钠、三氯奈德、曲恩汀、三苯格雷、triflavin、三氟洛辛、三氟巴占、三氟米酯、盐酸三氟培拉嗪、三氟哌多、三氟丙嗪、盐酸三氟丙嗪、曲氟尿苷、盐酸苯海索、曲洛司坦、盐酸曲马唑嗪、曲美孕酮、酒石酸阿利马嗪、三甲双酮、樟磺咪芬(Trimethaphan Camsylate)、盐酸曲美苄胺、甲氧苄啶、曲美托嗪、三甲曲沙、曲米帕明、曲莫前列素、盐酸曲莫沙明、三油酸甘油酯I 125、三油酸甘油酯I 131、甲磺酸曲沃昔芬、曲帕胺、盐酸曲吡那敏、盐酸曲普利啶、曲普瑞林、三磺嘧啶、曲氯新钾、曲格列酮、三乙醇胺、醋竹桃霉素、trombodipine、氨丁三醇、盐酸托烷色林、托吡卡胺、托品酯、托烷司琼、丙大观霉素、曲伐沙星、曲韦定、色氨酸、结核菌素、氯筒箭毒碱、盐酸妥布氯唑、tucarcsol、妥洛特罗、妥罗雄脲、泰巴氨酯、tylogenin、酪泮酸钠、酪氨酸、短杆菌素、酪氨酸磷酸化抑制剂(tyrphostins)、乌苯美司、乌达西泮、十一烯酸、乌拉莫司汀、乌拉地尔、脲、乌瑞替派、三磷酸尿苷、尿促卵泡素、尿激酶、熊二醇(Ursodiol)、伐昔洛韦、缬氨酸、戊诺酰胺、丙戊酸钠、丙戊酸、缬沙坦、伐米胺、vanadeine、万古霉素、vaninolol、盐酸伐哌前列素、伐普肽、variolin B、升压素、维库溴铵、维拉雷琐、马来酸维吖啶、文拉法辛、盐酸维拉朵林、藜芦胺(veramine)、盐酸维拉帕米、verdins、盐酸维立洛泮、维鲁司特、维罗茶碱、veroxan、维替泊芬、维司力农、马鞭草烷醇(vexibinol)、阿糖腺苷、氨己烯酸、盐酸维洛沙秦、硫酸长春花碱、柠檬酸长春布宁、乙烯磷、长春考酯、硫酸长春新碱、长春地辛、硫酸长春地辛、硫酸长春匹定、硫酸长春甘酯、硫酸长春罗新、长春瑞滨、长春西汀、长春培醇、vinxaltine、长春利定、维前列醇、维吉霉素、绿黄菌素、韦罗肟、牡荆黄素(vitaxin)、伏拉佐辛、伏立康唑、伏氯唑、伏高利特、华法林钠、扎莫特罗、呫诺美林、异丙氧蒽酸钠、烟酸占替诺(Xanthinol Niacinate)、珍米洛非班、联苯利平、联苯丁酸、希洛班、希莫洛芬、希帕胺、甲磺酸佐尔啡诺、甲苯磺酸甲苯乙脒、盐酸赛拉嗪、盐酸赛洛唑啉、木糖、yangambin、扎普利、扎考必利、扎鲁司特、扎西他滨、扎来普隆、扎螺酮、盐酸唑替丁、扎托洛芬、扎那米韦、占吉仑、扎诺特隆、善胃得(Zantac)、扎鲁司特(Zarirlukast)、扎替雷定、扎托司琼、马来酸扎托司琼、折那司他、甲磺酸泽来索兴(Zenazocine Mesylate)、折尼铂、折仑诺、齐多美辛、齐多夫定、齐罗硅酮、齐仑太尔、亚苄维C、齐留通、盐酸齐美定、十一烯酸锌、嗪多群、盐酸齐诺康唑、净司他丁、盐酸净特罗、净韦肟、齐拉西酮、Zobolt、佐芬普利钙、佐芬普利拉、盐酸佐拉敏、盐酸唑拉西泮、唑来膦酸、盐酸佐勒汀、佐米曲普坦、唑吡坦、佐美酸钠、佐美他平、盐酸佐尼氯唑、唑尼沙胺、佐匹克隆、唑泊司他、佐尔博霉素(Zorbamyciin)、盐酸佐柔比星、佐替平、珠卡赛辛。
如美国专利No.9745300、9708322、7183282、7071186、6552017、8648077、8598119、9751883、9371324、9315504、9428506、8993572、8309722、6713471、8779139、9168258、RE039680E1、9616061、9586960,和美国专利公开No.2017114037、2017183350、2015072964、2004034015、2017189398、2016310502、2015080404中所公开的那样,可用于本文的另一种药物活性物为卢美哌隆(lumateperone),其前述内容通过引用整体并入本文。
抗糖尿病活性物的另一些实例包括但不限于JTT-501(PNU-182716)(Reglitazar)、AR-H039242、MCC-555(Netoglitazone)、AR-H049020(Tesaglitazar)、CS-011(CI-1037)、GW-409544×、KRP-297、RG-12525、BM-15.2054、CLX-0940、CLX-0921、DRF-2189、GW-1929、GW-9820、LR-90、LY-510929、NIP-221、NIP-223、JTP-20993、LY 29311 Na、FK614、BMS 298585、R 483、TAK 559、DRF 2725(Ragaglitazar)、L-686398、L-168049、L-805645、L-054852、去甲基asteriquinone B1(L-783281)、L-363586、KRP-297、P32/98、CRE-16336和EML-16257。
可用于本文的勃起功能障碍治疗剂包括但不限于用于促进血液流向阴茎并用于实现自主神经活动(例如增加副交感神经(胆碱能)活动和减少交感神经(肾上腺)活动)的药剂。可用于治疗勃起功能障碍的活性物包括,例如,但不限于前列地尔、他达拉非、伐地那非、阿扑吗啡、盐酸育亨宾、柠檬酸西地那非、及其任意组合。在一个实施方案中,活性物为他达拉非。
用于治疗头痛和/或偏头痛的活性物或药物也可在本文中使用。具体活性物的实例包括但不限于曲坦类,例如依来曲坦、那拉曲坦、利扎曲坦(苯甲酸利扎曲坦)、舒马曲坦和佐米曲坦。在一个实施方案中,活性物为利扎曲坦,任选地与NSAID组合。
在一个实施方案中,活性物可为氯巴占、地西泮、他达拉非、利鲁唑、丁丙诺啡、纳洛酮、或丁丙诺啡与纳洛酮的组合。
活性物可为地西泮。当活性物为地西泮时,每个单独单位剂量可包含约1mg、约2mg、约2.5mg、约5mg、约10mg、约15mg或约20mg的地西泮。在某些实施方案中,口腔膜包含约5mg、约10mg或约15mg的地西泮。
活性物可为利鲁唑。当活性物为利鲁唑时,每个单独单位剂量可包含约10mg、约20mg、约25mg、约30mg或约50mg的利鲁唑。在一个实施方案中,口腔膜包含约50mg的利鲁唑。
活性物可为氯巴占。当活性物为氯巴占时,每个单独单位剂量可包含约1mg、约2mg、约2.5mg、约5mg、约10mg、约15mg或约20mg的氯巴占。在某些实施方案中,口腔膜包含约5mg或约20mg的氯巴占。
微粉化
本文所公开的口腔膜中使用的活性物可被微粉化。活性物可通过本领域已知的任何方式微粉化。
活性物的平均颗粒尺寸D90可小于约160微米、小于约120微米、小于约100微米、小于约80微米、小于约50微米、小于约20微米、小于约10微米,或为约8微米。活性物的平均颗粒尺寸D50可小于约30、小于约20、小于约10、小于约5微米、小于约4,或者D50为约3。活性物的平均颗粒尺寸D10可小于约10、小于约5、小于约3、小于约2,或者D10为约1。活性物可具有小于约15微米的平均颗粒尺寸D90、小于约4微米的平均颗粒尺寸D50和小于约2微米的平均颗粒尺寸D10。活性物可具有约8微米的平均颗粒尺寸D90、约3微米的平均颗粒尺寸D50和约1微米的平均颗粒尺寸D10。
最通常利用激光衍射光散射来测量0.02μm至2000μm/0.01μm至3500μm的颗粒的颗粒尺寸。在这种技术中,颗粒穿过激光的路径并衍射光。然后,利用颗粒与介质之间的折射率差异,将衍射光的角度与颗粒尺寸相关联。该测得的输出为体积分布,并且通常表示为Dx,其中x为分布的表达。例如,D90将反映所分析的颗粒捕获90%观察到的衍射的体积分布;因此90%的颗粒将落入该尺寸以下。通常使用颗粒尺寸的其他描述,例如会与具有该尺寸的颗粒的数量相关联的“数量分布”,这是因为较大颗粒的体积影响可能不成比例地加权。然而,基于激光衍射光散射的颗粒尺寸的这些替代统计描述是基于体积分布的数学计算;因此,除非另有说明,否则Dx的颗粒尺寸描述为体积分布。
已知优选小于200微米的平均颗粒尺寸以获得平滑的口腔膜。然而,进一步的开发表明,具有较细的平均颗粒尺寸,即细碎的颗粒,可改善膜的美感和溶出。进一步发现,较低膜剂量(例如5mg和10mg)的溶出测试结果显示,微粉化的活性物比包含经研磨的活性物(例如,平均颗粒尺寸D90为约100微米)的膜表现更好。
溶出谱
例如PION Rainbow动态溶出度监测仪的PION设备(“PION技术”)是准确、有效地实时测量百分比溶出数据的功能强大的分析仪器。PION技术利用先进的光纤进行原位动力学溶解性和过饱和UV监测以进行溶出测试,以确定药物释放的速率及其随时间的溶出度。PION技术使用单独的二极管阵列分光光度计,并且具有6至8个采集通道、浸入式探针和可互换的光程测头。PION技术具有实时数据显示,从而为活性物、制剂和药物产品的测试提供快速且可重现的结果。这些测量是准确的,即使在小体积和复杂基质的情况下也是如此。
基于光纤的溶出系统,例如PION技术,先前已与除口腔膜之外的剂型一起使用。然而,由于口腔膜的尺寸和密度,因此无法适当地利用这些系统;例如,甚至在进行任何测量之前,膜就已经溶解并释放活性物。为了克服此问题,必须设计和开发定制膜引入系统/保持器。定制膜引入系统/保持器防止膜漂浮并在溶出容器中被搅动。它同时还允许同时引入多层膜。这对于快速数据收集至关重要。此外,样品保持器、其与桨的距离、以及与光纤探针的距离和角度二者在进行一致准确的数据收集的同时确保USP的流动动力学要求方面发挥重要作用。图1中示出了用于PION技术的设备的一个非限制性示例性配置。如该图所示,系统配置有并行设置的多个系统,以对不同样品运行同时的测试。系统包含探针、溶出桨和定制样品保持器。定制样品保持器的放置存在选项(相对于流动的高度和角度)。也可改变保持器的尺寸以容纳膜的尺寸。此外,如本领域普通技术人员容易理解的那样,探针的路径长度可改变。如果路径长度太宽,则信号将过载。如果路径太窄,则信号将太弱。
图2是通过PION技术来获得溶出谱中使用的桨、保持器以及调节探针和保持器的高度的装置的另一示例性配置。在进行充分的桨搅动的情况下,预测探针高度不影响结果,但是样品保持器的取向可影响膜的崩解,并影响活性物溶出速率。如图1和2所示,例如,将样品保持器垂直于溶出容器的壁放置以最大程度地暴露。可通过重新定位保持器取向(将保持器从垂直扭转到另一期望的角度)来改变保持器相对于溶出容器的角度。可增大保持器的尺寸以容纳较大的膜,但是可限制允许的角度范围,例如,如果用于更大的膜的保持器而较大,则其调节的自由度会较小。如果扭转程度过深,则保持器或膜会接触容器的侧壁或接触旋转桨-负面影响测试。
发现通过定制样品保持器和采样集合管(manifold),PION技术可用于测试本文所公开的口腔膜的溶出度。通过使用PION技术,存在许多优点,例如:
1.不需要离线分析;
2.更多采样点可用;
3.能够评价多个波长;
4.能够评价变化速率(例如;拐点接受标准);
5.谱比较示出强度与储存条件之间的潜在区分能力。
发现通过PION技术测得的本文所公开的口腔膜的活性物溶出谱和速率通常与通过传统溶出法测得的溶出谱和速率相当,不同之处在于前者曲线更精确且更精确,并且因此,拐点是可确定的。使用光纤UV监控系统(例如PION技术),口腔膜的溶出谱可更准确且更精确。溶出谱是数据点的平均集合,示出从t=0直到经过100%的剂型或活性物溶出时的点的时间,剂型或活性物随时间的溶出百分比。“活性物溶出谱”是指活性物在从膜中释放之后的溶出谱。当活性物在从口腔膜剂型中释放之后溶出时,膜本身及其中的载体对活性物的溶出速率有一定影响。
例如,图9和10示出了活性物溶出谱,另外图13至23示出了PION技术可能带来的改善的且更精确的数据及导数。相反地,图8示出了通过传统溶出法测得的活性物溶出谱,其在关键的早期时间点对于快速释放剂型缺乏任何区分能力。
当使用PION技术时,口腔膜的活性物溶出谱的一阶导数(或“一阶导数”)可绘制成图,例如,如图19、21和23所示。一阶导数图提供了对活性物从膜中释放的速率的了解。一阶导数的强度和宽度与释放的速率成比例。例如,通过绘制这些导数,如通过一阶导数曲线的高度和宽度所示,可了解到在第一分钟内包含5mg和10mg活性物的口腔膜比包含20mg活性物的类似口腔膜释放更快且更充分。在这样的表现中,包含20mg活性物的口腔膜将具有更宽的曲线,表明释放更慢。对于所有曲线,当释放完成时,一阶导数趋近于0,并且容器中药物的浓度达到平台期(plateau)。
将期望如果活性物在不同的膜剂型中具有相同的颗粒尺寸分布,则活性物溶出谱将是相同的。然而,这并非总是如此。通过使用PION技术,在剂型之间可见明显的差异,表明膜和载体影响活性物的溶出速率。
二阶导数(或“二阶导数”)图提供了曲线的定性评估。一阶和二阶导数曲线二者都提供了最大值、最小值和拐点;提供了确定曲线何时升高/降低以及速率的能力。
在将膜置于介质中后,在约2分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约2%、大于约5%、大于约10%、大于约15%、大于约20%、大于约25%、大于约30%、大于约35%、大于约40%、大于约45%、大于约50%、或大于约55%。在约3分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约2%、大于约5%、大于约10%、大于约15%、大于约20%、大于约25%、大于约30%、大于约35%、大于约40%、大于约45%、大于约50%、大于约55%、大于约60%、约65%、或大于约70%。在约5分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约10%、大于约15%、大于约20%、大于约25%、大于约30%、大于约35%、大于约40%、大于约45%、大于约50%、大于约55%、大于约60%、约65%、或大于约70%。在约10分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约20%、大于约25%、大于约30%、大于约35%、大于约40%、大于约45%、大于约50%、大于约55%、大于约60%、大于约65%、大于约70%、大于约75%、大于约80%、大于约85%、或大于约90%。在约15分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约30%、大于约35%、大于约40%、大于约45%、大于约50%、大于约55%、大于约60%、大于约65%、大于约70%、大于约75%、大于约80%、大于约85%、大于约90%、大于约95%、或大于约98%。在约20分钟时,任选地通过PION技术测得的活性物的平均溶出度可为大于约60%、大于约65%、大于约70%、大于约75%、大于约80%、大于约85%、大于约90%、大于约95%、大于约98%、或大于约99%。如本文所测量的活性物的溶出度是在将膜置于介质中之后进行的。在置于介质中后,膜溶解,从而将活性物释放到介质中。
溶出速率是口腔膜或活性物溶解的速率,其是在某一时间点释放的%的计算量。溶出速率通过在所选择的设备中进行溶出测试来获得,并且根据某些溶出参数来测量。溶出参数包括储存条件(例如时间、温度和相对湿度)和测试参数(例如设备、转速、介质、介质温度、采样时间点、样品体积、样品过滤器、HPLC柱、流动相、流量、柱温、注入体积、检测波长和运行时间)。
“活性物溶出速率”是活性物溶出的速率,其是在某个时间点释放的百分比的计算量。在如本文所公开的口腔膜剂型的情况下,口腔膜溶解并释放活性物,然后以精确的速率(即,活性物溶出速率)进行溶出。活性物的溶出度也可表示为在某一时间点溶出的活性物的百分比(平均)。
除非另有说明,否则活性物的溶出度在口腔膜的以下储存条件下测量:约0个月至约36个月、超过0个月至约36个月、约6个月至约36个月、约6个月至约24个月、约9个月至约18个月、或约12个月,处于约20℃至约60℃、约25℃到约40℃、或约25℃下,以及高至约75%的相对湿度(RH),例如处于约60%RH下。
溶出测试可在“沉降”条件下进行,如USP<1092>所限定,沉降条件“作为形成药物物质的饱和溶液所需的至少三倍的介质的体积。当存在沉降条件时,溶出结果更有可能反映剂型的特性。”基于活性物的特征,例如溶解度和施用途径,不同的药物产品可需要不同的介质。如本领域普通技术人员容易理解的那样,在开发溶出方法时,可考虑以上因素。因此,USP<1092>还限定了介质评价的范围:“用于溶出的典型介质可包括以下(未按优先顺序列出):稀盐酸、1.2至7.5生理pH范围的缓冲剂(磷酸盐或乙酸盐)、模拟胃液或肠液(具有或不具有酶)、水和表面活性剂(具有或不具有酸或缓冲剂)。”表面活性剂可以是但不限于聚山梨酯80、月桂基硫酸钠和胆汁盐。对于一些药物,药物与某些缓冲剂或盐的不相容性可影响缓冲剂的选择。所使用的缓冲剂和酸的摩尔浓度可影响增溶效果,并且该因素可被评价。水溶液(酸性或缓冲溶液)可包含一定百分比的表面活性剂,例如十二烷基硫酸钠(SDS)、聚山梨酯或月桂基二甲基胺氧化物,以增强药物的溶解性。
在一个实施方案中,测量活性物在稀盐酸、1.2至7.5生理pH范围的缓冲剂(例如磷酸盐或乙酸盐)(包括但不限于0.05摩尔pH6.8的磷酸二氢钾缓冲剂)、模拟胃液或肠液(具有或不具有酶)(例如0.1N HCl)、水和表面活性剂(例如聚山梨酯80、月桂基硫酸钠和胆汁盐)中的溶出度。在另一个实施方案中,测量活性物在稀盐酸、0.05摩尔pH 6.8的磷酸二氢钾缓冲剂、0.1N HCl、水或0.5%月桂基硫酸钠中的溶出度。
对于包含地西泮的口腔膜,在将膜置于介质中后,任选地通过PION技术测得的,在约3分钟之后多于约2%的地西泮可溶出,在约5分钟之后多于约10%的地西泮可溶出,在约5分钟之后多于约15%的地西泮可溶出,或者在约5分钟之后约20%至约25%的地西泮可溶出。任选地通过PION技术测得的,在约10分钟之后多于约25%、多于约30%、或约35%至约40%的地西泮可溶出。任选地通过PION技术测得的,在约15分钟之后多于约42%、多于约48%、或约50%至约55%的地西泮可溶出。任选地通过PION技术测得的,在约20分钟之后多于约55%、多于约60%、或约60%至约70%的地西泮可溶出。任选地通过PION技术测得的,在约30分钟之后多于约85%、多于约90%、或约92%至约98%的地西泮可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约5mg地西泮的口腔膜,任选地通过PION技术测得的,在约3分钟之后多于约2%的地西泮可溶出,在约5分钟之后多于约15%的地西泮可溶出,或者在约5分钟之后约21%的地西泮可溶出。对于包含约5mg地西泮的口腔膜,任选地通过PION技术测得的,在约10分钟之后多于约30%、少于约38%、或约36%的地西泮可溶出。对于包含约5mg地西泮的膜,任选地通过PION技术测得的,在约15分钟之后少于约55%、多于约45%、或约50%的地西泮可溶出。对于包含约5mg地西泮的膜,任选地通过PION技术测得的,在约20分钟之后少于约70%、多于约60%、或约64%的地西泮可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约15mg地西泮的口腔膜,任选地通过PION技术测得的,在约3分钟之后多于约2%的地西泮可溶出,在约5分钟之后多于约20%的地西泮可溶出,在约5分钟之后多于约25%的地西泮可溶出,和/或在约5分钟之后约27%的地西泮可溶出。对于包含约15mg地西泮的膜,任选地通过PION技术测得的,在约10分钟之后多于约35%、少于约45%、或约41%的地西泮可溶出。对于包含约15mg地西泮的膜,任选地通过PION技术测得的,在约15分钟之后少于约60%、多于约45%、多于约50%、或约55%的地西泮可溶出。对于包含约15mg地西泮的膜,任选地通过PION技术测得的,在约20分钟之后少于约70%、多于约60%、多于约65%、或约68%的地西泮溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含利鲁唑的口腔膜,任选地通过PION技术测得的,在约3分钟之后多于约2%的利鲁唑可溶出,在约5分钟之后多于约30%的利鲁唑可溶出,和/或在约5分钟之后多于约35%的利鲁唑可溶出。对于包含利鲁唑的膜,任选地通过PION技术测得的,在约10分钟之后少于约75%、少于约73%、多于约60%、多于约65%、和/或多于约68%的利鲁唑可溶出。对于包含利鲁唑的膜,任选地通过PION技术测得的,在约15分钟之后少于98%、少于约95%、多于75%、和/或多于约80%的利鲁唑可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约50mg利鲁唑的口腔膜,任选地通过PION技术测得的,在约3分钟之后多于约2%的利鲁唑可溶出,在约5分钟之后多于10%的利鲁唑可溶出,在约5分钟之后多于20%的利鲁唑可溶出,在约5分钟之后多于30%的利鲁唑可溶出,在约5分钟之后少于约45%的利鲁唑可溶出,或者在约5分钟之后约40%的利鲁唑可溶出。对于包含约50mg利鲁唑的膜,任选地通过PION技术测得的,在约10分钟之后多于30%、多于40%、多于50%、少于约75%、或约71%的利鲁唑可溶出。对于包含约50mg利鲁唑的膜,任选地通过PION技术测得的,在约15分钟之后多于85%、少于93%、少于约91%、或约89%至约90%的利鲁唑可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含氯巴占的口腔膜,任选地通过PION技术测得的,在约1分钟之后多于约3%、多于约5%、多于约10%、或多于约15%的氯巴占可溶出。任选地通过PION技术测得的,在约1.5分钟之后多于约5%、多于约10%、多于约30%、或多于约40%的氯巴占可溶出。任选地通过PION技术测得的,在约2.5分钟之后多于约15%、多于约20%、多于约40%、或多于约60%的氯巴占可溶出。任选地通过PION技术测得的,在约3分钟之后多于约20%、多于约30%、多于约35%、多于约40%、或多于约45%的氯巴占可溶出。任选地通过PION技术测得的,在约5分钟之后多于约55%、多于约65%、多于约70%、或多于约75%的氯巴占可溶出。任选地通过PION技术测得的,在约6.5分钟之后多于约85%、多于约90%、或多于约91%的氯巴占可溶出。任选地通过PION技术测得的,在约10分钟之后多于约95%、或多于约99%的氯巴占可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约5mg氯巴占的口腔膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约1分钟之后多于约25%、多于约30%、或约38%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约1分钟之后多于约45%、多于约50%、或约59%的氯巴占可溶出。对于包含约5mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约60%、或多于约65%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约75%、或多于约80%的氯巴占可溶出。对于包含5mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约2分钟之后多于约80%、或多于约85%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约2分钟之后多于约85%、或多于约90%的氯巴占可溶出。对于包含约5mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约2.5分钟之后多于约95%、或约97%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约2.5分钟之后多于约95%、或多于约100%的氯巴占可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约10mg氯巴占的口腔膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约1分钟之后多于约15%、或多于约20%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约1分钟之后多于约35%、或多于约40%的氯巴占可溶出。对于包含约10mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约50%、或多于约55%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约65%、或多于约70%的氯巴占可溶出。对于包含约10mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约2分钟之后多于约70%、或多于约75%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约2分钟之后多于约80%、或多于约85%的氯巴占可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
对于包含约20mg氯巴占的口腔膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约2%、或约4%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约1.5分钟之后多于约5%、或约6%的氯巴占可溶出。对于包含约20mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约2.5分钟之后多于约10%、或多于约15%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约2.5分钟之后多于约25%、或多于约30%的氯巴占可溶出。对于包含约20mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约3.5分钟之后多于约40%、或约46%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约3.5分钟之后多于约65%、或约68%的氯巴占可溶出。对于包含约20mg氯巴占的膜,在将膜储存在约25℃下之后测得的,任选地通过PION技术测得的,在约5.5分钟之后多于约80%、或约83%的氯巴占可溶出,以及在将膜储存在约40℃下之后测得的,任选地通过PION技术测得的,在约5.5分钟之后多于约90%、或约94%的氯巴占可溶出。上述不同时间点时的溶出度的任意组合都在本发明的范围内。
活性物的溶出速率可有助于口腔膜的感官特性。分散在膜中的活性物的量与膜中溶出的活性物的量之间存在平衡。如果太多的活性物溶出而不是分散在膜中,则在将膜置于口腔中之后,患者会尝到活性物,其通常具有非常令人不愉快的味道。在一个实施方案中,按重量计少于约10%的活性物溶出(也称为溶解),并且多于约90%分散在口腔膜中。在另一些实施方案中,口腔膜中按重量计少于约8%、少于约5%、少于约2%、约0.1%至约10%、约0.5%至约5%、约0.5%至约2.5%、约1.0%至约2.0%、约0.5%、约0.8%、约1.0%、约1.2%、约1.5%、约1.8%、或约2.0%的活性物溶出。
溶出谱比较
对于药物产品更主要的变化,建议在相同条件下对参照产品和变化的产品进行溶出谱比较。(“Guidance for Industry,Dissolution Testing of Immediate ReleaseSolid Oral Dosage Forms”,美国卫生与公共服务部,食品和药物管理局,药品评价与研究中心(CDER),1997年8月,(在http://www.fda.gov/cder/guidance.htm可访问))。借助于(1)总体谱相似性和(2)每个溶出度采样时间点的相似性,溶出谱可被认为是相似的。
进行溶出谱比较的一种方式是通过使用利用相似性因子的模型独立方法。简单的模型独立方法利用差异因子(f1)和相似性因子(f2)来比较溶出谱((Moore,J.W.和H.H.Flanner,1996,“Mathematical Comparison of Dissolution Profiles,”Pharmaceutical Technology,20(6):64-74)。差异因子(f1)计算每个时间点时两条曲线之间的差异百分比(%),并且其为两条曲线之间相对误差的度量:
其中n为时间点的数目,Rt为时间t时参照(变化前)批次的溶出度值,以及Tt为时间t时测试(变化后)批次的溶出度值。
相似性因子(f2)为平方误差总和的对数倒数平方根变换,并且为两条曲线之间溶出百分比(%)相似性的度量。
确定差异因子和相似性因子的具体过程如下:
a.确定测试(变化后)产品和参照(变化前)产品两种产品的溶出谱。
b.使用每个时间间隔的两条曲线的平均溶出度值,利用以上方程式计算差异因子(f1)和相似性因子(f2)。
c.当f1值等于或小于15(0至15)并且f2值大于50(即50至100)时,曲线被认为是相似的,从而确保产品的相同性。
随着精确度的改善和PION技术的增强,活性物溶出谱可以以更高的准确度进行比较,并对以前被理解为不提供任何可计算的溶出度差异的变量进行比较。
聚合物
膜和/或其组分可以是水溶性的、水溶胀性的、水不溶性的、或这些中的一个或更多个的组合。术语“水溶性”可指至少部分可溶于水性溶剂(包括但不限于水)的物质。术语“水溶性”可不必须意指物质可100%溶于水性溶剂。术语“水不溶性”是指不可溶于水性溶剂(包括但不限于水)的物质。溶剂可包括水,或者替代地可包括其他溶剂(优选极性溶剂)自身或与水的组合。
膜可通过至少一种聚合物和溶剂的组合来产生,任选地包括其他组分。溶剂可为水、极性有机溶剂,包括但不限于乙醇、异丙醇、丙酮或其任意组合。在一些实施方案中,溶剂可为非极性有机溶剂,例如二氯甲烷。膜可通过利用所选择的流延法或沉积法和受控的干燥过程来制备。例如,膜可通过受控的干燥过程来制备,所述干燥过程包括向湿膜基质施加热能和/或辐射能以形成黏-弹性结构,从而控制膜的内容物的均一性。受控的干燥过程可包括使单独的空气、单独的热量、或热量和空气一起接触膜的顶部、膜的底部、或者支撑经流延、沉积或挤出的膜的基底,或者在干燥过程期间同一时间或不同时间接触多于一个表面。美国专利No.8,765,167和美国专利No.8,652,378中更详细地描述了这样的过程中的一些,所述专利通过引用并入本文。或者,可如美国专利公开No.2005/0037055 A1所述挤出膜,所述专利通过引用并入本文。
膜中包含的聚合物基质可以是水溶性的、水溶胀性的、或其组合。
聚合物基质包含聚合物。聚合物可为聚环氧乙烷。聚合物可包括纤维素、纤维素衍生物或树胶。聚合物可包括聚环氧乙烷、纤维素、纤维素衍生物如纤维素醚、或其组合。聚合物可为纤维素聚合物。在某些实施方案中,纤维素聚合物可为羟丙基甲基纤维素、羟乙基纤维素、羟乙基甲基纤维素、羟丙基纤维素、甲基纤维素、羧甲基纤维素和/或羧甲基纤维素钠。在某些实施方案中,聚合物可包括羟丙基甲基纤维素。在某些实施方案中,聚合物可包括聚环氧乙烷和纤维素醚,例如羟丙基甲基纤维素。在某些实施方案中,聚合物可包括聚环氧乙烷和/或聚乙烯吡咯烷酮。在某些实施方案中,聚合物基质可包括聚环氧乙烷和/或多糖。在某些实施方案中,聚合物基质可包括聚环氧乙烷、羟丙基甲基纤维素和/或多糖。在某些实施方案中,聚合物基质可包括聚环氧乙烷、纤维素聚合物、多糖和/或聚乙烯吡咯烷酮。在某些实施方案中,聚合物基质可包括选自以下的至少一种聚合物:短梗霉聚糖、聚乙烯吡咯烷酮、聚乙烯醇、藻酸钠、聚乙二醇、黄原胶、西黄蓍胶、瓜尔胶、金合欢胶(acacia gum)、阿拉伯胶(arabic gum)、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧乙烯基共聚物、淀粉、明胶、环氧乙烷、环氧丙烷共聚物、胶原蛋白、白蛋白、聚氨基酸、聚磷腈、多糖、壳多糖、壳聚糖、及其衍生物。可用的水溶性聚合物的另一些实例包括但不限于聚环氧乙烷、短梗霉聚糖、羟丙基甲基纤维素、羟乙基纤维素、羟丙基纤维素、聚乙烯吡咯烷酮、羧甲基纤维素、聚乙烯醇、藻酸钠、聚乙二醇、黄原胶、西黄蓍胶、瓜尔胶、金合欢胶、阿拉伯胶、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧乙烯基共聚物、淀粉、明胶、多糖、及其组合。
如本文所使用的短语“水溶性聚合物”及其变化形式是指至少部分溶于水的聚合物,并且期望地完全或绝大多数可溶于水,或者吸收水。吸收水的聚合物通常是指水溶胀性聚合物。本发明可用的材料可以是在室温和其他温度(例如超过室温的温度)下为水溶性的或水溶胀性的。此外,所述材料可以是在低于大气压的压力下为水溶性的或水溶胀性的。期望地,水溶性聚合物是水溶性的或水溶胀性的,具有按重量计至少20%的水吸收。具有按重量计25%或更高百分比水吸收的水溶性聚合物也是可用的。在一些实施方案中,由这样的水溶性聚合物形成的膜可以是充分水溶性的,从而在与体液接触时可溶解。
可用于并入所述膜的其他聚合物包括生物可降解的聚合物、共聚物、嵌段聚合物或其组合。要理解的是,与物理性分解的材料(即生物可侵蚀的材料)不同,术语“生物可降解的”旨在包括可发生化学降解的材料。并入所述膜的聚合物还可包括生物可降解或生物可侵蚀的材料的组合。已知的满足以上标准的可用聚合物或聚合物种类是:聚(乙醇酸)(PGA)、聚(乳酸)(PLA)、聚二烷、聚草酸酯、聚(α-酯)、聚酸酐、聚乙酸酯、聚已酸内酯、聚(原酸酯)、聚氨基酸、聚氨基碳酸酯、聚氨酯、聚碳酸酯、聚酰胺、聚(氰基丙烯酸烷酯)、及其混合物和共聚物。另一些有用的聚合物包括L-和D-乳酸的立体聚合物、双(p-羧基苯氧基)丙酸与癸二酸的共聚物、癸二酸共聚物、己内酯的共聚物、聚(乳酸)/聚(乙醇酸)/聚乙二醇共聚物、聚氨酯与聚(乳酸)的共聚物、α-氨基酸的共聚物、α-氨基酸与己酸的共聚物、α-谷氨酸苄酯与聚乙二醇的共聚物、琥珀酸酯与聚(二元醇)的共聚物、聚磷腈、聚羟基链烷酸酯、或其混合物。考虑二元和三元系统。聚合物基质可包含一种、两种、三种、四种或更多种组分。
可用的其他具体聚合物包括以Medisorb和Biodel商标销售的那些。Medisorb材料是由Dupont Company of Wilmington,Del销售的,一般统称为“丙交酯/乙交酯共聚物”,包含“丙酸的二羟基聚合物与羟基乙酸的羟基聚合物”。四种这样的聚合物包括以下:丙交酯/乙交酯100L,认为是具有338°F至347°F(170℃至175℃)范围内熔点的100%丙交酯;丙交酯/乙交酯100L,认为是具有437°F至455°F(225℃至235℃)范围内熔点的100%丙交酯;丙交酯/乙交酯85/15,认为是具有338°F至347°F(170℃至175℃)范围内熔点的85%丙交酯和15%乙交酯;以及丙交酯/乙交酯50/50,认为是具有338°F至347°F(170℃至175℃)范围内熔点的50%丙交酯和50%乙交酯。Biodel材料表示一类化学性质上不同的多种聚酸酐。
尽管可使用多种不同的聚合物,期望选择为膜提供黏膜黏附特性以及期望的溶解和/或崩解速率的聚合物。特别地,期望保持所述膜与黏膜组织相接触的时间取决于包含在组合物中的药物活性物的类型。一些药物活性物可仅需要几分钟就经由黏膜递送,而另一些药物活性物可需要长达几小时或甚至更长。因此,在一些实施方案中,如上所述的一种或更多种水溶性聚合物可用于形成膜。然而,在另一些实施方案中,可期望使用水溶性聚合物与水溶胀性的、水不溶性的和/或生物可降解的聚合物的组合。包含一种或更多种水溶胀性的、水不溶性的和/或生物可降解的聚合物可为膜提供比由水溶性聚合物单独形成的膜更慢的溶解或崩解速率。因此,所述膜可黏附至黏膜更长期的时间(例如,长达几小时),这对于递送某些药物活性物可以是期望的。
聚合物基质可包括树枝状聚合物,其可包括具有多种结构架构的高度支化的大分子。树枝状聚合物可包括树状聚合物、树枝状聚合物(树枝状接枝聚合物)、线性树枝状杂化物、多臂星形聚合物或超支化聚合物。
聚合物基质可包括超支化聚合物,其是在其结构中具有缺陷的高度支化的聚合物。然而,它们可在单步反应中合成,这相对于其他树枝状结构而言是有利的,并因此适用于大体积应用。这些聚合物的特性除了其球状结构之外,还有丰富的官能团、分子内腔、低黏度和高溶出度。树枝状聚合物已用于几种药物递送应用。参见例如Dendrimers as DrugCarriers:Applications in Different Routes of Drug Administration.J Pharm Sci,第97卷,2008,123-143,其通过引用并入本文。
树枝状聚合物可具有可包封药物的内部腔。由高度致密的聚合物链引起的位阻可防止药物结晶。因此,在配制聚合物基质中的可结晶药物时,支化的聚合物可提供其他优点。
合适的树枝状聚合物的实例包括但不限于基于聚(醚)的树突状物、树状聚合物和超支化聚合物;基于聚(酯)的树突状物、树状聚合物和超支化聚合物;基于聚(硫醚)的树突状物、树状聚合物和超支化聚合物;基于聚(氨基酸)的树突状物、树状聚合物和超支化聚合物;基于聚(芳基亚烷基醚)的树突状物、树状聚合物和超支化聚合物;基于聚(亚烷基亚胺)的树突状物、树状聚合物和超支化聚合物;基于聚(酰胺基胺)的树突状物、树状聚合物或超支化聚合物。
超支化聚合物的另一些实例包括聚(胺)、聚碳酸酯、聚(醚酮)、聚氨酯、聚碳硅烷、聚硅氧烷、聚(酯胺)、聚(砜胺)、聚(脲氨酯)和聚醚多元醇如聚甘油。
例如,在一些实施方案中,自支撑膜可包含单独的聚环氧乙烷或聚环氧乙烷与第二聚合物组分的组合。第二聚合物可以是另外的水溶性聚合物、水溶胀性聚合物、水不溶性聚合物、生物可降解的聚合物、或其任意组合。合适的水溶性聚合物包括而不限于以上提供的任何聚合物。在一个实施方案中,水溶性聚合物可以是亲水性纤维素聚合物,例如羟丙基纤维素和/或羟丙基甲基纤维素。在另一个实施方案中,一种或更多种水溶胀性的、水不溶性的和/或生物可降解的聚合物也可包含在基于聚环氧乙烷的膜中。可采用以上提供的任何水溶胀性的、水不溶性的或生物可降解的聚合物。第二聚合物可以以以下的量采用:按聚合物基质的重量计约0%至约80%,更具体地按重量计约30%至约70%,甚至更具体地按重量计约40%至约60%,包括按重量计大于约5%、大于约10%、大于约15%、大于约20%、大于约30%、大于约40%、大于约50%、大于约60%、以及大于约70%、约70%、小于约70%、小于约60%、小于约50%、小于约40%、小于约30%、小于约20%、小于约10%、或小于约5%。
聚合物在影响膜的黏度方面发挥重要作用。黏度是控制乳剂、胶体或混悬剂中活性物稳定性的液体的一种特性。通常来说,基质的黏度会在约400cps至约100,000cps、优选约800cps至约60,000cps、并且最优选约1,000cps至约40,000cps之间变化。期望地,在干燥过程开始时,成膜基质的黏度将快速增加。
可基于所选择的活性物根据基质内的其他组分来调节黏度。例如,如果组分不溶于所选择的溶剂内,则可选择防止组分沉降(将不利地影响所得膜的均一性)的适当的黏度。可以以不同的方式调节黏度。为了增加膜基质的黏度,可选择较高分子量的聚合物或者可添加交联剂,例如钙盐、钠盐和钾盐。还可通过调节温度或通过添加黏度增加组分来调节黏度。会增加黏度或稳定乳剂/混悬剂的组分包括较高分子量的聚合物和多糖以及树胶,包括而不限于藻酸盐、卡拉胶、羟丙基甲基纤维素、槐豆胶、瓜尔胶、黄原胶、右旋糖酐、阿拉伯胶、结冷胶及其组合。
还已经观察到,在单独使用时通常会需要增塑剂来获得柔性膜的某些聚合物可在无增塑剂的情况下进行组合并且也获得柔性膜。例如,当组合使用HPMC和HPC时,提供了具有适用于制造和储存的塑性和弹性的柔性坚固膜。无需另外的增塑剂或多元醇来用于柔性。
添加剂
可向本文所公开的膜添加添加剂。可并入本发明的膜中的多种添加剂可提供多种不同的功能。添加剂类的实例包括赋形剂、润滑剂、缓冲剂、稳定剂、发泡剂、色素、着色剂、填充剂(filler)、填充剂(bulking agent)、甜味剂、矫味剂、香料、释放调节剂、辅料、增塑剂、流动促进剂、脱模剂、多元醇、制粒剂、稀释剂、结合剂、缓冲剂、吸收剂、助流剂、黏合剂、抗黏剂、酸化剂、软化剂、树脂、缓和剂(demulcent)、溶剂、表面活性剂、乳化剂、弹性体及其混合物。这些添加剂可在一种或更多种活性物之前添加或者与其一起添加。膜中添加剂的量基于膜组合物的重量(其为其中全部组分的总重量)可高至约80%、约0.005%至约50%、约1%至约20%、或约3%至约20%,包括大于约1%、大于约5%、大于约10%、大于约20%、大于约30%、大于约40%、大于约50%、大于约60%、小于约80%、小于约70%、小于约60%、小于约50%、小于约40%、小于约30%、小于约20%、小于约10%、小于约5%、约3%、或小于约1%。
添加剂可选自甜味剂、矫味剂、味道增强剂、填充剂、增塑剂、着色剂(例如染料或色素)、渗透增强剂、缓冲剂、防腐剂、二氧化硅、抗黏剂、及其任意组合。
矫味剂可选自天然和合成的矫味液体。这样的物质的举例说明性列表包括挥发性油、合成矫咪油、矫味芳香剂、油、液体、油树脂或者来源于植物、叶、花、果实、茎的提取物、及其组合。实例的非限制性代表性列表包括薄荷油;可可;和柑橘油,例如柠檬、橙、葡萄、酸橙和葡萄柚;以及水果香精,包括苹果、梨、桃、葡萄、草莓、覆盆子、柠檬、酸橙、橙、樱桃、李子、菠萝、杏或其他水果矫味剂。
可用的矫味剂(flavor)或矫味剂(flavoring agent)包括天然和人造矫味剂。这些矫味剂可选自合成矫味油和矫味芳香剂、和/或油、油树脂和来源于植物、叶、花、果实等的提取物、及其组合。非限制性矫味油包括:留兰香油、肉桂油、辣薄荷油、丁香油、月桂油、百里香油、雪松叶油、肉豆蔻油、鼠尾草油和苦杏仁油。还可用的为人造、天然或合成的水果矫味剂,例如香草;巧克力;咖啡;可可;和柑橘油,包括柠檬、橙、葡萄、酸橙和葡萄柚;以及水果香精,包括苹果、梨、桃、草莓、覆盆子、樱桃、李子、菠萝、杏等。这些矫味剂可单独或组合使用。通常使用的矫味剂包括薄荷如辣薄荷、人造香草、肉桂衍生物和多种水果矫味剂,无论单独或是组合采用。还可使用例如醛和酯的矫味剂,包括乙酸肉桂酯、肉桂醛、柠檬醛、二乙缩醛、乙酸二氢香芹酯、甲酸丁子香酯、对甲基苯甲醚等。醛矫味剂的其他实例包括但不限于乙醛(苹果);苯甲醛(樱桃、杏仁);肉桂醛(肉桂);柠檬醛,即α-柠檬醛(柠檬、酸橙);橙花醛,即β-柠檬醛(柠檬、酸橙);癸醛(橙、柠檬);乙基香草醛(香草、奶油);洋茉莉醛(helotropine),即胡椒醛(香草、奶油);香草醛(香草、奶油);α-戊基肉桂醛(辛辣水果味矫味剂);丁醛(黄油、干酪);戊醛(黄油、干酪);香茅醛(多种类型的调节剂);癸醛(柑橘类水果);醛C-8(柑橘类水果);醛C-9(柑橘类水果);醛C-12(柑橘类水果);2-乙基丁醛(浆果类水果);己烯醛,即反式-2(浆果类水果);甲苯醛(樱桃、杏仁);藜芦醛(香草);12,6-二甲基-5-庚烯醛,即甜瓜醛(甜瓜);2二甲基辛醛(绿色水果);以及2-十二烯醛(柑橘、橘);樱桃;葡萄;其混合物;等等。
另一些可用的矫味剂包括醛和酯,例如苯甲醛(樱桃、杏仁);柠檬醛,即α柠檬醛(柠檬、酸橙);橙花醛,即β-柠檬醛(柠檬、酸橙);癸醛(橙、柠檬);醛C-8(柑橘类水果);醛C-9(柑橘类水果);醛C-12(柑橘类水果);甲苯醛(樱桃、杏仁);2,6-二甲基辛醇(绿色水果);以及2-十二烯醛(柑橘、橘);其组合;等等。
采用的矫味剂的量通常就优选而言取决于例如矫味剂类型、单独的矫味剂和期望的强度的这样的因素。为了获得最终产品期望的结果,量可变化。这样的变化在本领域技术人员的能力之内,而不需要过度的实验。通常来说,约0.1重量%至约30重量%的量可用于实施本发明。
在一个实施方案中,所述膜包含浆果矫味剂。浆果矫味剂可为覆盆子、草莓、蓝莓、波森莓(bousenberry)、黑莓或其组合。在另一个实施方案中,所述膜包含覆盆子矫味剂。浆果矫味剂,覆盆子、草莓、蓝莓、波森莓或黑莓矫味剂可以是天然的或人造的,并且可通过任何本领域已知的方式购买和/或制造。例如,可通过并入E.Aprea等“Volatile Compoundsof Raspberry Fruit:From Analytical Methods to Biological Role and SensoryImpact,”,Molecules 2015,20,2445-2474中公开的挥发性化合物的混合物来获得包含香味的覆盆子矫味剂,所述文献通过引用整体并入本文。在使用时,浆果矫味剂可以以按组合物的重量计约0.1%至约15%存在。在其某些实施方案中,浆果矫味剂以按组合物的重量计约0.5%至约10%、约1%至约8%、约2%至约7%、约3%、约4%、约5%、约6%、或约7%存在。
合适的甜味剂包括天然和人造甜味剂二者。合适的甜味剂的非限制性实例包括,例如:水溶性甜味剂,例如单糖、二糖和多糖,例如木糖、核糖、葡萄糖(右旋糖)、甘露糖、半乳糖、果糖(左旋糖)、蔗糖(糖)、高果糖玉米糖浆、麦芽糖、转化糖(来源于蔗糖的果糖和葡萄糖的混合物)、部分水解的淀粉、玉米糖浆固体和二氢查耳酮;水溶性人造甜味剂,例如可溶性糖精盐(即钠糖精盐或钙糖精盐)、环己氨基磺酸盐、3,4-二氢-6-甲基-1,2,3-氧杂噻嗪-4-酮-2,2-二氧化物的钠盐、铵盐或钙盐、3,4-二氢-6-甲基-1,2,3-氧杂噻嗪-4-酮-2,2-二氧化物的钾盐(乙酰磺胺酸-K)、糖精的游离酸形式等;基于二肽的甜味剂,例如衍生自L-天冬氨酸的甜味剂,例如L-天冬氨酰-L-苯丙氨酸甲酯(阿斯巴甜)、L-α-天冬氨酰-N-(2,2,4,4-四甲基-3-硫杂环丁烷基)-D-丙氨酰胺水合物、L-天冬氨酰-L-苯基甘油和L-天冬氨酰-L-2,5,二氢苯基甘氨酸、L-天冬氨酰-2,5-二氢-L-苯丙氨酸、L-天冬氨酰-L-(1-环己烯)-丙氨酸的甲酯等;来源于天然存在的水溶性甜味剂的水溶性甜味剂,例如普通糖(蔗糖)的氯化衍生物,已知为例如三氯蔗糖;以及基于蛋白质的甜味剂,例如thaurnatoccousdanielli(Thaurnatin I和II)。还可使用天然存在的高强度甜味剂,例如罗汉果、甜菊、甜菊苷、莫内林和甘草甜素。
通常来说,利用有效量的甜味剂来提供特定组合物所期望的甜味水平,并且该量会随所选择的甜味剂而变化。该量通常将为按组合物的重量计0.01%至约10%。可使用这些量来实现期望的甜味水平,而与从使用的任意任选的矫味油中获得的矫味水平无关。在某些实施方案中,甜味剂以按组合物的重量计约0.5%至约5%、约1%至约5%、约1.5%至约4%、约1.5%、约2%、约2.5%、约3%、约3.5%、约4%或约5%存在。
甜味剂可选自三氯蔗糖、甜菊、乙酰磺胺酸钾、糖精、果糖、阿斯巴甜、及其任意组合,并且可以以按组合物的重量计约0.5%至约5%、约1%至约5%、约1.5%至约4%、约1.5%、约2%、约2.5%、约3%、约3.5%、约4%或约5%存在。在一个实施方案中,按组合物的重量计约3%至约4%、约3%或约3.5%的三氯蔗糖、糖精、阿斯巴甜、及其任意组合存在于膜中。
可用于本发明的着色添加剂包括食品、药物和化妆品着色剂(FD&C)、药物和化妆品着色剂(D&C)、或外部药物和化妆品着色剂(外部D&C)。这些着色剂为染料、其对应的色淀、以及某些天然和衍生的着色剂。色淀是吸收在氢氧化铝上的染料。
着色剂的另一些实例包括已知的偶氮染料、有机或无机颜料、或者天然来源的着色剂。无机颜料是优选的,例如铁或钛的氧化物,这些氧化物以基于全部组分的重量的约0.001%至约10%、并且优选约0.5%至约3%的浓度添加。所述膜可为任何颜色,包括但不限于白色、透明、蓝色、绿色、红色、粉色、紫色、橙色或黄色。在一个实施方案中,膜是透明且透亮的。
所述膜还期望包含缓冲剂以控制pH。将任何期望水平的缓冲剂盘并入聚合物基质中,以提供在药物活性物从膜中释放时遇到的期望的pH水平。优选以足以控制活性物从膜中释放和/或吸收至体内的量来提供缓冲剂。缓冲剂可包括柠檬酸钠、柠檬酸、酒石酸氢盐或其任意组合。
在某些实施方案中,膜可包含增塑剂,所述增塑剂可包括聚环氧烷,例如聚乙二醇、聚丙二醇、聚乙烯-聚丙二醇;具有低分子量的有机增塑剂,例如甘油、单乙酸甘油酯、二乙酸甘油酯或三乙酸甘油酯、三醋精、聚山梨醇酯、鲸蜡醇、丙二醇、糖醇山梨醇、二乙基磺基琥珀酸钠、柠檬酸三乙酯、柠檬酸三丁酯、植物提取物、脂肪酸酯、脂肪酸、油;等等。增塑剂可以以基于膜组合物的重量的约0.1%至约40%、或约0.5%至约20%的浓度添加,包括大于约0.5%、大于约1%、大于约1.5%、大于约2%、大于约4%、大于约5%、大于约10%、大于约15%、约20%、大于约20%、小于约20%、小于约15%、小于约10%、小于约5%、小于约4%、小于约2%、小于约1%、以及小于约0.5%。还可添加改善膜材料的纹理特性的化合物,例如动物或植物脂肪,期望地呈氢化形式的动物或植物脂肪,尤其是在室温下为固体的那些。这些脂肪的熔点期望地为50℃或更高。优选为具有C12-、C14-、C16-、C18-、C20-和C22-脂肪酸的甘油三酯。这些脂肪可单独添加而不添加增量剂或增塑剂,并且可有利地单独或与甘油单酯和/或甘油二酯或磷脂(尤其是卵磷脂)一起添加。甘油单酯和甘油二酯期望地衍生自上述脂肪类型(即具有C12-、C14-、C16-、C18-、C20-和C22-脂肪酸)。基于膜组合物的重量,脂肪、甘油单酯、甘油二酯和/或卵磷脂的总量高至约5%或在约0.5%至约2%的范围内。
还可向本文所公开的膜添加多种其他组分和填充剂。这些可包括而不限于表面活性剂;另外的消泡剂;例如通过从膜中释放氧气来促进膜表面更平滑的西甲硅油;有助于保持组分的分散的热固性凝胶,例如果胶、角叉菜胶和明胶;以及提高某些活性组分的溶解性和/或稳定性的包合化合物,例如环糊精和笼状分子。
另一些添加剂可为无机填充剂,例如镁、铝、硅、钛的氧化物等,基于膜组合物的重量,浓度范围期望地为约按重量计0.02%至约3%,以及期望地为约0.02%至约1%。
以按总组合物的重量计约0.02%至约1%的浓度添加二氧化硅、硅酸钙或二氧化钛可以是有用的。这些化合物用作调质剂(texturizing agent)。
这些添加剂以足以实现其预期目的的量使用。通常来说,这些添加剂中某些的组合将改变活性成分的总体释放特征并且可用于调节,即阻止或加速释放。
可将抗黏剂并入本公开内容的口腔膜中。抗黏剂可选自润滑剂、抗黏剂、助流剂及其组合。抗黏剂例如通过降低挤出过程中对模具的黏性以及降低剂型施用期间对口腔顶部的黏性而有助于材料的流动特性。在膜的消耗期间,颗粒趋于黏附至口腔的顶部。这对于包含苦味药物例如如右美沙芬的膜是不期望的,因为黏附的颗粒逸出药物,这增加了使用者感知到的苦味的量。向膜中添加抗黏剂降低了对口腔顶部的黏附,从而有效地减少了消耗期间使用者可感知到的苦味。
抗黏剂还可赋予降低的膜与膜之间的摩擦系数,从而减少膜剂量单元即条带彼此黏附的问题。更具体地,在许多类型的膜包装中,条带彼此堆叠。抗黏剂的并入可允许当从包装中取出每个单位时单独的条带相对于彼此平滑地滑动。
用作抗黏剂的合适润滑剂的实例包括但不限于:硬脂酸盐,例如硬脂酸镁、硬脂酸钙和硬脂酸钠;硬脂酸;植物油(可作为sterotex商购);滑石;蜡;硬脂酸镁和月桂基硫酸钠的共混物(可作为stearowet商购);硼酸;苯甲酸钠;乙酸钠;氯化钠;DL-亮氨酸;分子量为4000的聚乙二醇(可作为Carbowax 4000商购);分子量为6000的聚乙二醇(可作为Carbowax6000商购);油酸钠;月桂基硫酸钠;月桂基硫酸镁;及其组合。
合适的抗黏剂的实例包括但不限于:滑石;玉米淀粉;合成的无定形二氧化硅;非晶(可作为Cab-O-Sil;syloid商购);DL-亮氨酸;月桂基硫酸钠;金属硬脂酸盐;及其组合。合适的助流剂的实例包括但不限于:滑石;玉米淀粉;合成的无定形二氧化硅;非晶(可作为Cab-O-Sil商购);syloid;气溶胶;及其组合。
维生素E是用于本发明的一些实施方案的另一种合适的抗黏剂。维生素E可用作膜中的抗黏剂和活性组分二者。期望地,采用维生素E TPGS(d-α生育酚聚乙二醇1000琥珀酸酯)。维生素E TPGS是来源于天然来源的水溶性形式的维生素E。与其他形式相比,维生素ETPGS易于吸收。此外,维生素E TPGS基本上不赋予膜味道。维生素E TPGS可用于溶液,例如与水的10%或20%溶液中。维生素E TPGS特别可用于降低膜的黏性和黏附于使用者口腔顶部的趋势。维生素E可以以按组合物的重量计约0.01%至约20%的量存在。
当存在时,抗黏剂可以以按膜组合物的重量计约0.01%至约20%包含在内。更具体地,抗黏剂可以以按膜组合物的重量计约0.01%至约10%、甚至更具体地按膜组合物的重量计约0.25%至约5%的量存在。
还可采用抗黏剂的组合。例如,可使用硬脂酸盐(例如硬脂酸镁)和二氧化硅的组合。具有4.5μm平均颗粒尺寸的二氧化硅产品SIPERNAT ABOUT 500LS(可商购自Degussa)适用于本文。硬脂酸镁和二氧化硅的组合可提供改善的助流特性,即,帮助膜条带在包装中相对于彼此平滑地滑动。因此,硬脂酸镁可以以按膜组合物的重量计约0.1%至约2.5%存在,并且二氧化硅可以以按膜组合物的重量计约0.1%至约1.5%存在。这样的抗黏剂的组合在包含不同矫味剂和/或活性物的多种膜中可以是有用的。
抗黏剂可包含在膜组合物本身中。例如,可形成包含抗黏剂的单层或多层膜。例如,多层膜可包括基本上彼此接触的两层、三层或更多层膜。膜层可彼此层合。抗黏剂可存在于多层膜的一层或更多层中。例如,一些实施方案可包括双层膜,其中抗黏剂存在于两个膜层中的一个中。一些实施方案可包括三层膜,其中抗黏剂存在于三层膜中外层的每一个中,但不存在于内层或中间层中。据此,可形成层的多种不同组合。
或者,抗黏剂可包含在用于涂覆膜的外表面的组合物中。例如,可将抗黏剂以湿涂或干涂(例如如加糖或无糖涂覆)的形式施加至膜。可以以任何常规方式用抗黏剂涂覆膜,例如但不限于浸涂、喷涂、撒粉或流化床。可涂覆一个或更多个膜表面。在一些实施方案中,可将抗黏涂层施加至基底,例如膜的背衬,而不是直接施加至膜本身。当将膜从背衬除去时,抗黏涂层可黏附至膜。
一些实施方案可包括脂肪和/或蜡作为抗黏剂。
如上所述,共同转让的美国专利No.7,425,292和美国专利No.8,765,167中描述的任何其他任选的组分也可包含在本文所述的膜中。
渗透增强剂
本文中公开的膜可以是渗透增强剂。活性物可以在单层的膜中与渗透活性增强剂组合,各自包含在单独的层中,或者可以各自以其他方式包含在同一剂型的离散区域中。在某些实施方案中,包含在聚合物基质中的活性物可分散在基质中。在某些实施方案中,包含在聚合物基质中的渗透增强剂可分散在基质中。
可将已知本领域使用的任何渗透增强剂并入本公开内容的膜中。术语“渗透增强剂”可与吸收增强剂和渗透增强剂互换。当经由膜递送至口腔时,渗透增强剂为可改善药物活性物通过对象的黏膜并进入到血流中的渗透性的组分。
渗透增强剂可以是具有通过与亲水性糖的键联而连接的疏水性烷基的非离子烷基糖苷。渗透增强剂可选自麦芽糖苷或麦芽糖苷衍生物、蔗糖苷(sucroside)或蔗糖苷衍生物、和香精油或香精油的组分。渗透增强剂可选自烷基硫代麦芽糖苷、麦芽糖苷、麦芽三糖苷、麦芽吡喃糖苷、十二烷基麦芽糖苷、十三烷基麦芽糖苷、十四烷基麦芽糖苷、十四烷基-β-D-麦芽糖苷、十二烷基-β-D-麦芽糖苷、十三烷基-β-D-麦芽糖苷、蔗糖苷、蔗糖单-十二酸酯、蔗糖单-十三酸酯、蔗糖单-十四酸酯及其组合。
根据组合物中的其他组分,渗透增强剂可将药物活性物的吸收率和量提高大于5%、大于10%、大于20%、大于30%、大于40%、大于50%、大于60%、大于70%、大于80%、大于90%、大于100%、大于150%、约200%或更大,或小于200%、小于150%、小于100%、小于90%、小于80%、小于70%、小于60%、小于50%、小于40%、小于30%、小于20%、小于10%、或者小于5%,或者这些范围的组合。
在某些实施方案中,膜包含具有通过与亲水性糖的键联而连接的疏水性烷基的可药用无毒、非离子烷基糖苷,其与选自以下的黏膜递送增强剂组合:(a)聚集抑制剂;(b)电荷改变剂;(c)pH控制剂;(d)降解酶抑制剂;(e)黏液溶解剂或黏液清除剂;(f)抗静电剂;(g)选自以下的膜渗透增强剂:(i)表面活性剂;(ii)胆汁盐;(ii)磷脂添加剂、混合胶束、脂质体或者载体;(iii)醇;(iv)烯胺;(v)NO供体化合物;(vi)长链两亲性分子;(vii)小疏水渗透增强剂;(viii)钠或水杨酸衍生物;(ix)乙酰乙酸的甘油酯;(x)环糊精或β-环糊精衍生物;(xi)中链脂肪酸;(xii)螯合剂;(xiii)氨基酸或其盐;(xiv)N-乙酰基氨基酸或其盐;(Xv)可降解所选膜组分的酶;(ix)脂肪酸合成的抑制剂;(x)胆固醇合成的抑制剂;和(xi)(i)-(x)中所述的膜渗透增强剂的任何组合;(h)上皮连接生理学的调节剂;(i)血管扩张剂;(j)选择性转运增强剂;以及(k)与化合物有效地组合、缔合、包含、包封或者结合的稳定的递送载剂、载体、黏膜黏附剂、支持物或者复合形成的物质,导致用于增强的经黏膜递送的化合物的稳定,其中具有经黏膜递送的增强剂的化合物的制剂提供了化合物在对象血浆中的增加的生物利用度。渗透增强剂在J.Nicolazzo,et al.,J.of Controlled Disease,105(2005)1-15中描述,其通过引用并入本文。
表面活性剂和胆汁盐已示出在体外和体内均增强多种化合物穿过颊黏膜的渗透性。从这些研究中获得的数据强烈表明渗透性的提高是由于表面活性剂对黏膜的胞间脂质的作用。
脂肪酸示出增强许多药物通过皮肤的渗透,并且这已经通过差示扫描量热法和傅立叶变换红外光谱法示出与胞间脂质的流动性的增加有关。
此外,用乙醇预处理已示出增强氚化水和白蛋白穿过舌腹侧黏膜的渗透性,并增强咖啡因穿过猪颊黏膜的渗透性。也有一些Azone.RTM.对化合物穿过口腔黏膜的渗透性的增强作用的报道。此外,壳聚糖(生物相容的和生物可降解的聚合物)已示出增强药物通过多种组织(如包括肠和鼻黏膜)的递送。
已经示出,通过使用多种类型的经黏膜和经皮渗透增强剂,例如胆汁盐、表面活性剂、脂肪酸及其衍生物、螯合剂、环糊精和壳聚糖,可改善经颊渗透。在用于药物渗透增强的这些化学物质中,胆汁盐是最常见的。
在Sevda Senel的Drug permeation enhancement via buccal route:possibilities and limitations,Journal of Controlled Release 72(2001)133-144(其通过引用并入本文)中讨论了胆汁盐对化合物的颊渗透的增强作用的体外研究。该文章还讨论了在约100mM浓度下的二羟基胆汁盐、甘氨脱氧胆酸钠(SGDC)和牛磺脱氧胆酸钠(TDC)和三羟基胆汁盐、甘氨胆酸钠(GC)和牛磺胆酸钠(TC)的颊上皮渗透性的影响的最新研究,包括与组织学作用相关的渗透性改变。异硫氰酸荧光素(FITC)、硫酸吗啡各自用作模型化合物。
壳聚糖在动物模型和人志愿者中也示出促进小极性分子和肽/蛋白质药物通过鼻黏膜的吸收。其他研究示出对化合物穿过肠黏膜和培养的Caco-2细胞的渗透的增强作用。
渗透增强剂可为植物提取物。植物提取物可为香精油或包括通过蒸馏植物材料而提取的香精油的组合物。在某些情况下,植物提取物可包括从植物材料提取的化合物的合成类似物(即,通过有机合成制成的化合物)。植物提取物可包括苯丙素类,例如苯丙氨酸、丁香油酚、丁香油酚乙酸酯、肉桂酸、肉桂酸酯、肉桂醛、氢肉桂酸、胡椒酚或黄樟脑,或其组合。植物提取物可以是丁香植物的香精油提取物,例如,来自丁香植物的叶、茎或花芽。丁香植物可为丁香(Syzygium aromaticum)。植物提取物可包含约20%至约95%的丁香油酚、包含约40%至约95%的丁香油酚、包含约60%至约95%的丁香油酚,并且例如,约80%至95%的丁香油酚。提取物还可包含约5%至约15%的丁香油酚乙酸酯。提取物还可包含石竹烯。提取物还可包含高至约2.1%的α-蛇麻烯。丁香香精油中以较低浓度包含的其他挥发性化合物可为β-蒎烯、柠檬烯、法尼醇、苯甲醛、2-庚酮或己酸乙酯。可将其他渗透增强剂添加至组合物以改善药物的吸收。合适的渗透增强剂包括天然或合成的胆汁盐,例如夫西地酸钠;甘氨胆酸或脱氧胆酸及其盐;脂肪酸及衍生物,例如月桂酸钠、油酸、油醇、甘油一油酸酯或者棕榈酰肉毒碱;螯合剂,例如EDTA二钠、柠檬酸钠和月桂硫酸钠、atone、胆酸钠、5-甲氧基水杨酸钠、失水山梨糖醇月桂酸酯、单月桂酸甘油酯、辛氧基壬基-9、月桂醇聚醚-9、聚山梨醇酯、固醇或甘油酯,例如辛酰己酰聚氧甘油酯,例如Labrasol。渗透增强剂可包括植物提取物衍生物和/或木质素单体。渗透增强剂也可以是真菌提取物。
已知一些植物来源的天然产物具有血管舒张作用。对于综述,参见McNeill J.R.和Jurgens,T.M.,Can.J.Physiol.Pharmacol.84:803-821(2006),其通过引用并入本文。具体地,在许多动物研究中已经报道了丁香油酚的血管舒张作用。参见例如Lahlou,S.,etat.,J.Cardiovasc.Pharmacol.43:250-57(2004),Damiani,C.E.N.,et al.,VascularPharmacol.40:59-66(2003),Nishijima,H.,et al.,Japanese J.Pharmacol.79:327-334(1998),和Hume W.R.,J.Dent Res.62(9):1013-15(1983),其各自通过引用并入本文。钙通道阻滞被认为是由植物香精油或其主要成分丁香油酚引起的血管舒张的原因。参见Interaminense L.R.L.et al.,Fundamental&Clin.Pharmacol.21:497-506(2007),其通过引用并入本文。
脂肪酸可用作药物制备中的非活性成分或者药物载剂。由于脂肪酸的某些功能作用和其生物相容性性质,脂肪酸也可用作制剂成分。游离的脂肪酸和作为复合脂质的一部分的脂肪酸均是主要的代谢燃料(储存和运输能量)、所有膜和基因调节剂的重要组成。对于综述,参见RustanA.C.和Drevon,C.A.,Fatty Acids:Structures and Properties,Encyclopedia of Life Sciences(2005),其通过引用并入本文。存在在人体中代谢的必需脂肪酸的两个家族:Ω-3和Ω-6多不饱和脂肪酸(PUFA)。如果在Ω碳的第三与第四碳原子之间建立第一双键,则将其称为Ω-3脂肪酸。如果第一双键在第六与第七碳原子之间,则将其称为Ω-6脂肪酸。PUFA通过添加碳原子和通过去饱和(氢提取)而在体内进一步代谢。作为Ω-6脂肪酸的亚油酸代谢为γ-亚麻酸、二高-γ-亚麻酸、花生四烯酸、肾上腺酸、二十四碳四烯酸、二十四碳五烯酸和二十二碳五烯酸。作为Ω-3脂肪酸的α-亚麻酸代谢为十八碳四烯酸、二十碳四烯酸、二十碳五烯酸(EPA)、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸和二十二碳六烯酸(DHA)。
据报道,脂肪酸例如棕榈酸、油酸、亚油酸和二十碳五烯酸经由涉及激活Na.sup.+K.sup.+-APTase泵的机制诱导了猪冠状动脉平滑肌细胞的松弛和超极化以及具有顺-不饱和度增加的脂肪酸具有更高的效能。参见Pomposiello,S.I.et al.,Hypertension 31:615-20(1998),其通过引用并入本文。令人感兴趣的是,根据剂量、动物物种、花生四烯酸施用的方式和肺循环的趋势(tones),肺血管对花生四烯酸(亚油酸的代谢产物)的反应可为血管收缩或血管舒张。例如,据报道花生四烯酸引起环氧化酶依赖性和环氧化酶非依赖性肺血管扩张。参见Peddersen,C.O.et al.,J.Appl.Physiol.68(5):1799-808(1990);以及参见Sparwhake,E.W,et al.,J.Appl.Physiol.44:397-495(1978)和Wicks,T.C.et al.,Circ.Res,38:167-71(1976),其各自通过引用并入本文。
许多研究报道了二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)在作为可摄入形式施用后对血管反应性的影响。一些研究发现,单独的EPA-DHA或EPA抑制去甲肾上腺素的血管收缩作用或增加前臂微循环中对乙酰胆碱的血管舒张反应。参见Chin,J.P.F.,et al.,Hypertension 21:22-8(1993),以及Tagawa,H,et al.,J Cardiovasc Pharmacol 33:633-40(1999),其各自通过引用并入本文。另一研究发现,EPA和DHA均增加全身动脉顺应性,并倾向于降低脉压和总血管阻力。参见Nestel,P.et al.,Am J.Clin.Nutr.76:326-30(2002),其通过引用并入本文。同时,研究发现,DHA而非EPA,增强高脂血症超重人群的血管舒张机制并减弱前臂微循环中的收缩反应。参见Mori,T.A.,et al.,Circulation 102:1264-69(2000),其通过引用并入本文。另一研究发现DHA对体外的分离的人冠状动脉的有节奏收缩的血管舒张作用。参见Wu,K.-T.et al.,Chinese J.Physiol.50(4):164-70(2007),其通过引用并入本文。
肾上腺素能受体(或肾上腺素受体)是一类G蛋白偶联受体,其为儿茶酚胺,尤其是去甲肾上腺素(norepinephrine/noradrenaline)和肾上腺素(epinephrine/adrenaline)的目标。肾上腺素与α-和β-肾上腺素受体二者相互作用,分别引起血管收缩和血管舒张。尽管α受体对肾上腺素不那么敏感,但是当激活时,它们凌驾于(override)由β肾上腺素受体介导的血管舒张之上,因为周围的α1受体比β肾上腺素受体更多。结果是高水平的循环肾上腺素引起血管收缩。在较低水平的循环肾上腺素下,β-肾上腺素能受体刺激占主要地位,引起血管舒张,随后外周血管阻力降低。已知α1肾上腺素能受体用于平滑肌收缩,瞳孔放大,皮肤、黏膜和腹部脏器的血管收缩以及胃肠道(GI)和膀胱的括约肌收缩。α1-肾上腺素能受体是Gq蛋白偶联受体超家族的成员。激活时,异三聚体G蛋白Gq激活磷脂酶C(PLC)。作用机制涉及与钙通道的相互作用和改变细胞中钙的含量。对于综述,参见Smith R.S.et al.,Journal of Neurophysiology,102(2):1103-14(2009),其通过引用并入本文。许多细胞拥有这些受体。
α1-肾上腺素能受体可以是脂肪酸的主要受体。例如,据报道广泛用于治疗良性前列腺增生(BPH)的锯棕榈提取物(SPE)结合.α1.-肾上腺素、毒蕈碱和1,4-二氢吡啶(1,4-DHP)钙通道拮抗剂受体。参见Abe M.,et al.,Biol.Pharm.Bull.32(4)646-650(2009),以及Suzuki M.et al.,Acta Pharmacologica Sinica 30:271-81(2009),其各自通过引用并入本文。SPE包括多种脂肪酸,包括月桂酸、油酸、肉豆蔻酸、棕榈酸和亚油酸。月桂酸和油酸可非竞争性地与α1-肾上腺素、毒蕈碱和1,4-DHP钙通道拮抗剂受体结合。
在某些实施方案中,渗透增强剂可以是肾上腺素能受体相互作用剂。肾上腺素能受体相互作用剂是指修饰和/或以其他方式改变肾上腺素能受体的作用的化合物或物质。例如,肾上腺素能受体相互作用剂可通过增加或降低受体的结合能力来阻止受体的刺激。这样的相互作用剂可以以短效或长效形式提供。某些短效相互作用剂可快速发挥作用,但其效果仅持续几个小时。某些长效的相互作用剂可能需要较长的时间发挥作用,但其效果可持续更久。相互作用剂可基于例如期望的递送和剂量、活性药物成分、渗透修饰剂、渗透增强剂、基质和所治疗的病症中的一个或更多个来选择和/或设计。肾上腺素能受体相互作用剂可以是肾上腺素能受体阻滞剂。肾上腺素能受体相互作用剂可以是萜烯(例如,在植物的香精油中发现的,衍生自异戊二烯单元的挥发性不饱和烃)或C3-C22醇或酸,优选C7-C18醇或酸。在某些实施方案中,肾上腺素能受体相互作用剂可包括法尼醇,亚油酸、花生四烯酸、二十二碳六烯酸、二十碳五烯酸和/或二十二碳五烯酸。酸可以是羧酸、磷酸、硫酸、异羟肟酸,或其衍生物。衍生物可以是酯或酰胺。例如,肾上腺素能受体相互作用剂可以是脂肪酸或脂肪醇。
C3-C22醇或酸可以是具有直链C3-C22烃链的醇或酸,例如任选地包含至少一个双键、至少一个三键、或者至少一个双键和一个三键的C3-C22烃链;所述烃链任选地经以下取代:C1-4烷基、C2-4烯基、C2-4炔基、C1-4烷氧基、羟基、卤素、氨基、硝基、氰基。C3-5环烷基、3至5元杂环烷基、单环芳基、5至6元杂芳基、C1-4烷基羰氧基、C1-4烷基环氧基羰基、C1-4烷基羰基或者甲酰基;并进一步任选地被--O--、--N(Ra)--、--N(Ra)--C(O)--O--、--O--C(O)--N(Ra)--、--N(Ra)--C(O)--N(Rb)--、或--O--C(O)--O--间断。Ra和Rb各自独立地为氢、烷基、烯基、炔基、烷氧基、羟基烷基、羟基或者卤代烷基。
具有较高不饱和度的脂肪酸是增强药物渗透的有效候选物。不饱和脂肪酸示出比饱和脂肪酸更高的增强性,并且增强性随着双键数量而增加。参见A.Mittal,et al,Statusof Fatty Acids as Skin Penetration Enhancers--A Review,Current Drug Delivery,2009,6,pp.274-279,其通过引用并入本文。双键的位置也影响脂肪酸的增强活性。源自双键位置差异的脂肪酸理化特性的差异最有可能决定这些化合物作为皮肤渗透增强剂的效力。皮肤分布随着双键的位置移向亲水端而增加。还报道,在偶数位置具有双键的脂肪酸比在奇数位置具有双键的脂肪酸更迅速地影响角质层和真皮二者的结构扰动。链中的顺式不饱和键可趋于增加活性。
肾上腺素能受体相互作用剂可以是萜烯。已报道萜烯在香精油中的降压活性。参见Menezes I.A.et al.,Z.Naturforsch.65c:652-66(2010),其通过引用并入本文。在某些实施方案中,渗透增强剂可以是倍半萜烯。倍半萜烯是由三个异戊二烯单元构成的一类萜烯,并且具有经验式C15H24。如单萜,倍半萜烯可以是无环的或包含环,包括许多独特的组合。生物化学修饰,例如氧化或重排,产生相关的倍半萜烯。
肾上腺素能受体相互作用剂可以是不饱和脂肪酸,例如亚油酸。在某些实施方案中,渗透增强剂可以是法尼醇。法尼醇是作为无环倍半萜烯醇的15碳有机化合物,其是天然的焦磷酸法呢酯的去磷酸化形式。在标准条件下,其为无色液体。其为疏水的,因此不溶于水,但可与油混溶。法尼醇可从植物例如香茅、橙花、仙客来和晚香玉的油中提取。其为在脊椎动物中由甲羟戊酸生物合成胆固醇的中间步骤。其具有淡淡的花香或微弱的柑橘青柠气味,并用于香水和矫味剂中。据报道,法尼醇优先于主要的造血细胞选择性地杀伤急性骨髓白血病母细胞和白血病细胞系,参见Rioja A.et al.,FEBS Lett 467(2-3):291-5(2000),其通过引用并入本文。已报道法呢基类似物的血管活性特性。参见Roullet,J.-B.,et al.,J.Clin.Invest.,1996,97:2384-2390,其通过引用并入本文。法尼醇和N-乙酰基-S-反式、反-法呢基-L-半胱氨酸(AFC)(法呢基化蛋白的羧基端的合成模拟物)均抑制大鼠主动脉环的血管收缩。
在一个实施方案中,膜包含渗透增强剂,所述渗透增强剂包含苯丙素类、法尼醇、Labrasol、和亚油酸中的一个或更多个。在一个实施方案中,渗透增强剂是选自以下的苯丙素类:丁香油酚;乙酸丁香油酚;肉桂酸;肉桂酸酯;肉桂醛;氢化肉桂酸;胡椒酚;黄樟素;或其组合。
在一个实施方案中,膜包含作为植物提取物的渗透增强剂。植物提取物可以是丁香植物的香精油提取物、丁香植物的叶的香精油提取物、丁香植物的花芽的香精油提取物、丁香植物的茎的香精油提取物,或其组合。在一个实施方案中,植物提取物可以是合成的。植物提取物可包含约20%至约95%的丁香油酚、约40%至约95%的丁香油酚、约60%至约95%的丁香油酚或者约80%至约95%的丁香油酚。
均一性与制造
对于本发明的目的,术语非自聚集一致不均匀性是指本发明的由除极性溶剂以外的一种或更多种组分形成的膜提供这样的能力:当通过常规干燥法例如高温空气浴使用干燥烘箱、干燥通道、真空干燥器或其他这样的干燥设备形成膜时,随着膜正常经受,膜内组分的聚集或聚结的出现基本上减少(即,很少或没有)。如本发明中使用的术语不均匀性,包括将并入单一组分(例如聚合物)以及组分的组合(例如聚合物和活性物)的膜。一致不均匀性包括基本上不存在聚集体或聚结体,这在用于形成膜的常规混合和加热干燥方法中常见。
此外,本文中公开的膜具有基本上均一的厚度,其同样未通过使用用于干燥水基聚合物体系的常规干燥方法来提供。没有均一的厚度可能不利地影响在给定膜的整个范围或区域中组分分布的均一性。
本文中公开的膜通过适当选择的聚合物和极性溶剂的组合来产生,任选地包括活性成分以及本领域中已知的其他填料。这些膜通过使用选定的流延或沉积方法和受控的干燥过程提供膜内组分的非自聚集一致不均匀性。受控干燥过程的实例包括但不限于使用均指定给Aquestive Therapeutics,Inc.的美国专利No.7,425,292;7,357,891;7,666,337;8,603,514;8,017,150;8,663,667;8,652,378;8.900,497;8,900,498;9,108,340;9,855,221;和9,931,305中公开的设备,其全部整体并入本文。另一种用于获得膜的干燥技术为在没有不受控气流的情况下的受控的辐射干燥,例如红外和射频辐射(即,微波)。
干燥过程的目的是提供干燥膜的方法,其避免了与常规干燥方法相关的复杂化问题(complication),例如知名的“波纹”和传质效应,所述常规干燥方法首先干燥了膜的上表面,将水分困在内部。在常规的烘箱干燥法中,随着困在内部的水分随后蒸发,顶表面通过被撕开然后再次形成而改变。通过连续的表面起皮然后再次打开起皮的表面以允许蒸发的这种表面破坏,导致膜的不均一和厚度不均一。此外,过量的气流,例如热气流,在干燥过程期间在基质获得足够的固体性之前可能在可流动的基质中引起传质(即,波动)。这种波纹效应,无论是由于表面起皮/破裂/再次形成或者传质引起,当颗粒经受这些不受控的机械力和热力并因此在膜内移动时,都在膜中产生活性物含量的不均一。这种移动破坏了混合过程期间达到的整个膜上活性物的基本均一性,而需要保持均一性,以产生从流延膜上切下的尺寸基本相同的剂量单元,每剂量单元各自具有一定量的活性物,其相对于期望的活性物的量(标记量)变化不大于10%。
通过本发明避免了这些复杂化问题,并且通过在形成可流动膜基质的充分固化之前防止膜基质的起皮/破裂/再次形成或传质来提供均一的膜,以防止活性颗粒移动和团聚或聚集。本公开内容提供了几种控制干燥过程的方法,从而防止了常规干燥方法中存在的有害作用,并保持了在混合期间实现的基质中活性物的基本均一性。还期望快速进行干燥,以通过快速产生黏性来将活性物“锁在内部”,以实现足够的固体基质以防止实质化移动。
然后可将经流延和干燥的膜切割成基本上相等的尺寸(长度、宽度和厚度)的个体剂量单元,并且这些剂量单元将具有相对于期望的活性物的量(标记量)变化不大于10%的活性物含量。
控制常规干燥的不良影响的方法包括控制烘箱气流以在基质在皮肤下方干燥之前防止波纹、防止块体移动和防止表面的过早起皮。希望气流从顶部,以一定距离、一定角度和一定速度指向膜,以使得当气流撞击膜时产生的力无法克服膜基质的屈服值(yieldvalue),即低于任何可移动或以其他方式引起形成基质的成膜组合物的波纹和不均一性的力水平。
受控干燥还可包括首先将热量引导至膜的底表面以从膜的深处向上开始干燥。这可通过在基本上没有顶部气流的情况下将热量施加到膜的底表面,或者在不引起过早起皮的波纹的情况下通过同时对底部和顶部施加热量来实现。
或者,可通过引入受控的微波以蒸发膜内的水或其他极性溶剂来完成干燥。当施加微波时,必须注意确保基质的温度不变得太高以致于基质发生起泡(boiling),这将导致其中的活性物的不均一。
用于受控干燥的又一替代方法可包括:使用平衡的流体流(例如平衡的气流)进行干燥,其中,控制底部和顶部气流以提供均一的膜并避免如本文所述的波纹和过早起皮。在这种情况下,引导至膜顶部的气流不应产生由于气流产生的力将导致存在于湿膜的颗粒运动的状况。此外,应期望控制引导至膜底部的气流,使得膜不因来自空气的力而抬起。膜上方或下方的不受控的气流可能在最终的膜产品中产生不均一性。还可适当地调节顶表面周围区域的湿度水平,以防止聚合物基质表面过早闭合或起皮。
这种干燥膜的方式提供了一些优点。其中有更快的干燥时间和更均一的膜表面,以及对于膜中任何给定区域的组分的均一分布。此外,更快的干燥时间允许在膜内快速建立黏度,进一步促进了组分的均一分布并减少了最终膜产品中组分的聚集。期望地,膜的干燥将在约十分钟或更短内发生,或更期望地在约五分钟或更短内发生。
当重视减少组成组分的聚集时,本发明产生了格外均一的膜产品。此外,避免引入过量空气和消除混合过程中的过量空气在促进膜和由此切下的剂量的均一性方面是理想的;此外,选择聚合物和溶剂以提供受控的黏度并如上所讨论通过以快速方式来干燥膜,同时避免膜的波纹或块体移动,这在保持和提供当消减至标记量时具有期望的活性物含量的均一性的膜和由其切下的剂量单元方面是期望的。因此通过注意这些参数实现了剂量单元中活性物含量的这种均一性。
本公开内容的产品和方法依赖于膜的多个产生步骤之间的相互作用以提供基本上降低膜内组分的自聚集的膜。具体地,这些步骤包括用于形成膜的特定方法、制备组合物混合物防止气泡夹杂物、控制成膜组合物的黏度以及干燥膜的方法。更具体地,当活性物不溶于所选择的极性溶剂中,混合物中组分的较大黏度特别可用以防止活性物沉淀。然而,黏度不能太大以至于阻碍或防止所选择的流延方法,其由于逆向辊涂提供厚度基本上一致的膜的能力而期望地包括逆向辊涂。
除膜或成膜组分或基质的黏度之外,考虑了其他考虑因素以实现期望的膜均一性。例如,实现了稳定的悬浮液,其防止非胶体应用中的固体(例如药物颗粒)沉降。本发明提供的一种方法是平衡颗粒相(ρp)和液相(ρ1)的密度并提高液相的黏度(μ)。对于分离的颗粒,斯托克斯定律(Stokes law)如下将黏性流体中半径(r)的刚性球体的终端沉降速度(Vo)联系起来:Vo=(2grr)(ρp-ρ1)/9μ。
然而,在高颗粒浓度下,局部颗粒浓度将影响局部黏度和密度。悬浮液的黏度是固体体积分数的强函数,并且颗粒-颗粒和颗粒-液体相互作用将进一步阻碍沉降速度。
Stokian分析已表明,例如,第三相(分散的空气或氮气)的并入促进悬浮液的稳定性。此外,提高颗粒的数量导致基于固体体积分数的阻碍沉降效应。在稀颗粒悬浮液中,沉降速率v可表示为:
类似地,悬浮液的黏度取决于所分散固体的体积分数。对于非相互作用球形颗粒的稀悬浮液,悬浮液黏度的表达式可表示为:
其中C是常数。
液相的黏度是关键的,并且期望地通过将液体组合物定制成具有低屈服应力值的黏弹性非牛顿流体来进行改性。这相当于在静止时产生高黏度连续相。黏弹性或高度结构化流体相的形成为颗粒沉降提供了额外的阻力。此外,可控制絮凝或聚集使颗粒-颗粒相互作用最小化。净效应是保持均质分散相。
向悬浮液的水相添加水胶体提高黏度,可产生黏弹性,并且可根据水胶体的类型、其浓度和颗粒组成、几何形状、尺寸和体积分数而赋予稳定性。分散相的平均颗粒尺寸分布需要通过选择高黏度介质中的最小实际平均颗粒尺寸(即<500μm)来控制。在低剪切速率下存在轻微的屈服应力或弹性体也可引起永久稳定性,与表观黏度无关。临界粒径可由屈服应力值计算。在分离的球形颗粒的情况下,通过给定黏度的介质沉降中产生的最大剪切应力可给出为:
τmax=3Vμ/2r。
对于假塑性流体,该剪切应力方案的黏度在牛顿平台处很可能为零剪切速率黏度。
稳定的悬浮液是制备待进料到膜流延机器膜中的预混合组合物以及在湿膜阶段维持该稳定性直至已发生充分干燥以将颗粒和基质锁定在足够固体的形式以使得维持均一性的重要特性。对于黏弹性流体系统,必须使长时间(例如24小时)产生稳定悬浮液的流变学与高速膜流延操作的要求相平衡。膜的一种期望特性是剪切变稀或假塑性,由此黏度随剪切速率提高而降低。时间依赖性剪切效应(例如触变性)也是有利的。结构恢复和剪切稀化行为是重要的性质,如膜在形成时自流平(self-level)的能力。
本发明组合物和膜的流变学要求相当严格。这是由于需要在宽剪切速率范围内具有可接受黏度值的黏弹性流体基质中产生稳定的颗粒悬浮液,例如30重量%至60重量%。在混合、泵送和膜流延期间,剪切速率可在10秒-1至105秒-1的范围内经历,并且假塑性是优选实施方案。
在膜流延或涂覆中,流变学也是形成具有期望均一性的膜的能力的决定性因素。剪切黏度、拉伸黏度、黏弹性、结构恢复将影响膜的质量。作为一个举例说明性实例,剪切稀化假塑性流体的流平性如下获得:
α(n-1/n)=αo (n-1/n)-((n-1)/(2n-1))(τ/K)1/n(27π/λ)(3+n)/n h(2n+1)/n t
其中α是表面波振幅,αo是初始振幅,λ是表面粗糙度的波长,并且“n”和“K”均是黏度幂律指数。在该实例中,流平行为与黏度相关,随n减小而提高并且随K提高而减小。
期望地,本公开内容的膜或成膜组合物具有非常迅速的结构恢复,即当膜在加工期间形成时,其结构和组成均一性不会分裂或变得不连续。这样的非常迅速的结构恢复延迟颗粒沉降和沉积。此外,膜或成膜组合物期望地是剪切稀化的假塑性流体。这样的考虑到例如黏度和弹性的特性的流体促进薄膜形成和均一性。
因此,组分混合物的均一性取决于多个变量。如本文中所述的,所得混合组合物和湿流延膜的组分黏度、混合技术和流变性是本发明的重要方面。此外,平均颗粒尺寸和颗粒形状的控制也是一个考虑因素。期望地,平均颗粒尺寸可为200微米或更小,150微米或更小或者100微米或更小。此外,这样的颗粒可以是球形的、基本上球形的或非球形的,例如不规则形状的颗粒或椭圆形颗粒。椭圆形颗粒或椭圆体是理想的,因为与球形颗粒相比,其由于倾向于以更低的程度沉降而能够维持成膜基质的均一性。
在混合阶段可采用多种技术来防止最终膜中的气泡夹杂物(bubble inclusion)。为了提供最终产品中基本上没有气泡形成的组合物混合物,采用消泡剂或表面张力降低剂。此外,期望地控制混合物速度来防止将空气吸入混合物的方式的混合物空化(cavitation)。最后,可通过干燥膜之前使混合物静置足够的时间以使气泡逸出来进一步实现气泡降低。期望地,本发明方法首先形成不具有活性成分(例如药物颗粒)或挥发性物质(例如矫味油)的成膜组分的母料(masterbatch)。在即将流延之前,向母料的较小混合物添加活性物。因此,可使母料预混合物静置较长时间,而无需担心药物或其他成分的不稳定性。
当形成包括除了任何添加剂和活性成分之外的成膜聚合物和极性溶剂的基质时,这可以以许多步骤来完成。例如,可一起添加所有成分或可制备预混物。预混物的优点是除活性物之外,所有成分都可提前组合,以及活性物恰好在膜形成之前添加。这对于在持续暴露于水、空气或其他极性溶剂的情况下可能降解的活性物尤其重要。
例如在美国专利No.8,765,167中公开了用于制备本发明的膜的设备,其全部内容整体并入本文。
此外,本文中公开的膜可包含对温度敏感的颗粒,例如可以是挥发性的矫味剂或者可具有低降解温度的药物。在这种情况下,可降低干燥温度同时增加干燥时间以充分干燥本发明的均一膜。此外,与顶部干燥相比,底部干燥还倾向于导致较低的内部膜温度。在底部干燥中,与顶部干燥相比,蒸发蒸汽更容易将热量从膜带走,这降低了内部膜的温度。这种较低的内部膜温度通常导致降低的药物降解和某些挥发性成分(例如矫味剂)的损失减小。
此外,在将组合物或基质流延成膜之后,可将颗粒或微粒添加至成膜组合物或基质中。例如,可在干燥膜之前将颗粒添加至膜。可将颗粒受控地对膜计量,并通过合适的技术,例如通过使用刮刀(未示出)(其为轻微地或温和地接触膜表面并受控地将颗粒布置到膜表面上的装置)布置在膜上。其他合适的但非限制性的技术包括使用附加的辊将颗粒布置在膜表面上,将颗粒喷洒到膜表面上等。可将颗粒布置在相对的膜表面中的一个或两个上,即,顶部和/或底部的膜表面。期望地,将颗粒牢固地布置在膜上,例如包埋到膜中。此外,期望这样的颗粒没有被完全包封或完全包埋到膜中,而是保持暴露于膜的表面,例如在其中颗粒部分包埋或部分包封的情况下。
颗粒可以是任何可用的感官剂、美容剂、药剂或其组合。期望地,药剂是掩味的或受控释放的药剂。可用的感官剂包括矫味剂和甜味剂。可用的美容剂包括口气清新剂或减充血剂,例如薄荷醇,包括薄荷醇晶体。
通过提供厚度均一的膜,监测和控制膜的厚度也有助于均一膜的产生。膜的厚度可用例如Beta Gauges的计量表监测。计量表可在干燥设备的末端(即干燥烘箱或通道)与另外的计量表连接,以通过反馈回路来通讯,以控制并调节涂覆设备中的开口,导致均一膜厚度的控制。
膜产品通常通过组合经适当选择的聚合物和极性溶剂,以及根据需要的任何活性成分或填料而形成。期望地,组合中的溶剂含量为总组合的至少约30重量%。期望通过辊涂使通过该组合形成的基质形成为膜,然后期望通过快速且受控的干燥过程进行干燥以保持膜的均一性,更具体地,非自聚集的一致不均匀性。所得膜将期望地包含小于约10重量%的溶剂,更期望地小于约8重量%的溶剂,甚至更期望地小于约6重量%的溶剂并且最期望地小于约2%。溶剂可以是水、极性有机溶剂,包括但不限于乙醇、异丙醇、丙酮、二氯甲烷或其任何组合。
考虑到以上讨论的参数,例如但不限于流变学特性、黏性、混合方法、流延方法和干燥方法,也影响本发明的不同组分的材料选择。此外,利用适当的材料选择的这种考虑提供了本发明的组合物,包括药物和/或化妆品剂型或膜产品,其在流延湿膜内具有一种或更多种活性物的基本均一的分布并且在干燥过程期间保持这种基本均一的分布,使得可从经连续流延和干燥的膜切下相同尺寸的剂量单元,当与活性物的期望量(即,对于每个剂量单元的活性物的标记量)相比,该剂量单元具有基本均一的活性物的量存在。期望地,连续流延的自支撑膜的均一性是通过从自支撑的连续流延膜上切下基本上相等尺寸的单个单位剂量来测量的,所述单位剂量的变化不大于所述至少一种活性物的期望量的10%。为了清楚起见,假设膜的单位剂量的期望量可以是例如10mg的一种或更多种给定药物。本发明的膜需要均一性,使得从经连续流延并干燥的膜切下的膜的基本相等的单位剂量变化将不大于期望量的10%,即单位剂量变化将不大于+/-1mg或换言之9mg至11mg。
形成膜
本文中公开的膜在干燥之前必须形成为连续流延的湿膜或湿片。术语“连续流延”旨在指代相对高速的制造过程,所述过程使用其上流延并形成有湿膜基质的传送带基底,然后使其继续进入干燥设备(如烘箱)中,然后进一步连续传送到卷起的心轴上用于储存,或者直接进入切割和包装站。术语连续旨在区分这样的过程:例如在实验室环境中进行的那些,例如其中将湿膜基质流延到托盘上。
在将期望的组分组合以形成包含聚合物、水和活性物或期望的其他组分的多组分的基本均一的基质之后,通过本领域已知的任何方法,例如挤出、涂覆、铺展、流延或拉伸多组分基质将组合形成为湿片或膜。如果需要多层膜,这可通过共挤出组分的多于一种组合(其可为相同或不同组成)来实现。多层膜还可通过将湿膜基质连续涂覆、连续铺展或者连续流延到已经形成的并期望地已经干燥的膜层上来实现。
尽管可使用多种不同的连续成膜技术,但是期望选择将提供柔性膜的方法,例如逆向辊涂。膜的柔性允许膜片出于储存或在被切割成单独的剂量形式之前被轧制并运输。期望地,膜还可以是自支撑的,或者换言之,能够在不存在单独支撑物下维持其完整性和结构。此外,本发明的膜可选自可食用或可摄取的材料。
连续涂覆或连续流延方法特别地可用于形成本发明的膜的目的。具体实例包括逆向辊涂、凹版涂覆、浸渍或浸涂、计量棒或mayer棒涂覆、槽模或挤出涂覆、间隙或辊衬刮刀涂覆(knife over roll coating)、气刀涂覆、帘式涂覆、或其组合,尤其是当期望多层膜时。
当根据本发明形成膜时,特别期望连续辊涂,或更具体地,逆向辊涂。该步骤提供了所得膜的优异的控制和均一性,这是本发明期望的。在该方法中,通过精确设定上计量辊与其下方的施加辊之间的间隙来在施加辊上测量涂覆材料。当绕过施加辊邻近的支撑辊时,涂料从施加辊转移至基底。三辊和四辊方法都是常见的。
凹版涂覆方法依赖于在涂覆浴中运行的雕刻辊,其用涂覆材料填充辊的雕刻点或线。通过刮刀擦去辊上的过量涂料,并随后在涂料在雕刻辊和压力辊之间通过时,涂料沉积到基底上。
间接凹版(Offset Gravure)是常见的,其中涂料在转移到基底之前沉积在中间辊上。
在简单的浸渍或浸涂方法中,将基底浸入涂料的浴中,所述涂料通常具有低黏以使涂料在基底出现时能够流回浴中。
在计量棒涂覆方法中,当涂料通过浴辊时,在基底上沉积过量的涂料。有时称为Meyer棒的绕线计量棒允许在基底上保留期望量的涂料。该量由在棒上使用的线的直径决定。
在槽模方法中,涂料通过重力或在压力下被挤压出通过槽并到基底上。如果涂料是100%固体,则该方法称为“挤出”,并且在此情况下,线速度通常比挤出速度快得多。这使得涂层相当薄于槽的宽度。
间隙或辊衬刮刀方法依赖于施加至基底的涂料,其然后穿过“刮刀”和支撑辊之间的“间隙”。当涂料和基底通过时,过量物被刮去。
气刀涂覆是其中将涂料施加至基底,并通过来自气刀的强力射流将过量物“吹走”。该方法可用于水性涂料。
在帘式涂覆方法中,底部具有槽的浴允许涂料的连续帘落入两个传送机之间的间隙中。使待涂覆的物体以受控的速度沿传送机通过,并且如此在其上表面上接收涂料。
基底可以是已知本领域使用的任何材料。例如,其可以是聚酯膜,例如任选地经涂覆的聚对苯二甲酸乙二醇酯、塑料片、玻璃或基于纤维素的纸。基底可以是聚对苯二甲酸乙二醇酯(例如,mylar)或羊皮纸(parchment paper)。当基底是聚对苯二甲酸乙二醇酯时,其可以是双轴取向的聚对苯二甲酸乙二醇酯,其在其底表面或顶表面上任选地经电晕处理。
干燥膜
干燥步骤也是关于保持膜组合物的均一性的影响因素。当在不存在黏度增加的组合物或者其中黏度受控的组合物,例如通过选择聚合物,膜中的组分可能具有增加的聚集或聚结的趋势时,受控的干燥过程特别重要。用精确剂量形成膜的替代方法将不需要受控的干燥过程,其为在生产线上,将膜流延在预定的腔上,或者在将剂量单元从连续流延膜(其不包含活性物)切下后将期望量的活性物施加到单个剂量单元上。这两种替代方法不具有与保持从混合过程经过干燥过程的活性物含量的均一性有关的相同的挑战,与在流延之前将活性物并入膜基质中的连续流延膜一样。使用这些替代方法,不可能发生活性物向相邻剂型的迁移。当需要受控或快速干燥过程时,这可通过多种方法来完成。可使用的多种方法包括那些需要施加热量的方法。以保持在湿膜中获得的均一性,或者更具体地,非自聚集的一致不均匀性的方式从膜上除去液体载体。
如上所述,使用热气流来干燥湿的连续流延膜,这不产生如上所讨论的湿的、可流动的流延膜基质的波纹;湿的、可流动的流延膜基质的传质;或过早的表面起皮。为实现其而选择的参数包括确保气流以一定的距离、角度和速度从顶部指向膜,使得当气流撞击膜时产生的力不克服膜基质的屈服值,即低于可移动或以其他方式引起形成基质的成膜组合物的波纹和不均一性的任何力水平。期望地但非必需地,当膜进入烘箱时,使膜暴露于高温差下,使得水含量迅速去除以快速固化可流动的基质并将活性物锁定在更固态的结构中。这样做,并且只要注意确保在整个干燥过程中保持膜的均一性,就可使用仅从顶部或传送基底上方散发的空气、使用仅从传送基底的底部散发的空气、或者通过使用来自传送基底的上方和下方(膜的顶部和底部)二者的空气来干燥连续流延的膜基质。
因此,在干燥过程的一个方面中,可从膜的底部至膜的顶部来干燥膜。期望地,存在的任何顶部气流必须不引起以上讨论的非均一性情况。一旦经过了初始凝固期并形成了充分固态的黏弹性结构,就算没有消除,也大大降低了产生波纹和过早起皮的可能性。这可在干燥过程的前几分钟内发生,例如约前0.5分钟至约4.0分钟。以该方式控制干燥,防止了由常规干燥方法导致的膜的顶表面的破坏和再形成。在制造环境中干燥连续流延的湿膜包括将湿的可流动膜基质流延到传送基底上。
在一些情况下,可优选通过向膜的底表面并由此在传送基底的下方供应气流来开始干燥过程。在这种情况下,来自气流的热量首先施加到膜的底部侧,以提供必要的能量来蒸发或以其他方式除去液体载体。与空气干燥的膜(在露天干燥)或通过常规干燥方法干燥的膜相比,以该方式干燥的膜干燥地更快且更均匀。与首先在顶部和边缘干燥的经空气干燥的膜相比,通过向底部施加热量而干燥的膜在中心和边缘同时干燥。这也防止了通过常规方法干燥的膜发生的成分沉降。膜干燥的外空气温度可为约130℃或更低,条件是膜基质自身未达到沸点(例如100℃)或将破坏其均一性的足够高的温度。期望地,外空气温度可为约100℃或更低或者约80℃或更低。
控制干燥过程的另一种方法可单独使用或与上文中所公开的另一些受控方法组合使用,包括控制和改变干燥膜的干燥装置内的湿度。以这种方式,可避免膜的顶面的过早干燥。
此外,还已经发现干燥时间的长度可以适当地控制,即,与成分(以及特别是矫味油和药物)的热敏感性和挥发性相平衡。可以平衡传送机的能量、温度和长度和速度的量来适应这种活性物并且最小化在最终膜中的损失、降解或无效。
合适的干燥方法的一个具体实例通过对于Magoon(“Magoon”)的美国专利No.4,631,837而公开,通过引用并入本文,其特别针对干燥果肉(fruit pulp)的方法。在本发明的一个实施方案中,本发明人使该方法适应于薄膜的制备。
Magoon的方法和设备基于水的有趣特性。尽管水通过传导和对流二者在其内部以及向其周围传送能量,但水只能在水中以及向水辐射能量。因此,Magoon的装置包括放置果肉于其上的表面,其通透红外线辐射。表面的下面与温度控制的水浴接触。水浴温度理想地控制在温度略低于水的沸腾温度。当湿的果肉放置在装置的表面上时,这产生“折射窗”。这意味着允许红外能量通过表面仅辐射到果肉所占据的表面上的区域,直到果肉被干燥。Magoon的装置为本发明的膜提供了高效的干燥时间,降低了膜组分聚集的情况。
根据每个层的厚度和层的数量,本文公开的最终的干燥的自支撑膜和由其制成的剂量单元的厚度可变化。可调节层的厚度和数量(即,一层或多层,例如,二、三、四或更多)二者,以改变侵蚀动力学。膜初始可具有约500μm至约1,500μm,或约20密耳至约60密耳的厚度,并且当干燥时具有约3μm至约250μm,或约0.1密耳至约10密耳的厚度。期望地,干燥膜将具有约2密耳至约8密耳,并且更期望地约3密耳至约6密耳的厚度。
如果最终的自支撑膜产品(或由其制成的剂量单元)具有两层,则总膜厚度可为约0.005mm至约2mm、约0.01mm至约1mm或约0.1mm至约0.5mm。总膜厚度可大于约0.1mm、大于约0.2mm、约0.5mm、大于约0.5mm、小于约0.5mm、小于约0.2mm或小于约0.1mm。每个层的厚度可在层状自支撑膜的总厚度的约10%至约90%、或约30%至约60%变化。任何一层可大于10%、大于20%、大于30%、大于40%、大于50%、大于70%、大于90%、约90%、小于90%、小于70%、小于50%、小于40%、小于30%、小于20%或小于10%的层状自支撑膜总厚度。各层的优选厚度可在约0.01mm至约0.9mm,或约0.03mm至约0.5mm变化。
本文中公开的最终膜产品和剂量单元可在约30秒至约24小时、约30秒至约30分钟、约1分钟至约24小时、约1分钟至约30分钟、约1分钟至约20分钟、约3分钟至约40分钟或约5分钟至约30分钟内溶出(其包括分散和溶出)。本文公中开的最终的自支撑膜产品和剂量单元可在大于约1分钟、大于约5分钟、大于约7分钟、大于约10分钟、大于约12分钟、大于约15分钟、大于约20分钟、大于约30分钟、约30分钟或小于约30分钟、小于约20分钟、小于约15分钟、小于约12分钟、小于约10分钟、小于约7分钟、小于约5分钟或小于约1分钟内溶出。舌下溶出速率可能比经颊溶出速率更短。
更具体地,口腔溶出膜剂量单元(也称为“单位剂量”)可分为三个主要类别:快速溶出、中等溶出和缓慢溶出。口腔溶出膜剂量单元还可包括以上类别中任意的组合。快速溶出膜剂量单元可在口腔中在约1秒至约30秒,包括大于约1秒、大于约5秒、大于约10秒、大于约20秒且小于约30秒内溶出。中等溶出膜剂量单元可在口腔中在约1分钟至约30分钟,包括大于约1分钟、大于约5分钟、大于约10分钟、大于约20分钟且小于约30分钟内溶出。缓慢溶出膜剂量单元可在口腔中在大于约30分钟,包括约30分钟至约24小时、约30分钟至约12小时、约30分钟至约10小时以及约1小时至约10小时内溶出。快速溶出膜剂量单元可包含(或由以下组成)低分子量亲水性聚合物(例如,分子量为约1,000至约9,000道尔顿的聚合物,或分子量高至约200,000道尔顿的聚合物)。相反,缓慢溶出膜剂量单元可包含高分子量聚合物(例如具有数百万的分子量)。
对于中等溶出膜剂量单元的某些优点可能在于其可相当快地溶出,同时具有良好的黏膜黏附水平。中等溶出膜剂量单元还可以是柔性的、可快速润湿的,并且通常对患者无刺激性。这种中等溶出膜剂量单元可提供足够快的溶出速率,例如在约1分钟至约20分钟之间,同时提供可接受的黏膜黏附水平,使得一旦将膜放置在患者的口腔中其就不容易被移除。这可确保将药物活性物完全递送给患者。
自支撑意指膜在没有任何单独支撑的情况下保持其完整性和结构。本公开内容的膜被配制为在口腔黏膜中吸收,即例如经颊或舌下。尽管可使用多种不同的成膜技术,但是期望选择将提供柔性膜的方法,例如逆向辊涂。膜的柔性允许膜的片被卷起并运输用于储存或在被切割成单独的剂型之前。
膜的用途
本文中公开的薄膜非常适合于许多用途。膜组分的高度均一性使其特别好地适合并入药物。此外,可选择在构造膜中使用的聚合物以允许一定范围的膜崩解时间。膜将崩解的时间的变化或延长可实现对活性物释放的速率的控制,这可允许缓释递送系统。此外,膜可用于将活性物施用到多个身体表面中的任一个,特别是包括黏膜(例如口腔、肛门、阴道、眼科黏膜)、在皮肤表面上或例如在手术期间在身体内的伤口的表面、和相似的表面的那些。
膜可用于经口施用活性物。这是通过制备如上所述的膜并将其引入到哺乳动物的口腔中来实现的。可制备该膜并在将其黏附至第二层或支持层,在使用(即,引入口腔)之前从其上取出。可使用黏合剂将膜黏附至可以是本领域已知的且优选不是水溶性的任何一种的支持或背衬材料。如果使用黏合剂,则期望是可食用的并且不改变活性物性质的食品级黏合剂。黏膜黏附组合物是特别可用的。在许多情况下,膜组合物本身充当黏膜黏附剂。
膜可施用于哺乳动物的舌下方或施用至舌。当期望时,可优选对应于舌形状的特定的膜形状。因此,膜可被切割成这样的形状,其中与舌的背面对应的膜的一侧将比与舌的前面对应的那一侧更长。具体地,所期望的形状可以是三角形或梯形的形状。理想地,膜将黏附至口腔,防止其从口腔中喷射,并且当膜溶解时允许更多的活性物质引入口腔。
本文中公开的膜的另一种用途是利用当膜引入液体时快速溶解的趋势。通过制备根据本发明的膜,将其引入液体并使其溶解可将活性物引入液体。这可用于制备活性物的液体剂型或用于对饮料进行调味。
本发明的膜理想地包装在密封的防空气和防潮包装中以保护活性物免于暴露氧化、水解、挥发以及与环境相互作用。此外,本发明的膜在与唾液或黏膜区接触后立即溶解,这消除了用水冲洗剂量的需求。
期望地,根据规定的方案或治疗,例如10天至90天供应(取决于特定的治疗),将一系列这样的单位剂量包装在一起。单个自支撑膜可在没有背衬的情况下单独包装,或在背衬上包装并剥离以使用。
使用方法
本文还公开了治疗人的癫痫、癫痫发作和其他形式的发作的方法,包括以单个单位剂量向人施用口腔膜用于递送期望量的活性物。膜包含:a)水溶性聚合物基质、水溶胀性聚合物基质或水溶性且水溶胀性聚合物基质;b)平均颗粒尺寸D90小于约160微米的活性物;以及c)选自以下的添加剂:甜味剂、矫味剂、增味剂、填料、增塑剂、染料、色素、渗透增强剂、缓冲剂、防腐剂、二氧化硅、抗黏剂及其任何组合。口腔膜中的活性物可具有以上讨论的任何溶出谱和速率。
活性物可以是本文所述的任何活性物。在某些实施方案中,活性物可以是氯巴占、地西泮、利鲁唑或其任何组合。
另一个实施方案涉及治疗人的Lennox-Gastaut综合征的方法,包括向人施用本文中公开的口腔膜。
结合这些实施方案(使用方法)使用的术语具有与以上讨论相同的含义和定义。
通过以下实施例更充分地示出了本发明的特征和优点,提供这些实施例是出于说明的目的,并且不应以任何方式解释为限制本发明。
实施例
实施例1-氯巴占
制备具有表1中示出的以下组成的口腔膜以比较经研磨和微粉化的活性物。
表1:包含经研磨或微粉化的氯巴占的口腔膜的制剂
图3示出了包含经研磨(D90=106微米)和微粉化(D90=8.3微米)的5mg氯巴占的膜(N=3)以及RLD Onfi片剂的平均活性物溶出谱。表2展示了图3中示出的一些图示描述的数据点。
表2:对于包含经研磨或微粉化的氯巴占的口腔膜的溶出测试
因此,包含微粉化的氯巴占的口腔膜比包含经研磨的氯巴占的口腔膜表现更好(即,明显更快地溶出)。
实施例2-包含地西泮的口腔膜的溶出研究
制备包含5mg和15mg的活性物的包含地西泮的口腔薄膜(DBSF)。使用传统溶出法和PION技术测试了在25℃下12个月的储存条件下5mg和15mg DBSF的溶出。本文所使用的传统溶出法是测试固体口腔剂型(例如片剂和胶囊剂)的溶出特征的常用方法。传统的溶出方法利用改良的USP设备5设置,以及用于保持膜固定所必要的改良样品保持器。传统溶出方法的所有其他方面与其他固体口腔剂型的方面相似,包括在特定时间点手动采样和收集样品,然后使用HPLC离线分析样品。传统的溶出方法在实践上受限于手动采样和样品等分试样取出的频率和一致性。PION技术利用具有非传统设置的传统溶出浴。该浴设置有设备2(桨),在桨上方安装有经改良的样品保持器。在线光纤探针位于容器内部。以预定的间隔原位对样品进行测试。采样是自动进行的,并且在线分析,而没有样品取出、手动采样或离线HPLC测试的必要。表3展示了用于测试DBSF的传统溶出法与PION技术之间的系统参数比较。
表3:传统溶出法与PION技术的示例性系统参数
图4是示出通过传统溶出法测得的DBSF的活性物溶出谱的图。图5是示出通过PION技术测得的DBSF的活性物溶出谱的图。表4和5中展示了许多数据点以及通过传统溶出法获得的结果与使用PION技术获得的结果的比较。
表4:对于包含5mg地西泮的DBSF的活性物溶出速率和比较
表5:对于包含15mg地西泮的DBSF的活性物溶出速率和比较
根据以上表4和5中展示的计算,5mg口腔膜的活性物溶出谱相似,而15mg口腔膜的活性物溶出谱不同。然而,通过使用PION技术,活性物溶出谱精确得多,并且是增强的,其具有更多的可用的时间间隔。在传统溶出法的情况下,活性物溶出谱仅包含7个数据点,而使用PION技术获得的活性物溶出谱具有该数量的五倍以上。此外,当使用PION技术时可立即获得数据,而使用传统溶出法的第一个数据点在5分钟处。在这些快速溶解的剂型的情况下,在5分钟标记之前的活性可以是重要且有区别的因素。
实施例3-包含利鲁唑的口腔膜的溶出研究
制备了包含50mg的利鲁唑的口腔薄膜(ROSF)。使用传统溶出法和PION技术在0.1NHCl(模拟胃部条件的介质)中测试了在25℃下储存约6个月后的50mg ROSF的溶出。上面的表3展示了对于测试ROSF,用于传统溶出法和PION技术的参数。
图6是通过传统的溶出测试测得的ROSF的活性物溶出谱的图。图7是通过PION技术测得的ROSF的活性物溶出谱的图。表6展示了许多数据点以及通过传统溶出法获得的结果与使用PION技术获得的结果的比较。
表6:对于ROSF的活性物溶出速率和比较
根据以上表6中展示的计算,50mg的包含利鲁唑的口腔膜的活性物溶出谱是相似的。然而,通过使用PION技术,活性物溶出谱精确得多,并且是增强的,其具有更多可用的时间间隔。在传统溶出法的情况下,活性物溶出谱仅包含6个数据点,而使用PION技术获得的活性物溶出谱具有该数量的五倍以上。此外,当使用PION技术时可立即获得数据,而使用传统溶出法的第一个数据点在5分钟处。对于这些快速溶解的剂型,在5分钟标记之前的活性可以是重要且有区别的因素。
实施例4-包含氯巴占的口腔膜的溶出研究
制备包含氯巴占的口腔薄膜(COSF),其包含5mg、10mg和20mg的具有如表7所示组成的活性物。
表7:COSF制剂的组成
在本文的实施例中使用的COSF包含平均颗粒尺寸D90为6至8微米的氯巴占。
使用传统溶出法和PION技术测试了5mg和20mg COSF的溶出。上表3展示了用于测试COSF的传统溶出法和PION技术使用的参数。
图8是示出通过分别在25℃和40℃和60RH下,在保质期和加速条件下储存约24个月之后通过传统溶出法测得的5mg COSF的活性物溶出谱的图。如其中所示,膜在最开始的采样点几乎完全释放。在10分钟之前的非常关键的时间段(大多数溶出发生时),没有关于活性物溶出谱的信息。同样,在该图中传统溶出法的精度不足是明显可见的,其中两个样品在0分钟至10分钟的活性物溶出谱之间没有可检测的差异。
相反,图9和10示出了通过PION技术测得的COSF样品的活性物溶出谱。如这些图中所示,在不同的储存条件下以及在不同的剂量量下的样品之间存在明显可检测的差异。图9是通过PION技术在不同剂量和温度下测量的COSF的活性物溶出谱的图;图10是与图9中相同的研究的增强和平滑曲线。图10描绘了这些COSF剂量在不同储存条件下,在约25℃和约40℃下约12个月的储存条件之后从0至10分钟的活性物溶出谱。表8和9中展示了许多数据点和使用PION技术在不同温度下获得的结果的比较。
表8:5mg COSF的活性物溶出速率和比较
表9:20mg COSF的活性物溶出速率和比较
图9和10以及表8和9中展示的计算示出了通过使用PION技术的可能的精度,包括以分钟的若干分之一测量数据点。这在包含不同量活性物的口腔膜之间和在不同储存条件下的剂型之间产生了可识别的可测量的差异。
图11和图12描绘了在图9和10中通过PION技术测量的活性物溶出谱的二阶导数。由此,可实现精确拐点(在图上标识)的计算。
实施例5:COSF剂量比较
制备包含氯巴占(COSF)的口腔薄膜,其包含5mg、10mg和20mg的具有如表7所示组成的活性物。将膜在约25℃下和60RH储存约24个月,然后使用PION技术进行测试以确定活性物溶出谱在包含不同量活性物的COSF之间如何变化。以上表3展示了用于PION技术的参数。
图13绘出了实际获得的数据点,而图14是图13中示出的点的平滑曲线。如这些图中所示,每个膜的活性物溶出谱之间存在可检测的差异。5mg COSF具有最快的释放(最陡的曲线,在2.5分钟时达到100%),然后是10mg COSF(在3.0分钟时达到100%释放),最后,20mg COSF具有最慢的释放谱,在7.0分钟后接近100%。
图15是图13的活性物溶出谱的一阶导数图。该图提供了关于释放速率的信息。一阶导数的强度和宽度与释放速率成比例。如图中一阶导数曲线的高度和宽度所示,5mg和10mg COSF在第一分钟内释放得更快且更充分,而20mg COSF释放得更慢,即曲线更短且更宽(更低强度)。对于所有曲线,随着释放的完成,一阶导数接近0,并且血管中的药物浓度达到平台期。5mg和10mg COSF一阶导数曲线基本等同,并且比20mg COSF曲线更早达到平台期。
再次如以上关于图8指出的,使用传统的溶出法,图13、14和15中示出的这些差异将是不明显的。只有利用PION技术的增强的辨别能力,才可以检测和记录这些差异。
实施例6:不同储存条件下COSF的比较
使用PION技术在以下情况下测试如上制备的5mg、10mg和20mg COSF:1)在约25℃下和60RH储存约24个月后;2)在约40℃下和60RH储存约24个月后;或3)最终产品完成后(无储存时间,T=约0个月)。上表3展示了用于PION技术的参数。比较活性物溶出谱以确定不同的储存条件如何影响溶出速率。
图16示出了5mg、10mg和20mg COSF在约25℃下和60RH储存约24个月后,和在约40℃下和60RH储存约24个月后的活性物溶出谱。对于所有膜强度,在40℃下储存的样品中的活性物比在25℃下储存的同一剂型中的活性物溶出更快。在40℃下储存的5mg COSF中的活性物溶出最快,然后是在40℃下储存的10mg COSF,而20mg COSF样品具有最慢的溶出谱。在此可看出PION系统的增强的辨别能力。使用PION技术获得的活性物溶出谱足够精确,以示出基于膜强度和储存条件的差异,二者均出乎意料地影响了活性物的溶出速率。
基于FDA指南的统计分析进一步证明了不同样品之间的相似性或缺乏相似性(强度/储存条件/年龄/等)。使用PION技术,相似性或缺乏相似性比传统溶出法更明显,因为精度的提高以及一阶导数计算值。例如,如表10所示,在25℃下的5mg至10mg证明了统计相似性,而在25℃相对于40℃下的5mg至10mg没有证明统计相似性。对于相似性,f2(相似系数)必须不小于50,f1(差异系数)必须不大于15。
表10:统计相似性比较
图18示出了5mg、10mg和20mg COSF在约25℃下和60RH储存约24个月之后,以及未储存(T=约0个月)的活性物溶出谱。对于5mg和10mg COSF二者,储存后测试的样品比同一强度(T=0)的最终产品样品溶出更快。
关于统计相似性,最终产品5mg和10mg COSF的活性物溶出谱在统计学上与等同储存的样品不相似。最终产品20mg COSF样品的活性物溶出谱在统计学上与储存的20mg COSF样品相似。
表11:最终产品和储存产品的统计相似性比较
图17和19分别是图16和18的图的一阶导数曲线。如图中的一阶导数曲线的高度和宽度所示,5mg和10mg COSF在第一分钟内溶解得更快且更充分,而20mg COSF溶解更慢,即曲线更短且更宽(更低的强度)。对于所有曲线,当溶解完成时一阶导数接近0,并且血管中的药物浓度达到平台期。5mg和10mg COSF一阶导数曲线比20mg COSF曲线更早达到平台期。
实施例7:介质的比较
使用PION技术制备并测试(无储存阶段)5mg、10mg和20mg COSF,以确定介质选择如何影响溶出速率。以上表3展示了用于PION技术的参数。因此,在以下的浴中测试了活性物在各膜中的溶出:0.1N HCl、用氢氧化钠调节至pH6.8的磷酸二氢钾的0.05摩尔溶液、或者水。
图20示出了5mg、10mg和20mg COSF在不同介质中的活性物溶出谱。图21是图20的一阶导数曲线。即使具有PION技术的提高的辨别能力,选择的介质也不影响溶出;溶解在不同介质中的同一强度的样品在统计上相似。在传统溶出法的情况下,除非存在明显的溶解性问题,否则活性物溶出谱将通常不提供这种增强的信息。
实施例8:液体混合物和膜的释放的比较
设计实验以评价另外的赋形剂对活性物释放的影响。特异性是方法开发的一个方面,以确保药物产品内包含的任何赋形剂均不干扰活性物的定量。因此,通过PION技术测量了以下样品的活性物溶出谱,并展示在图22中:
·5mg COSF最终产品(在图22中称为“5mg标称(nominal)”);
·干燥之前的膜组合物的液体混合物;
·安慰剂,其为具有除活性物外的所有赋形剂的膜;和
·5mg COSF最终产品,但具有两倍量的赋形剂(在图22中称为“5mg w/2安慰剂”)。
如图22所示,安慰剂作为没有活性物的膜,示出一些干扰--约20%的响应。因此,单独的赋形剂和膜剂型对活性物溶出谱有影响。图23是图22的一阶导数曲线。
假定液体混合物中的活性物比膜中的活性物溶出更快,膜需要水合、溶胀然后释放活性物。然而,出乎意料地是发现膜比液体混合物具有更快的溶出谱。基于这些结果,认为将水分吸收到基质中的干膜促进了活性物的释放和溶出。
实施例9:基底性能的评价
进行了这样的实验:改变在制造包含20mg氯巴占的口腔膜期间,特别是在干燥步骤中所使用的基底。特别地,使用40密耳(mil)间隙,将COSF20mg制剂用于涂覆多种基底,以用于比较评价。将经涂覆的基底在80℃下干燥15分钟。评价经干燥的涂覆基底,结果展示于表12中。
表12:多种涂覆基底的特性和比较
在干燥后,所有经干燥的膜样品都能够从基底上移除。然而,膜的边缘与玻璃基底有强的黏附,而对于经电晕处理的聚对苯二甲酸乙二醇酯基底有中等黏附。表现最好的基底是聚对苯二甲酸乙二醇酯(未处理)。
实施例10:氯巴占在COSF中间体和最终产品中的溶解性的评价
进行了实验以评估氯巴占在液体混合物(预干燥)和口腔膜(COSF)中的溶解性。制备包含10mg和20mg氯巴占的口腔薄膜,然后将其溶解在1.5ml水中。评估了另外两个样品-一个是在水中的活性物(没有将赋形剂添加至用于口腔膜的组合物);而第二种是用于膜的液体混合物,但是在成膜(即干燥)之前测试。表13展示了评价结果。
表13:氯巴占的溶解性
如上表所示,在每个测试样品中,约1%至约2%的氯巴占溶出,而超过98%保持分散。作为膜的液体混合物组合物的湿块体样品,其中溶出的活性物低于随后用1.5ml水水合的膜样品。这是因为成膜方法中的干燥过程增加了制剂中活性物的溶解性。溶解性是干燥过程和膜尺寸(例如厚度)的函数。例如,10mg膜具有比20mg膜更高的溶出百分比,因为10mg膜更薄,因此在干燥过程期间每单位面积的热暴露更大。溶解性也与口腔膜的口感特征成比例。
尽管已经描述了目前被认为是本发明的某些期望的实施方案,但是本领域技术人员将认识到,在不脱离本发明的精神的情况下,可对其进行改变和修改,并且其旨在包括落入本发明的真实范围内的所有这样的改变和修改。
Claims (45)
1.用于以单独单位剂量递送期望量的活性物的口腔膜,所述膜包含:
a)水溶性聚合物基质、水溶胀性聚合物基质、或水溶性且水溶胀性聚合物基质;
b)平均颗粒尺寸D90小于约160微米的所述活性物;以及
c)选自以下的添加剂:甜味剂、矫味剂、味道增强剂、填充剂、增塑剂、染料、色素、渗透增强剂、缓冲剂、防腐剂、二氧化硅、抗黏剂、及其任意组合;
其中,在将所述膜置于介质中后,在约3分钟之后多于约2%的所述活性物溶于所述介质中。
2.权利要求1所述的膜,其中所述活性物的平均颗粒尺寸D90小于约120微米。
3.权利要求2所述的膜,其中所述活性物的平均颗粒尺寸D90小于约100微米。
4.权利要求2所述的膜,其中所述活性物的平均颗粒尺寸D50小于约30微米。
5.权利要求4所述的膜,其中所述活性物的平均颗粒尺寸D50小于约20微米。
6.权利要求2所述的膜,其中所述活性物的平均颗粒尺寸D10小于约10微米。
7.权利要求6所述的膜,其中所述活性物的平均颗粒尺寸D10小于约5微米。
8.权利要求1所述的膜,其中所述单独单位剂量包含约0.5mg至约100mg的所述活性物。
9.权利要求8所述的膜,其中所述活性物为氯巴占。
10.权利要求1所述的膜,其中在将所述膜置于所述介质中后,在约3分钟之后多于约10%的所述活性物溶出。
11.权利要求1所述的膜,其中在将所述膜置于所述介质中后,在约5分钟之后多于约40%的所述活性物溶出。
12.权利要求1所述的膜,其中在将所述膜置于所述介质中后,在约5分钟之后多于约50%的所述活性物溶出。
13.用于以单独单位剂量递送期望量的活性物的口腔膜,所述膜包含:
d)水溶性聚合物基质、水溶胀性聚合物基质、或水溶性且水溶胀性聚合物基质;
e)为氯巴占且平均颗粒尺寸D90小于约160微米的所述活性物;以及
f)选自以下的添加剂:甜味剂、矫味剂、味道增强剂、填充剂、增塑剂、染料、色素、渗透增强剂、缓冲剂、防腐剂、二氧化硅、抗黏剂、及其任意组合;
其中,在将所述膜置于介质中后,在约3分钟之后多于约20%的所述活性物溶于所述介质中。
14.权利要求13所述的膜,其中所述活性物的平均颗粒尺寸D90小于约120微米。
15.权利要求14所述的膜,其中所述活性物的平均颗粒尺寸D90小于约100微米。
16.权利要求13所述的膜,其中所述活性物的平均颗粒尺寸D50小于约30微米。
17.权利要求16所述的膜,其中所述活性物的平均颗粒尺寸D50小于约20微米。
18.权利要求14所述的膜,其中所述活性物的平均颗粒尺寸D10小于约10微米。
19.权利要求18所述的膜,其中所述活性物的平均颗粒尺寸D10小于约5微米。
20.权利要求13所述的膜,其中在将所述膜置于所述介质中后,在约3分钟之后多于约30%的所述活性物溶出。
21.权利要求13所述的膜,其中在将所述膜置于所述介质中后,在约5分钟之后多于约55%的所述活性物溶出。
22.权利要求13所述的膜,其中在将所述膜置于所述介质中后,在约1.5分钟之后多于约5%的所述活性物溶出。
23.权利要求13所述的膜,其中所述单独单位剂量包含约2mg至约20mg的氯巴占。
24.权利要求23所述的膜,其中所述单独单位剂量包含约5mg的氯巴占。
25.权利要求24所述的膜,其中在将所述膜置于所述介质中后,在约1分钟之后多于约30%的所述活性物溶出。
26.权利要求24所述的膜,其中在将所述膜置于所述介质中后,在约2分钟之后多于约80%的所述活性物溶出。
27.权利要求24所述的膜,其中在将所述膜置于所述介质中后,在约2.5分钟之后多于约95%的所述活性物溶出。
28.权利要求23所述的膜,其中所述单独单位剂量包含约10mg的氯巴占。
29.权利要求28所述的膜,其中在将所述膜置于所述介质中后,在约1.5分钟之后多于约50%的所述活性物溶出。
30.权利要求28所述的膜,其中在将所述膜置于所述介质中后,在约2.5分钟之后多于约70%的所述活性物溶出。
31.权利要求23所述的膜,其中所述单独单位剂量包含约20mg的氯巴占。
32.权利要求31所述的膜,其中在将所述膜置于所述介质中后,在约1.5分钟之后多于约2%的所述活性物溶出。
33.权利要求31所述的膜,其中在将所述膜置于所述介质中后,在约3.5分钟之后多于约40%的所述活性物溶出。
34.权利要求13所述的膜,其包含选自以下的甜味剂:三氯蔗糖、甜菊、乙酰磺胺酸钾、糖精、果糖、阿斯巴甜、及其任意组合。
35.权利要求34所述的膜,其中所述甜味剂以按组合物的重量计约0.5%至约5%存在。
36.权利要求13所述的膜,其包含为水果矫味剂的所述矫味剂。
37.权利要求36所述的膜,其中所述水果矫味剂为浆果矫味剂。
38.权利要求37所述的膜,其中所述浆果矫味剂以按组合物的重量计约0.1%至约15%存在。
39.权利要求13所述的膜,其中所述口腔膜中按所述活性物的总量的重量计少于约10%溶出。
40.根据前述权利要求中任一项所述的膜,其中在测试溶出度之前,所述膜被储存在一个或更多个以下条件下:超过0个月至约36个月、处于约20℃至约60℃下、高至约75%的相对湿度(RH)、及其任意组合。
41.根据前述权利要求中任一项所述的膜,其中所述介质是提供沉降条件的任意溶剂。
42.根据权利要求41所述的膜,其中所述介质选自:稀盐酸、1.2至7.5生理pH范围的缓冲剂、模拟胃液或肠液、水、表面活性剂、及其任意组合。
43.权利要求1所述的膜,其还包括权利要求2至12、39和40中的任一项或更多项。
44.权利要求13所述的膜,其还包括权利要求14至42中的任一项或更多项。
45.治疗人的癫痫和/或癫痫发作的方法,所述方法包括向所述人施用前述权利要求中任一项所述的口腔膜单独单位剂量。
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CN114010575A (zh) * | 2021-10-22 | 2022-02-08 | 江苏谛奇医药科技有限公司 | 新斯的明及其衍生物的新制剂 |
CN114983984A (zh) * | 2022-07-26 | 2022-09-02 | 山东达因海洋生物制药股份有限公司 | 一种用于哮喘治疗复方口溶膜剂及其制备方法 |
CN114983984B (zh) * | 2022-07-26 | 2023-09-01 | 山东达因海洋生物制药股份有限公司 | 一种用于哮喘治疗复方口溶膜剂及其制备方法 |
CN117631135A (zh) * | 2024-01-25 | 2024-03-01 | 四川大学 | 一种双功能柔性水凝胶光纤及其制备方法和应用 |
CN117631135B (zh) * | 2024-01-25 | 2024-04-09 | 四川大学 | 一种双功能柔性水凝胶光纤及其制备方法和应用 |
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CA3110997A1 (en) | 2020-03-12 |
US20230145752A1 (en) | 2023-05-11 |
US20200101009A1 (en) | 2020-04-02 |
US11541002B2 (en) | 2023-01-03 |
JP2021536466A (ja) | 2021-12-27 |
WO2020051317A1 (en) | 2020-03-12 |
EP3846778A1 (en) | 2021-07-14 |
BR112021004053A2 (pt) | 2021-05-25 |
US20230149304A1 (en) | 2023-05-18 |
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