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CN1809343A - 含有三氯半乳蔗糖作为增甜剂的速溶口服可消耗膜 - Google Patents

含有三氯半乳蔗糖作为增甜剂的速溶口服可消耗膜 Download PDF

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CN1809343A
CN1809343A CNA2004800175922A CN200480017592A CN1809343A CN 1809343 A CN1809343 A CN 1809343A CN A2004800175922 A CNA2004800175922 A CN A2004800175922A CN 200480017592 A CN200480017592 A CN 200480017592A CN 1809343 A CN1809343 A CN 1809343A
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oil
film
water
pharmaceutically active
active agent
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尼马·M·库尔卡尼
洛里·D·库马
艾伯特·F·索格
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Macneil -Ppc Ltd By Share Ltd
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Warner Lambert Co LLC
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Abstract

一种适合于粘附到并溶解于包括人的温血动物的口腔的可消耗的膜，其包括至少一种水溶性的聚合物，掩蔽味道有效量的增甜剂以及具有通过增甜剂理想地掩蔽足够令人不快的味道的药物活性剂。

Description

含有三氯半乳蔗糖作为增甜剂的速溶口服可消耗膜
优先权信息
该申请要求美国申请号10/423,398优先权，该美国申请10/423,398为美国申请09/395,104的后续部分申请，其中美国申请09/395,104要求美国临时申请60/101,798的优先权。
发明领域
本发明与递送一种或多种药物活性剂的速溶口服可消耗膜有关，更具体而言与包含用于改善膜味道的增甜剂的速溶口服可消耗膜有关。
发明背景
人用治疗产品能够配制成多种的剂型，包括片剂、胶囊、锭剂或可食用的薄膜组合物贴剂。施用于口腔的可食用的薄膜组合物可以被设计成递送药物至口腔粘膜。一种这样的实例是Pfizer Inc of New York制造的LISTERINE POCKETPAKSTM牌的口腔治疗贴剂产品，是以精油组合的形式有效递送药物具体为抗微生物剂的可食用的膜组合物的成功实例。
常规的速溶口服可消耗膜可加入食用香料及/或增甜剂以改善膜的味道及/或其中含有的组分(例如药物活性剂)。特别是用于含有苦味组分的膜时，用于这种膜的食用香料及/或增甜剂通常仅提供有限的味道改善。因此，在本领域仍需要开发可消耗的含有增甜剂的膜，其至少基本上改善膜和其组分的味道。
发明概述
本发明的一个实施方案提供了一种适合于粘附到并溶解于包括人的温血动物的口腔的可消耗的膜，所述膜包括至少一种水溶性的聚合物、掩蔽味道有效量的增甜剂以及具有通过增甜剂理想地掩蔽足够令人不快的味道的药物活性剂。在本发明的另一个实施方案中，提供了一种可消耗的适合于粘附到并溶解于包括人的温血动物的口腔的可消耗的膜，包括至少一种水溶性的聚合物、掩蔽味道有效量的三氯半乳蔗糖(sucralose)以及药物活性剂。
本发明也涉及制备柔软的、非自体粘附的尤其适合于口服递送药物活性剂的膜的方法，其中所述方法包括制备包括至少一种水溶性聚合物的成膜混合物；制备包括增甜剂和药物活性剂的水相；合并水相和成膜混合物形成水合聚合物凝胶；将水合聚合物凝胶在基质(substrate)上浇铸成形以形成铸型凝胶(cast gel)；并干燥铸型凝胶形式以形成可消耗的膜。
发明详述
本发明的实施方案涉及生理可接受的膜，其具体而言非常适合于在患有疾病、症状或病症的包括人的温血动物的口腔中溶解，并粘附到口腔的粘膜上。这种膜适合递送药物活性剂以治疗患病的温血动物。
在本发明的一个方面，提供可消耗的适合粘附到并溶解于包括人的恒温动物的口腔的膜，所述膜包括至少一种水溶性的聚合物、掩蔽味道有效量的增甜剂以及具有通过本增甜剂理想地掩蔽足够令人不快的味道的药物活性剂。
可消耗的膜可包括一种或多种下列成分，包括但不限于水、抗微生物剂、附加的成膜剂或水溶性聚合物、增塑剂、矫味剂、硫磺沉淀剂、唾液刺激剂、冷却剂、表面活性剂、稳定剂、乳化剂、增稠剂、粘合剂、着色剂、甘油三酯、聚氧化乙烯、丙二醇、增甜剂、芳香剂、防腐剂等，如在1999年9月14日提交的共同在审的美国专利申请09/395,104中Leung等的描述，全部引入此处作为参考。
在本发明的一个实施例中，可消耗的膜是单层的形式。
此处所用的术语“可消耗的”意指包括含有可食用的化合物的物质，当对消费者给药时，其足够耐受而不导致不良副作用。使可消耗的膜成形并整形为适于包括人的温血动物的口腔给药。具体而言该膜非常适合于在口腔中迅速溶解。溶解的膜粘附于口腔的表面，典型地为口腔上腭或舌，并能提供药物活性剂的快速递送体系。
除非另外指定，所用术语“％重量”是基于最终产物(即膜，与用于制备该膜的制剂相对)的总重量，表示对象成分占总干重的百分数。理论值可以不同于实验值，因为实际上，该膜典型地保留一些水及/或可用于制备最终产物的其它物质如醇类(例如，乙醇)。
在一种实施方案中，本发明的可消耗的膜包括药物活性剂和增甜剂，该增甜剂显著地改善药物活性剂味道用于增强产品性能并使消费者接受。根据本发明通过改善含有药物活性剂的膜的味道，涉及该膜的治疗顺应性和粘着性可显著地增强。适合的增甜剂包括天然的和人造增甜剂。
有用的增甜剂包括如A)水溶性的增甜剂如单糖、二糖和多糖，B)水溶性的人工增甜剂如可溶性糖精盐等，C)基于二肽的增甜剂如L-天冬氨酸衍生的增甜剂等，D)基于蛋白质的增甜剂如thaumatoccous danielli(甜蛋白(Thaumatin)I和II)及其混合物。附加的适合的增甜剂包括三氯半乳蔗糖、阿司帕坦、乙酰舒泛钾(acesulfam potassium)、neotame、糖精、木糖醇及其混合物。
增甜剂采用的有效量将部分地根据具体增甜剂的选择而改变。“掩蔽味道的有效量”指足够至少减少、掩蔽或消除包含于本发明膜中的药物活性剂的令人不快的味道(例如苦味的)的增甜剂的量。除具体的增甜剂外，掩蔽味道的有效量可随要掩蔽的味道的类型及/或程度以及包含于膜的具体的载体和成份而改变。在一个实施方案中，增甜剂可以以掩蔽味道的有效量存在于本发明的干燥膜中，有效量的范围是膜重量的约0.1％重量～10％，优选1％～6％，更优选约是2％～4％。
一种实施方案包括作为增甜剂的三氯半乳蔗糖。三氯半乳蔗糖为具有强烈甜味的氯化蔗糖衍生物。三氯半乳蔗糖已经被公开有效掩蔽或去除多种食品添加剂和药物活性剂导致的令人不快的味道尤其是苦味。通过将三氯半乳蔗糖加到本发明的膜中，将有益地实现增强甜味以及理想地掩蔽其中可能含有的食品添加剂和药物活性剂(例如，氢溴酸右美沙芬，法莫替丁)所产生的任何令人不快的味道。
本发明的水溶性的聚合物具有制备本发明的膜的成膜性能。用于本发明的膜的水溶性聚合物选自支链淀粉、羟丙基甲基纤维素、羟乙基纤维素、羟基丙基纤维素、聚乙烯基吡咯烷酮、羧甲基纤维素、聚乙烯醇、海藻酸钠、聚乙二醇、黄蓍胶、瓜尔胶、金合欢树胶、阿拉伯胶、聚丙烯酸、甲基丙烯酸酯共聚物、羧基乙烯基聚合物(carboxyvinyl polymer)、直链淀粉、高直链淀粉、羟丙基化高直链淀粉、糊精、果胶、甲壳质、壳聚糖、果聚糖、爱生兰、胶原、明胶、玉米蛋白、谷蛋白、大豆蛋白分离物、乳清蛋白分离物、酪蛋白及其混合物。在本发明的一个实施方案中，水溶性的聚合物为支链淀粉，其可以以膜重量的约0.01％～99％的量存在，在另一个实施方案中为膜重量的约10％～80％，在另一个实施方案中，为膜重量的约20％～70％以及在又一个实施方案中，为膜重量的约30％～50％。
此处所用的术语“药物活性剂”是指包含除了食品添加剂以外的药剂，其在已经给药的机体中及/或机体上促进结构及/或功能的变化。这些药剂没有具体限制，然而，它们应该是生理可接受的而且与膜相容。可能味道令人不快的合适的药物活性剂包括，但不限于，
(a)抗微生物剂如三氯生、西吡氯铵、度米芬、季铵盐、锌化合物、血根碱、氟化物、阿立西定、奥克巴胺、EDTA等；
(b)非甾体抗炎药如阿司匹林、对乙酰氨基酚、布洛芬、酮洛芬、二氟尼柳、非诺洛芬钙、氟比洛芬钠、萘普生、托美汀钠、吲哚美辛、塞来考昔、罗非考昔等；
(c)止咳药如苯佐那酯、乙二磺酸咳美芬、薄荷醇、氢溴酸右美沙芬、盐酸氯苯胺丙醇等；
(d)解充血药如盐酸伪麻黄碱、去氧肾上腺素、苯丙醇胺、硫酸伪麻黄碱等；
(e)抗组胺类如马来酸溴苯那敏、马来酸氯苯那敏、马来酸卡比沙明、延胡索酸氯马斯汀、马来酸右氯苯那敏、盐酸二苯醇胺(diphenylhydraminehydrochloride)、马来酸阿扎他定、柠檬酸苯海拉明、盐酸二苯拉林、琥珀酸多西拉敏、盐酸异丙嗪、马来酸吡拉明、柠檬酸曲吡那敏、盐酸曲普利啶、阿伐斯汀、溴苯吡胺、右氯苯那敏、非索非那定、氯雷他定、西替利嗪等；
(f)祛痰剂如愈创甘油醚、吐根、碘化钾、水合萜二醇等；
(g)止泻药如洛哌丁胺等；
(h)组胺II受体拮抗剂如法莫替丁、雷尼替丁等；
(i)质子泵抑制剂如奥美拉唑、兰索拉唑等；
(i)全身非选择性CNS抑制剂如脂族醇、巴比妥类等；
(k)全身非选择性CNS兴奋剂如咖啡因、尼古丁、士的宁、印防己毒素、戊四唑等；
(I)选择性改变CNS功能的药物如苯基乙内酰脲、苯巴比妥、扑米酮、卡马西平、乙琥胺、甲琥胺、苯琥胺、三甲双酮、安定、地西泮、苯乙酰脲、苯丁酰脲、乙酰唑胺、溴化舒噻嗪、加巴喷丁、苯妥英等；
(m)抗帕金森氏综合征药如左旋多巴、金刚烷胺等；
(n)麻醉止痛剂如吗啡、海洛因、氢吗啡酮、美托酮、氧吗啡酮、左吗南、可待因、二氢可待因酮、羟考酮、纳洛芬、纳洛酮、纳屈酮等；
(o)解热镇痛剂如水杨酸盐、保泰松、吲哚美辛、非那西汀等；
(p)精神药理学药物如氯丙嗪、甲氧异丁嗪、氟哌丁苯、氯氮平、利血平、丙咪嗪、反苯环丙胺、苯乙肼、锂等；
药物活性剂以有效量使用，所述的有效量将部分地根据选择的药物活性剂而改变。“有效量”是指足以至少减少或减轻治疗的病症、症状或疾病，但足够低以避免任何不良副作用的药物活性剂的量。除具体的活性剂外，药物活性剂的有效量可随疾病、症状或病症的类型及/或严重程度、被治疗的患者的年龄和身体状态、治疗持续时间、共同治疗的性质、采用药物活性剂的具体形式(例如盐)以及具体的施加药物活性剂的载体而改变。
本发明制剂中的药物活性剂的量可调至在典型地从4到24小时变化的预定时段内递送药物活性剂的预定剂量。例如，在本发明的一个实施方案中，膜能以每12小时给药一个剂量，以递送药物有效量的活性剂如右美沙芬，例如在12小时期间内给予需要如此给药的患者。本发明的膜的药物活性剂的典型成人剂量可包含约0.1mg～130mg，优选约0.1mg～65mg的药物活性剂(例如，氢溴酸右美沙芬)。
包含能经快速溶解的膜的贴剂递送的具体药物活性剂的剂量的实例在表A中阐述。
表A
  药物活性剂   剂量
  马来酸氯苯那敏   4-12mg
  马来酸溴苯那敏   4mg
  右氯苯那敏   2mg
  右溴苯那敏   2mg
  盐酸曲普利啶   2.5mg
  西替利嗪   5-10mg
  阿伐斯汀   8mg
  马来酸阿扎他定   1mg
  氯雷他定   5-10mg
  盐酸去氧肾上腺素   5-10mg
  盐酸右美沙芬   10-30mg
  昔多芬   25-100mg
  酮洛芬   12.5-25mg
  琥珀酸舒马曲坦   35-70mg
  佐米曲坦   2.5mg
  洛哌丁胺   2mg
  法莫替丁   5-10mg
  尼古丁   1-15mg
  盐酸苯海拉明   12.5-25mg
  盐酸伪麻黄碱   15-60mg
  阿托伐他汀   5-80mg
  伐地考昔   5-20mg
  苯磺酸氨氯地平   2.5-10mg
  罗非考昔   5-25mg
  盐酸Setraline   10-100mg
  齐拉西酮   20-80mg
  依立曲坦   10-40mg
  硝酸甘油   0.3-0.6mg
除非另有说明，本发明膜中的活性剂的量指定为在膜制剂已经干燥并成膜之后的重量百分数。通常，用于膜的活性剂的量为约0.01％～约80％重量，优选为约2.5％～约40％重量，而更优选为约5％～约30％重量。
本发明的膜组合物也可用来提供营养上可接受的组分如维生素、矿物质、微量元素以及纤维(优选可溶解的纤维)。
适合于在本发明组合物中加入的维生素的实例包括药物或营养上可接受的形式的维生素A、维生素D、维生素E、维生素K、维生素C、叶酸、硫胺、核黄素、维生素B(6)、维生素B(12)、烟酸、生物素以及panthotenicacid。适合于在本发明组合物中加入的矿质元素以及微量元素的实例包括药物或营养上可接受的形式的钙、钠、钾、磷、镁、锰、铜、锌、铁、硒、铬以及钼。
此处所用的术语可溶解的纤维是指能基本上在结肠进行发酵以制备短链脂肪酸的纤维。适合的可溶解的纤维的实例包括carubin、果胶、黄蓍胶、谷物β葡聚糖(cereal beta glucan)等。它们可为水解或非水解的。
在本发明另外的实施方案中，可消耗的膜还可包括抗微生物剂，包括但不限于精油，如描述于共同在审的U.S.专利申请号09/395,104，由Leung等在1999年9月14日提交，在此全部引入作为参考。这些精油可选自例如香芹酚、麝香草酚、桉叶素、薄荷醇、水杨酸甲酯、丁香油酚、gerianol、马鞭草烯酮等及其组合。精油优选的组合之一用于LISTERINE牌嗽口水和口腔治疗用贴剂，其可能为最著名的抗菌口腔组合物的实例，已证实有效杀死口腔内导致噬菌斑、齿龈炎和口臭的微生物。LISTERINE牌嗽口水和口腔贴剂通过组合精油类达到抗微生物效应。这些精油包括有效杀死不良微生物的精确平衡量的麝香草酚、水杨酸甲酯、薄荷醇和桉叶素(在下文中称“优选的精油”)。
用于膜组合物的优选的精油的量可以改变，只要它们提供足够抗微生物效应的量。通常，精油的量至多为膜重量的约30％，并且优选地从约0.05％到约18％。在一种优选方案中，麝香草酚、水杨酸甲酯和桉叶素的量各为膜重量的约0.01％至约4％，优选地从约膜重量0.05％至约3.0％，并更优选地为膜重量的约0.07％至约2.0％。薄荷醇能以组合物的重量的约0.01％至约15％的量存在，优选地为膜重量的约2.0％至约9.0％并且更优选地为膜重量的3％至9％。包括优选精油的精油的理想的和有用的量能够被本领域技术人员容易地确定并且可超过优选的量，只要总精油的含量不产生加工问题如粘附即可。在一些实施方案中，精油以共同有效的量被组合以杀死引起牙斑、齿龈炎和口臭的噬菌斑产生菌。
对于掺入精油的实施方案，由于可消耗品中相对高的油含量应避免使用湿润剂，以免产生过湿的、自身粘附的膜。在一种实施方案中，可消耗的膜包括不为甘油的增塑剂，其中甘油还是湿润剂，以及不为山梨醇的增甜剂，其中山梨醇还是轻微的湿润剂。
唾液刺激剂也可被加到本发明的可消耗的膜中。有用的唾液促进剂公开于U.S.专利号4,820,506中，在此全部引入作为参考。
本发明可消耗的膜也可包括防腐剂。防腐剂以最多约5％的量加入，优选为膜重量的约0.01％～1％。优选的防腐剂包括苯甲酸钠、对羟基苯甲酸甲酯、对羟苯甲酸丙酯及山梨酸钾。其它适合的防腐剂包括但不限于依地酸盐(亦称为乙二胺四乙酸或EDTA盐，如EDTA二钠)。
本发明的另一个实施方案涉及制备本发明的可消耗的膜的方法。通常，将至少一种镇咳药和粘膜涂布有效量的粘膜涂布剂溶于水以形成水相。水相还可包括增甜剂、着色剂等。制备包括至少一种水溶性聚合物(例如支链淀粉)的成膜混合物。将水相和成膜混合物合并并充分地混合形成水合聚合物凝胶。任选地，包括有机成份如精油及其它油类(例如甘油、橄榄油)、食用香料、表面活性剂(例如聚山梨酯80、Atmos 300、Atsurf596K)等的有机相可与水相、成膜混合物或水合聚合物凝胶合并。将得到的水合聚合物凝胶在适合的基质上浇铸形成铸型凝胶。然后将铸型凝胶干燥形成可消耗的膜。
在另一个实施方案中，提供了制备可消耗的膜优选的方法，理想的情况是通过用水初次水合水溶性的聚合物初次形成成膜混合物。然后通过将其它水溶性的成份如镇咳药、粘膜涂布剂(例如果胶)、增甜剂、着色剂等溶解在水中制备水相。分别地，将有机成份如精油及其它油类(例如甘油、橄榄油)、食用香料、表面活性剂(例如聚山梨酸酯80、Atmos 300、Atsurf 596K)等混合在一起。然后，通过混合成膜聚合物相和水相，然后添加有机相，制备最终的制剂。合并的混合物形成乳剂或水合聚合物凝胶。
然后将得到的水合聚合物凝胶浇铸在适合的基质上并干燥形成膜。膜优选地风干并在暖风下干燥并切成需要的尺寸、包装并存储。包装的膜可包含约0.1％至10％重量的量的水分，并且更优选地约为4％至7％重量。
成膜混合物还可包括稳定剂如黄胞胶、刺槐豆胶、角叉菜胶等及其组合。将这些成份混合并在温水中水合，优选地为去离子水，直到形成凝胶，可用约30至约48小时。将水优选地加热到约20℃至约40℃的温度以促进水合。水的量典型地为凝胶重量的约40％至约80％。然后用约1至约48小时将得到的水合凝胶冷却至约20℃至约30℃的温度。
除镇咳药和粘膜涂布有效量的粘膜涂布剂例如果胶外，水相可包括添加剂如着色剂、葡糖酸铜和增甜剂。典型地水相包含基于最终凝胶混合物总重量的约5％至约80％重量。
如果在制剂中使用糖精钠作为可被选择的增甜剂以及葡萄糖酮作为被选择的硫磺沉淀剂，优选分别在溶液中溶解它们以避免沉淀。
在本发明另一个实施方案中，水溶性聚合物优选地以粉末的形式加到水相中形成水合聚合物凝胶。在约室温将得到的水合聚合物凝胶充分地搅拌约30分钟至约48小时，然后排气以至少基本上地除去所有气泡。将得到的均匀的混合物浇铸在适合的基质上然后干燥形成需要的膜。
对于包含精油的可消耗的膜，还将精油加到有机相中并将有机相和水合聚合物凝胶混合。具体而言，精油如薄荷醇和麝香草酚能任选地与油类混合形成含油混合物。然后可以将其它精油如水杨酸甲酯和桉叶素以及表面活性剂加到含油混合物中。然后将油混合物加到水合聚合物凝胶中并混合直到形成均匀的凝胶。将得到的均匀的凝胶浇铸在适合的基质上然后干燥形成可消耗的膜。
在一种制备可消耗的膜的实施方案中，水溶性的聚合物可在不将水加热的情况下水合以减少制备方法的能源成本。此外，因为加热可导致挥发性成份蒸发的不良的损失，在水合过程期间避免加热可能是优选的。对于包含精油的膜，由于精油的损失，加热可能也影响组合物的杀菌活性。
不限于任何理论，据信成膜成份如水溶性聚合物可以在不加热的情况下，由已知为道南平衡的离子效应而水合并混合。在溶液中有电解质参与的情况下，水溶性聚合物有效地降低了形成的聚合物凝胶的粘度，因此增加水合过程的效率。制剂的水溶性成份提供电解质，该电解质是在加入水溶性聚合物前溶于水合溶液。高剪切力混合也促进水合，其破坏粉末的结块，提供更大的与水接触的表面面积。此外，产生于剪切区的局部加热效应，在基本上地没有升高物质的温度情况下，提供水合的能量。
实施例1
根据下列步骤将表1列出的成份合并用于制备本发明的可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP69加到水相中并在约70℃至80℃搅拌约4至5小时。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将山梨酸钾和着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料、甘油、薄荷醇、聚山梨酯80和Atmos300合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇和三氯半乳蔗糖一起混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合，得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感决定)。
                               表1
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   22.7322   7.7289   38.6447
  AmberliteIRP69   16.0000   24.2477   8.2442   41.2211
  黄胞胶   0.0769   0.1165   0.0396   0.1981
  槐树豆胶   0.0901   0.1365   0.0464   0.2321
  角叉菜胶   0.3861   0.5851   0.1989   0.9947
  支链淀粉   20.5919   31.2066   10.6102   53.0512
  山梨酸钾   0.0772   0.1170   0.0398   0.1989
  纯净水   -   -   66.0000   330.0000
  薄荷醇   2.5740   3.9008   1.3263   6.6314
  薄荷香料   0.2579   0.3908   0.1329   0.6644
  樱桃香料(Givudan)   0.2579   0.3908   0.1329   0.6644
  酸樱桃(IFF)   2.2350   3.3871   1.1516   5.7581
  WarmSensation(Mane)   0.5518   0.8362   0.2843   1.4216
  人工掩蔽剂香料(Robertet)   0.4139   0.6273   0.2133   1.0663
  Succulence(IFF)   0.2579   0.3908   0.1329   0.6644
  FD&C Red#40   0.0098   0.0149   0.0050   0.0252
  聚山梨酯80NF   0.4504   0.6826   0.2321   1.1604
  Atmos 300   0.4504   0.6826   0.2321   1.1604
  甘油   1.9305   2.9256   0.9947   4.9736
  甘露醇USP   2.5740   3.9008   1.3263   6.6314
  三氯半乳蔗糖   1.8000   2.7279   0.9275   4.6374
  总计   65.9857   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例2
根据下列步骤，将表2列出的成份合并用于制备本发明可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP64加到水相中并在约70℃至80℃搅拌约4至5小时。将果胶用甘油混合并将混合物慢慢加入到水相中然后在高速率下充分地混合。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将山梨酸钾和着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料和薄荷醇合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇和三氯半乳蔗糖一起混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感决定)。
                                    表2
材料 mg/剂量*   ％/w/w*干燥膜   ％w/w实际批 g/批
  氢溴酸右美沙芬   15.0000   22.9235   7.8353   39.1765
  Amberlite IRP64   16.0000   24.4518   8.3576   41.7882
  果胶USP   0.3500   0.5349   0.1828   0.9141
  黄胞胶   0.0769   0.1175   0.0402   0.2008
  槐树豆胶   0.0901   0.1377   0.0471   0.2353
  角叉菜胶   0.3861   0.5901   0.2017   1.0084
  支链淀粉   20.5919   31.4693   10.7562   53.7812
  山梨酸钾   0.0772   0.1180   0.0403   0.2016
  纯净水   -   -   65.8199   329.0995
  薄荷醇   2.5740   3.9337   1.3445   6.7227
  薄荷香料   0.2579   0.3941   0.1347   0.6736
  樱桃香料(Givudan)   0.2579   0.3941   0.1347   0.6736
  酸樱桃(IFF).   2.2350   3.4156   1.1675   5.8373
  Warm Sensation(Mane)   0.5518   0.8433   0.2882   1.4412
  人工掩蔽剂香料(Robertet)   0.4139   0.6325   0.2162   1.0810
  Succulence(IFF)   0.2579   0.3941   0.1347   0.6736
  FD&C Red#40   0.0098   0.0150   0.0051   0.0256
  甘油   1.9305   2.9503   1.0084   5.0420
  甘露醇USP   2.5740   3.9337   1.3445   6.7227
  三氯半乳蔗糖   1.8000   2.7508   0.9402   4.7012
  总计   65.4349   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例3
根据下列步骤，将表3列出的成份合并用于制备本发明可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP69加到水相中并在约70℃至80℃搅拌约4至5小时。将果胶非常慢地加到水相中并在高速率下混合。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将山梨酸钾、增甜剂和着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料、甘油、薄荷醇和表面活性剂合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感决定)。
                                表3
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   22.6123   7.7289   38.6445
  Amberlite IRP69   16.0000   24.1197   8.2442   41.2208
  果胶USP   0.3500   0.5276   0.1803   0.9017
  黄胞胶   0.0769   0.1159   0.0396   0.1981
  槐树豆胶   0.0901   0.1358   0.0464   0.2321
  角叉菜胶   0.3861   0.5820   0.1989   0.9947
  支链淀粉   20.5919   31.0420   10.6102   53.0509
  山梨酸钾   0.0772   0.1164   0.0398   0.1989
  纯净水   -   -   65.8199   329.0995
  薄荷醇   2.5740   3.8803   1.3263   6.6314
  薄荷香料   0.2579   0.3888   0.1329   0.6644
  樱桃香料(Givudan)   0.2579   0.3888   0.1329   0.6644
  樱桃香料掺合物(IFF)   2.2350   3.3692   1.1516   5.7580
  Warm Sensation(Mane)   0.5518   0.8318   0.2843   1.4216
  人工掩蔽剂香料(Robertet)   0.4139   0.6239   0.2133   1.0663
  Succulence(IFF)   0.2579   0.3888   0.1329   0.6644
  FD&C Red#40   0.0098   0.0148   0.0050   0.0252
  聚山梨酯80NF   0.4504   0.6790   0.2321   1.1604
  Atmos 300   0.4504   0.6790   0.2321   1.1604
  甘油   1.9305   2.9102   0.9947   4.9735
  甘露醇USP   2.5740   3.8803   1.3263   6.6314
  三氯半乳蔗糖   1.8000   2.7135   0.9275   4.6373
  总计   66.3357   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例4
根据下列步骤，将表4列出的成份合并用于制备本发明可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP64加到水相中并在约70℃至80℃搅拌约4至5小时。将果胶非常慢地加到水相中并在高混合率下混合。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将山梨酸钾和着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料、甘油、薄荷醇和表面活性剂合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇和三氯半乳蔗糖一起混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感决定)。
                             表4
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   22.6123   7.7289   38.6445
  Amberlite IRP64   16.0000   24.1197   8.2442   41.2208
  果胶USP   0.3500   0.5276   0.1803   0.9017
  黄胞胶   0.0769   0.1159   0.0396   0.1981
  槐树豆胶   0.0901   0.1358   0.0464   0.2321
  角叉菜胶   0.3861   0.5820   0.1989   0.9947
  支链淀粉   20.5919   31.0420   10.6102   53.0509
  山梨酸钾   0.0772   0.1164   0.0398   0.1989
  纯净水   -   -   65.8199   329.0995
  薄荷醇   2.5740   3.8803   1.3263   6.6314
  薄荷香料   0.2579   0.3888   0.1329   0.6644
  樱桃香料(Givudan)   0.2579   0.3888   0.1329   0.6644
  酸樱桃(IFF)   2.2350   3.3692   1.1516   5.7580
  Warm Sensation(Mane)   0.5518   0.8318   0.2843   1.4216
  人工掩蔽剂香料(Robertet)   0.4139   0.6239   0.2133   1.0663
  Succulence(IFF)   0.2579   0.3888   0.1329   0.6644
  FD&C Red#40   0.0098   0.0148   0.0050   0.0252
  聚山梨酯80NF   0.4504   0.6790   0.2321   1.1604
  Atmos 300   0.4504   0.6790   0.2321   1.1604
  甘油   1.9305   2.9102   0.9947   4.9735
  甘露醇USP   2.5740   3.8803   1.3263   6.6314
  三氯半乳蔗糖   1.8000   2.7135   0.9275   4.6373
  总计   66.3357   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例5
根据下列步骤，将表5列出的成份合并用于制备本发明可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP69加到水相中并在约70℃至80℃搅拌约4至5小时。将果胶非常慢地加到水相中并在高混合率下混合。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将山梨酸钾和着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和PURE-COTE B793一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料、甘油、橄榄油、薄荷醇和表面活性剂合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇和三氯半乳蔗糖一起混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要尺寸(根据例如剂量和口感决定)。
                                  表5
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   19.5740   10.6759   106.7593
  Amberlite IRP69   16.0001   20.8790   11.3877   113.8771
  果胶USP   0.3499   0.4566   0.2490   2.4905
  黄胞胶   0.0769   0.1003   0.0547   0.5470
  槐树豆胶   0.0901   0.1175   0.0641   0.6409
  角叉菜胶   0.3860   0.5037   0.2747   2.7474
  PURE-COTE B793   20.5919   26.8711   14.6559   146.5586
  山梨酸钾   0.0772   0.1008   0.0550   0.5498
  纯净水   -   -   45.4586   454.5856
  薄荷醇   2.5740   3.3589   1.8320   18.3202
  薄荷香料   0.2579   0.3366   0.1836   1.8357
  樱桃香料(Givudan)   0.2579   0.3366   0.1836   1.8357
  酸樱桃(IFF)   2.2350   2.9165   1.5907   15.9070
  Warm Sensation(Mane)   0.5518   0.7200   0.3927   3.9270
  人工掩蔽剂香料(Robertet)   0.4140   0.5402   0.2946   2.9463
  Succulence(IFF)   0.2579   0.3366   0.1836   1.8357
  FD&C Red#40   0.0099   0.0129   0.0070   0.0704
  聚山梨酯80NF   0.4505   0.5878   0.3206   3.2060
  Atmos 300   0.4505   0.5878   0.3206   3.2060
  甘油   8.7335   11.3966   6.2158   62.1585
  橄榄油   3.49934   4.5586   2.4863   24.8634
  甘露醇USP   2.5740   3.3589   1.8320   18.3202
  三氯半乳蔗糖   1.8001   2.3490   1.2812   12.8116
  总计   76.6324   100.0000   100.0000   1000.0000
 *假定所有水被蒸发
实施例6
根据实施例5的步骤，将表6列出的成份合并用于制备本发明可消耗的膜，由Amberlite IRP69代替Amberlite IRP64。
                                 表6
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   18.5409   10.3611   103.6107
  Amberlite IRP69   16.0001   19.7771   11.0519   110.5186
  果胶USP   0.3499   0.4325   0.2417   2.4170
  黄胞胶   0.0769   0.0950   0.0531   0.5309
  槐树豆胶   0.0901   0.1113   0.0622   0.6220
  角叉菜胶   0.3860   0.4771   0.2666   2.6664
  PURE-COTE B793   20.5919   25.4529   14.2236   142.2363
  山梨酸钾   0.0772   0.0955   0.0534   0.53335
  纯净水   -   -   44.1179   451.1788
  薄荷醇   2.5740   3.1817   1.7780   17.7799
  薄荷香料   0.2579   0.3188   0.1782   1.7816
  樱桃香料(Givudan)   0.2579   0.3188   0.1782   1.7816
  酸樱桃(IFF)   2.2350   2.7626   1.5438   15.4379
  Warm Sensation(Mane)   0.5518   0.6820   0.3811   3.8112
  人工掩蔽剂香料(Robertet)   0.4140   0.5117   0.2859   2.8594
  Succulence(IFF)   0.2579   0.3188   0.1782   1.7816
  FD&C Red#40   0.0099   0.0122   0.0068   0.0684
  聚山梨酯80NF   0.4505   0.5568   0.3111   3.1114
  Atmos 300   0.4505   0.5568   0.3111   3.1114
  甘油   11.6446   14.3935   8.0434   80.4337
  橄榄油   4.8519   5.9973   3.3514   33.5140
  甘露醇USP   2.5740   3.1817   1.7780   17.7799
  三氯半乳蔗糖   1.8001   2.2250   1.2434   12.4337
  总计   80.9021   100.0000   100.0000   1000.0000
 *假定所有水被蒸发
实施例7
根据下列步骤，将表7列出的成份合并用于制备本发明可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水中以得到水相。将Amberlite IRP69加到水相中并在约70℃至80℃搅拌约4至5小时。将果胶非常慢地加到水相中并在高混合率下混合。将水相冷却至约50℃并用适量的水替代蒸发损耗。然后将着色剂加入水相并充分混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中，将食用香料、薄荷醇和表面活性剂合并并混合溶解以得到有机相。
E)在独立的容器中，用剩余的10％的水将甘露醇和三氯半乳蔗糖一起混合。然后将succulence加到得到的混合物中并溶解。
F)将步骤D)和E)的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要尺寸(根据例如剂量和口感决定)。
                              表7
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   22.5510   7.7080   19.2699
  Amberlite IRP64   16.0000   24.0544   8.2218   20.5545
  果胶USP   0.3500   0.5262   0.1799   0.4496
  黄胞胶   0.0769   0.1156   0.0395   0.0988
  槐树豆胶   0.0901   0.1355   0.0463   0.1157
  角叉菜胶   0.3861   0.5805   0.1984   0.4960
  支链淀粉   20.5919   30.9579   10.5814   26.4536
  山梨酸钾   0.0772   0.1161   0.0397   0.0992
  纯净水   -   -   65.8199   164.5498
  薄荷醇   2.5740   3.8698   1.3227   3.3067
  薄荷香料   0.2579   0.3877   0.1325   0.3313
  樱桃香料(Givudan)   0.2579   0.3877   0.1325   0.3313
  酸樱桃(IFF)   2.2350   3.3601   1.1485   2.8712
  Warm Sensation(Mane)   0.5518   0.8296   0.2835   0.7089
  人工掩蔽剂香料(Robertet)   0.4139   0.6223   0.2127   0.5317
  Succulence(IFF)   0.2579   0.3877   0.1325   0.3313
  胭脂红(carmine)   0.1900   0.2856   0.0976   0.2441
  聚山梨酯80NF   0.4504   0.6771   0.2314   0.5786
  Atsurf 596K   0.4504   0.6771   0.2314   0.5786
  甘油   1.9305   2.9023   0.9920   2.4800
  甘露醇USP   2.5740   3.8698   1.3227   3.3067
  三氯半乳蔗糖   1.8000   2.7061   0.9250   2.3124
  总计   66.5159   100.0000   100.0000   250.0000
 *假定所有水被蒸发
实施例8
根据实施例7的步骤，将表8列出的成份合并用于制备本发明可消耗的膜。
                               表8
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   22.5772   7.7169   38.5846
  Amberlite IRP69   16.0000   24.0823   8.2314   41.1569
  果胶USP   0.3500   0.5268   0.1801   0.9003
  黄胞胶   0.0769   0.1157   0.0396   0.1978
  槐树豆胶   0.0901   0.1356   0.0464   0.2318
  角叉菜胶   0.3861   0.5811   0.1986   0.9932
  支链淀粉   20.5919   30.9938   10.5937   52.9686
  胭脂红   0.1900   0.2860   0.0977   0.4887
  纯净水   -   -   65.8199   329.0995
  薄荷醇   2.5740   3.8742   1.3242   6.6211
  薄荷香料   0.2579   0.3882   0.1327   0.6634
  樱桃香料(Givudan)   0.2579   0.3882   0.1327   0.6634
  酸樱桃(IFF)   2.2350   3.3640   1.1498   5.7491
  Warm Sensation(Mane)   0.5518   0.8305   0.2839   1.4194
  人工掩蔽剂香料(Robertet)   0.4139   0.6230   0.2129   1.0647
  Succulence(IFF)   0.2579   0.3882   0.1327   0.6634
  聚山梨酯80NF   0.4504   0.6779   0.2317   1.1586
  Atmos 300   0.4504   0.6779   0.2317   1.1586
  甘油   1.9305   2.9057   0.9932   4.9658
  甘露醇USP   2.5740   3.8742   1.3242   6.6211
  三氯半乳蔗糖   1.8000   2.7093   0.9260   4.6301
  总计   66.4387   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例9
按照不包括树脂的实施例7的步骤，将表9列出的成份合并用于制备本发明可消耗的膜。
                                   表9
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  右美沙芬(光谱)   10.9900   18.3460   5.5038   27.5189
  果胶USP   0.5250   0.8764   0.2629   1.3146
  胭脂红   0.1900   0.3172   0.0952   0.4758
  黄胞胶   0.1154   0.1926   0.0578   0.2888
  槐树豆胶   0.1352   0.2256   0.0677   0.3384
  角叉菜胶   0.5792   0.9668   0.2900   1.4502
  支链淀粉   30.8879   51.5621   15.4686   77.3431
  纯净水   -   -   70   350.0000
  薄荷醇   2.5740   4.2969   1.2891   6.4453
  薄荷香料   0.8000   1.3355   0.4006   2.0032
  樱桃香料(Givudan)   0.8000   1.3355   0.4006   2.0032
  酸樱桃(IFF)   2.2350   3.7310   1.1193   5.5964
  Warm Sensation(Mane)   0.8000   1.3355   0.4006   2.0032
  人工掩蔽剂香料(Robertet)   0.8000   1.3355   0.4006   2.0032
  Succulence(IFF)   0.2579   0.4305   0.1292   0.6458
  聚山梨酯80NF   0.4504   0.7519   0.2256   1.1278
  Atmos 300   0.4504   0.7519   0.2256   1.1278
  甘油   2.0400   3.4054   1.0216   5.1082
  三氯半乳蔗糖   2.7000   4.5072   1.3522   6.7608
  甘露醇USP   2.5740   4.2969   1.2891   6.4453
  总计   59.9042   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例10
根据实施例7的步骤，将表10列出的成份合并用于制备本发明可消耗的膜。
                               表10
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  右美沙芬(粉碎的)   10.9900   26.6157   9.2695   18.5390
  Amberlite IRP69   2.4000   5.8123   2.0243   4.04486
  果胶USP   0.2698   0.6534   0.2276   0.4551
  胭脂红   0.1464   0.3546   0.1235   0.2470
  黄胞胶   0.0594   0.1439   0.0501   0.1002
  槐树豆胶   0.0694   0.1681   0.0585   0.1171
  角叉菜胶   0.2975   0.7205   0.2509   0.5019
  支链淀粉   15.8694   38.4327   13.3850   26.7701
  纯净水   -   -   65.1728   130.3456
  薄荷醇   2.5740   6.2337   2.1710   4.3421
  薄荷香料   0.1987   0.4812   0.1676   0.3352
  樱桃香料(Givudan)   0.1987   0.4812   0.1676   0.3352
  酸樱桃(IFF)   1.7225   4.1716   1.4528   2.9057
  Warm Sensation(Mane)   0.4252   1.0298   0.3586   0.7173
  人工掩蔽剂香料(Robertet)   0.3190   0.7726   0.2691   0.5381
  Succulence(IFF)   0.1987   0.4812   0.1676   0.3352
  聚山梨酯80NF   0.3470   0.8404   0.2927   0.5854
  Atmos 300   0.3470   0.8404   0.2927   0.5854
  甘油   1.4877   3.6029   1.2548   2.5096
  甘露醇USP   1.9837   4.8041   1.6732   3.3463
  三氯半乳蔗糖   1.3873   3.3598   1.1701   2.3402
  总计   41.2914   100.0000   100.0000   200.0000
 *假定所有水被蒸发
实施例11
根据下列步骤将表11列出的成份合并用于制备本发明的可消耗的膜：
A)山梨酸钾和着色剂用80％的水混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和PURECOTE B793一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以形成水合聚合物凝胶。
D)在独立的容器中用20％的剩余水混合甘露醇和三氯半乳蔗糖，然后将其加到水合聚合物凝胶中并充分混合。
E)将磨碎的盐酸法莫替丁加到水合聚合物凝胶中并彻底地混合。
F)将食用香料、甘油、橄榄油和表面活性剂合并并在独立的容器中彻底地混合。
G)将步骤F)得到的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要尺寸(根据例如剂量和口感确定)。
                               表11
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  法莫替丁   10.0000   15.2065   5.3223   106.4453
  黄胞胶   0.1154   0.1754   0.0614   1.2278
  槐树豆胶   0.1352   0.2055   0.0719   1.4386
  角叉菜胶   0.5792   0.8807   0.3082   6.1648
  PURE COTE B793   30.8879   46.9695   16.4393   328.7865
  山梨酸钾   0.1158   0.1761   0.0616   1.2326
  纯净水   -   -   65.0000   1300.0000
  香草薄荷香料(IFF)   2.0000   3.0413   1.0645   21.2891
  聚山梨酯80NF   0.6756   1.0273   0.3596   7.1914
  Atsurf 596K   0.6756   1.0273   0.3596   7.1914
  甘油   10.0000   15.2065   5.3223   106.4453
  橄榄油   4.0000   6.0826   2.1289   42.5781
  FD&C Blue#1   0.0160   0.0243   0.0085   0.1703
  甘露醇USP   3.8610   5.8712   2.0549   41.0985
  三氯半乳蔗糖   2.7000   4.1057   1.4370   28.7402
  总计   65.7615   100.0000   100.0000   200.0000
 *假定所有水被蒸发
实施例12
根据实施例11描述的步骤将表12列出的成份合并用于制备本发明的可消耗的膜，其中由Tapioca Starch J474替代PURE COTE B793。
                                 表12
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  法莫替丁   10.0000   9.7503   4.4512   26.6148
  黄胞胶   0.1154   0.1125   0.0513   0.3070
  槐树豆胶   0.1352   0.1318   0.0602   0.3597
  角叉菜胶   0.5792   0.5647   0.2578   1.5416
  Tapioca Starch J474   67.6870   65.9970   30.1291   180.1720
  山梨酸钾   0.1158   0.1129   0.0515   0.3082
  纯净水   -   -   54.3478   324.9998
  香草薄荷香料(IFF)   2.0000   1.9501   0.8902   5.237
  聚山梨酯80NF   0.6756   0.6587   0.3007   1.7983
  Atsurf 596K   0.6756   0.6587   0.3007   1.7983
  甘油   10.0000   9.7503   4.4512   26.6184
  橄榄油   4.0000   3.9001   1.7805   10.6474
  FD&C Blue#1   0.0160   0.0156   0.0071   0.0426
  甘露醇USP   3.8610   3.7646   1.7186   10.2774
  三氯半乳蔗糖   2.7000   2.6326   1.2018   7.1870
  总计   102.5607   100.0000   100.0000   598.0000
 *假定所有水被蒸发
实施例13
根据下列步骤将表13列出的成份合并用于制备本发明的可消耗的膜：
A)将着色剂、葡萄糖酸酮、乙酰舒泛钾盐和阿司帕坦溶于水并混合约30分钟以得到水相。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在独立的容器中将薄荷香料、Physcool、麝香草酚、水杨酸甲酯、桉叶素和薄荷醇合并并混合溶解以得到有机相。
E)将有机相加到水合聚合物乳液中并均匀地混合得到最终聚合物乳剂混合物。将最终聚合物乳剂混合物倒在模具中并铸型以便在室温下形成需要的厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感决定)。
                                 表13
  材料   ％/w/w*干燥膜   ％w/w实际批   g/批
  黄胞胶   0.1393   0.0344   0.1722
  槐树豆胶   0.2786   0.0689   0.3444
  角叉菜胶   1.3929   0.3444   1.7222
  支链淀粉   66.9165   16.5475   82.7374
  FD&C Green No.3   0.0106   0.0026   0.0131
  葡萄酸铜   1.4459   0.3575   1.7877
  乙酰舒泛钾   1.8083   0.4472   2.2359
  阿司帕坦   5.7875   1.4312   7.1558
  纯净水   -   75.2714   376.3571
  薄荷香料   10.8500   2.6830   13.4152
  Physcool/薄荷香料   0.3625   0.0896   0.4482
  麝香草酚   0.5295   0.1309   0.6546
  水杨酸甲酯   0.7575   0.1873   0.9367
  桉叶素   0.7575   0.1873   0.9367
  薄荷醇   8.9635   2.2165   11.0827
  总计   100.0000   100.0000   500.0000
 *假定所有水被蒸发
实施例14
根据下列步骤将表14列出的成份合并用于制备本发明的可消耗的膜：
A)在75℃将氢溴酸右美沙芬混合并溶于90％水以得到水相。将碳酸氢钠加入并混合约1小时。将Amberlite IRP69加到水相中并在约70℃至80℃搅拌约2小时。将得到的混合物冷却到50℃并用适量的水代替蒸发损耗。然后将着色剂加到水相中并充分地混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉慢慢地加入并迅速地混合在一起形成成膜的混合物。将混合物以低速率混合过夜。将分散在甘油中的果胶非常慢地加到成膜混合物中并在高混合速率下混合。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合速率的条件下过夜混合以制备水合聚合物凝胶。
D)在另一个容器中，将剩余的10％的水加入以溶解甘露醇和三氯半乳蔗糖。然后将Succulence加入并混合溶解。将得到的混合物加到水合聚合物凝胶中。
E)在独立的容器中将食用香料、薄荷醇和表面活性剂合并并混合溶解以得到有机相。
F)将步骤D和E)的混合物加到一起并均匀混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感确定)。
                               表14
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  氢溴酸右美沙芬   15.0000   27.3219   9.6903   484.5135
  Amberlite IRP69   8.0000   14.5717   5.1681   258.4072
  果胶USP   0.2698   0.4914   0.1743   8.7148
  无水碳酸氢钠   4.0000   7.2858   2.5841   129.2036
  胭脂红   0.1464   0.2667   0.0946   4.7289
  黄胞胶   0.0594   0.1082   0.0384   1.91187
  槐树豆胶   0.0694   0.1264   0.0448   2.2417
  角叉菜胶   0.2975   0.5419   0.1922   9.6095
  支链淀粉   15.8690   28.9047   10.2517   512.5830
  纯净水   -   -   64.5329   3226.6450
  薄荷醇   2.5740   4.6884   1.6629   83.1425
  薄荷香料   0.1987   0.3619   0.1284   6.4182
  樱桃香料(Givudan)   0.1987   0.3619   0.1284   6.4182
  樱桃香料掺合物(IFF)   1.7225   3.1375   1.1128   55.6383
  Warm Sensation(Mane)   0.4252   0.7745   0.2747   13.7343
  人工掩蔽剂香料(Robertet)   0.3190   0.5810   0.2061   10.3040
  Succulence(IFF)   0.1987   0.3619   0.1284   6.4182
  聚山梨酯80NF   0.3470   0.6320   0.2242   11.2084
  Atmos 300   0.3470   0.6320   0.2242   11.2084
  甘油   1.4877   2.7100   0.9611   48.0573
  甘露醇USP   1.9837   3.6132   1.2815   64.0753
  三氯半乳蔗糖   1.3873   2.5269   0.8962   44.8110
  总计   54.9011   100.0000   100.0000   50000.0000
 *假定所有水被蒸发
实施例15
根据下列步骤，将表15列出的成份合并用于制备本发明的可消耗的膜：
A)在50℃将氢溴酸右美沙芬与水混合并溶解以得到水相。将山梨酸钾和增甜剂加到水相中并搅拌。然后将二氧化钛加入并将混合物更进一步地搅拌。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉一起混合形成成膜混合物。
C)将成膜混合物慢慢地加到A)的水相中而迅速地混合。将得到的混合物在低混合率下过夜混合得到水合聚合物凝胶。
D)在独立的容器中将甘油和橄榄油混合。将薄荷醇和甘草酸单铵加入到甘油/橄榄油混合油中并在45℃加热溶解。然后将Physcool、聚山梨酸酯80和Atmos 300加到得到的混合物中并更进一步混合得到有机相。
E)将步骤D)得到的混合物加到水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。然后将樱桃香料加到聚合物凝胶混合物中。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感确定)。
                             表15
  材料   mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
  包衣的右美沙芬(60％右旋)   25.0000   27.7778   8.4515   0.2770
  黄胞胶   0.1625   0.1805   0.0549   0.0018
  槐树豆胶   0.1896   0.2106   0.0641   0.0021
  角叉菜胶   0.8124   0.9027   0.2746   0.0090
  支链淀粉   43.3286   48.1429   14.6478   0.4800
  山梨酸钾   0.1625   0.1805   0.0549   0.0018
  乙酰舒泛钾   1.3540   1.5045   0.4577   0.0150
  阿司帕坦NF   3.7913   4.2125   1.2817   0.0420
  纯净水   -   -   69.5744   2.2799
  Physcool   0.2708   0.3009   0.0915   0.0030
  薄荷醇   2.7080   3.0089   0.9155   0.0300
  樱桃香料(Givudan)   0.1354   0.1504   0.0458   0.0015
  甘草酸单铵(MAG)   0.0271   0.0301   0.0092   0.0003
  聚山梨酯80NF   0.9478   1.0531   0.3204   0.0105
  Atmos 300   0.9478   1.0531   0.3204   0.0105
  甘油   8.1241   9.0268   2.7465   0.0900
  橄榄油   1.3540   1.5045   0.4577   0.0150
  FD&C green#3   0.0070   0.0078   0.0024   0.0001
  二氧化钛   0.6770   0.7522   0.2289   0.0075
  总计   90.0000   100.0000   100.0000   3.2770
 *假定所有水被蒸发
实施例16
根据下列步骤，将表16列出的成份合并用于制备本发明的可消耗的膜：
A)将氢溴酸右美沙芬混合并在75℃溶于水中得到水相。将AmberliteIRP69加到水相中并在约70℃至80℃搅拌约2小时。将得到的混合物冷却到50℃并用适量的水代替蒸发损耗。然后将增甜剂和山梨酸钾加到水相中并充分地混合。
B)在独立的容器中将成膜成份、黄胞胶、槐树豆胶、角叉菜胶和支链淀粉慢慢地加入并迅速地混合在一起形成成膜混合物。将混合物在低速率下混合过夜。
C)将成膜混合物慢慢地加到A)的水相中，随后在低混合率的条件下过夜混合以制备水合聚合物凝胶。
D)在另一个容器中，将醇与薄荷醇混合。然后将Physcool加到得到的混合物中并混合。然后将甘草酸单铵、聚山梨酸酯80和Atmos 300和香料加到得到的混合物中并更进一步混合得到有机相。将甘油和甘露醇加到混合物中并混合。
E)将步骤D)得到的混合物加到步骤C)的水合聚合物凝胶中并均匀地混合得到最终聚合物凝胶混合物。将最终聚合物凝胶混合物倒在模具中并铸型以便在室温下形成需要厚度的膜。将膜在暖风下干燥并切成需要的尺寸(根据例如剂量和口感确定)。
                               表16
 材料   Mg/剂量*   ％/w/w*干燥膜   ％w/w实际批   g/批
 氢溴酸右美沙芬   15.0000   21.4286   9.2666   11.4615
 Amberlite IRP69   16.0000   22.8571   9.8843   12.2256
 黄胞胶   0.0944   0.1348   0.0485   0.0600
 槐树豆胶   0.1101   0.1573   0.0566   0.070
 角叉菜胶   0.4718   0.6740   0.2425   0.3000
 支链淀粉   25.1613   35.9447   12.9359   16.0000
 山梨酸钾   0.0944   0.1348   0.0485   0.0600
 乙酰舒泛钾   0.7863   1.1233   0.4042   0.5000
 阿司帕坦NF   2.2016   3.1452   1.1319   1.4000
 纯净水   -   -   56.7561   70.2000
 乙醇USP   -   -   4.0425   5.000
 Physcoo1   0.1573   0.2247   0.0808   0.1000
 薄荷醇   2.3589   3.3698   1.2127   1.5000
 薄荷香料   0.1573   0.2247   0.0808   0.1000
 覆盆子香料(Givudan)   0.7863   1.1233   0.4042   0.5000
 甘草酸单铵(MAG)   0.0157   0.0225   0.0081   0.0100
 聚山梨酯80NF   0.5504   0.7863   0.2830   0.3500
 Atmos 300   0.5504   0.7863   0.2830   0.3500
 甘油   2.3589   3.3698   1.2127   1.5000
 甘露醇USP   3.14520   4.4931   1.6170   2.0000
 总计   70.000   100.0000   100.0000   123.6872
*假定所有水被蒸发
前述的讨论仅仅公开并描述了本发明的示范性实施方案。本领域技术人员将轻易地从这种讨论和伴随的权利要求中认识到，在不背离下列权利要求限定的本发明的实质和范围前提下可产生多种改变、改良和变化。

Claims (15)

1.适合于粘附到并溶解于包括人的温血动物的口腔的可消耗的膜，其包括至少一种水溶性聚合物、掩蔽味道有效量的三氯半乳蔗糖和药物活性剂。
2.权利要求1的可消耗的膜，还包括第二种增甜剂，该增甜剂选自糖精、阿司帕坦、木糖醇、乙酰舒泛钾及其混合物。
3.权利要求1的可消耗的膜，其中增甜剂以基于可消耗的膜的总量的约0.1％～10％的量存在。
4.权利要求1的可消耗的膜，其中药物活性剂选自乙酰水杨酸、对乙酰氨基酚、布洛芬、酮洛芬、二氟尼柳、非诺洛芬钙、萘普生、托美汀钠、吲哚美辛、氟比洛芬钠、塞来考昔、伐地考昔、罗非考昔及其混合物。
5.权利要求1的可消耗的膜，其中药物活性剂为伐地考昔。
6.权利要求1的可消耗的膜，其中药物活性剂选自苯佐那酯、乙二磺酸咳美芬、薄荷醇、氢溴酸右美沙芬、盐酸氯苯胺丙醇及其混合物。
7.权利要求1的可消耗的膜，其中药物活性剂选自盐酸伪麻黄碱、去氧肾上腺素、苯丙醇胺、硫酸伪麻黄碱及其混合物。
8.权利要求1的可消耗的膜，其中药物活性剂选自马来酸溴苯吡胺、马来酸氯非那敏、马来酸氯苯吡醇胺、延胡索酸氯马斯汀、马来酸右氯苯那敏、盐酸苯海拉明、马来酸阿扎他定、柠檬酸苯海拉明、盐酸二苯拉林、琥珀酸多西拉敏、盐酸异丙嗪、马来酸吡拉明、柠檬酸曲吡那敏、盐酸曲普利啶、阿伐斯汀、氯雷他定、溴苯那敏、右溴苯那敏、非索非那定、西替利嗪及其混合物。
9.权利要求1的可消耗的膜，其中药物活性剂选自法莫替丁、雷尼替丁及其混合物。
10.权利要求1的可消耗的膜，其中至少一种水溶性的聚合物选自支链淀粉、羟丙基甲基纤维素、羟乙基纤维素、羟基丙基纤维素、聚乙烯基吡咯烷酮、羧甲基纤维素、聚乙烯醇、海藻酸钠、聚乙二醇、黄蓍胶、瓜尔胶、金合欢树胶、阿拉伯胶、聚丙烯酸、甲基丙烯酸甲酯共聚物、羧基乙烯基聚合物、直链淀粉、高直链淀粉、羟丙基化高直链淀粉、糊精、果胶、甲壳质、壳聚糖、果聚糖、爱生兰、胶原、明胶、玉米蛋白、谷蛋白、大豆蛋白分离物、乳清蛋白分离物、酪蛋白及其混合物。
11.权利要求1的可消耗的膜，其中所述至少一种水溶性聚合物为支链淀粉。
12.权利要求1的可消耗的膜，其中药物活性剂为至少一种精油，该精油选自麝香草酚、薄荷醇、水杨酸甲酯(冬青油)、桉叶素、香芹酚、樟脑、茴香脑、香芹酮、丁香酚、异丁香酚、柠檬烯、osimen、正癸醇、citronel、α-salpineol、乙酸甲酯、乙酸香茅醇酯、甲基丁香酚、桉油醇、芳樟醇、ethyllinalaol、safrolar vanillin、留兰香油、薄荷素油、柠檬油、橙油、鼠尾草油、迷迭香油、肉桂油、众香子油、月桂油、香柏叶油、gerianol、马鞭草烯酮、茴香油、月桂油、苯甲醛、香柠檬油、苦扁桃、氯麝酚、肉桂醛、香茅油、丁香油、煤焦油、桉树油、愈创木酚、熏衣草油、芥子油、安息油、水杨酸苯酯、松油、松叶油、黄樟油、穗熏衣草油、苏合香脂、麝香草油、妥鲁香脂、terpentine oil、丁香油及其组合。
13.权利要求12的可消耗的膜，其中至少一种精油选自麝香草酚、水杨酸甲酯、桉油精、薄荷醇及其混合物。
14.权利要求1的可消耗的膜，其中所述膜为单层的形式。
15.用于在包括人的温血动物口腔内递送药物活性剂的方法，所述方法包括将权利要求1的可消耗的膜给药至口腔。
CNA2004800175922A 2003-04-25 2004-04-13 含有三氯半乳蔗糖作为增甜剂的速溶口服可消耗膜 Pending CN1809343A (zh)

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CN104126656A (zh) * 2014-07-22 2014-11-05 上海海洋大学 一种具有抑菌功能的壳聚糖-橘皮精油复合保鲜膜
CN111372555A (zh) * 2017-11-21 2020-07-03 3M创新有限公司 口腔用水包植物基油乳液及使用方法

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