CN105916680A - 用于药物的层压袋 - Google Patents
用于药物的层压袋 Download PDFInfo
- Publication number
- CN105916680A CN105916680A CN201580004472.7A CN201580004472A CN105916680A CN 105916680 A CN105916680 A CN 105916680A CN 201580004472 A CN201580004472 A CN 201580004472A CN 105916680 A CN105916680 A CN 105916680A
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- CN
- China
- Prior art keywords
- layer
- lamination
- bag
- completely
- active pharmaceutical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2068—Venting means
- A61J1/2075—Venting means for external venting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
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Abstract
本发明涉及包含活性药物成分的层压袋、包装活性药物成分的方法以及层压袋用于包装活性药物成分的用途。
Description
发明领域
本发明涉及包含活性药物成分的层压袋、包装活性药物成分的方法以及层压袋用于包装活性药物成分的用途。
发明背景
已开发了各种层压包装材料,其保护包装的材料免受水分、光和空气且在某些情况下维持包装的内容物的水分含量。US 1,538,277描述了来自层压片的用于食品和商品的包装。层压片包含金属箔(例如,锡箔)内层,所述内层利用固体石蜡层与浸渍蜡的中间纸片相连,和涂有蜡质材料的外部包装纸。所述包装不透气地密封包装的内容物。US 2,400,390描述了通过将铝箔或锡箔粘附性地层压到氯化橡胶膜上而形成的真空包装片材。在真空中热密封氯化橡胶膜的边缘以形成耐水分、光和空气的包装。US 3,560,223中描述了在多层盒中原位烹调的食品。管状盒是通过将多层热塑性膜层压到金属箔的两面而形成的。由此形成的密封盒相对不受水分和氧气传递的影响。US 4,096,309描述了高强度和性能的自密封包装层压材料。层压材料由非织造纺粘聚合物长丝(例如,聚乙烯或聚酯)外部片材、柔性金属箔(优选铝)第二层和热密封性聚烯烃内层组成。光滑的无孔材料(例如Kraft纸)表层与外部的纺粘聚合物长丝层结合。US 4,364,989中描述了用于零食的多层包装材料。所述材料包含聚丙烯外层、低密度聚乙烯层压板和共挤出物内层组成。共挤出的内层包含高密度聚乙烯第一层、聚丙烯第二层和乙烯甲基丙烯酸酯第三层组成。乙烯甲基丙烯酸酯表面涂布有聚偏二氯乙烯乳剂,施加热后该乳剂将内层密封在一起。US 2013/0213827中描述了用于储存食物的柔性容器,其具有液体吸收材料制成的垫,所述垫被布置在最接近开口端以吸收液体同时在热密封开口端之前排空柔性容器。
上述层压袋设计用于包装食品和商品。用于包装药品的创新思维聚焦于配方产品例如片剂,例如如WO 2013/076734中所述用于泡罩包装的可生物降解膜。
适合散装药物用途的常规包装一般包含盒型非柔性体。活性药物成分(API)在HDPE桶或瓦通纸盒中储存和运送。与此类包装有关的一个问题是:它们消耗了大量塑料和纸,这对环境造成了负面影响,其中每年有成千上万的海鸟和哺乳动物由于塑料摄入或缠绕而死亡。而且,随着塑料和纸的不断消耗,越来越难处理不可生物降解的废物。此外,现有技术中的盒型非柔性容器具有另一个主要的缺点:装满的容器所占的空间比药品本身所占的空间要大得多。这在其中占据最小空间很关键的运输和储存中是一个问题。然而,常规包装容器(例如,盒和筒)通常装备精良以抵挡外部水分到达往往敏感的药品并且还对机械损伤有弹性。
因此,需要能够显著降低塑料和纸的消耗的创新包装。本发明的技术目的是生产克服了上述技术问题的适合药物用途的包装结构,即:使得柔性包装具有经济性同时具有对水分渗透和机械损伤的充足弹性。
发明详述
本发明描述了填充有活性药物成分的层压袋。层压袋已知用于塑料颗粒的包装。然而,塑料颗粒是高度稳定的化合物,其不需要特定的温度、湿度或其它控制且恰恰相反,层压袋在本发明的领域(即,散装活性药物成分)中被需要。我们已经发现:包含聚酯、金属(例如锡或铝)、尼龙和聚乙烯这四层的袋能够保护活性药物成分在储存和运输期间避免外部水分。比现有包装相比时,出乎意料地发现质量和稳定性相同或者甚至更好。
在本发明的语境中,术语“袋”指的是非刚性容器。术语“层压的”指的是层压的结果,层压是制造多层材料的技术,以使得复合材料由于使用了不同的材料而实现了改进的强度、稳定性、隔音性、外观或其它性质。层压材料通常通过热、压力、焊接或粘合剂来永久组装。术语“阿莫西林”指的是化合物(2S,5R,6R)-6-[[(2R)-氨基(4-羟苯基)乙酰基]氨基]-3,3-二甲基-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸并且还打算包括其盐及其水合物,尤其是钠盐及三水合物。术语“氨比西林”指的是化合物(2S,5R,6R)-6-[[(2R)-氨基苯基乙酰基]氨基]-3,3-二甲基-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸并且还打算包括其盐及其水合物,尤其是钠盐及一水合物、三水合物和倍半水合物(sesquihydrate)。术语“阿托伐他汀”指的是化合物(βR,δR)-2-(4-氟苯基)-β,δ-二羟基-5-(1-甲基乙基)-3-苯基-4-[(苯基氨基)-羰基]-1H-吡咯-1-庚酸及其内酯、水合物和盐,尤其是钙盐、钙盐三水合物、内酯和钠盐。术语“头孢克洛”指的是化合物(6R,7R)-7-[[(2R)-氨基苯基乙酰基]氨基]-3-氯代-8-氧代-5-硫代-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸并且还打算包括其盐及其水合物,尤其是一水合物。术语“头孢羟氨苄”指的是化合物(6R,7R)-7-[[(2R)-氨基-(4-羟苯基)乙酰基]氨基]-3-甲基-8-氧代-5-硫代-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸及其盐和水合物,尤其是一水合物。术语“头孢氨苄”指的是化合物(6R,7R)-7-[[(2R)-氨基苯基乙酰基]氨基]-3-甲基-8-氧代-5-硫代-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸及其盐和水合物,尤其是一水合物、盐酸盐一水合物和钠盐。术语“头孢拉定”指的是化合物(6R,7R)-7-[[(2R)-氨基-1,4-环己二烯-1-基乙酰基]氨基]-3-甲基-8-氧代-5-硫代-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸并且还打算包括其盐及其水合物,尤其是二水合物和一水合物。术语“氯唑西林”指的是化合物(2S,5R,6R)-6-[[[3-(2-氯代苯基)-5-甲基-4-异恶唑基]羰基]氨基]-3,3-二甲基-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸及其盐和水合物,尤其是苄星(benzathine)盐、钠盐和钠盐一水合物。术语“双氯西林”指的是化合物(2S,5R,6R)-6-[[[3-(2,6-二氯代苯基)-5-甲基-4-异恶唑基]羰基]氨基]-3,3-二甲基-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸及其盐和水合物,尤其是钠盐一水合物。术语“氟氯西林”指的是化合物(2S,5R,6R)-6-[[[3-(2-氯代-6-氟苯基)-5-甲基-4-异恶唑基]羰基]氨基]-3,3-二甲基-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸及其盐和水合物,尤其是钠盐一水合物。术语“苯唑西林”指的是化合物(2S,5R,6R)-3,3-二甲基-6-[[(5-甲基-3-苯基-4-异恶唑基)羰基]氨基]-7-氧代-4-硫代-1-氮杂双环[3.2.0]庚烷-2-羧酸及其盐和水合物,尤其是钠盐一水合物。术语“罗素伐他汀”指的是化合物(3R,5S,6E)-7-[4-(4-氟苯基)-6-(1-甲基乙基)-2-[甲基(甲基磺酰基)氨基]-5-嘧啶基]-3,5-二羟基-6-庚酸及其内酯、水合物和盐,尤其是钙盐。
在第一方面,本发明提供含有活性药物成分的层压袋,其特征在于:所述层压袋包含完全包围所述活性药物成分的内部聚乙烯层和完全包围所述内部聚乙烯层的金属层。金属可以是铝或者锡。
在第一种实施方式中,层压袋还包含脂族聚酰胺(例如尼龙,如尼龙-6,6;尼龙-6;尼龙-6,9;尼龙-6,10;尼龙-6,12;尼龙-11;尼龙-12和尼龙-4,6)层。优选地,所述脂族聚酰胺层完全包围内部聚乙烯层。最优选地,尼龙层位于所述聚乙烯层和所述铝层之间。在另一种优选实施方式中,层压袋还包含完全包围所述内部聚乙烯层的聚酯层。合适聚酯的优选实例有聚丁二酸丁二醇酯(PBS)、聚对苯二甲酸丁二醇酯(PBT)、聚已酸内酯(PCL)、聚己二酸乙二醇酯(PEA)、聚萘二甲酸乙二醇酯(PEN)、聚萘二甲酸乙二醇酯(PET)、聚乙醇酸(PGA)、聚羟基脂肪酸酯(PHA)、聚羟基丁酸酯(PHB)、聚(3-羟基丁酸-共-3-羟基戊酸酯)(PHBV)、聚乳酸(PLA)和聚对苯二甲酸丙二醇酯(PTT)。最优选地,聚酯是PET。在一个最优选的实施方式中,层压袋包含内部聚乙烯层、完全包围所述内部聚乙烯层的尼龙层、完全包围所述尼龙层的铝层和完全包围所述铝层的聚酯层。
在第二种实施方式中,层厚度为3-3000μm、优选地5-2000μm、更优选地10-1000μm、最优选地12-750μm。优选地,聚乙烯层的厚度为50-300μm、更优选地100-200μm。优选地,尼龙层的厚度为10-50μm、更优选地12-25μm。优选地,金属层的厚度为300-1000μm、更优选地500-750μm。优选地,聚酯层的厚度为10-50μm、更优选地10-25μm。
在第三种实施方式中,层压袋的层在两层之间包含粘合剂。合适的粘合剂是本领域技术人员已知的,例如双组分聚氨酯粘合剂。
在本发明的第四种实施方式中,单向阀与层压袋相连。单向阀被用于在装置(例如,本发明的层压袋)中造成单向流。单向阀可以是允许气体顺流、防止气体逆流的弹性体密封元件。在本发明的层压袋中,连接单向阀以使得气体能够从层压袋的内部流到外部。存在适用于本发明中的各种设计可用。如果需要低开启压力和易组装性,则一种优选的单向阀是鸭嘴阀。如果需要一定的开启压力或者较高流量下的低压降,则伞形阀是优选的。本领域技术人员知道可用于本发明中的各种类型单向阀的存在和功能,所述单向阀例如Belleville阀、十字形狭缝阀、圆顶阀、鸭嘴阀、微型阀球和伞形阀。上述阀可商购并且可以由各种材料(通常但不一定是聚合物)制成。可根据本领域技术人员已知的程序将上述阀组装到本发明的层压袋中。
在本发明的第五种实施方式中,活性药物成分是选自由阿莫西林、氨比西林、头孢克洛、头孢羟氨苄、头孢罗齐、头孢氨苄、头孢拉定、氯唑西林、双氯西林、氟氯西林和苯唑西林组成的组的抗生素或者选自由阿托伐他汀、洛伐他汀、制霉菌素、匹伐他汀、普伐他汀、罗素伐他汀和辛伐他汀组成的组的他汀类。优选地,抗生素是阿莫西林,最优选地以阿莫西林三水合物的形式。
在第六种实施方式中,活性药物成分在包装于本发明的层压袋中之前被包装在一个或两个分开的袋中。优选地,活性药物成分被包装在聚乙烯袋中。更优选地,得到的被包装在聚乙烯袋中的活性药物成分被包装在第二个袋中。所述第二个袋可以是聚乙烯膜或金属膜,这取决于通常由消费者决定的具体需要。合适的金属膜是铝和锡,优选铝。
在第二方面,本发明提供包装活性药物成分的方法,所述方法包括:使所述活性药物成分进入如本发明的第一方面中所述的层压袋中。可以利用本领域技术人员已知的自动化填充包设备进行活性药物成分的***。
在第三方面,本发明提供如本发明的第一方面中所述的层压袋用于包装活性药物成分的用途,所述活性药物成分例如阿莫西林、氨比西林、阿托伐他汀、头孢克洛、头孢羟氨苄、头孢罗齐、头孢氨苄、头孢拉定、氯唑西林、双氯西林、氟氯西林、洛伐他汀、制霉菌素、苯唑西林、匹伐他汀、普伐他汀、罗素伐他汀和辛伐他汀。
估计通过大抗生素生产设备使用本发明的层压袋将会减少使用接近400mt塑料和纸,从而导致每年减少1500mt CO2。关于大抗生素生产设备进一步估计的优点是:保护不可再生的化石燃料(和因此电力)、节省超过500000l原油(1.75l原油产生1kg HDPE)、或者节省约24000GJ能量(~100MJ.kg-1塑料需要1l原油)。此外,所需的储存和运输空间减少总计多达80%(从而导致在用于仓库中的电力消耗和冷却过程以及运输所用燃料方面的节能)。
附图说明
图1是单向阀的示意图(顶部,A):A1代表外部,气流不能从此处通过单向阀;A2代表内部,气流能够从此处通过单向阀。B(底部)中描述了单向阀在本发明的层压袋中的位置和运作。在层压袋上施加压力(B1)之后,气体从内部(B2)流到外部(B3)。压力释放后,没有返回的气流。
实施例
实施例1
层压袋的性质
测定层压袋的物理性质,所述层压袋包含厚度为135μm的内部聚乙烯(线性低密度聚乙烯,LLDPE)层,接着是厚度为15μm的尼龙(定向聚酰胺,OPA)层,接着是厚度为635μm的铝层,最后是厚度为12μm的聚酯(PET)层。两层之间存在粘合剂:聚乙烯和尼龙之间3μm粘合剂,尼龙和铝之间3μm粘合剂且铝和聚酯之间4μm粘合剂。
每表面单元的重量:
抗张强度:
耐刺穿性:
外/内:
·最大力: 49N
·变形: 0.72cm
·最大能量: 14.0N.cm
内/外:
·最大力: 60N
·变形: 0.79cm
·最大能量: 20.0N.cm
密封强度(P:230kPa,t:1.5s):
·密封强度: 94N.15mm-1
·温度: 200℃
阻隔性能:
·透氧性(23℃和0%相对湿度): <0.1cc.m-2/24h
·透湿性(38℃和90%相对湿度): <0.1g.m-2/24h
防滑性:
·静态COF: >0.6
·动态COF: >0.5
撕裂度:
·MD: >10000mN
·TD: >15000mN
实施例2
包装在层压袋中的阿莫西林三水合物的稳定性
将几批次的阿莫西林三水合物储存在40±2℃和75±5%的相对湿度(RH)下6个月。在0、1、2、3和6个月后分析样品。批次A1和A2代表现有包装(在聚乙烯第一袋、铝或聚乙烯第二袋以及为瓦通纸盒或HDPE鼓的第三袋中的25kg批次的阿莫西林)且批次B1和B2代表根据本发明的包装(在聚乙烯第一袋、聚乙烯第二袋以及为实施例1中所述层压袋的第三袋中的25kg批次的阿莫西林)。层压袋还带有单向阀。针对稳定性研究,根据ICH和EU指南进行储存和分析。阿莫西林三水合物的规格如下:
4个受检批次的稳定性数据如下:
表1:批次A1和A2(包装在聚乙烯第一袋、铝或聚乙烯第二袋以及为瓦通纸盒或HDPE鼓的第三袋中的25kg批次的阿莫西林三水合物)的稳定性数据。
表2:批次B1和B2(包装在聚乙烯第一袋、聚乙烯第二袋以及为实施例1中所述层压袋的第三袋中的25kg批次的阿莫西林三水合物)的稳定性数据。
比较表1和表2中所示结果之后,可以清楚看出:相较于以传统方式包装和储存阿莫西林三水合物,将阿莫西林三水合物包装在根据本发明的层压袋中导致相同或改善的稳定性结果。
Claims (15)
1.含有活性药物成分的层压袋,其特征在于:所述层压袋包含完全包围所述活性药物成分的内部聚乙烯层和完全包围所述内部聚乙烯层的铝层。
2.根据权利要求1所述的层压袋,其还包含完全包围所述内部聚乙烯层的尼龙层和/或完全包围所述内部聚乙烯层的聚酯层。
3.根据权利要求2所述的层压袋,其中所述尼龙层位于所述聚乙烯层和所述铝层之间且其中所述聚酯层完全包围所述铝层。
4.根据权利要求3所述的层压袋,其包含内部聚乙烯层、完全包围所述内部聚乙烯层的尼龙层、完全包围所述尼龙层的铝层和完全包围所述铝层的聚酯层。
5.根据权利要求1-4中任一项所述的层压袋,其中所述各层的厚度为10-1000μm。
6.根据权利要求3-5中任一项所述的层压袋,其中所述聚乙烯层的厚度为50-300μm,所述尼龙层的厚度为10-50μm,所述铝层的厚度为300-1000μm且所述聚酯层的厚度为10-50μm。
7.根据权利要求1-6中任一项所述的层压袋,其中两层之间存在粘合剂。
8.根据权利要求1-7中任一项所述的层压袋,其还包含单向阀,所述单向阀的位置使得气体能够从所述层压袋的内部传递到外部。
9.根据权利要求1-8中任一项所述的层压袋,其中所述活性药物成分是选自由阿莫西林、氨比西林、头孢克洛、头孢羟氨苄、头孢罗齐、头孢氨苄、头孢拉定、氯唑西林、双氯西林、氟氯西林和苯唑西林组成的组的抗生素或者选自由阿托伐他汀、洛伐他汀、制霉菌素、匹伐他汀、普伐他汀、罗素伐他汀和辛伐他汀组成的组的他汀类。
10.根据权利要求9所述的层压袋,其中所述活性药物成分是阿莫西林三水合物。
11.根据权利要求1-10中任一项所述的层压袋,其中所述活性药物成分包装在聚乙烯袋中。
12.根据权利要求11所述的层压袋,其中包装在聚乙烯袋中的所述活性药物成分被包装在第二个袋中,所述第二个袋是聚乙烯或铝。
13.包装活性药物成分的方法,所述方法包括:使活性药物成分进入层压袋中,所述层压袋包含内部聚乙烯层和完全包围所述内部聚乙烯层的铝层。
14.层压袋用于包装活性药物成分的用途,所述层压袋包含内部聚乙烯层和完全包围所述内部聚乙烯层的铝层。
15.根据权利要求14所述的用途,其中所述层压袋还包含完全包围所述内部聚乙烯层的尼龙层和/或完全包围所述内部聚乙烯层的聚酯层。
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IN111DE2014 IN2014DE00111A (zh) | 2014-01-15 | 2015-01-12 | |
PCT/EP2015/050392 WO2015107016A1 (en) | 2014-01-15 | 2015-01-12 | Laminated bag for pharmaceuticals |
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US (1) | US20160331638A1 (zh) |
EP (1) | EP3094492B1 (zh) |
CN (1) | CN105916680A (zh) |
ES (1) | ES2742103T3 (zh) |
HK (1) | HK1225698A1 (zh) |
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WO2014028745A2 (en) * | 2012-08-17 | 2014-02-20 | Archon Pharmaceutical Consulting Llc | A system for compounding and packaging ready to reconstitute drug powders of solutions to a solution or to a suspension or to an injectable |
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- 2015-01-12 ES ES15701485T patent/ES2742103T3/es active Active
- 2015-01-12 WO PCT/EP2015/050392 patent/WO2015107016A1/en active Application Filing
- 2015-01-12 IN IN111DE2014 patent/IN2014DE00111A/en unknown
- 2015-01-12 EP EP15701485.3A patent/EP3094492B1/en active Active
- 2015-01-12 CN CN201580004472.7A patent/CN105916680A/zh active Pending
- 2015-01-12 PL PL15701485T patent/PL3094492T3/pl unknown
- 2015-01-12 US US15/111,262 patent/US20160331638A1/en not_active Abandoned
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IN2014DE00111A (zh) | 2015-07-17 |
PL3094492T3 (pl) | 2019-11-29 |
HK1225698A1 (zh) | 2017-09-15 |
EP3094492B1 (en) | 2019-05-15 |
EP3094492A1 (en) | 2016-11-23 |
US20160331638A1 (en) | 2016-11-17 |
ES2742103T3 (es) | 2020-02-13 |
WO2015107016A1 (en) | 2015-07-23 |
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