CN103153580A - 制备熔体挤出的膜的方法和熔体挤出的膜 - Google Patents
制备熔体挤出的膜的方法和熔体挤出的膜 Download PDFInfo
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- CN103153580A CN103153580A CN2011800162320A CN201180016232A CN103153580A CN 103153580 A CN103153580 A CN 103153580A CN 2011800162320 A CN2011800162320 A CN 2011800162320A CN 201180016232 A CN201180016232 A CN 201180016232A CN 103153580 A CN103153580 A CN 103153580A
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Abstract
熔体挤出的膜通过包括以下步骤的方法制备:共混a)水溶性聚合物、b)活性成分、和c)任选的添加剂,和使共混物经受熔体挤出以制备挤出的熔体,以1.5至20的预拉伸比拉伸所述挤出的熔体形成厚度为至少0.04mm的膜。
Description
技术领域
本发明涉及制备熔体挤出的膜的方法。
背景技术
活性成分,例如药或医药品,可以按片剂形式制备以允许精确和一致的剂量。但是,制备和分配药物的这种形式具有很多缺点,包括必须添加大比例辅料以获得能够处理的尺寸,较大药物形式需要另外的储存空间,分配包括计数趋向错误的片剂。而且,很多人难以吞咽片剂。尽管可以使片剂分离成较小的块或甚至以克服吞咽困难的方式碾碎,但是这对于很多片剂或丸剂形式不是适当的解决方法。例如,碾碎或破坏片剂或丸剂形式以促进单独或与食物混合物的摄取也可能破坏控释性质。
作为片剂和烷基的替换方式,膜可以用于携载活性成分。但是,历史上的膜和从其制备药物给药系统的方法具有很多不利的特征,这些不利特征使得它们无法用于实践。美国专利申请公开2005/037055在段落[0005]–[0012]中详细讨论了已知膜的缺点,例如膜组分的聚集,这导致活性成分的非均质分布或不均匀的膜,特别是如果膜相对较厚。不均匀的膜是由用于干燥聚合物水溶液以制备膜的常规技术所引起,其中表面水立即蒸发形成聚合物膜或表皮。蒸发膜表面以下的剩余水导致对膜表面的重复破坏和再形成,这观察为“波纹效应(ripple effect)”,它会产生不均匀的膜。为解决这些问题,US2005/037055提出生产快速溶解的膜产物,该膜产物包含单独的水溶性聚环氧乙烷或其与不含添加的增塑剂的亲水纤维素聚合物的组合。使聚合物、水、和活性或其它组分通过涂布、铺展、流延或拉伸多组分基质并从膜的底部干燥至膜的顶部而形成片材或膜。可替换地,膜通过挤出形成。根据US2005/037055的实施例,活性成分的含量小于5重量%的快速溶解薄膜通过滚涂制备。尽管教导的干燥方法可以用于获得均匀的膜,但是US2005/037055并未解决有效制备膜的问题,其中大而受控量的活性成分到可以结合到膜中。
发明内容
本发明的一个方面是制备熔体挤出的膜的方法,其包括以下步骤:共混a)水溶性聚合物、b)活性成分、和c)任选的添加剂,和使共混物经受熔体挤出以制备挤出的熔体,以1.5至20的预拉伸比拉伸所述挤出的熔体形成厚度为至少0.04mm的膜。本发明的另一方面是可根据上述方法制备的熔体挤出的膜。
具体实施方式
在本发明用于制备熔体挤出的膜的方法的第一步骤中,将a)水溶性聚合物、b)活性成分、和c)任选的添加剂共混。优选地,制得的共混物包含10至99%、更优选为15至90%、最优选为40至80%的水溶性聚合物a),优选为1至70、更优选为10至60%、最优选为20至40%的活性成分b)以及优选为0至50、更优选为5至45%、最优选为10至40%的任选的添加剂c),基于共混物的总重量。
水溶性聚合物a)和活性成分b)的总量优选为至少75%,更优选为至少85%,最优选为至少95%,基于所述共混物的总重量。共混物可以包含一种或多种水溶性聚合物a),一种或多种活性成分b),和一种或多种任选的添加剂c),但是它们的总量通常在上述范围内。
水溶性聚合物a)在水中的溶解度通常为至少1克,更优选为至少3克,最优选为至少5克,在100克蒸馏水中在25°C和1个大气压下测得。水溶性聚合物a)优选地选自一种或多种多糖,明胶,聚(氨基酸),例如聚(天冬氨酸)或聚(谷氨酸);聚乳酸或这样的聚合酸的盐,或一种或多种合成聚合物,选自聚环氧烷烃,例如重均分子量为至少10,000的环氧乙烷均聚物和共聚物,包含聚合形式的以下物质的均聚物和共聚物:不饱和酸或其盐,例如丙烯酸,甲基丙烯酸,或其盐,不饱和酰胺,例如丙烯酰胺;乙烯基酯,乙烯基醇,乙酸酯,例如乙酸乙烯基酯;烯烃亚胺,例如乙烯亚胺;氧乙烯烷基醚,乙烯基吡咯烷酮,乙烯基唑烷酮,乙烯基甲基唑烷酮,乙烯磺酸,乙烯基胺,乙烯基吡啶,烯键式不饱和硫酸盐/酯或磺酸盐/酯,或一种或多种这些聚合物的组合。
水溶性聚合物a)的重均分子量通常为至少15,000g/mol,优选为至少20,000g/mol,更优选为至少25,000g/mol,最优选为至少30,000g/mol。重均分子量的优选上限极大地取决于聚合物的类型。通常,水溶性聚合物的重均分子量为至多10,000,000g/mol,优选为至多8,000,000g/mol,更优选为至多5,000,000g/mol。重均分子量可以根据标准测试方法ASTM D-4001-93(2006)通过光散射确定。
一种优选类型的水溶性聚合物a)是多糖。多糖的实例包括阿拉伯树胶,黄原胶树胶,刺梧桐树胶,黄芪胶,茄替胶,角叉胶,右旋糖苷,藻酸盐,琼脂,胞外多糖胶,没食子甘露聚糖(gallactomannans)例如瓜尔胶,胶质,淀粉,淀粉衍生物,瓜尔胶衍生物和黄原胶衍生物。淀粉衍生物,瓜尔胶衍生物和黄原胶衍生物更详细地描述于欧洲专利EP0504870B,第3页,第25-56行和第4页,第1-30行。有用的淀粉衍生物是例如淀粉醚,例如羟基丙基淀粉或羧甲基淀粉。有用的瓜尔胶是例如羧甲基瓜尔胶,羟基丙基瓜尔胶,羧甲基羟基丙基瓜尔胶或阳离子化的瓜尔胶。优选的羟基丙基瓜尔胶及其生产描述于美国专利4,645,812,第4-6栏。优选的多糖是纤维素酯或纤维素醚。优选的纤维素醚是羧基-C1-C3-烷基纤维素,例如羧甲基纤维素;羧基-C1-C3-烷基羟基-C1-C3-烷基纤维素,例如羧甲基羟基乙基纤维素;C1-C3-烷基纤维素,例如甲基纤维素;C1-C3-烷基羟基-C1-3-烷基纤维素,例如羟基乙基甲基纤维素,羟基丙基甲基纤维素或乙基羟基乙基纤维素;羟基-C1-3-烷基纤维素,例如羟基乙基纤维素或羟基丙基纤维素;混合的羟基-C1-C3-烷基纤维素,例如羟基乙基羟基丙基纤维素,或烷氧基羟基乙基羟基丙基纤维素,烷氧基是直链或支化的并且包含2至8个碳原子。最优选地,组合物包含水溶性纤维素醚,例如甲基纤维素,其取代DS甲氧基的甲基程度为1.2至2.2,优选为1.5至2.0;或羟基丙基甲基纤维素,其DS甲氧基为0.9至2.2,优选为1.1至2.0;和MS羟基丙氧基为0.02至2.0,优选为0.1至1.2。通常,多糖的重均分子量为至多5,000,000g/mol,优选为至多500,000g/mol,更优选为至多300,000g/mol。
另一种优选类型的水溶性聚合物a)是聚环氧乙烷。本申请使用的术语“聚环氧乙烷”包括环氧乙烷的均聚物和共聚物。环氧乙烷共聚物可以是通过环氧乙烷与至少一种其它氧化物的混合物聚合反应制备的无规共聚物,例如1,2-环己烯环氧化物,1,2-丁烯环氧化物,烯丙基缩水甘油醚,甲基丙烯酸缩水甘油酯,表氯醇,1,3-丁二烯二环氧化物,苯乙烯氧化物,4-乙烯基-1-环己烯1,2-环氧化物,4-(2-三甲氧基甲硅烷基乙基)-1,2-环氧环己烯和4-乙烯基-1-环己烯二环氧化物,优选为环氧烷烃,例如环氧丙烷,1,2-丁烯环氧化物,或异丁烯氧化物。其它有用的环氧乙烷共聚物是通过顺序添加环氧乙烷与至少一种其它环氧烷烃制备的嵌段共聚物,其中在添加之后的单体之前几乎全部消耗第一单体。可替换地,环氧乙烷共聚物可以包括共聚形式的环氧乙烷和另一种可共聚的单体,例如丙烯酸甲酯,丙烯酸乙酯,己内酯,碳酸亚乙基酯,碳酸三亚甲基酯,1,3-二氧戊环,二氧化碳,羰基硫化物,四氢呋喃,甲基异氰酸酯,或甲基胩。优选的环氧乙烷共聚物是环氧乙烷与表氯醇的共聚物或环氧乙烷与环己烯氧化物的共聚物。环氧乙烷共聚物通常包含至少约50摩尔%、优选为至少约70摩尔%、更优选为至少约85摩尔%的环氧乙烷单元。最优选的环氧乙烷聚合物是环氧乙烷均聚物。聚环氧乙烷的重均分子量优选为约50,000g/mol至约10,000,000g/mol,更优选为约70,000g/mol至约8,000,000g/mol,最优选为约90,000g/mol至约5,000,000g/mol。用于本发明组合物的聚环氧乙烷可商购自The Dow Chemical Company。使用的聚环氧乙烷的平均分子量将通常影响选择的加工条件。与平均分子量小于或等于约5,000,000g/mol的聚环氧乙烷相比,极高平均分子量聚环氧乙烷,例如大于约5,000,000g/mol,在挤出工艺中通常需要较高的加工温度,扭矩和/或压力。
更优选地,水溶性聚合物是上述纤维素醚或上述聚环氧乙烷,聚乙烯基吡咯烷酮或包含聚合形式的丙烯酸、甲基丙烯酸、丙烯酸或甲基丙烯酸的盐、乙酸乙烯基酯、乙烯亚胺、或氧乙烯烷基醚的聚合物。最优选地,上述纤维素醚或上述聚环氧乙烷或纤维素醚和聚环氧乙烷的组合用于制造本发明的膜。
已经发现,本发明的熔体挤出方法特别适用,条件是选择水溶性聚合物a),使其软化点高于活性成分b)在大气压的熔点。水溶性聚合物a)的软化点根据差示扫描量热法(DSC)测定。通过DSC测得的软化点定义为无定形聚合的玻璃化转变温度或半结晶聚合物的结晶熔点。优选地,选择水溶性聚合物a),使其软化点比活性成分的熔点高至少10°C,更优选为高至少20°C,最优选为高至少50°C。聚合物组合物可以包含增塑剂使其呈现为可热熔体挤出的。增塑剂应该能够降低聚合物的玻璃化转变温度或软化点以便于允许降低热熔体挤出过程中的加工温度、挤出机扭矩和压力。但是,通常应该选择增塑剂的含量和类型,使得玻璃化转变温度或软化点未减少至不适当的程度。由增塑剂降低的水溶性聚合物a)的软化点优选为仍比活性成分的熔点高至少10°C,更优选为高至少20°C。
多种活性成分可以结合进用于制备熔体挤出的膜的共混物中,特别是生物活性成分,特别是与健康有关的生物活性成分,例如维生素,草药和矿物补剂,口服护理成分和药,但是也可以是不直接与健康有关的活性成分,例如香料、颜料、掩盖味道的化合物,化妆品活性成分,或农业中的活性成分。活性成分包括疏水、亲水和两性的化合物。活性成分并非必须可溶于组合物的任何给定组分中。活性成分可以溶解、部分溶解或悬浮在组合物的聚合物基质中。活性成分在使用的熔体挤出工艺条件下应该通常是稳定的。稳定表示显著部分的活性成分在整个熔体挤出工艺中不会显著降解或分解。出乎意料地,已经发现本发明熔体挤出的膜可以具有高含量的活性成分,例如1至70%,更优选为10至60%,最优选为20至40%,基于膜的总重量,并且熔体挤出的膜仍可以制备。所得膜的优点在于,膜的给定区域可以包含高浓度的活性成分,因此需要较小的膜带来提供治疗剂量。此外,在膜中较高活性成分的浓度提供活性成分的较快可用,因为在膜崩解之前必须溶解较少的聚合物。
可以结合进有待熔体挤出的组合物中的活性成分可以用于治疗适应症,例如作为实例且不受限制地为,炎症,痛风,血胆脂醇过多,细菌感染,AIDS,肺结核,真菌感染,阿米巴感染,寄生虫感染,癌症,肿瘤,器官排斥,糖尿病,心力衰竭,关节炎,哮喘,疼痛,充血,尿道感染,阴道感染,发作有关的失调,忧郁症,精神病,痉挛,糖尿病,血液凝块,高血压和节育。
可以结合进有待熔体挤出的组合物中的活性成分可以用于治疗适应症,例如作为实例且不受限制地为,炎症,痛风,血胆脂醇过多,细菌感染,AIDS,肺结核,真菌感染,阿米巴感染,寄生虫感染,癌症,肿瘤,器官排斥,糖尿病,心力衰竭,关节炎,哮喘,疼痛,充血,尿道感染,阴道感染,发作有关的失调,忧郁症,精神病,痉挛,糖尿病,血液凝块,高血压和节育。
可以通过本发明的膜给药的活性成分是实例是,醋丁洛尔(acebutolol),乙酰半胱氨酸,乙酰基水杨酸,阿昔洛韦(acyclovir),阿普唑仑(alprazolam),阿法骨化醇(alfacalcidol),尿囊素(allantoin),别嘌呤醇(allopurinol),氨溴索(ambroxol),氨基羟丁基卡那霉素(amikacin),阿米洛利(amiloride),氨基乙酸,胺碘酮(amiodarone),阿密曲替林(amitriptyline),氨氯地平(amlodipine),阿莫西林(amoxicillin),氨比西林(ampicillin),抗坏血酸维生素C(ascorbicacid),天冬氨酰苯丙氨酸甲酯(aspartame),阿司咪唑(astemizole),阿替洛尔(atenolol),氯地米松(beclomethasone),苄丝肼(benserazide),盐酸苄烷铵(benzalkonium hydrochloride),苯坐卡因(benzocaine),苯甲酸,倍他米松(betamethasone),苯扎贝特(bezafibrate),生物素(biotin),比哌立登(biperiden),比索洛尔(bisoprolol),溴西泮(bromazepam),溴己新(bromhexine),溴麦角环肽(bromocriptine),布地奈德(budesonide),丁苯羟酸(bufexamac),丁咯地尔(buflomedil),丁螺环酮(buspirone),咖啡因(caffeine),樟脑(camphor),卡托普利(captopril),氨甲酰氮草(carbamazepine),卡比多巴(carbidopa),卡铂(carboplatin),头孢克洛(cefachlor),头孢氨苄(cefalexin),头孢羟氨苄(cefadroxil),头孢唑啉(cefazoline),头孢克肟(cefixime),头孢噻肟(cefotaxime),头孢他啶(ceftazidime),头孢曲松(ceftriaxone),司来吉兰(selegiline),氯霉素(chloramphenicol),洗必太(chlorhexidine),氯苯那敏(chlorpheniramine),氯噻酮(chlortalidone),胆碱(choline),环胞菌素(cyclosporin),西司他丁(cilastatin),甲氰咪胍(cimetidine),环丙沙星(ciprofloxacin),西沙必利(cisapride),顺铂(cisplatin),克拉霉素(clarithromycin),克拉维酸(clavulanicacid),氯米帕明(clomipramine),氯硝西泮(clonazepam),氯压定(clonidine),克霉唑(clotrimazole),可待因(codeine),消胆胺(cholestyramine),色甘酸(cromoglycic acid),氰钴维生素(cyanocobalamin),去乙酰环丙氯地孕酮(cyproterone),去氧孕烯(desogestrel),地塞米松(dexamethasone),右泛醇(dexpanthenol),右美沙芬(dextromethorphan),右丙氧芬(dextropropoxiphene),地西泮(diazepam),双氯芬酸(diclofenac),异羟洋地黄毒苷(digoxin),双氢可待因(dihydrocodeine),双氢麦角胺(dihydroergotamine),氢化麦角素(dihydroergotoxin),地尔硫(diltiazem),苯海拉明(diphenhydramine),双嘧达莫(dipyridamole),安乃近(dipyrone),丙吡胺(disopyramide),多潘立酮(domperidone),多巴胺(dopamine),多西环素(doxycycline),依那普利(enalapril),麻黄碱(ephedrine),肾上腺素(epinephrine),维生素D2(ergocalciferol),麦角胺(ergotamine),红霉素(erythromycin),雌二醇(estradiol),炔雌醇(ethinylestradiol),依托泊苷(etoposide),蓝桉(Eucalyptusglobulus),法莫替丁(famotidine),非洛地平(felodipine),非诺贝特(fenofibrate),非诺特罗(fenoterol),芬太奴(fentanyl),黄素单核苷酸(flavin mononucleotide),氟康唑(fluconazole),氟桂利嗪(flunarizine),氟尿嘧啶(fluorouracil),氟西汀(fluoxetine),氟比洛芬(flurbiprofen),利尿磺胺(furosemide),戈洛帕米(gallopamil),吉非贝齐(gemfibrozil),庆大霉素(gentamicin),银杏(Gingkobiloba),格列本脲(glibenclamide),格列吡嗪(glipizide),氯氮平(clozapine),光果甘草(Glycyrrhiza glabra),灰黄霉素(griseofulvin),愈创甘油醚(guaifenesin),氟哌丁苯(haloperidol),肝磷脂(heparin),透明质酸(hyaluronicacid),二氢氯噻(hydrochlorothiazide),氢可酮(hydrocodone),氢化可的松(hydrocortisone),氢吗啡酮(hydromorphone),异丙托羟铵(ipratropiumhydroxide),布洛芬(ibuprofen),亚胺培南(imipenem),茚甲新(indomethacin),碘海醇(iohexol),碘帕醇(iopamidol),硝酸异山梨酯(isosorbide dinitrate),单硝酸异山梨酯(isosorbide mononitrate),异维A酸(isotretinoin),伊曲康唑(itraconazole),酮替芬(ketotifen),酮康唑(ketoconazole),酮洛芬(ketoprofen),酮咯酸(ketorolac),拉贝洛尔(labetalol),乳果糖(lactulose),卵磷脂(lecithin),左卡尼汀(levocarnitine),左旋多巴(levodopa),左谷酰胺(levoglutamide),左炔诺孕酮(levonorgestrel),甲状腺素,利多卡因(lidocaine),脂肪酶,丙咪嗪,赖诺普利(lisinopril),洛哌丁胺(loperamide),劳拉西泮(lorazepam),洛伐他汀(lovastatin),甲孕酮(medroxyprogesterone),薄荷醇(menthol),甲氨蝶呤(methotrexate),甲基多巴(methyldopa),甲泼尼龙(methylprednisolone),甲氧氯普胺(metoclopramide),美托洛尔(metoprolol),咪康唑(miconazole),咪达唑仑(midazolam),二甲胺四环素(minocycline),米诺地尔(minoxidil),米索前列醇(misoprostol),吗啡(morphine),多种维生素的混合物或组合以及天然盐,甲麻黄碱(N-methylephedrine),萘呋胺(naftidrofuryl),甲氧萘丙酸(naproxen),新霉素(neomycin),尼卡地平(nicardipine),尼麦角林(nicergoline),烟碱(nicotinamide),烟碱(nicotine),烟酸(nicotinic acid),硝苯地平(nifedipine),尼莫地平(nimodipine),硝西泮(nitrazepam),尼群地平(nitrendipine),尼扎替丁(nizatidine),炔诺酮(norethisterone),诺氟沙星(norfloxacin),甲基炔诺酮(norgestrel),去甲替林(nortriptyline),制霉菌素(nystatin),氧氟沙星(ofloxacin),奥美拉唑(omeprazole),昂丹司琼(ondansetron),胰液素(pancreatin),泛酰醇(panthenol),泛酸(pantothenic acid),对乙酰氨基酚(paracetamol),青霉素G(penicillin G),青霉素V(penicillin V),苯巴比妥(phenobarbital),己酮可可碱(pentoxifylline),苯氧甲基青霉素(phenoxymethylpenicillin),苯肾上腺素(phenylephrine),苯基丙醇胺(phenylpropanolamine),苯妥英(phenytoin),吡罗昔康(piroxicam),多粘菌素B(polymyxin B),聚维酮碘(povidone-iodine),普伐他汀(pravastatin),普拉西泮(prazepam),哌唑嗪(prazosin),脱氢皮质甾醇(prednisolone),泼尼松(prednisone),溴麦角环肽(bromocriptine),普罗帕酮(propafenone),普萘洛尔(propranolol),丙羟茶碱(proxyphylline),伪麻黄碱(pseudoephedrine),维生素B6(pyridoxine),奎纳定(quinidine),雷米普利(ramipril),雷尼替丁(ranitidine),利血平(reserpine),松香油(retinol),核黄素(riboflavin),利福平(rifampicin),芦丁(rutoside),糖精(saccharin),沙丁胺醇(salbutamol),salcatonin,水杨酸,辛伐他汀(simvastatin),生长激素(somatropin),索他洛尔(sotalol),螺内酯(spironolactone),硫糖铝(sucralfate),舒巴坦(sulbactam),磺胺甲唑(sulfamethoxazole),柳氮磺吡啶(sulfasalazine),舒必利(sulpiride),三苯氧胺(tamoxifen),替加氟(tegafur),替普瑞酮(teprenone),特拉唑嗪(terazosin),特布他林(terbutaline),特非那定(terfenadine),四环素(tetracycline),茶碱(theophylline),硫胺(thiamine),噻氯匹定(ticlopidine),噻吗洛尔(timolol),氨甲环酸(tranexamic acid),维甲酸(tretinoin),氟羟氢化泼尼松丙酮化物(triamcinolone acetonide),氨苯蝶啶(triamterene),甲氧苄氨嘧啶(trimethoprim),曲克芦丁(troxerutin),尿嘧啶(uracil),丙戊酸(valproic acid),万古霉素(vancomycin),戊脉安(verapamil),维生素E(vitamin E),亚叶酸(folinic acid),齐多夫定(zidovudine)。
优选的活性成分是布洛芬(作为外消旋物、对映异构体或富集的对映异构体),酮洛芬,氟比洛芬,乙酰基水杨酸,戊脉安,对乙酰氨基酚,硝苯地平,卡托普利,奥美拉唑,雷尼替丁,曲马多,环胞菌素,群多普利和治疗肽(therapeutic peptides)。
用于本发明的其它优选的活性成分包括止泻药例如洛呱丁胺AD(immodium AD),抗组胺药,止咳药,解充血药,维生素,和口气清新剂(breath fresheners)。单独或组合用于感冒、疼痛、发烧、咳嗽、充血、流鼻涕和敏感症的常用药,例如对乙酰氨基酚、马来酸氯苯那敏、右美沙芬、伪麻黄碱HCl和苯海拉明,可以包含在本发明的膜组合物中。
本申请也可以使用抗焦虑药例如阿普唑仑(作为购得);安定药例如氯氮平(clozopin)(作为购得)和氟哌丁苯(作为购得);非类固醇消炎药(NSAID's)例如dicyclofenacs(作为购得)和依托度酸(etodolac)(作为购得),抗组胺药例如氯雷他定(loratadine)(作为购得),阿司咪唑(作为HismanalTM购得),萘丁美酮(nabumetone)(作为购得),和氯马斯汀(Clemastine)(作为购得);止呕吐药例如盐酸格拉司琼(granisetron hydrochloride)(作为购得)和大麻隆(nabilone)(作为CesametTM购得);支气管扩张剂例如硫酸沙丁胺醇(albuterol sulfate)(作为购得);抗抑郁剂例如盐酸氟西汀(作为购得),盐酸舍曲林(sertraline hydrochloride)(作为购得),和盐酸帕罗西汀(paroxtine hydrochloride)(作为购得);止偏头痛药(anti-migraines)例如ACE-抑制剂例如依那普利拉(enalaprilat)(作为购得),卡托普利(作为购得)和赖诺普利(作为购得);抗阿尔茨海默病药物,例如尼麦角林;和CaH-拮抗剂例如硝苯地平(作为和购得),和盐酸戊脉安(作为购得)。
活性抗酸性成分包括但不限于下列:氢氧化铝,二羟基铝氨基乙酸盐,氨基乙酸,磷酸铝,二羟基铝碳酸钠,碳酸氢盐,铝酸铋,碳酸铋,碱式碳酸铋,碱式棓酸铋,碱式硝酸铋,碱式甲硅烷基硅酸铋(bismuth subsilysilate),碳酸钙,磷酸钙,柠檬酸根离子(酸或盐),氨基乙酸,水合铝酸镁硫酸盐,镁加铝,硅铝酸镁,碳酸镁,甘氨酸镁,氢氧化镁,氧化镁,三硅酸镁,乳固体,铝一元或二元磷酸钙,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。
化妆品活性成分可以包括口气清新的化合物如薄荷醇,其它香料或香氛,特别是用于口腔卫生的那些,以及用于牙齿和口腔清洁的活性成分例如季铵碱。香料的效果可以使用香料增强剂如酒石酸、柠檬酸、香草醛等增强。
这种可用于本发明的滋养补充剂的实例范围包括但不限于,樱桃提取物(Cherry extract),Ginkgo biloba提取物,Kava Kava提取物,高丽参提取物(Ginseng extract),锯齿形美洲蒲葵提取物(Saw Palmetto extract),酸果蔓或蓝莓提取物(cranberry or blueberry extract),番茄提取物(tomato extract),cordyceps sinensis提取物,石榴,接骨木,以及整个浆果家族,草莓,树莓,樱桃,黑树莓,波森莓(boysenberry)等,葡糖胺硫酸盐,吡啶羧酸铬,牛奶蓟提取物(Milk thistle extract),葡萄籽提取物(Grape seed extract),麻黄(MaHuang)提取物,辅酶Q10,水溶性维生素例如维生素C尼亚新,维生素B1和维生素B12,和脂溶性维生素例如维生素A、D、E、和K,矿物例如钙、镁和锌等。
特别适用于包含在待熔体挤出的聚合物组合物中的活性成分的实例是布洛芬(作为外消旋物、对映异构体或富集的对映异构体),酮洛芬,氟比洛芬,乙酰基水杨酸,戊脉安,对乙酰氨基酚,硝苯地平,卡托普利,奥美拉唑,雷尼替丁,曲马多,环胞菌素,群多普利和治疗肽(therapeutic peptides)。
当多糖,例如甲基纤维素或羟基丙基甲基纤维素用作水溶性聚合物a)时,活性成分的熔点优选为小于150°C。当聚环氧乙烷用作水溶性聚合物a)时,活性成分的熔点优选为小于65°C。
有待熔体挤出的共混物包含一种或多种任选的添加剂c),例如一种或多种崩解剂,填料,颜料,着色剂,润滑剂,增塑剂,稳定剂例如抗氧化剂,增滑剂和抗粘连剂。但是,本发明的一个优点是,并非必须将一种或多种润滑剂或增塑剂或稳定剂或增滑剂或抗粘连剂添加到有待熔体挤出制备本发明膜的共混物中。
崩解剂可以作为任选的添加剂c)结合进待熔体挤出的共混物中以减少制得的熔体挤出的膜的崩解或溶解时间。有用的崩解剂是,例如但不限于,单糖和二糖,糖醇,交联的羧甲基纤维素的盐和分子量低于水溶性聚合物a)的分子量的水溶性聚合物。
本申请描述的a)、b)、和任选的c)的共混物通常是可熔体挤出的。如本申请使用,术语"可熔体挤出的"是指可以熔体挤出的、特别是热熔体挤出的混配物或组合物。可热熔体挤出的聚合物组合物是当它们不是粒子形式例如粉末或颗粒时在25°C和大气压足够刚性、但是能够在升高的温度或压力下(这表示在高于25°C的温度或高于大气压的压力)变形或形成半流体状态的那些。尽管用于制造本发明膜的聚合物组合物无需包含增塑剂以使其呈现为可热熔体挤出的,但是增塑剂可以作为另外的组分包含在组合物中。增塑剂应该能够降低聚合物的玻璃化转变温度或软化点以便于允许降低热熔体挤出过程中的加工温度、挤出机扭矩和压力。增塑剂也通常允许降低聚合物熔体的粘度,从而允许降低热熔体挤出过程中的加工温度和挤出机扭矩。有用的增塑剂是,例如,十六烷醇,甘油三酸酯,聚环氧乙烷-聚环氧丙烷二醇(Pluronic),三醋精或柠檬酸三乙酯。当使用具有非常高的分子量例如大于约5,000,000g/mol的水溶性聚合物时,有利地添加增塑剂。
在将共混物进料到用于熔体挤出的装置中之前,组分a)、b)、和任选的c)可以预混合。用于熔体挤出的装置,特别是有用的挤出机是本领域已知的。可替换地,在加热步骤之前或过程中,组分a)、b)、和任选的c)可以单独进料到挤出机中并在该装置中共混。尽管在本发明的一些实施方式中,待进料到挤出机中的组合物或组分可以包含液体物质,但是干燥进料有利地用于本发明的熔体挤出法。使已经进料到挤出机中的组合物或组分在下述温度穿过挤出机的加热区域,该温度将使混合物或其至少一种或多种组分熔融或软化以形成共混物,在整个共混物中分散着活性成分。使共混物经受熔体挤出并使用卷绕辊使其离开挤出机模头。典型的挤出加工温度为50至210°C,优选为70至200°C,更优选为100至190°C。应该选择操作温度范围,从而使得活性成分和共混物其它成分在加工过程中的降解或分解最小。用于实践本发明的挤出机优选为装备以处理干燥进料的可商购的型号,其具有固体运输区域、一个或多个加热区域、和挤出模头。对于挤出机特别有利的是具有多个单独的可控制温度的加热区域。单螺杆或多螺杆挤出机,优选为双螺杆挤出机,可以用于本发明的熔体挤出方法。
熔融或软化的混合物的“熔体拉伸伸长率”优选为50至5000%,更优选为200至2500%,最优选为400至1500%。熔体拉伸伸长率由方程((Vf-Vi)/Vi)*100表示,其中Vi是在所述挤出机模头的膜速度,Vf是在所述卷绕辊的膜速度。卷绕辊,也称为流延辊或冷却辊,是熔融的制剂在离开模头之后接触的第一个表面。控制辊旋转速度,以从挤出的物质提供所需膜厚度和预拉伸速率。
将挤出物模塑、优选为拉伸,至所需厚度的膜,即,至少0.04mm、优选为0.05至0.30mm的厚度。上述组分a)、b)、c)和任选的d)以上述重量比通常形成具有足够熔体强度的熔体,使得挤出物可以被拉伸成预拉伸比为1.5至20、优选为2.5至17、更优选为3至10,最优选为3.5至7的膜。本申请使用的术语“预拉伸比”是所述挤出机模头的间隙与所述拉伸膜在所述卷绕辊的厚度之比。
单层膜或多层膜可以根据本发明的方法制备。如果生产多层膜,厚度为至少0.04mm的制得的膜在熔体挤出的过程中或之后与一层或多层其它膜组合以制备多层膜。例如,当它仍是温的或热的时或在其已经冷却之后,挤出并拉伸的膜层可以与其它膜层组合。可替换地,熔体挤出的多层膜可以经共挤出制备,其中所述层中的一个或多个由包含上述组分a)、b)、和任选的c)的共混物制备。
单层膜或多层膜可以根据本领域已知的方式切割成剂量形式。
本发明通过以下实施例进一步说明,不认为这些实施例限制本发明的范围。除非另有说明,否则所有的份和百分比均基于重量。
实施例
实施例1-12
熔体挤出的膜包含以下物质。
POLYOXTMWSR N-10聚(环氧乙烷)聚合物的分子量为约100,000g/mol。POLYOXTMWSR N-80聚(环氧乙烷)聚合物的分子量为约200,000g/mol。METHOCEL E50是羟基丙基甲基纤维素,其甲氧基含量为27.5至31%和羟基丙基含量为7至12%,粘度为40-60mPa.s,作为2wt%的水溶液测得。Kollidon90F聚乙烯基吡咯烷酮的重均分子量Mw为1,000,000至1,500,000g/mol。
组分A和B都经差示扫描量热法分析以确定它们的热转变。样品通过将待分析的所需量的物质称重(5至10mg)到密封铝盘中制备。在分析前,盖上盖子并压接封闭。扫描以10°C/min的加热速率从0运行至250°C。在分析之前,使用标准实验室对流烘箱在110°C将纤维素醚、苯肾上腺素和Kollidon90F干燥过夜。
在用于挤出之前,组分A和B使用实验室V-共混机共混10分钟。在与布洛芬的任何共混之前,羟基丙基甲基纤维素在40°C的烘箱中干燥最小化的24小时。
熔体挤出的膜使用常规双螺杆挤出机或单螺杆挤出机制备。
双螺杆挤出
常规双螺杆挤出使用Leistritz型号ZSE micro18-mm双螺杆挤出机产生。该机器具有通过改变变速箱和螺杆元件同时运行同向旋转和反向旋转结构的能力。该装置由2.2KW驱动发动机驱动并且最大螺杆速度为500rpm。存在的装置具有8个机筒区域(各自5个直径),总共40个长度/直径加工区域。
同时使用同向旋转和反向旋转的螺杆结构。反向旋转构造用于大多数样品。其包含两个捏合模块区域,以使得能够在第一捏合模块区域熔融和混合,以及经敞开的机筒区域以减量进料模式下游添加a)水溶性聚合物、b)活性成分、或c)任选的添加剂。设计同向旋转螺杆结构以证明可使制剂熔融、混合和泵送,而无需使用捏合模块和传统的混合元件。
两个Brabender型号FW/18/5减量进料器用于将原料进料到挤出机的进料机筒区域。氮气管线安装在进料料斗和垂直PVC进料柱(feed leg)上,以便于使原料和进料口惰性。
使用定制设计的接头块将水平配置的流延膜模头连接于挤出机的末端。模头为标准6英寸(152mm)宽衣架风格设计,具有一个节流杆。在每次实验的开始,模唇间隙设定在约32密耳(0.81mm)。模头相对于流延装置的距离水平位于1.5英寸(38mm)处,在垂直位置等于流延辊的中心线。膜规格受模头间隙以及模头和流延装置之间的拉伸量控制。流延装置为Killion单-辊10-英寸(254mm)直径流延装置,具有一组压送辊。对于所有实验,流延辊温度保持在31°C。在Killion膜卷筒上收集膜。
单螺杆挤出
单螺杆挤出使用装备有1.25英寸直径(32mm)和24/1长度/直径比的螺杆的Davis标准挤出机进行。水溶性聚合物a)和活性成分b)的共混物以减量进料模式进料到挤出机中。挤出机进料衣架设计的8英寸(203mm)宽流延膜模头。在每次实验的开始,模唇间隙设定在约30密耳(0.76mm)。模头温度在所有实施例中为140°C。膜挤出物水平进料到3-辊垂直堆(roll verticalstack)。顶部辊是橡胶的,中部和底部辊是钢的。使用Mokon Compu-Mate100控制器控制辊的温度。膜经辊堆运送至膜卷绕位置。K-Tron型号KCLKT-20进料器用于重量模式以进料挤出机。
表1总结了使用双螺杆挤出机和单螺杆挤出机的挤出结果。
表1
*不含活性成分
表2总结了双螺杆挤出机实验的挤出机条件;表3总结了单螺杆挤出机实验的挤出机条件。
表2
表3
负载有活性成分的本发明的膜具有足够的熔体伸长率以便于拉伸。与不包含活性成分的膜相比,本发明膜具有相当的熔体拉伸伸长率和预拉伸比,而不管活性成分的含量高达25%并且不管工艺设备的类型。
实施例26:聚乙烯基吡咯烷酮的挤出
Kollidon90F聚乙烯基吡咯烷酮(组分A)和布洛芬(组分B)以50/50比率(Kollidon90F/布洛芬)按照上述在挤出之前共混。
膜挤出使用装备有1.25英寸直径(32mm)和24/1长度/直径比的通用螺杆的Davis标准挤出机进行。挤出机装备有8英寸(203mm)宽流延膜模头,其模头间隙为约0.025英寸(0.64mm)。使用垂直的3辊堆(roll stack)将挤出的膜从模头拉出并冷却。使用Mokon Compu-Mate100控制器将钢流延辊控制在14.5°C。挤出机设定点为:机筒区域1=70°C,机筒区域2=120°C,机筒区域3=135°C,模头区域1=135°C,模头区域2=135°C。挤出机螺杆速率为25rpm。将制剂以2.5kg/小时的速率使用K-tron型号KCLKT-20进料器以重量模式进料到挤出机中。轻松制得0.005英寸(0.127mm)厚的膜。流延辊速度为3.5英尺每分钟(1.1m/min)。制得的膜的宽度为5.0英寸(127mm)。
与聚乙烯基吡咯烷酮/布洛芬对比的样品以比率49/51(POLYOX N-80/布洛芬)使用实验室V-共混机共混10分钟。在与上述相同的设备上进行膜挤出。挤出机设定点是:机筒区域1=60°C,机筒区域2=100°C,机筒区域3=100°C,模头区域1=100°C,模头区域2=100°C。挤出机螺杆速率为45rpm。将制剂以4.5kg/小时的速率使用K-tron型号KCLKT-20进料器以重量模式进料到挤出机中。在该加工温度,布洛芬和POLYOX N-80都完全熔融。因为挤出物的极低的粘度而不能制得膜。
Claims (15)
1.制备熔体挤出的膜的方法,包括以下步骤
共混a)水溶性聚合物,b)活性成分,和c)任选的添加剂,和
使所述共混物经受熔体挤出以制备挤出的熔体,以1.5至20的预拉伸比拉伸所述挤出的熔体形成厚度为至少0.04mm的膜。
2.权利要求1的方法,其中所述膜以2.5至17的预拉伸比挤出成膜。
3.权利要求1或2的方法,其中所述任选的添加剂是崩解剂。
4.权利要求1至3中任一项的方法,其中所述水溶性聚合物a)和所述活性成分b)的总量为至少75%,基于所述共混物的总重量。
5.权利要求1至4中任一项的方法,其中所述活性成分b)的量为10至60%,基于所述共混物的总重量。
6.权利要求1至5中任一项的方法,其中所述水溶性聚合物是纤维素醚,聚环氧乙烷,聚乙烯基吡咯烷酮或包含聚合形式的丙烯酸、甲基丙烯酸、丙烯酸或甲基丙烯酸的盐、乙酸乙烯基酯、乙烯亚胺、或氧乙烯烷基醚的聚合物。
7.权利要求1至6中任一项的方法,其中所述水溶性聚合物是纤维素醚或聚环氧乙烷,或纤维素醚和聚环氧乙烷的组合。
8.权利要求1至7中任一项的方法,其中所述水溶性聚合物a)的量为15至90%,基于所述共混物的总重量。
9.权利要求1至8中任一项的方法,用于制备单层的熔体挤出的膜。
10.权利要求1至9中任一项的方法,其中所述水溶性聚合物a)的软化点高于所述活性成分b)的软化点。
11.权利要求1至10中任一项的方法,其中使所述共混物经受熔体挤出,使其离开挤出机模头并使用卷绕辊拉伸成膜,得到熔体拉伸伸长率为50至5000%的膜,其中所述熔体拉伸伸长率=((Vf-Vi)/Vi)*100,其中Vi是在所述挤出机模头的膜速度,Vf是在所述卷绕辊的膜速度。
12.权利要求11的方法,其中所述熔体拉伸伸长率为200至2500%。
13.权利要求1至12中任一项的方法,用于制备厚度为0.05mm至0.30mm的膜。
14.权利要求1至13中任一项的方法,其中厚度为至少0.04mm的膜在熔体挤出的过程中或之后与一层或多层其它膜组合以制备多层膜。
15.可根据权利要求1至14中任一项的方法制备的熔体挤出的膜。
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WO2014127133A1 (en) * | 2013-02-13 | 2014-08-21 | Northwestern University | Method for processing polymers and/or polymer blends from virgin and/or recycled materials via solid-state/melt extrusion |
WO2019006122A1 (en) | 2017-06-28 | 2019-01-03 | University Of Pittsburgh-Of The Commonwealth System Of Higher Education | HOT EXTRUSION FOR VAGINAL FILM PHARMACEUTICAL PRODUCTS |
KR20210107813A (ko) * | 2018-12-27 | 2021-09-01 | 다우 도레이 캄파니 리미티드 | 핫멜트성을 갖는 경화성 실리콘 시트의 제조 방법 |
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- 2011-02-25 CN CN2011800162320A patent/CN103153580A/zh active Pending
- 2011-02-25 JP JP2013501274A patent/JP5827310B2/ja not_active Expired - Fee Related
- 2011-02-25 KR KR1020127027921A patent/KR101837927B1/ko active IP Right Grant
- 2011-02-25 BR BR112012018818A patent/BR112012018818A2/pt not_active Application Discontinuation
- 2011-02-25 US US13/035,233 patent/US20110236666A1/en not_active Abandoned
- 2011-02-25 WO PCT/US2011/026234 patent/WO2011119289A2/en active Application Filing
- 2011-02-25 EP EP11708364A patent/EP2555912A2/en not_active Withdrawn
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EP1627893A1 (en) * | 2003-05-27 | 2006-02-22 | Asahi Kasei Kabushiki Kaisha | Biodegradable resin film or sheet and process for producing the same |
CN101360483A (zh) * | 2006-01-19 | 2009-02-04 | 陶氏环球技术公司 | 含有乙基纤维素的生物活性组合物 |
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Also Published As
Publication number | Publication date |
---|---|
JP5827310B2 (ja) | 2015-12-02 |
WO2011119289A2 (en) | 2011-09-29 |
KR101837927B1 (ko) | 2018-03-13 |
US20110236666A1 (en) | 2011-09-29 |
JP2013523482A (ja) | 2013-06-17 |
WO2011119289A3 (en) | 2013-02-07 |
KR20130069599A (ko) | 2013-06-26 |
EP2555912A2 (en) | 2013-02-13 |
BR112012018818A2 (pt) | 2016-04-12 |
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