CN103298590B - 小的膜条带的制造 - Google Patents
小的膜条带的制造 Download PDFInfo
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- CN103298590B CN103298590B CN201180056133.5A CN201180056133A CN103298590B CN 103298590 B CN103298590 B CN 103298590B CN 201180056133 A CN201180056133 A CN 201180056133A CN 103298590 B CN103298590 B CN 103298590B
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- B29C48/15—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
- B29C48/154—Coating solid articles, i.e. non-hollow articles
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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Abstract
本发明涉及用于形成膜的方法。特别地,本发明涉及通过使用个体的泵将个体的湿的膜产品沉积在基底(substrate)上从而在基底上形成膜。
Description
发明领域
本发明涉及用于形成膜(film)的方法。特别地,本发明涉及通过使用个体的泵在基底上形成膜,特别是小的膜条带(smallfilmstrip)。
发明背景
膜用于施用活性试剂(例如药物(pharmaceutical)、化妆品和其他材料)的用途变得越来越流行。这种膜应具有相当均一的大小以及组分的基本均一分布。当膜包含药用组分时,组分的基本均一分布是十分重要的,以确保精确的剂量。
可以以任何期望的方式形成膜,并且在一些情况中,可用于在基底的表面上形成膜。基底用于形成膜的用途不仅提供了加工中的容易性,而且还可有助于包装膜产品。通常,使湿膜形成基质(wetfilm-formingmatrix)沉积在基底的表面上,之后干燥以形成所得膜,之后制定所得膜的大小并将其切成个体的膜条带产品。但是,遗憾的是,这种典型过程因制定大小和切割过程而导致了大量的废弃膜。
此外,传统加工方法使用具有多个槽模(slotdie)或其他孔口(orifice)的单一泵输送机制(onepumpingmechanism)。这种方法具有通过孔口不均衡地分配湿膜形成基质的趋势,给出不规则且不均一的剂量。此外,在具有高固体或颗粒含量之膜基质的情况下,孔口可具有变得被阻塞的趋势。单一泵输送机制用于多个孔口的用途可能无法提供疏通被阻塞孔口的足够的压力,导致某些孔口分配更高量的膜形成基质。因此,这种传统加工的最终结果是潜在的不均一剂量以及缺乏组分均一性的产品。
本发明力图解决采用传统膜加工引起的问题,例如,通过提供这样的方法:在不需要制定膜产品大小的情况下持续地生产膜产品,而同时提供均一的膜剂。
发明概述
在本发明的一个实施方案中,提供了形成多个个体的膜产品的方法,其包括以下步骤:(a)提供存放膜形成基质的贮库(reservoir);(b)提供与所述贮库相关联的多个个体的容积泵;(c)提供多个孔口,其中每个孔口与个体的容积泵相关联;(d)将所述膜形成基质从所述贮库供料至所述个体的容积泵;(e)从每个所述容积泵通过与其相关联的孔口分配预定量的所述膜形成基质;和(f)将个体的湿的膜产品挤出至基底上。
本发明的其他实施方案可提供形成多个个体的膜条带的方法,其包括以下步骤:(a)提供存放膜形成基质的贮库;(b)提供与所述贮库相关联的多个个体的计量泵;(c)提供多个孔口,其中每个孔口与个体的计量泵相关联;(d)将所述膜形成基质从所述贮库供料至所述多个个体的计量泵;(e)从每个所述计量泵通过与其相关联的孔口分配预定量的所述膜形成基质;和(f)通过所述孔口将个体的湿的膜条带挤出至基底上。
在本发明的另一个实施方案中,提供了用于形成多个个体的膜产品的装置,其包括:用于存放膜形成基质的贮库;与所述贮库相关联的多个个体的容积泵;多个孔口,每个孔口与容积泵相关联;基底;和用于使所述基底穿过所述装置的设备。
在本发明的另一个实施方案中,提供了形成多个个体的膜贴片的方法,其包括以下步骤:(a)提供包含第一聚合物材料的基底,所述基底具有顶面,其中所述基底沿着第一方向持续地移动;(b)提供存放膜形成基质的贮库,所述膜形成基质包含第二聚合物材料和活性物;(c)提供与所述贮库相关联的多个个体的容积泵;(d)提供多个孔口,其中每个孔口与个体的容积泵相关联,其中每个孔口通过间隙彼此分开;(e)将所述膜形成基质从所述贮库供料至所述个体的容积泵;(f)从每个所述容积泵通过与其相关联的孔口分配预定量的所述膜形成基质;(g)随着所述基底沿着所述第一方向移动,将所述预定量的所述膜形成基质挤出至所述基底的所述顶面上,以形成多个个体的湿的膜产品;以及(h)干燥所述个体的湿的膜产品以形成包含第一层基底和第二层干燥的膜产品的多个贴片。
附图说明
图1是能够形成个体的膜产品的本发明之一个实施方案的描述。
图2是能够形成个体的膜条带的本发明之第二实施方案的描述。
图3A和3B是由本发明之一个可替换实施方案形成的膜贴片的描述。
图4是能够形成基底和基底之表面上多个个体的膜产品的本发明之另一个实施方案的描述。
发明详述
本发明涉及用于为形成膜产品而设计的方法和装置,其包括含有至少一种活性组合物的膜产品。具体地,本发明涉及在基底上形成膜产品同时维持个体的膜产品的含量均一性和结构完整性的方法。本发明还提供用于形成使在膜加工中通常需要废弃的量最小化之膜产品的方法和装置。膜系统体现了这样的技术领域,在向对有需要之个体施用药(drug)、药剂(medicament)和多种其他活性物(active)以及试剂(agent)递送系统的范围中具有主要的优点。为了提供表现出有利特征和期望性质(包括含量均一性)的期望终产品,膜条带的加工和制造以及膜技术是技术上的需要并且难以处理。
本文所使用的术语“药物”、“药剂”、“药”和“活性物”可以相互交换使用,并且是指可用于预防或治疗病症的物质或组合物。这些术语可包括药物、营养品、化妆品、生物制剂、生物有效物质等。
应理解,术语“膜”包括任何厚度(包括膜和膜条带、片(sheet)、盘(disc)、圆片(wafer)等)、任何形状(包括矩形、正方形或其他期望的形状)的递送系统。膜可以是连续卷绕之膜的形式或者可以被制成期望的长度和宽度。本文中描述的膜可以是适合用于预期用途的任何期望的厚度和大小。例如,本发明的膜可以被制成使其可以放置在使用者口腔中的大小。其他膜可以被制成用于使用者皮肤(即局部使用)的大小。例如,一些膜可以具有约0.1至约10密耳的相对薄的厚度,而另一些可以具有约10至约30密耳的稍厚的厚度。对于一些膜,尤其是旨在用于局部的那些,厚度可能甚至更大,即,大于约30密耳。此外,术语“膜”包括包被在膜和类似物上的单层组合物和多层组合物(例如复合薄膜(laminatedfilm))。通过膜的加工,干燥的膜形式的组合物保持组分的均一分布。膜可以在两层膜之间包含药剂袋或药剂区。
本文中使用的术语“贴片”旨在包含多层膜产品,其中第一层(或“背衬层(backinglayer)”)是具有比第二层(或“活性层”)低的溶解速率的膜产品。本文中描述的贴片通常包含彼此粘附或层压的第一层和第二层,其中第二层具有比第一层小的长度和/或宽度,使得在第二层的外面可见第一层的至少一部分表面(包括,但不限于,图3B中所示以及本文中进一步详细描述的设计)。
通过本发明形成的膜可适合用于施用至使用者之身体的至少一个区域,例如粘膜区域或使用者之体内的区域(例如内脏的表面上)。在本发明的一些实施方案中,所述膜旨在用于经口施用。在另一些实施方案中,所述膜旨在用于局部施用。本文中使用的术语“局部剂(topicalagent)”意在涵盖施用于特定表面区域的活性物。例如,在一个实施方案中,局部剂被施用在皮肤的区域。在另一些实施方案中,还可使局部剂施用于身体的粘膜区域,例如身体的经口(例如口腔(buccal)、舌下、舌)、阴道、眼睛和肛门区域。仍在一些实施方案中,使局部剂应用至使用者的内脏或其他的身体表面(例如在手术期间),其中可在手术完成后使所述局部剂移出或留在身体内。在另一些实施方案中,使局部剂应用于硬的表面,例如需要治疗的特定表面。在另一些实施方案中,本发明的膜是可吸收的,并且旨在放置于使用者的口中并随着膜崩解而咽下。
药剂可以分散在整个膜中,或者其可以沉积在膜的一个或更多个表面上。无论哪种方式,期望每单位面积的药剂量在整个膜中基本均一。“单位面积”旨在包括合适的单位面积,例如一个典型剂量单位的面积。期望地,本发明的膜具有在给定膜的整个体积中的均一的组分分布。这种均一性包括每单位体积的膜具有基本均一的药剂量,无论药剂是在膜的基质中,还是被包被、层压或固定在其一个或更多个表面上。当这种膜被切成个体的单位时,可以非常精确的知道单位中的药剂量。对于本文中形成的膜,本领域普通技术人员应理解,所得的膜不需要精确地100%均一。全部所需要的程度是,所述膜是“基本均一”,即,微量的不均一性被理解为是可接受的。“基本均一”可包括,例如,膜每个区域彼此之间在含量上约90%均一,或者膜每个区域彼此之间在含量上约95%均一,以及最期望地膜每个区域彼此之间在含量上约99%均一。
期望的是,通过本发明形成的任何个体的膜产品(即,具有基本类似质量和体积的产品)彼此之间在含量上是基本均一的。即,通过本发明形成的个体的膜产品(包括大约相等大小的个体的剂量)应具有与每个其他膜产品大约相同含量的组合物。当然,应理解的是,在制造过程期间预期有一些偏差,但期望的是,个体的膜产品彼此之间在含量上应是至少90%均一的。换句话说,“基本均一”可意指个体的膜产品彼此之间应变化不超过约10%。在一些实施方案中,“基本均一”可意指个体的膜产品彼此之间应变化不超过约5%。
药剂在整个膜中的均一性对于向使用者施用精确且有效剂量的药剂来说非常重要。可以使用多种形成均一膜的方法以及多种聚合物、添加剂和填料,包括美国专利No.7,425,292、7,357,891和7,666,337中描述的那些方法和材料,其全部内容通过引用并入本文。在本文中讨论的膜中可包含任何数目的活性组分或药用剂。可将所述活性组分沉积在本文中形成的膜产品的任何层内或可将它们放置在膜产品的一个或更多个表面上。
可用的药的非限制性实例包括血管紧张素转换酶抑制剂、抗心绞痛药、抗心律失常药、平喘药、抗胆固醇血症药(anti-cholesterolemic)、镇痛药、麻醉药、抗惊厥药、抗抑郁药、抗糖尿病药、止泻制剂、解毒药、抗组胺药、抗高血压药、抗炎剂、抗脂质剂、抗躁狂药、止呕药、抗中风药、抗甲状腺制剂(anti-thyroidpreparation)、抗肿瘤药(anti-tumordrug)、抗病毒剂、痤疮药、生物碱、氨基酸制剂、镇咳药、抗尿酸血症药、抗病毒药、促合成代谢制剂(anabolicpreparation)、系统性和非系统性抗感染剂、抗肿瘤药(anti-neoplastic)、抗帕金森氏病剂、抗风湿剂、食欲刺激药、生物应答调节剂、血液调节剂、骨代谢调节剂、心血管剂、中枢神经系统刺激剂、胆碱酯酶抑制剂、避孕药、减充血剂、膳食补充剂、多巴胺受体激动剂、子宫内膜异位治疗药、酶类、勃起功能障碍治疗药、生育剂(fertilityagent)、胃肠病药、顺势治疗药(homeopathicremedy)、激素类、高钙血症和低钙血症治疗药、免疫调节剂、免疫抑制剂、偏头痛制剂、晕动病治疗药(motionsicknesstreatment)、肌肉松弛药、肥胖症治疗剂、骨质疏松制剂、催产药、副交感神经阻滞药(parasympatholytic)、拟副交感神经药(parasympathomimetic)、前列腺素、心理治疗药、呼吸系统剂(respiratoryagent)、镇静药、辅助戒烟药、交感神经阻滞剂、震颤制剂(tremorpreparation)、泌尿道药物、血管舒张药、泻药、抗酸药、离子交换树脂、解热药、食欲抑制剂、祛痰剂、抗焦虑剂、抗溃疡剂、抗炎物质、冠状动脉扩张器(coronarydilator)、脑血管扩张器、外周血管扩张器、精神药物(psycho-tropic)、刺激剂、抗高血压药、血管收缩剂、偏头痛治疗剂、抗生素、安定药、抗精神病药、抗肿瘤药、抗凝剂、抗血栓药、催眠药、镇吐药(anti-emetic)、止呕药、抗惊厥药、神经肌肉药(neuromusculardrug)、高血糖和低血糖剂、甲状腺和抗甲状腺制剂、利尿剂、解痉药、子宫弛缓药(uterinerelaxant)、抗肥胖药、红血球生成药、平喘剂、咳嗽抑制剂、粘液溶解剂、DNA和基因修饰药及其组合。
预期用于本发明的药用活性成分的实例包括抗酸药、H2-拮抗剂和镇痛药。例如,可以单独使用成分碳酸钙或使用其与氢氧化镁和/或氢氧化铝的组合来制备抗酸剂量。此外,抗酸药可以与H2-拮抗剂组合使用。
镇痛药包括阿片类(opiates)和阿片衍生物,例如羟考酮(可商购为);布洛芬(可商购为MotrinMotrinAdvilMotrinMotrinIbu- Ibu-MidolCramp MotrinMigraine和)、阿司匹林(可商购为Genuine和)、对乙酰氨基酚(可商购为SilapapSilapapTylenolTylenolExtraTylenolInfants’TylenolTylenolT-Q- 和)及其组合,其可任选地包含咖啡因。可以用于本发明的另一些疼痛缓解药包括盐酸哌替啶(可商购为)、辣椒素(可商购为)、硫酸吗啡和盐酸纳曲酮(可商购为)、盐酸氢吗啡酮(可商购为)、萘磺酸丙氧芬和对乙酰氨基酚(可商购为Darvocet-)、芬太尼(可商购为和)、透明质酸钠(可商购为)、阿达木单抗(可商购为)、琥珀酸舒马曲坦(可商购为)、离子渗透型芬太尼(fentanyliontophoretic)(可商购为)、柠檬酸邻甲苯海明(orphenadrinecitrate)(可商购为)、四水水杨酸镁(可商购为)、盐酸羟吗啡酮(可商购为Opana)、美索巴莫(methocarbamol)(可商购为)、卡利普多(carisoprodol)(可商购为)、盐酸曲马朵(可商购为和)、硫酸吗啡(可商购为MS)、美他沙酮(可商购为)、盐酸羟考酮(可商购为)、对乙酰氨基酚/盐酸羟考酮(可商购为)、羟考酮/阿司匹林(可商购为)、重酒石酸氢可酮/对乙酰氨基酚(可商购为)、重酒石酸氢可酮/布洛芬(可商购为)、奈帕芬胺(nepafenac)(可商购为)和普瑞巴林(pregabalin)(可商购为)。
本发明还可包括药物如NSAID,包括依托度酸(可商购为)、酮洛酸氨丁三醇(可商购为或)、萘普生钠(可商购为)、氟比洛芬(可商购为)、双氯芬酸钠/米索前列醇(可商购为)、塞来昔布(可商购为)、舒林酸(可商购为)、奥沙普秦(可商购为)、吡罗昔康(可商购为)、吲哚美辛(可商购为)、美洛昔康(可商购为)、甲芬那酸(可商购为)、托美丁钠(可商购为)、三水杨酸胆碱镁(可商购为)、双氯芬酸钠(可商购为)、双氯芬酸钾(可商购为或)和米索前列醇(可商购为)。阿片激动剂和拮抗剂(如丁丙诺啡和纳洛酮)为用于本发明的药的另一些实例。用于本发明的另一些优选活性成分的另一些优选药包括止泻药(如洛哌丁胺(loperamide)(可商购为Imodium QCAnti-HealthCareAmericaAnti-LeaderA-和)、硝唑尼特(可商购为)和盐酸地芬诺酯/硫酸阿托品(可商购为))、抗组胺剂、镇咳药、减充血剂、维生素和呼吸清新剂(breathfreshener)。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(可商购为))。
另一些可用于本发明的活性物包括但不限于:酒精依赖的治疗药,如阿坎酸钙(可商购为);过敏治疗药物,如盐酸异丙嗪(可商购为)、苯磺酸贝他斯汀(可商购为)、氢可酮磺化二乙烯苯-乙烯苯共聚物(hydrocodonepolistirex)/氯苯吡胺磺化二乙烯苯-乙烯苯共聚物(可商购为)、盐酸西替利嗪(可商购为)、盐酸西替利嗪/盐酸伪麻黄碱(可商购为Zyrtec-)、盐酸异丙嗪/磷酸可待因(可商购为含可待因)、吡嘧司特(可商购为)、盐酸非索非那丁(可商购为)、盐酸美克洛嗪(meclizinehydrochloride)(可商购为)、盐酸氮斯汀(azelastinehydrochloride)(可商购为)、尼扎替丁(可商购为)、地洛他定(可商购为)、色甘酸钠(可商购为)、盐酸依匹斯汀(可商购为)、盐酸氮斯汀(可商购为)、泼尼松龙磷酸钠(可商购为Orapred)、盐酸奥洛他定(可商购为)、富马酸酮替芬(可商购为)和孟鲁司特钠(可商购为);以及抗组胺剂,如苯海拉明HCl(可商购为)、氯雷他定(可商购为)、阿斯咪唑(可商购为)、萘丁美酮(可商购为)、苯海拉明HCL(可商购为)和氯马斯汀(可商购为)。
本发明的膜还可以包含阿尔茨海默病治疗药物,如盐酸他克林(可商购为)、加兰他敏(可商购为)、盐酸多奈哌齐(可商购为)、酒石酸卡巴拉汀(可商购为)、辛炔(可商购为)和美金刚(可商购为);贫血症药物,如氰钴维生素(可商购为)和菲立莫妥(ferumoxytol)(可商购为);麻醉药,如具有苯佐卡因的安替比林(可商购为 和);心绞痛药物,如苯磺酸氨氯地平(可商购为)、硝酸甘油(可商购为Nitro-Nitro- Transderm-)、单硝酸异山梨醇(可商购为)和二硝酸异山梨醇(可商购为);镇咳药,如愈创木酚甘油醚(guaifensin);抗阿尔茨海默病剂,例如尼麦角林;以及CaH-拮抗剂,如硝苯地平(可商购为和)。
用于本发明的活性物还可包括平喘药,如硫酸沙丁胺醇(可商购为)、异丙托溴铵(可商购为)、昔萘酸沙美特罗(salmeterolxinafoate)(可商购为)、扎鲁司特(可商购为)、氟尼缩松(可商购为)、硫酸奥西那林(可商购为)、沙丁胺醇吸入剂(可商购为)、硫酸特布他林(可商购为)、福莫特罗(可商购为)、色甘酸钠(可商购为)、盐酸左旋沙丁胺醇(可商购为)、齐留通(可商购为)、丙酸氟替卡松/沙美特罗(可商购为)、硫酸沙丁胺醇/曲安奈德(可商购为)、二甲黄嘌呤(可商购为)和倍氯米松(可商购为 );血管性水肿药物,如C1酯酶抑制剂(人)(可商购为)和艾卡拉肽(可商购为);以及抗菌药物,如甲氧苄啶/磺胺甲唑(可商购为)、莫匹罗星(可商购为)、甲硝唑(可商购为)、乙酰磺胺异唑(可商购为)、次水杨酸铋和甲硝唑/盐酸四环素(可商购为Helidac)、呋喃妥因(可商购为)、诺氟沙星(可商购为)、琥乙红霉素/乙酰磺胺异唑(可商购为)和左氧氟沙星(可商购为)。
本发明还可包含一种或更多种抗生素,包括阿莫西林(可商购为)、氨苄西林(可商购为和)、阿莫西林/克拉维酸钾(可商购为)、盐酸莫西沙星(可商购为)、贝西沙星(可商购为)、克拉霉素(可商购为)、头孢布坦(可商购为)、头孢呋辛酯(可商购为)、头孢丙烯(可商购为)、盐酸环丙沙星(可商购为和)、克林霉素磷酸酯(可商购为Cleocin)、盐酸多西环素(可商购为)、地红霉素(可商购为)、红霉素(可商购为E.E.E-Ery-和)、局部用红霉素(可商购为A/T/T-)、吉米沙星(可商购为)、氧氟沙星(市场上已知为 )、泰利霉素(可商购为)、盐酸洛美沙星(可商购为)、盐酸米诺环素(可商购为)、磷霉素氨丁三醇(fosfomycintromethamine)(可商购为)、具钾青霉素(penicillinwithpotassium)(可商购为Penicillin)、甲氧苄啶(可商购为)、盐酸环丙沙星(可商购为Proquin)、利福平、异烟肼和吡嗪酰胺(可商购为)、头孢托仑(可商购为)、头孢克肟(可商购为)、四环素(可商购为Achromycin和)、妥布霉素(可商购为)、利福昔明(可商购为)、阿奇霉素(可商购为)、阿奇霉素混悬剂(可商购为)、利奈唑胺(可商购为)、过氧苯甲酰和克林霉素(可商购为)、红霉素和过氧苯甲酰(可商购为)、地塞米松(可商购为)、环丙沙星和地塞米松(可商购为)、硫酸多粘菌素B/硫酸新霉素/氢化可的松(可商购为)、硫酸粘杆菌素/硫酸新霉素/醋酸氢化可的松/通佐溴胺(可商购为Cortisporin-TC)、头孢氨苄盐酸盐(可商购为)、头孢地尼(可商购为)和加替沙星(可商购为)。
另一些可用的活性物包括癌症治疗药物,包括环磷酰胺(可商购为)、甲氨蝶呤(可商购为和)、柠檬酸他莫昔芬(可商购为)、贝伐单抗(可商购为)、依维莫司(可商购为)、帕唑帕尼(可商购为)和阿那曲唑(可商购为);白血病治疗物,例如奥法木单抗(可商购为);抗血栓药,例如抗凝血酶重组冻干粉(可商购为)、普拉格雷(可商购为);抗凝剂,例如具持续释放双嘧达莫的阿司匹林(可商购为)、华法林钠(可商购为)、双嘧达莫(可商购为)、达肝素(可商购为)、达那肝素(可商购为)、依诺肝素(可商购为)、肝素(可商购为Hep-Lock、Hep-Pak、Hep-PakCVC、HeparinLockFlush)、亭扎肝素(可商购为)和硫酸氢氯吡格雷(可商购为);镇吐药,例如盐酸格拉司琼(可商购为)和大麻隆(可商购为)、盐酸曲美苄胺(可商购为)和盐酸昂丹司琼(可商购为);抗真菌治疗物,例如酮康唑(可商购为)、泊沙康唑(可商购为)、环吡酮(可商购为)、灰黄霉素(可商购为Gris-)、硝酸奥昔康唑(可商购为)、氟康唑(可商购为)、硝酸舍他康唑(可商购为)、盐酸特比萘芬(可商购为)、环吡酮(可商购为)、制霉菌素/曲安奈德(可商购为Mycolog-)、硝酸益康唑(可商购为)、伊曲康唑(可商购为)和特康唑(可商购为)。
活性物还可以包括抗炎药物,如硫酸羟氯喹(可商购为)、丙酸氟替卡松(可商购为)、康纳单抗(可商购为)安西奈德(可商购为)、甲基强的松龙(可商购为)、布地奈德(可商购为Entocort)、阿那白滞素(可商购为)、二醋酸双氟拉松(可商购为)和依那西普(可商购为);解痉药物,如苯巴比妥/硫酸莨菪碱/硫酸阿托品/氢溴酸东莨菪碱(可商购为);抗病毒治疗物,如磷酸奥司他韦(可商购为);抗寄生虫药物,包括替硝唑(可商购为);食欲治疗药物,如醋酸甲地孕酮(可商购为Megace)、盐酸芬特明(可商购为Adipex-)和盐酸二乙胺苯丙酮(可商购为);关节炎药物,包括来氟米特(可商购为)、赛妥珠单抗(可商购为)、双氯芬酸钠(可商购为)、戈利木单抗(可商购为)和托珠单抗(可商购为);膀胱控制药物,如曲司氯铵(可商购为)、醋酸去氨加压素(可商购为)、酒石酸托特罗定(可商购为)、氯化奥昔布宁(可商购为或)、达非那新(可商购为)和琥珀酸索非那新(可商购为);血管收缩药物,如马来酸甲麦角新碱(可商购为);血浆尿酸调节剂,如拉布立酶(可商购为);缺铁性贫血药物,如菲立莫妥(可商购为);淋巴瘤药物,如普拉曲沙(可商购为)、罗米地辛(可商购为);疟疾药物,如蒿甲醚/苯芴醇(可商购为);低钠血症药物,如托伐普坦(可商购为);用于治疗冯威利布兰德疾病(vonWillebranddisease)的药物(可商购为);抗高血压药物,如曲前列环素(可商购为)、他达那非(可商购为);降胆固醇药物,包括帕立骨化醇(可商购为)、匹伐他汀(可商购为)、洛伐他汀、烟酸(可商购为)、盐酸考来替泊(可商购为)、瑞舒伐他汀钙(可商购为)、氟伐他汀钠(可商购为)、阿托伐他汀钙(可商购为)、洛伐他汀(可商购为)、烟酸(可商购为)、普伐他汀钠(可商购为)、具缓冲型阿司匹林的普伐他汀钠(可商购为Pravigard)、消胆胺(可商购为)、辛伐他汀和烟酸(可商购为)、阿替洛尔、氯噻酮(可商购为)、阿替洛尔(可商购为)、非诺贝特(可商购为)、非诺贝特(可商购为)、依泽替米贝/辛伐他汀(可商购为)、考来维仑(可商购为)、富马酸比索洛尔(可商购为)、依泽替米贝(可商购为)、富马酸比索洛尔/氢氯噻嗪(可商购为)和辛伐他汀(可商购为)。
本文的活性物还可以包括慢性肾病药物,如帕立骨化醇(可商购为);避孕药,包括依托孕烯(可商购为)、醋酸炔诺酮、炔雌醇(可商购为Loestrin24)、炔雌醇、诺孕曲明(可商购为Ortho)、左炔诺孕酮(可商购为Plan)、左炔诺孕酮和炔雌醇(可商购为)、左炔诺孕酮、炔雌醇(可商购为)和醋酸甲羟孕酮(可商购为Depo-);COPD药物,如酒石酸阿福特罗(可商购为)和异丙托溴铵、硫酸沙丁胺醇(可商购为);咳嗽抑制剂,包括苯佐那酯(可商购为)、愈创甘油醚、磷酸可待因(可商购为Tussi-Organidin)以及对乙酰氨基酚、磷酸可待因(可商购为Tylenolwith);用于治疗糖尿病的药物,包括盐酸吡格列酮、盐酸二甲双胍(可商购为ACTOplus)、甲磺酸溴隐亭(可商购为)、利拉鲁肽(可商购为)、沙格列汀(可商购为)、盐酸吡格列酮(可商购为)、格列美脲(可商购为)、马来酸罗格列酮、盐酸二甲双胍(可商购为),马来酸罗格列酮(可商购为),马来酸罗格列酮(可商购为)、艾塞那肽(可商购为)、氯磺丙脲(可商购为)、盐酸比格列酮、格列美脲(可商购为)、盐酸二甲双胍(可商购为)、格列吡嗪(可商购为)、格列本脲、二甲双胍(可商购为)、盐酸二甲双弧(可商购为)、西他列汀(可商购为)、地特胰岛素(detemir)(可商购为)、格列吡嗪、盐酸二甲双胍(可商购为)、格列本脲(可商购为)、瑞格列奈(可商购为)、阿卡波糖(可商购为)、那格列奈(可商购为)、醋酸普兰林肽(可商购为)和妥拉磺脲(可商购为)。
本发明的另一些可用的药物可包括消化药物,如柳氮磺胺吡啶(可商购为)、雷贝拉唑钠(可商购为)、鲁比前列酮(可商购为)、盐酸双环胺(可商购为)、硫糖铝(可商购为)、乳果糖(可商购为)、多库酯(可商购为)、巴柳氮二钠(可商购为)、氯沙坦钾(可商购为)、奥沙拉嗪钠(可商购为)、盐酸氯氮克利溴铵(可商购为)、艾美拉唑镁(可商购为)、法莫替丁(可商购为)、兰索拉唑(可商购为)、兰索拉唑和萘普生(可商购为Prevacid)、阿莫西林/克拉霉素/兰索拉唑(可商购为)、奥美拉唑(可商购为)、泮托拉唑钠(可商购为)、盐酸甲氧氯普胺(可商购为或)、西咪替丁(可商购为)、盐酸雷尼替丁(可商购为)和奥美拉唑、碳酸氢钠(可商购为);利尿剂,包括螺内酯、氢氯噻嗪(可商购为)、螺内酯(可商购为)、布美他尼(可商购为)、托拉塞米(torsemide)(可商购为)、氯噻嗪(可商购为)、呋塞米(可商购为)、美托拉宗(可商购为)和氢氯噻嗪、氨苯蝶啶(可商购为)。
本文可用的试剂还可包括用于气肿(emphysema)的治疗物,如噻托溴铵(可商购为);纤维肌痛药物,如盐酸米那普仑(可商购为);用于治疗痛风的药物,如秋水仙碱(可商购为)和非布索坦(可商购为);灌肠治疗物,包括氨基水杨酸(可商购为和);癫痫药物,包括丙戊酸(可商购为)、非尔氨酯(可商购为)、拉莫三嗪(可商购为)、普里米酮(可商购为)、奥卡西平(可商购为)、唑尼沙胺(可商购为)、左乙拉西坦(可商购为)和苯妥英钠(可商购为)。
本文可用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的药和用于影响自主神经活动的药,如增强副交感神经的(胆碱能的)和减弱交感神经的(肾上腺激素能的)活动。用于治疗勃起功能障碍的可用药物包括,例如,作为前列地尔(可商购为)、他达那非(可商购为)、伐地那非(可商购为)、阿朴吗啡(可商购为)、盐酸育亨宾(可商购为)和柠檬酸西地那非(可商购为)而可获得的那些药物。
本文可用的药物还可包括眼药物和治疗物,如盐酸地匹福林(可商购为)、缬更昔洛韦(可商购为)、更昔洛韦眼用凝胶(可商购为);苯磺酸贝他斯汀(可商购为)、贝西沙星(可商购为)、溴芬酸(可商购为)、氟米龙(可商购为)、盐酸毛果芸香碱(可商购为)、环孢素(可商购为)、酒石酸溴莫尼定(可商购为Alphagan)、盐酸多佐胺/马来酸噻吗洛尔(可商购为)、比马前列素(可商购为)、马来酸噻吗洛尔(可商购为)、曲伏前列素(可商购为)、拉坦前列素(可商购为)、碘化二乙氧膦酰硫胆碱(可商购为Phospholine)和兰尼单抗(ranibizumab)(可商购为);流体控制剂,例如乙酰唑胺(可商购为);胆结石药物,包括熊去氧胆酸(ursodiol)(可商购为);用于治疗齿龈炎的药物,包括葡萄糖酸氯已定(可商购为);头痛药物,包括布他比妥/磷酸可待因/阿司匹林/咖啡因(可商购为含可待因)、盐酸那拉曲坦(可商购为)、阿莫曲普坦(可商购为)、酒石酸麦角胺/咖啡因(可商购为)、布他比妥/对乙酰氨基酚/咖啡因(可商购为)、布他比妥/阿司匹林/咖啡因(可商购为)、琥珀酸夫罗曲坦(可商购为)、苯甲酸利扎曲坦(可商购为)、粘液酸异美汀/氯醛比林/对乙酰氨基酚(可商购为)、甲磺酸双氢麦角胺(可商购为)、氢溴酸依拉曲坦(可商购为)和佐米曲坦(可商购为);流感药物,如嗜血杆菌b缀合疫苗;破伤风类毒素缀合物(可商购为);和心脏治疗物,包括硫酸奎尼丁、二硝酸异山梨醇/盐酸肼苯哒嗪(可商购为)、地高辛(可商购为)、醋酸氟卡尼(可商购为)、盐酸美西律(可商购为)、磷酸丙吡胺(可商购为)、盐酸普鲁卡因胺(可商购为)和普罗帕酮(可商购为)。
另一些可用的药物包括肝炎治疗物,包括恩替卡韦(可商购为)、乙肝免疫球蛋白(可商购为HepaGam)和利巴韦林(copegus/rebetol/ribasphere/vilona/virazole)(可商购为);疱疹治疗物,包括盐酸伐昔洛韦(可商购为)、喷昔洛韦(可商购为)、阿昔洛韦(可商购为)和泛昔洛韦(可商购为);用于高血压的治疗物,包括依那普利拉(可商购为)、卡托普利(可商购为)和赖诺普利(可商购为)、盐酸维拉帕米(可商购为)、雷米普利(可商购为)、奥美沙坦酯(可商购为)、氨氯地平/阿托伐他汀(可商购为)、盐酸尼卡地平(可商购为)、盐酸地尔硫(可商购为)、盐酸喹那普利(可商购为)、盐酸喹那普利/氢氯噻嗪(可商购为)、培哚普利(可商购为)、坎地沙坦酯(可商购为)、坎地沙坦酯/氢氯噻嗪(可商购为Atacand)、厄贝沙坦/氢氯噻嗪(可商购为)、厄贝沙坦(可商购为)、苯磺酸氨氯地平/奥美沙坦酯(可商购为)、盐酸左布诺洛尔(可商购为)盐酸倍他洛尔(可商购为)、奈必洛尔(可商购为)、卡托普利/氢氯噻嗪(可商购为)、甲磺酸多沙唑嗪(可商购为)、盐酸可乐定(可商购为)、卡维地洛(可商购为)、纳多洛尔(可商购为)、纳多洛尔/苄氟噻嗪(可商购为)、缬沙坦(可商购为)、伊拉地平(可商购为)、醋酸胍那苄(可商购为)、盐酸胍法辛(可商购为或)、氯沙坦钾/氢氯噻嗪(可商购为)、盐酸普萘洛尔(可商购为)、盐酸普萘洛尔/氢氯噻嗪(可商购为)、依普利酮(可商购为)、安倍生坦(可商购为)、马来酸依那普利/非洛地平(可商购为)、酒石酸美托洛尔(可商购为)、盐酸贝那普利(可商购为)、盐酸贝那普利/氢氯噻嗪(可商购为Lotensin)、氨氯地平/盐酸贝那普利(可商购为)、吲达帕胺(可商购为)、群多普利(可商购为)、替米沙坦(可商购为)、替米沙坦/氢氯噻嗪(可商购为Micardis)、盐酸哌唑嗪(可商购为)、阿米洛利、氢氯噻嗪(可商购为)、福辛普利钠(可商购为ZZXT)、福辛普利钠/氢氯噻嗪(可商购为Monopril-)、吲哚洛尔(可商购为)、非洛地平(可商购为)、柠檬酸西地那非(可商购为)、尼索地平(可商购为)、群多普利/盐酸维拉帕米(可商购为)、阿利克仑(可商购为)、甲磺酸依普沙坦(可商购为)、甲磺酸依普沙坦/氢氯噻嗪(可商购为Teveten)、莫西普利盐酸盐/氢氯噻嗪(可商购为)、莫西普利盐酸盐(可商购为)、马来酸依那普利/氢氯噻嗪(可商购为)和赖诺普利/氢氯噻嗪(可商购为)。
本发明还可包括用于治疗HIV/AIDS的药物,如安普那韦(可商购为)、替普那韦(可商购为)、依法韦仑/恩曲他滨/泰诺福韦(可商购为)、拉米夫定/齐多夫定(可商购为)、硫酸茚地那韦(可商购为)、拉米夫定(可商购为)、沙奎那韦(可商购为)、扎西他滨(可商购为)、洛匹那韦/利托那韦(可商购为)、福沙那韦钙(可商购为)、利托那韦(可商购为)、齐多夫定(可商购为)、硫酸阿扎那韦(可商购为)、依法韦仑(可商购为)、阿巴卡韦/拉米夫定/齐多夫定(可商购为)、地达诺新(可商购为)、甲磺酸奈非那韦(可商购为)、奈韦拉平(可商购为)、富马酸替诺福韦酯(可商购为)、司他夫定(可商购为)和硫酸阿巴卡韦(可商购为);同型半胱氨酸去除剂,包括无水甜菜碱(可商购为);药物,如胰岛素(可商购为和);和HPV治疗物,例如人乳头瘤病毒疫苗(可商购为)或人乳头瘤病毒二价(humanpapillomavirusbivalent)(可商购为);免疫抑制剂,包括环孢素(可商购为和Apo-)。
可用于本发明的试剂还可包括催乳激素抑制剂,如甲磺酸溴隐亭(可商购为);有助于压力测试的药物,例如瑞加德松(可商购为);秃顶药物,包括非那雄胺(可商购为和);胰腺炎治疗物,如吉非贝齐(可商购为);激素药物,如醋酸炔诺酮/炔雌醇(可商购为)、醋酸戈舍瑞林(可商购为)、黄体酮凝胶(可商购为)、黄体酮(可商购为)、鲑鱼降钙素(可商购为)、骨化三醇(可商购为)、左甲状腺素钠(synthroid)(可商购为 )、睾酮(可商购为 和);绝经期药物,如雌二醇/醋酸炔诺酮(可商购为)、屈螺酮/雌二醇(可商购为)、雌二醇/左炔诺孕酮(可商购为Climara)、雌二醇/醋酸炔诺酮(可商购为)、雌二醇(可商购为和)、酯化雌激素和甲睾酮(可商购为)、雌激素(可商购为 Vivelle-)、雌酮硫酸酯哌嗪(可商购为)、缀合雌激素(可商购为)和醋酸甲羟孕酮(可商购为);月经药物,包括醋酸亮丙瑞林(可商购为LupronDepot)、凝血酸(可商购为)和醋酸炔诺酮(可商购为);以及肌肉松弛药,包括盐酸环苯扎林(可商购为)、替扎尼定(可商购为)和硫酸茛菪碱(可商购为)。
本文可使用的试剂还可包括骨质疏松症药物,包括伊班膦酸钠(可商购为)、利塞膦酸(可商购为)、盐酸雷洛昔芬(可商购为)和阿仑膦酸钠(可商购为);促排卵药,包括柠檬酸克罗米酚(可商购为);佩吉特病治疗物,如依替膦酸二钠(可商购为);胰酶缺乏症药物,如胰脂肪酶(可商购为或);用于治疗帕金森病的药物,如二盐酸普拉克索(可商购为)、盐酸罗匹尼罗(可商购为)、卡比多巴/左旋多巴(可商购为Sinemet)、卡比多巴/左旋多巴/恩他卡朋(可商购为)、盐酸司来吉兰(可商购为)、雷沙吉兰(可商购为)、恩他卡朋(可商购为)和盐酸司来吉兰(可商购为);多发性硬化药物,如达伐吡啶(可商购为)和干扰素β-Ib(可商购为);前列腺药物,包括氟他胺(可商购为)、尼鲁米特(可商购为)、度他雄胺(可商购为)、盐酸坦索罗辛(可商购为)、盐酸特拉唑嗪(可商购为)和盐酸阿夫唑嗪(可商购为)。
本发明的膜还可包含精神病药物,包括阿普唑仑(可商购为)、氯氮平(可商购为)、氟哌啶醇(可商购为)、盐酸氟西汀(可商购为)、盐酸舍曲林(可商购为)、阿塞那平(可商购为)、伊潘立酮(可商购为)、盐酸帕罗西汀(可商购为)、阿立哌唑(可商购为)、胍法辛(可商购为)、苯丙胺和甲基苯丙胺(可商购为和)、盐酸氯米帕明(可商购为)、盐酸丁螺环酮(可商购为)、氢溴酸西酞普兰(可商购为)、盐酸度洛西汀(可商购为)、哌甲酯(可商购为Ritalin、)、双丙戊酸钠(丙戊酸)(可商购为)、硫酸右苯丙胺(可商购为)、盐酸文拉法辛(可商购为)、司来吉兰(可商购为)、卡马西平(可商购为)、碳酸锂(可商购为)、马来酸氟伏沙明/盐酸右哌甲酯(可商购为)、盐酸齐拉西酮(可商购为)、甲磺酸双氢麦角碱(可商购为)、草酸依他普仑(可商购为)、氯氮(可商购为)、盐酸吗茚酮(可商购为)、硫酸苯乙肼(可商购为)、替沃噻吨(可商购为)、盐酸地昔帕明(可商购为)、苯二氮类(例如可商购为的那些)、盐酸去甲替林(可商购为)、硫酸反苯环丙胺(可商购为)、丙氯拉嗪、米氮平(可商购为)、利培酮(可商购为)、富马酸喹硫平(可商购为)、盐酸多塞平(可商购为)盐酸托莫西汀(可商购为)、马来酸三甲丙咪嗪(可商购为)、奥氮平/盐酸氟西汀(可商购为)、盐酸丙咪嗪(可商购为)、盐酸普罗替林(可商购为)、盐酸丁氨苯丙酮(可商购为Wellbutrin和Wellbutrin)和奥氮平(可商购为)。
本文可用的试剂还可包括降尿酸治疗物,包括别嘌醇(可商购为);发作(seizure)药物,包括加巴喷丁(可商购为)、乙苯妥英(可商购为)、氨己烯酸(可商购为)和托吡酯(可商购为);用于带状疱疹的治疗物,如带状疱疹活疫苗(可商购为);皮肤护理药物,包括卡西波曲(可商购为)、优特克单抗(可商购为)、特拉万星(可商购为)、异维A酸(可商购为)、氢化可的松/双碘喹啉(可商购为)、磺胺醋酰钠/硫(可商购为)、壬二酸(可商购为)、过氧苯甲酸(可商购为Desquam-)、阿达帕林(可商购为)、氟尿嘧啶(可商购为)、吡美莫司(可商购为)、局部用红霉素(可商购为A/TT-)、氢化可的松(可商购为)、甲硝唑(可商购为)、多西环素(可商购为)、维甲酸(可商购为Retin-和)、对甲氧酚/维甲酸(可商购为)、维生素A酸(可商购为)、卡泊三醇水合物/二丙酸倍他米松(可商购为)、他扎罗汀(可商购为)、醋酸氟轻松(可商购为)、地索奈德(可商购为)、硝酸咪康唑/氧化锌(可商购为)、酮康唑(可商购为)和依法珠单抗(可商购为)。
本文可用的另一些试剂可包括睡眠障碍药物,包括扎莱普隆(可商购为)、艾司佐匹克隆(可商购为)、酒石酸唑吡坦(可商购为Ambien )、劳拉西泮(可商购为)、盐酸氟西泮(可商购为)、三唑仑(可商购为)、氯硝西泮(可商购为)、巴比妥类,例如)、莫达非尼(可商购为)、替马西泮(可商购为)、雷美替胺(可商购为)、氯酸钾(可商购为)、地西泮(可商购为)、夸西泮(可商购为)和艾司唑仑(可商购为);戒烟药物,例如瓦伦尼克林(可商购为)、烟碱如和盐酸丁氨苯丙酮(可商购为);和类固醇类,包括二丙酸阿氯米松(可商购为)、二丙酸倍他米松(可商购为)、糠酸莫美他松(可商购为)、氟替卡松(可商购为FloventFlovent)、醋酸氟轻松(可商购为)、糠酸莫美他松一水合物(可商购为)、去羟米松(可商购为)、克霉唑/二丙酸倍他米松(可商购为)、醋酸泼尼松龙(可商购为Pred BudesonideRhinocort)、泼尼松龙磷酸钠(可商购为)、地索奈德(可商购为)和丙酸卤倍他索(可商购为)。
本发明的膜还可含有可用于甲状腺疾病治疗的试剂,如激素TC和TD(可商购为Armour);用于钾缺乏症治疗的试剂,包括氯化钾(可商购为Micro-);甘油三酯调节剂,包括ω-3-酸乙酯(可商购为);泌尿系统药物,如盐酸非那吡啶(可商购为)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(可商购为);产前维生素(可商购为Advanced Prenate);体重控制药物,包括奥利司他(可商购为)和盐酸西布曲明(可商购为)。
预期用于本发明的常用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(bismuthsubcarbonate)、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)、氨基醋酸、水合硫酸镁铝、氢氧化镁铝、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(milksolid)、磷酸铝二氢钙或磷酸铝氢钙(aluminummono-ordibasiccalciumphosphate)、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。
本发明所使用的药用活性剂可包含过敏原或抗原,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,其为猫或其他有毛动物皮肤和毛发脱落的小鳞屑(tinyscale);昆虫,例如屋尘螨、蜜蜂和黄蜂(wasp);以及药品,如青霉素。
在形成膜的一个特定方法中,将湿膜基质沉积在基底的表面上。可使用任何期望的基底,包括,例如聚酯薄膜(mylar)、纸、塑料、金属、箔及其组合。必要时,可层压基底。还可在于其上沉积湿膜基质之前在一个或更多个表面上化学处理基底。期望地,所述基底是基本平直的,但是是柔软(flexible)的以允许卷起,例如用于贮存或用于包装形成的膜产品。基底可包含一个或更多个坝状物(dam),例如在2010年2月24日提交的申请人的共同代决美国专利申请序列号No.12/711,883中公开的,其全部内容通过引用并入本文。在一些实施方案中,基底可包含可溶解和/或可吸收膜的预形成片,其中使湿膜形成基质沉积在片上,提供多层膜产品。仍在一些实施方案中,基底在其表面上可包含多个预形成膜产品,并且将湿膜基质沉积在预形成膜产品的表面上。
基底可具有期望的任何长度和宽度,这取决于用于加工膜之装置的大小。基底的长度不是关键的,因为在连续之基础上通常可将基底供料至膜形成装置并相应地由使用者制定大小。制定基底之宽度以将其供料至所使用的装置中,并且可如期望地进行改变。通常由基底的宽度确定可在该基底上制备的膜产品的宽度。例如,可在基底上制备以基本并排的方式排列的多个膜条带或个体的膜产品,并且这些膜条带或产品的累积宽度决定基底的期望宽度。那么,通常是批次大小确定膜的累积宽度,继而确定基底的最佳宽度。个体的膜条带或产品的宽度可相对较小,例如,约2mm至约30mm。个体的膜条带的宽度可以是约2mm至约10mm,或者约10mm至约20mm。在一些实例中,可期望个体的膜条带包含大于30mm的宽度。应理解,“个体的膜条带的宽度”旨在为平均宽度,并且在通过本发明形成的个体的膜条带之间可以存在一些变化。
可在基底上沉积任何数目的个体的膜条带或产品。在一些实施方案中,可在基底上沉积约2至约30个个体的膜条带或产品,所述膜条带或产品以基本并排的方式排列,具有分开相邻之膜条带的间隙。在一些实施方案中,在基底上可以有约10至约20个个体的膜条带或产品。例如,在测试运行或其他实验过程期间,可期望在基底上仅沉积一个膜条带或产品。期望地,基底的宽度比干膜条带或产品和其间任意间隙的累积宽度宽至少1英寸。在加工一个或更多个产品中具有比干膜条带或产品和其间之间隙的累积宽度宽的基底是有用的,因为这允许在加工期间的一些偏差。
在使用中,如将在以下进一步详细描述地,将湿膜形成基质沉积在基底的顶面上。在一个优选的实施方案中,通过挤出将湿基质沉积在基底上,但是,可通过任何期望的方式(包括涂布、铸造、喷涂或其他方式)将湿基质沉积在基底上。可以在一种连续带或条带中沉积湿基质,其导致干燥的膜条带,之后所述干燥的膜条带能够被切成数个较小的个体剂量。或者,可以以离散量沉积湿基质,使得沉积的湿基质具有这样的宽度和长度,能够被干燥以形成具有期望宽度和长度的个体的膜产品。
一旦在基底的表面上沉积,可通过任何期望的干燥方式来干燥沉积的湿基质,包括但不限于在之前通过上文引用并入的专利和申请中所述的那些方法。例如,可在烘箱中使膜基质迅速干燥,从而以在首个约0.5至约4.0分钟内提供粘弹性块状物(mass),因此“锁助”膜形成基质的组分。之后可使所得粘弹性块状物进一步干燥以提供最终膜产品。在基底的表面上干燥膜产品的一个益处是可以使膜快速并有效地干燥,导致具有基本平直形式的膜。还可以使膜在干燥期间变得粘附至基底的表面,这有助于包装和分配最终产品。必要时,可将所得干燥的膜产品和在其上沉积所述所得干燥的膜产品的基底一起模切(diecut)并包装,从而使在包装之前将膜产品从基底上移除之需要最小化。例如,可期望使膜产品保持粘附至基底,并且将膜产品/基底产品提供给最终使用者。例如,本方法可用于形成连续的膜产品条带,其可通过例如在2010年2月24日提交的题为“DeviceAndSystemForDetermining,PreparingAndAdministeringTherapeuticallyEffectiveDoses”的美国专利申请号No.12/711,899的申请人共同代决申请(其全部内容通过引用并入本文)中描述的装置进行卷起和分配。
参照附图,本发明提供了用于在最低浪费下有效和连续产生膜产品(尤其是个体的膜产品或膜条带)的系统和方法。通过本发明形成的膜产品提供高含量均一性,并因此提供具有高度精确剂量的膜产品。在图1所示的一个实施方案中,提供了膜形成装置10。膜形成装置10包括基底20。如上所述,可由任何期望的材料形成基底,包括,例如聚酯薄膜、纸、塑料、金属、箔及其组合。必要时,基底20可以是层压的。还可在于其上沉积湿膜基质之前化学处理基底20。期望地,基底20是基本平直的,但是是柔软的以允许卷起。
在一些实施方案中,基底20可包含膜的预形成片(例如可施用至一个或更多个身体表面的可吸收膜或其他生物可相容膜产品)。预形成的膜片可以是自支持的并通过装置供料,或者其可在另一个基底上预形成,从而通过装置而用两者供料。基底20包含顶面和底表面(未示出)。在该实施方案中,能够将湿膜基质沉积在基底20的顶面上。在基质20为膜的预形成片的一些实施方案中,其上湿膜形成基质的沉积提供了多层膜产品,其中预形成膜是第一层(或“背衬层”),沉积的膜形成基质形成了第二层(或“活性层”)。可能有用的是,第一层不包含活性物,而第二层包含活性物,但是两层均可包含活性物。之后可制定所得多层膜的大小并切割以提供个体的多层膜产品。
在另一些实施方案中,基底20可以是非可吸收产品片(即,纸、聚酯薄膜等),在其顶面上包含多个在其上形成的预形成可吸收膜产品。在该实施方案中,可将湿膜基质沉积在预形成膜产品的顶面上。该实施方案形成了多层膜产品,而不需要进一步制定多层膜产品的大小或切割多层膜产品。在另一些实施方案中,以下进一步详细描述,装置10可包括用于在将一个或更多个第二层膜产品沉积在沉积的第一层膜产品之前在基底20的顶面上形成第一层膜产品的设备。
使用之前可将基底20作为基底20的连续卷状物来贮存。在使用中,将基底20的第一末端(未示出)沿着箭头A所示的方向供料至装置10中。使用期间,基底20可以沿着方向A连续行进,在此期间,将湿膜基质沉积在基底20的顶面上,在干燥过程期间被沿着方向A牵引,如以下将进一步详细描述。基底20可以以任何期望的速率行进。鉴于期望烘箱温度,必要时可改变基底20行进的速率以适合膜形成材料的干燥需要。例如,如果期望较长的干燥时间,那么基底20可以以较低速率通过装置10。如果需要较短的干燥时间,那么基底20可以以较高速率通过装置10。此外,在一些实施方案中,速率可控制其上沉积的湿的膜产品的厚度。例如,在挤出过程中,基底20的较快速率可导致其上沉积较薄的湿的膜产品,反之亦然。
如上所述,基底20可以是任何期望的长度或宽度。期望地,基底20的宽度足以允许多个个体的膜产品的沉积以基本并排的方式排列。例如,基底20可足够宽以允许约2至约30个个体的膜产品的沉积基本并排排列。个体的膜产品可在相邻的膜条带之间具有间隙,从而允许用于较简单的加工和分配。
装置10包括贮库30,其被设计用于存放预定量的膜形成基质。膜形成基质包含任何期望的膜形成组分,包括,例如聚合物、溶剂、甜味剂、活性剂、填料等。可用于膜形成基质的组分包括在美国出版物No.2005/0037055中公开的那些,其内容以其全部通过引用并入本文。贮库30可包括多于一个的分隔的框槽(housing)或隔室以贮存膜形成基质的多种组分。例如,可期望在分开的容器中贮存活性组分(而非溶剂或聚合物),直到紧接着在基底20上沉积之前。贮库30优选地是加压的,使得其可有效地推动其中存放的膜形成基质通过装置10。
在一些实施方案中,装置10能够挤出膜形成基质,如以下将进一步详细描述。在一些这样的实施方案中,可期望膜形成基质具有高粘性和/或高固体含量。例如,膜形成基质可包含至少30%固体含量,或者其可包含至少25%固体含量,或者其可包含至少20%固体含量。在另一些实施方案中,基质在流体载体中可以是固体的浆体或悬液。本文中描述的装置10和方法允许加工具有高固体含量的这种膜形成基质,而不担忧系统中的障碍或阻塞。或者,必要时,膜形成基质可具有低固体含量,以及可具有较低粘性。优选的是,膜形成基质具有足够的粘性,从而通常在基底20的表面上沉积之后维持其形状。
连接贮库30的是供料管线或进给管40,其与贮库30流体连接并且将贮库30与多个容积泵50、50’相连接。供料管线40可由任何期望的材料制得,并可具有期望的任何厚度或半径。优选的是,供料管线40具有足够的半径,从而在没有阻塞、障碍或表现出关于不足以将材料供应至泵的足够压力下降下将膜形成基质从贮库30有效地运送至容积泵50。装置10可包括期望的任何数目的容积泵50,这取决于使用者希望生产的个体的膜产品的数目。在一个实施方案中,装置10中的每个容积泵50将用于形成膜产品,因此使用的容积泵50的数目可决定形成的膜产品的数目。期望在装置10中以并排的方式排列容积泵50。供料管线40期望地以并行的方式将膜形成基质从贮库30供料至容积泵50,因此允许每个容积泵50在基本相等的基础上用膜形成基质供料。
容积泵50可以是使用者期望的任何类型泵送装置。期望地,容积泵50为各自大约相等的大小和形状,并且能够从其中分配基本相同量的膜形成基质。尤其期望使用能够在每个泵送循环分配已知量基质的泵50。此外,泵50应能够在通过泵送分配预定量的膜形成基质之后重新注满膜形成基质。特别是,期望泵50在每个泵送循环之后重新注满基本相同量的膜形成基质。因此,每个泵送循环(其包含一次分配膜形成基质和一次重新注满膜形成基质)应包含基本恒定量的膜形成基质。如可理解地,不考虑使用的泵的类型,重要的是泵50提供湿膜基质的精确和一致分配,从而确保每个所得膜产品间的基本均一性。
在一个实施方案中,容积泵50是活塞泵。必要时,容积泵50可包括双活塞泵(dualpistonpump),其中,随着泵50分配一定体积的膜形成基质,泵50同时重新注满另一体积的膜形成基质。在另一些实施方案中,容积泵50可包括齿轮泵。对于含膜贴片的形成,双活塞泵是特别地期望的。装置10可包括至少一个活塞泵、至少一个双活塞泵、至少一个齿轮泵和其组合的组合。活塞泵和双活塞泵是尤其优选的,因为这种泵具有“吸回(suckback)”能力,因此能够防止或降低从其中泵送湿膜基质后流出的量。活塞泵和双活塞泵还提供了随着基底20移动而连续装载和挤出湿膜形成基质的能力。这些泵是有效的,并且还避免了使头歧管(headmanifold)来回移动的需要(如在典型系统中)。
在一些实施方案中,容积泵50可具有可变的冲程和/或可变的速度设定。即,容积泵50可具有可变的冲程,允许使用者能够改变与泵50相关联的冲程以适合特定的需要。在一些实施方案中,容积泵50可分配在约4微升/冲程至约100微升/冲程之间的任何量。容积泵50还可以是可变速度泵,以允许使用者设定期望的特定速度用于形成特定膜产品。例如,如果使用者期望较长的干燥时间,那么可将容积泵50设定为较慢的分配速度,允许较长的过程以及因此较长的干燥时间。或者,对于较短的干燥时间,可期望较高速度泵。容积泵50的速度和冲程可通过装置10与基底20行进的速度有关。
应适当制定本文中使用的容积泵50的大小以提供期望的膜体积。特别地,应制定容积泵50的大小以注满并分配足够量的膜形成基质,从而形成具有期望体积的一个个体的膜产品。例如,在一个实施方案中,期望的所得干燥的个体的膜产品可以是以总重量计约1mg至约20mg。在一些实施方案中,干燥的个体的膜产品可以是以总重量计60mg或更少。应理解,湿的膜产品的重量将高于所得干燥的膜产品,这是因为失去了某些挥发物。容积泵50应能够分配每泵送循环约3微升至约250微升,或者每泵送循环250微升或更少。对于经皮系统,期望的所得个体的干燥的膜产品可以是以总重量计约10mg至约2000mg。因此,容积泵50应能够分配每泵送循环约30微升至约10毫升,以提供期望的所得干燥的膜重量。
在另一个实施方案中,容积泵50可以是正排量泵(positivedisplacementpump)。实例包括渐进腔式泵(progressivecavitypump,又称为progressingcavitypump)、偏心螺杆泵(eccentricscrewpump)或甚至仅腔式泵(cavitypump)。该类型泵的一个特定实例是泵(由Moyno,Inc.制造)。额外的正排量泵包括齿轮泵、罗茨泵(rotarylobepump)、活塞泵、隔膜泵、螺杆泵(screwpump)、液压泵、叶片泵、再生(周边)泵(regenerative(peripheral)pump)和蠕动泵。本发明的系统可包括上述容积泵50中的一种或多于一种。
每个容积泵50期望与涂层头歧管60相关联,所述涂层头歧管60包括多个孔口70、70’。期望地,每个容积泵50与一个个体的孔口70相关联。容积泵50与与其相关联的孔口70流体连通,因此允许从泵50通过孔口70泵送膜形成基质。在一个特定的实施方案中,孔口70是槽模,但孔口70可以是期望的任何其他开口或模。期望地制定孔口70的大小,从而允许形成期望的膜产品。
孔口70期望地与基底20相连通,使得当通过孔口70分配特定量的湿膜形成基质时,使湿膜形成基质沉积在基底20的顶面上。因此,在一个实施方案中,歧管60具有第一侧65A和第二侧65B,孔口70从第一侧65A至第二侧65B贯穿歧管60。泵50与歧管的第一侧65A连通。湿膜基质从贮库30泵送,通过供料管线40,通过泵50,通过孔口70,并沉积在基底20上,在操作期间,基底20沿着方向A行进。特别期望的是,湿膜基质通过孔口70直接挤出在基底20上,因此湿膜基质应具有足够高的粘性和/或固体含量,从而允许挤出。此外,湿膜形成基质应具有足够的粘性,从而通常在于基底20的表面上沉积之后维持其形状和大小。当然,预期的是,基质可以可替换地具有较低粘性,并且基质可通过孔口70简单地流至基底20上。基底20可具有形成的离散坝状物、井(well)或袋状物(pocket),可将湿膜形成基质沉积其中。
在一个实施方案中,可将多个个体的湿的膜产品80、80’以基本并排的方式沉积在基底20的表面上。随着基底20穿过装置10,使个体的湿的膜产品80沉积在基底20上,并且优选地,使每个个体的湿的膜产品80挤出至基底20的区域上,所述区域中没有个体的湿的膜产品80已被挤出。因此,基底20可沿着其长度和其宽度具有沉积的多个个体的湿的膜产品80。制定每个个体的湿的膜产品80的大小,从而提供期望的最终干燥的膜产品。在于其上沉积湿的膜产品80期间,基底20行进的速度可决定或控制湿的膜产品80的大小。特别是,可通过基底20的速度控制湿的膜产品80的厚度,其中,较快移动基底20可提供较薄湿的膜产品80,反之亦然。
在使用期间,每个泵50以道(lane)(85A、85B、85C)将多个个体的湿的膜产品80分配至基底20上。每个道(85)包含多个个体的湿的膜产品80。期望地,每个个体的湿的膜产品80具有基本均一的大小、形状和含量。以这种方式,可以以大量精确性了解每个个体的湿的膜产品80之间的已知剂量。可直接在非膜基底20上沉积个体的湿的膜产品80,或者可在是预形成膜的基底20上沉积个体的湿的膜产品80(从而形成多层膜产品)。期望的是,容积泵50将个体的湿的膜产品80重复地分配至基底20的表面上,从而形成个体的湿的膜产品80的道85。
可在基底20的表面上沉积任何数目的个体的湿的膜产品80。湿的膜产品80的道85的数目取决于装置10中泵50和孔口70的数目。例如,如果装置10包括五个泵50以及与其相关联的孔口70;那么将会有五条在基底20上形成的湿的膜产品80的道85。在装置10中可使用任何数目的泵50和孔口70,并期望在装置10中可以有约2至约30个泵50和孔口70。因此,可以有约2至约30条在基底20上形成的个体的湿的膜产品80的道85。取决于泵50和基底20的速度和速率,每条道85可以有任何数目的个体的湿的膜产品80。如图1所示,期望地在道85中的每个个体的膜产品80之间存在细长的间隙,并且在每个相邻的道85之间存在细长的间隙。个体的湿的膜产品80之间的间隙可有助于加工和随后对所得膜产品的包装。
如上所述,基底20可包含其上预形成的可吸收膜产品,其中可直接在预形成膜产品的顶面上沉积湿的膜产品80。基底上的预形成膜产品可以是膜的连续片。或者,在一些实施方案中,基底20可具有在其表面上预形成的多个个体的膜产品,并且在已经在基底20上预形成的个体的膜产品的表面上沉积湿膜基质(从而形成多层膜产品)。以该方式,可在很少至没有所需的切割和制定大小的情况下形成多层膜产品,因为当干燥时多层的个体的膜产品可简单地从基底20上移除。
个体的湿的膜产品80可以是期望的任何形状,包括正方形、矩形、圆形或另一些期望的形状。个体的湿的膜产品80可以是期望的任何大小,这取决于期望的所得干燥的膜产品的大小。在一些实施方案中,湿的膜产品80可以是小的膜产品,即,在质量上每个大约为1mg。必要时,个体的膜产品80可以较大,例如在质量上每个个体的膜产品为约1mg至200mg。个体的膜产品80可以是200mg或更少,或者100mg或更少。对于经皮系统,个体的膜产品80可以是约10mg至约2000mg,或者2000mg或更少,或者1000mg或更少。
如上所述,在制造过程期间基底20沿着方向A移动。基底20的速率以及泵50的速率确定了加工期间在基底20上沉积的个体的膜产品的数目。在将个体的膜产品80沉积在基底20上之后,使基底沿着方向A继续朝向干燥装置90(例如烘箱)移动。可通过任何期望的方式干燥湿的膜产品80,例如上述的那些干燥方法。在完成干燥过程之后,可从基底上移除多个干燥的个体的膜产品并包装用于分配。或者,可卷起具有干燥的膜产品的基底20并贮存用于将来使用。
在另一个实施方案中,可沿着基底20模切干燥的个体的膜产品以包装用于分配。特别地,在基底20上包含预形成膜的一些实施方案中,切割干燥的个体的膜产品可以是有用的,从而形成切割的多层膜产品。期望地,当从基底20上切割干燥的膜产品时,基底20和其上任何预形成膜产品可不包含任何活性组分。同样,可丢弃从个体的膜产品上切割的剩余材料,无潜在昂贵材料(包括活性物)的浪费。
在一个可替换的实施方案中,图2所示,可将装置110用于形成膜产品180的连续条带或道。形成膜产品180的连续条带可能是有用的,例如在分配膜的连续卷状物的装置中,如上所述。形成膜产品180的连续条带还可有利于贮存、包装和/或分配目的。如上所述,使湿的膜条带产品180沉积在基底120上,所述基底120可以是非膜基底(即,聚酯薄膜、纸等,如上所述)或其上可包含预形成膜。基底120沿着箭头A标记的方向通过如上所述的装置110。
装置110包括如上所述的贮库130,其可以是加压的。将贮库130设计用于存放膜形成基质。必要时,贮库130可包括多于一个隔室,因此能够直到恰好在形成膜产品之前分开存放多种膜形成组分,即,保持将溶剂和聚合物与活性组分分开存放。
供料管线140与贮库130相连接,并使贮库130与多个容积泵150、150’相连接。容积泵150可以是期望的任何泵送机制,并且优选地应是允许从其中连续和均一地分配湿膜基质的泵送机制。通过分配均一和连续量的湿膜基质,可在基底120的表面上形成均一的膜产品180的条带。特别期望的是,膜产品180的每个条带每单位面积包含基本均一量的内含物,尤其是每单位面积包含已知量的活性物。每个条带180应具有基本相同的厚度、宽度和粘性,从而提供基本均一的最终膜产品。因此,容积泵150应能够分配基本均一和连续量的湿的膜产品。在一个期望的实施方案中,容积膜泵150为齿轮泵或计量泵。可使用本领域中任何已知的齿轮泵和/或计量泵。
在装置110中可以存在任何数目的容积泵150,期望地以如图2所示的基本并排的方式排列。优选地,每个容积泵150之间存在空间或间隙,其有助于加工以及随后收集和包装膜产品。相邻的容积泵150之间的间隙的大小应足够大以使得容易制造,但不需要太大而使其降低了装置110中可用泵150的数目。
容积泵150的数目决定了由装置110形成的膜产品180条带的数目。例如,在装置中可以有约2至约30个容积泵150,且更特别的是在装置中有约10至约20个容积泵150。每个容积泵150通过供料管线140与贮库130流体连通,使得在操作期间在均一和连续的基础上将膜形成基质从贮库130提供至泵150。在操作期间,向位于离贮库最近的容积泵150提供的膜形成基质的量应基本等于向位于离贮库最远的容积泵150提供的膜形成基质的量。这确保了所得膜产品180的条带在所有条带180中具有基本均一的含量。
每个容积泵150与歧管160的第一侧165A相相关联,使得可通过歧管160分配膜形成基质。歧管160包括多个贯穿其的孔口170。孔口170从第一侧165A至第二侧165B贯穿歧管160。在一个优选的实施方案中,每个孔口170与一个容积泵150流体连通,使得可通过一个孔口170从一个容积泵150分配膜形成基质。因此,孔口170的数目应等于容积泵150的数目。在一个期望的实施方案中,孔口170是槽模,但孔口170可以是任何期望的开口,可通过其来供料湿膜形成基质。还期望每个孔口170大约与彼此相同大小,包括大约相同的高度、宽度、长度和形状。在该方式中,分配的所得膜产品180的条带将各自具有基本均一的形状、大小和含量。
在使用期间,容积泵150各自通过歧管160通过孔口170分配湿膜形成基质。将湿膜形成基质从孔口170直接沉积在基底120的表面上。在加工期间,使基底120以方向A沿着装置110移动。特别期望使用能够在制造过程期间持续地分配膜形成基质的容积泵150,从而形成膜产品180的连续条带。
基底120的移动速度连同容积泵150的分配速率,控制在基底120的表面上沉积的湿膜形成基质的量。可期望基底120以慢速率移动,例如,如果湿膜形成基质是高粘性的。或者,可期望基底120以较快速率移动,例如,如果湿膜形成基质粘性较低。基底120沿着方向A从歧管160移动至干燥装置190(例如干燥烘箱或用于干燥湿膜基质的其他设备)。基底120的速度和干燥装置190的大小将决定在干燥装置190中干燥湿的膜产品180的时间长度。例如,较快移动基底120和/或较短干燥装置190,湿的膜产品180的干燥将具有与比其较慢移动基底120和/或较长干燥装置190时相比更短的时间长度。
个体的湿的膜产品180条带期望地沿着基底120之表面的长度以列(即,185A、185B、185C)排列。特别优选的是,湿的膜产品180条带以基本并排的方式排列,相邻的道185之间具有足够的空间或间隙以有助于加工和随后收集/包装膜产品。可以存在与期望一样多的列185,每个列185由个体的容积泵150和相关联的孔口170形成。此外,每个相邻的列185之间的空间大约等于装置110中相邻的孔口170之间的空间。膜材料的每个列185期望地是连续沉积的湿膜基质的道,使得在干燥完成后,可收集和包装干燥的膜产品的个体的列185。例如,可期望将个体的列185从基底120上移除并卷起,其中可由最终使用者将其存放在分配装置中用于使用。或者,可沿着基底120切割列185以提供具有基底衬底之膜的连续条带185。此外,可将干燥的膜的条带180切成大约相等大小和形状的个体的膜产品,每个个体的膜产品为一个剂量单位。
在图3A和3B所示的一个特定实施方案中,可使装置用于形成一系列个体的多层产品。例如,个体的多层产品可包括含活性物的贴片。可使图1所示和上述的装置特别地用于形成个体的多层产品,例如贴片。在该实施方案中,基底210可包含可吸收和/或可溶解的膜220的片(本文中也称为“第一层”),其形成了含活性物层的背衬层。在一些实施方案中,可吸收膜220的片可以是基底210,例如如果可吸收膜220的片是自支持的并且能够通过装置自己供料。优选的是,第一层220由粘膜粘附、生物可相容、可溶解的材料制得。可期望的是,第一层220是慢溶解膜片。“慢溶解”是指片220具有比其上粘附的含活性物层(如下所述)的溶解速率久的溶解速率。可在分开的基底上形成第一层220,例如聚酯薄膜、纸或上述其他非可吸收背衬层。可预形成第一层220并干燥,其可以是未干燥的,或者其可以是部分干燥的。例如,第一层220可以是膜形成材料的粘弹性块状物。
第一层220具有第一表面225。如上所述,在加工期间,使多个个体的含活性物之湿膜层230(本文中也称为“第二层”)沉积在第一层220的第一表面225上。期望地,含活性物的湿膜层230由生物可相容聚合物材料制得,其以比第一层220快的速率溶解。如上所述,期望地通过多个容积泵以基本并排的方式沉积含活性物的湿膜层230,在相邻的含活性物之湿膜层230之间存在期望的间隙。
在使个体的含活性物膜层230沉积在第一层220上并干燥后,应使两层(220、230)彼此充分粘附,使得它们不分开。单独的干燥过程可使220、230两层彼此有效粘附,或者在第一层220与含活性物的膜层230之间可以存在应用的粘附组合物。
一旦使含活性物的膜层230(和第一层220(如果必要))充分干燥,那么可制定第一层220的大小并切割。在一个实施方案中,沿着第一方向240(在相邻的含活性物膜层230之间)以及基本垂直于第一方向240的第二方向250(在相邻的含活性物膜层230之间)切割可溶解膜220的片,从而形成一系列个体的多层产品260。如图3B可见,多层产品260包含第一层220和粘附于其上的第二层230。第一层220期望地比第二层230慢地溶解。第二层230期望地包含至少一种活性组分。必要时,第一层220可包含至少一种活性组分,其可与第二层230中的活性组分相同或不同。
在一个实施方案中,优选的是第二层230的大小比第一层220小,即,第二层230的长度和/或宽度比与其相关联的第一层220的长度和/或宽度小。以该方式,第二层230之侧以外暴露出第一层220的至少一部分第一侧225。尤其优选的是,在第二层230之整个外围附近暴露出第一层220的一部分第一侧225。例如,如图3B所示,第二层230可具有比第一层220小的长度和宽度,并且通常将第二层沉积在第一层220的中心。因此,在第二层230之整个外围附近暴露出第一层220之第一侧225。或者,第一层220和第二层230的宽度和/或长度可大约相等。在另一个实施方案中,第一层220和第二层230的一侧或更多侧彼此平齐。
优选的是,至少第一层220之第一侧225由粘膜粘附材料制得,使得可将其充分地应用至使用者身体的粘膜表面并与其粘附。例如,可将所得多层产品260应用至使用者的任何皮肤表面,例如,粘膜表面,包括使用者的口腔、鼻腔、眼、阴道或直肠表面,或者可应用至内部身体器官(例如在手术期间)。在该实施方案中,使用者可将个体的多层产品260应用至皮肤表面,使得第一层220之第一侧225与皮肤表面接触并基本与其粘附。在该实施方案中,含活性物层230直接朝向使用者的皮肤表面。如果第二层230以比第一层220快的速率溶解时,那么可允许第二层230在使用者之皮肤表面的方向上完全溶解,以允许第二层230中包含的一种或更多种任何活性物完全吸收至使用者的身体中。
当然,应理解,上述多层膜产品实施方案可由含活性物膜产品的连续条带(如图2所示和如上所述)形成,这与个体的含活性物膜层230不同。在一个这样的实施方案中,产品可以以这种方式切割,使得在第二层条带之外暴露出第一层220之第一表面225的两个相反侧。
在图4所示的另一个实施方案中,装置310可包括第一膜形成区域310A和第二膜形成区域310B。在一些这样的实施方案中,第一膜形成区域310A可包括第一贮库315,其存放第一膜形成基质。第一膜形成基质通常包含如上所述的膜形成组分,并且可包含活性物或其可不含活性物。装置310包括基底320,其由非可吸收材料(例如聚酯薄膜、纸和上述其他材料)制得。如上述另一些实施方案所述,基底320沿着箭头A所示的方向移动穿过装置310,即,从第一膜形成区域310A至第二膜形成区域310B。第一膜形成区域310A包括第一歧管325,其与第一贮库315流体连接,并旨在于使用期间将第一膜形成材料的连续片330沉积在基底320上。任选地,在第一歧管325之后而在第二膜形成区域310B之前的位置可以存在沉积的第一干燥装置(未示出)。
在使用期间,装置310使第一膜形成材料的片330沉积在基底320上,形成膜形成材料的第一层。可期望的是,在进入第二膜形成区域310B之前,立即干燥第一膜形成材料的片330。或者,可在进入第二膜形成区域310B之前部分干燥第一膜形成材料的片330,例如,以形成膜材料的粘弹性块状物。
第一层膜形成材料330(无论是干燥、未干燥或部分干燥)通过装置310行进至第二膜形成区域310B中。第二膜形成区域310B可包括关于图1或2中所述实施方案的上述组分和方法。例如,第二膜形成区域310B包括第二贮库340,其与第二供料管线345流体连通。第二供料管线345与多个容积泵350相连通。多个容积泵350与第二歧管355相连通,第二歧管355包括多个孔口360。如上所述,期望地,每个孔口360与一个容积泵350相相关联。第二膜形成区域310将多个湿的膜产品365以基本并排的方式以一系列的列(即,370A、370B)沉积在第一层膜形成材料330上。
第一层膜材料330和多个湿的膜产品365通过装置310进行至干燥装置375中,干燥装置375可以是干燥烘箱。例如通过上述的干燥方法来干燥湿的膜产品365(和第一层膜(如果必要))。
一旦充分干燥,可如期望地制定所得多层膜产品(包含第一层330和多个现在干燥的膜产品365)的大小并切割,或者可将其贮存用于将来使用。期望地,第一层330和膜产品365彼此粘附,其可通过以下简单地实现:干燥过程或在沉积膜产品365之前在第一层330与膜产品365之间可以存在应用的粘附组合物。
本发明考虑到并且前提是理解许多这样的问题:所述问题可不利地影响材料通过槽模的流量,这可导致材料流量的变化。某些参数的轻微变化可不期望地改变所得膜的内含物均一性,特别是活性物均一性,这是通过从单一泵供料的多个槽模产生的。在个体的膜或剂量当中的内含物均一性(特别是活性物均一性)在膜制造中是尤其重要的。本发明最小化或同时消除了与使用单一泵相关的潜在问题,如将在以下解释。
在典型系统中和在本发明中,优选的槽模是具有三个维度的矩形孔口:高度(B)、宽度(W)和长度(L)。长度(L)被理解为孔口从模的前方到后方的长度,如图1所示,从第一侧65A至第二侧65B的长度。通过矩形模(例如本发明的槽模)的流量可由Hagen-Poiseuille方程定义:
在上述方程中,Q是容积流率,P是压力,μ是流体流过模的粘性。当在典型的装置中流过多个孔口(例如具有单一泵的槽模涂布器供料具有多个槽模的歧管)时,许多因素可不利地影响流率。甚至这些因素轻微的变化可显著地影响流率,因此影响由装置形成的膜的含量。通过本发明减少或消除了这种系统的潜在不利影响。
例如,压力变化可影响流率,因为在槽模中槽的入口处流量与压力成比例。如果期望基本均一的流量穿过多个槽模,那么重要的是在每个槽模的入口处具有基本相等的压力水平。为了实现穿过所有模的该相等的压力水平,具有对其供料的一个单一泵的歧管设计必须防止歧管内部的流量免受外力的干扰。即,这种歧管内的流量必须不受在流动的流体中之组分的温度、粘性或非均一性分散或凝集(clumping)之变化的干扰。
此外,槽模的高度可对流过流体的流率具有影响。流量与槽的高度的三次方成比例,其通常是槽模的最窄维度。由于这通常是最小的维度,所以不同槽之间该维度中的任何可变性将对基质之流率的可变性百分比具有潜在的高影响,因为所述基质被供料至每个槽模。为了解决该问题,关键是,装置中的每个槽模具有彼此相同的高度维度。甚至在装置中相邻槽模之间的3%的高度差异将导致几乎10%的流率变化。
可影响流率的另一个因素是流过模的流体的粘性。流率与粘性成反比例,使得局部粘性因力的变化(例如温度或不均一性(颗粒在基质中的凝集))将影响通过该槽的流率以及随后通过其余槽模的流率。甚至流率的轻微变化可不利地影响由随后的槽模形成的膜的内含物(包括活性内含物)的均一性。
在本发明中,通过离开连接至个体的槽模之个体的溶剂泵的流量来确定和控制通过每个个体的槽模的流率。本发明通过使用与个体的槽模相关联的多个个体的泵来克服上述问题。在每个个体的泵当中,压力可保持基本恒定水平。此外,由于每个槽模与个体的泵相关联,所以相邻的槽模之间的高度变化将不会对彼此产生影响。最后,使用个体的泵可容易地考虑粘性变化以及使基于其中变化的任何潜在影响最小化。
虽然可通过使用针对多个个体的槽模的单一泵供料歧管来潜在地解决上述问题,但是这种装置将需要包括:不受任何外力影响的歧管;同等的槽模;和在从第一个槽模到最后一个槽模粘性没有降低的情况下的完全均一之流动基质的粘性。这种装置将是笨重的并难以实现。
如本领域技术人员可领会的,本发明通过提供这样的系统和方法基本解决了与这种单一泵装置相关的问题,所述系统和方法提供了每个具有其自己个体的泵的槽模。本系统允许系统中槽模之间和当中的较大控制性和稳定性。用本发明以有效和控制的方式调整了在上述Hagen-Poiseuille方程中所述的潜在问题。结果是系统中每个槽模当中的更可预测和均一的产品。
已经描述了本发明的许多实施方案。但是,将理解的是,在不背离本发明的精神和范围的情况下可进行多种修改。此外,适当时,可以以多种方式修改或与上述不同的顺序进行上述步骤。因此,可替换的实施方案是在本公开的范围内的。
Claims (48)
1.形成多个个体的膜产品的方法,其包括以下步骤:
(a)提供存放膜形成基质的贮库;
(b)提供与所述贮库相连接的多个个体的容积泵;
(c)提供歧管,其包含多个孔口,其中所述歧管包含第一侧和第二侧,其中每个孔口从所述岐管的所述第一侧延伸至所述歧管的所述第二侧,其中每个孔口在所述岐管的所述第一侧与所述个体的容积泵之一流体连通,该容积泵是孔口自己的个体的容积泵;
(d)将所述膜形成基质从所述贮库供料至所述个体的容积泵;
(e)从每个所述个体的容积泵通过与其流体连通的孔口从所述岐管的所述第一侧至所述歧管的所述第二侧分配预定量的所述膜形成基质;和
(f)从每个所述孔口将多个个体的湿的膜产品直接沉积至基底上。
2.根据权利要求1所述的方法,其中所述基底是底膜。
3.根据权利要求1所述的方法,其中所述基底沿着第一方向从所述多个孔口移动至干燥装置。
4.根据权利要求1所述的方法,其中所述基底沿着第一方向从所述多个孔口持续地移动至干燥装置。
5.根据权利要求1所述的方法,其中重复步骤(d)至步骤(f)。
6.根据权利要求5所述的方法,其中使所述个体的湿的膜产品挤出至所述基底的区域上,在所述区域上没有已经挤出的个体的湿的膜产品。
7.根据权利要求1所述的方法,其中每个所述个体的容积泵每泵送循环分配250微升或更少。
8.根据权利要求1所述的方法,其中所述膜形成基质为至少25%固体。
9.根据权利要求1所述的方法,其还包括以下步骤:
(g)干燥所述多个个体的湿的膜产品以形成多个干燥的个体的膜产品。
10.根据权利要求9所述的方法,其中将所述多个干燥的个体的膜产品进行模切。
11.根据权利要求1所述的方法,其中所述个体的容积泵是活塞泵。
12.根据权利要求1所述的方法,其中所述个体的容积泵是可变速度活塞泵。
13.根据权利要求1所述的方法,其中所述个体的容积泵是可变冲程活塞泵。
14.根据权利要求1所述的方法,其中所述个体的容积泵是双活塞泵。
15.根据权利要求1所述的方法,其中每个所述孔口是槽模。
16.根据权利要求1所述的方法,其中每个所述个体的湿的膜产品与每个个体的湿的膜产品之间具有均一的内含物。
17.形成多个个体的膜条带的方法,其包括以下步骤:
(a)提供存放膜形成基质的贮库;
(b)提供与所述贮库相连接的多个个体的计量泵;
(c)提供歧管,其包含多个孔口,其中所述歧管包含第一侧和第二侧,其中每个孔口从所述岐管的所述第一侧延伸至所述歧管的所述第二侧,其中每个孔口在所述岐管的所述第一侧与所述个体的计量泵之一流体连通,该计量泵是孔口自己的个体的计量泵;
(d)将所述膜形成基质从所述贮库供料至所述多个个体的计量泵;
(e)从每个所述个体的计量泵通过与其流体连通的孔口分配预定量的所述膜形成基质;和
(f)从每个所述孔口将多个个体的湿的膜条带直接沉积至基底上。
18.根据权利要求17所述的方法,其中所述基底是底膜。
19.根据权利要求17所述的方法,其中所述基底沿着第一方向从所述多个孔口持续地移动至干燥装置。
20.根据权利要求17所述的方法,其中使所述个体的湿的膜条带挤出至所述基底的区域上,在所述区域上没有已经挤出的湿的膜条带。
21.根据权利要求17所述的方法,其中所述膜形成基质为至少25%固体。
22.根据权利要求17所述的方法,其还包括以下步骤:
(g)干燥所述个体的湿的膜条带以形成多个干燥的个体的膜条带。
23.根据权利要求22所述的方法,其中将至少一个干燥的个体的膜条带卷起并贮存用于将来使用。
24.根据权利要求22所述的方法,其中可将至少一个干燥的个体的膜条带切成个体的膜产品。
25.根据权利要求17所述的方法,其中每个所述孔口是槽模。
26.根据权利要求17所述的方法,其中将每个所述个体的湿的膜条带挤出形成所述基底上的狭窄条带。
27.根据权利要求17所述的方法,其中每个所述个体的湿的膜条带与每个个体的湿的膜条带之间具有均一的内含物。
28.用于形成多个个体的膜产品的装置,其包括:
(a)用于存放膜形成基质的贮库;
(b)与所述贮库相连接的多个个体的容积泵;
(c)歧管,其包含多个孔口,其中所述歧管包含第一侧和第二侧,其中每个孔口从所述岐管的所述第一侧延伸至所述歧管的所述第二侧,其中每个孔口在所述岐管的所述第一侧与所述个体的容积泵之一流体连通,该容积泵是孔口自己的个体的容积泵;
(d)基底;和
(e)用于使所述基底通过所述装置的设备。
29.根据权利要求28所述的装置,其中所述贮库是加压的。
30.根据权利要求28所述的装置,其中所述个体的容积泵是旋转活塞泵。
31.根据权利要求28所述的装置,其中每个个体的容积泵每泵送循环排出250微升或更少。
32.根据权利要求28所述的装置,其中每个个体的容积泵具有变化的冲程能力。
33.根据权利要求28所述的装置,其中每个个体的容积泵具有变化的速度能力。
34.根据权利要求28所述的装置,其中所述个体的膜产品是小的膜产品。
35.根据权利要求34所述的装置,其中所述个体的膜产品各自为20mg。
36.根据权利要求34所述的装置,其中每个所述的个体的膜产品低于60mg。
37.根据权利要求28所述的装置,其还包括干燥装置。
38.根据权利要求28所述的装置,其中所述每个所述的孔口是槽模。
39.形成多个个体的膜贴片的方法,其包括以下步骤:
(a)提供基底,所述基底包含可溶解聚合物材料的片,所述片具有顶面,其中所述基底沿着第一方向持续地移动;
(b)提供存放湿膜形成基质的贮库,所述湿膜形成基质包含第二聚合物材料和活性物;
(c)提供与所述贮库相连接的多个个体的容积泵;
(d)提供歧管,其包含多个孔口,其中所述歧管包含第一侧和第二侧,其中每个孔口从所述岐管的所述第一侧延伸至所述歧管的所述第二侧,其中每个孔口在所述岐管的所述第一侧与所述个体的容积泵之一流体连通,该容积泵是孔口自己的个体的容积泵,其中每个孔口通过间隙彼此分隔开;
(e)将所述湿膜形成基质从所述贮库供料至所述个体的容积泵;
(f)从每个所述容积泵通过与其流体连通的孔口从所述岐管的所述第一侧至所述歧管的所述第二侧分配预定量的所述膜形成基质;
(g)从每个所述孔口将所述预定量的所述湿膜形成基质直接沉积至所述片的所述顶面上,以形成多个湿的膜产品;以及
(h)干燥所述湿的膜产品以形成多个多层膜贴片,其包含含有所述片的第一层和含有干燥的膜产品的第二层。
40.根据权利要求39所述的方法,其中重复步骤(e)至步骤(g)。
41.根据权利要求39所述的方法,其中所述第一层具有比所述第二层慢的溶解速率。
42.根据权利要求39所述的方法,其还包括以下步骤:
(i)切割所述第一层以提供个体的膜贴片,其中所述个体的膜贴片包含一个干燥的膜产品。
43.根据权利要求42所述的方法,其中所述个体的膜贴片的所述第一层的所述顶面具有比所述第二层大的宽度或大的长度,并且其中所述第一层的至少一部分所述顶面不与所述第二层相接触。
44.根据权利要求43所述的方法,其还包括以下步骤:
(j)使所述个体的膜贴片放置在使用者的皮肤上,其中使所述第二层与所述使用者的皮肤相接触,并且其中使所述第一层的至少一部分所述顶面与所述使用者的皮肤相接触。
45.根据权利要求43所述的方法,其还包括以下步骤:
(k)使所述个体的膜贴片放置在使用者的粘膜组织上,其中使所述第二层与所述使用者的皮肤相接触,并且其中使所述第一层的至少一部分所述顶面与所述使用者的皮肤相接触。
46.根据权利要求4所述的方法,其中所述干燥装置是干燥烘箱。
47.根据权利要求19所述的方法,其中所述干燥装置是干燥烘箱。
48.根据权利要求37所述的装置,其中所述干燥装置是干燥烘箱。
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2011
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- 2011-10-21 WO PCT/US2011/057233 patent/WO2012054810A2/en active Application Filing
- 2011-10-21 KR KR1020197000375A patent/KR102005223B1/ko active IP Right Grant
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- 2011-10-21 EP EP11835203.8A patent/EP2629947B1/en active Active
- 2011-10-21 KR KR1020137012954A patent/KR101937457B1/ko active IP Right Grant
- 2011-10-21 AU AU2011316903A patent/AU2011316903A1/en not_active Abandoned
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JP2013540161A (ja) | 2013-10-31 |
CN103298590A (zh) | 2013-09-11 |
US20190329476A1 (en) | 2019-10-31 |
EP2629947A2 (en) | 2013-08-28 |
KR20140022766A (ko) | 2014-02-25 |
CA2815467C (en) | 2019-09-03 |
US10272607B2 (en) | 2019-04-30 |
CA3049346C (en) | 2021-09-21 |
WO2012054810A2 (en) | 2012-04-26 |
CA2815467A1 (en) | 2012-04-26 |
JP2016204381A (ja) | 2016-12-08 |
KR102005223B1 (ko) | 2019-07-29 |
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ES2732821T3 (es) | 2019-11-26 |
EP2629947A4 (en) | 2014-10-15 |
KR20190007091A (ko) | 2019-01-21 |
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EP3566841B1 (en) | 2024-02-07 |
AU2011316903A1 (en) | 2013-05-23 |
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JP2019171379A (ja) | 2019-10-10 |
WO2012054810A3 (en) | 2012-06-14 |
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US20120100202A1 (en) | 2012-04-26 |
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