CN1429545A - 作为增重增强剂的二甲基硅油 - Google Patents
作为增重增强剂的二甲基硅油 Download PDFInfo
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- CN1429545A CN1429545A CN02121867A CN02121867A CN1429545A CN 1429545 A CN1429545 A CN 1429545A CN 02121867 A CN02121867 A CN 02121867A CN 02121867 A CN02121867 A CN 02121867A CN 1429545 A CN1429545 A CN 1429545A
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Abstract
包含成膜剂和增重增强剂的成膜组合物,其中所说的增重增强剂选自二甲基硅油、吐温80和它们的混合物,其中使用的增重增强剂的量是能增加干燥时底物所获得的成膜组合物的增重量的足够数量。
Description
相关申请的相互参照
本申请是2002年4月12号申请的申请号为__的美国专利申请(代理人记事表号MCP303)的继续部分,它要求了在2001年5月15号申请的申请号为60/291,127的美国申请和2001年9月28号申请的申请号为60/325,726的美国申请的优先权,它们在此均被全部引入作为参考。
本发明的领域
本发明涉及一种新的、水溶性的、不含明胶的用于浸涂底物的组合物和制造该类剂型的方法,其中所说的浸涂底物如片剂和胶囊。本发明进一步涉及一种增加在浸涂包衣的片剂或囊片上形成的水溶性、不含明胶的膜的重量的方法。
本发明的背景技术
在这一百年的大多数时间中,硬明胶胶囊是用于处方和非处方(OTC)药的流行的剂型。将具有不同颜色的半个胶囊结合起来为制造商提供了区别各种不同的药品的独特方法。许多病人更喜欢胶囊而不是片剂,因为他们认识到胶囊更容易吞咽。消费者的这种偏爱促使药品制造商以胶囊的形式来销售某一产品,即使这种产品也存在片剂形式。
一般而言,使用自动机械设备来制造空的硬明胶胶囊。这种设备包括成排的安装在棒或板上的不锈钢针,这些不锈钢针被浸在维持均一温度和流动性的明胶溶液中。然后将这些针从明胶溶液中抽出,旋转,然后插入干燥的干燥炉中,向该干燥炉中通入湿度受控制的过滤空气的强风。在干燥期间,在每根针上就形成了二分之一个胶囊壳的粗品。然后将每个二分之一个胶囊壳剥离下来,修剪到均一的长度,填充,与另外合适的相配的另一半相结合。
胶囊产品一种供替代的选择是囊片,它是一种长椭圆形的固体片剂,该片剂常用诸如纤维素醚之类的不同聚合物进行包衣以改善其美学效果、稳定性和吞咽性能。典型地,该类高分子以有机溶剂溶液或水分散体的形式通过喷雾被应用于片剂表面。但是,这种喷雾包衣的片剂缺乏硬明胶胶囊有光泽的表面和典雅外观。此外,商业上也不易得到喷雾包衣各半颜色不同的片剂。
胶囊产品的另一种供替代的选择是“明胶囊片(gelcaps)”,它是一种典雅的、表面有光泽的、消费者偏爱的剂型,其制备是将延长的片剂的各半浸入两种不同颜色的明胶溶液中。见专利号为4,820,524;5,538,125;5,685,589;5,770,225;5,198,227;和5,296,233的美国专利,所有这些文献在这里均被引入作为参考。一种相似的剂型,“明胶衣片(geltab)”在商业上是可以得到的,它是通过将圆形的、凸面的片剂的两边分别浸入不同颜色的明胶溶液中,该方法的描述见专利号为5,228,196、US 5,436,026和US 5,679,406的美国专利,所有这些文献在这里引入用作参考。这里所说的诸如“明胶囊片”和“明胶衣片”的概念被包括在所说的广义的“片剂”中。
但是,作为一种包衣材料,明胶存在一定的缺点和局限性,包括在长期存储后可能由于明胶的交联而导致的溶解速率的下降,在生产过程中明胶溶液可能会被微生物污染,以及大量的干燥技术条件需要的过程长。此外,因为为了维持明胶的流动性,典型的用于底物上的明胶材料需要将温度升高到至少40℃,而为了减少微生物的生长,底物的温度需要维持在约50℃,所以用明胶包衣时与之相关的能耗成本可能会很高。
人们进行了各种努力来制造不含明胶的硬壳胶囊。例如WO 00/18835公开了一种通过常规的浸渍模塑处理用于制造硬胶囊壳的淀粉醚或氧化淀粉与水解胶体的组合物。该法还可参见US 4,001211(胶囊是通过将针浸入热凝胶化的甲基纤维素醚组合物中来进行制备的)。但是,由于潜在的观念的改变(tamperingconcerns),硬明胶胶囊不再是消费者(非处方)药品、食品补充剂或其它此类产品优选的传递系统。此外,钢针浸入然后干燥以在其上形成硬胶囊壳的理想组合物的性质不一定与浸涂片剂在其上形成包衣的组合物的性质相同。例如,用于硬胶囊制剂和包衣片剂的组合物间的相关的物理性质如粘度、增重、膜厚、抗张强度、弹性以及水分含量将会是不同的。参见US 1,787,777(底物和包衣溶液的最佳温度,在溶液中的滞留时间,以及干燥条件不同)。
将片剂或胶囊浸入不含明胶的包衣体系中的缺点之一是得到的包衣常常缺乏足够的抗张强度、弹性、硬度和厚度。此外,向该类不含明胶的包衣体系中加入增塑剂常会使得到的片剂的包衣柔软发粘,在加工过程中没有足够的硬度来维持其形状和光滑度。此外,许多不含明胶的的组合物在将片剂仅仅进行浸渍后不能以足够的数量粘附在底物上以得到均一的膜。进一步地,许多不含明胶的组合物缺乏在浸涂和干燥过程中维持均一颜色分散体所必须的流变学性质。虽然人们已经进行了多种努力来改善这些组合物的流变学性质,如为了增加其粘度而增加其中的固体含量,但是,这样的组合物的经常会产生不希望出现的包衣美学缺陷,如表面坚硬,光泽下降,以及没有均一的包衣膜厚度。
需要找到一种浸涂包衣材料,不仅能够制造出一种与明胶包衣的制剂一样典雅、有光泽、很光滑、消费者喜爱的制剂,而且该制剂没有明胶的局限性,尤其是没有如上所述的这些局限性。
本发明的概述
本发明提供了一种膜形成组合物,该组合物包含下列组分、由下列成分组成和/或基本组成:a)成膜剂;b)增重增强剂,该增强剂选自二甲基硅油、吐温80及其混合物,当应用于底物时其量足以增加底物所获得的成膜组合物的增重量。
本发明的另外一个实施方案是一种增加被浸蘸成形的底物上干的包衣层增重的方法,该方法包括当该包衣材料包含成膜剂时,向该包衣材料中加入有效量的增重增强剂,该增重增强剂选自二甲基硅油、吐温80及其混合物。
本发明的又一个实施方案是一种改善被浸蘸成形的底物上的干的包衣组合物层的色彩均一度的方法,该方法包括:
当该包衣组合物包含成膜剂和着色剂时,向该包衣组合物的水分散体中加入有效量的二甲基硅油、吐温80或它们的混合物。
我们发现当用本发明的组合物对制剂进行包衣时,可以得到一种与明胶包衣的制剂一样典雅、有光泽、很光滑、消费者喜爱的制剂,而且该制剂没有与明胶有关的局限性,尤其是没有如上所述的这些局限性。我们还发现当这种组合物用于浸涂和喷雾包衣操作时,不会抑制所包衣活性物质的溶解活性。此外,我们发现用这种组合物包衣的制剂在向其中加入增重增强剂的同时色彩均一性也得到了改善。
本发明的详细描述
在本文中,“胶囊”指一种可以将可给药的一定剂量的组分包封起来的坚硬的壳体隔室。本发明所说的“片剂”指任何形状或尺寸的压制或模塑的固体制剂。这里所说的“囊片”指固体、长椭圆形的片剂。“明胶囊片”指有光滑的凝胶包衣的固体囊片,“明胶衣片(geltabs)”指侧面扁平、相对两个表面为圆锥状、有光滑的凝胶状包衣的固体片剂。这里所说的“硬度”指的是膜或包衣表现出来的膜/包衣抵抗撞击变形的能力。这里所说的涉及非高分子材料的“水溶性”,指的是微溶至易溶,即溶解1份非高分子材料水溶性溶质需要不多于100份的水中。见Remington,“The Science and Practice of Pharmacy”,第208-209页(2000)。这里所说的涉及高分子材料的“水溶性”指的是该聚合物在水中可以膨胀,在其分子水平下可以分散在水中形成分散体或胶体“溶液”。这里所说的“表面光泽”涉及用本文中实施例7所述的方法在60度入射角时测得的光的反射率。
二甲聚硅氧烷是一种众所周知的药学材料,其由含有分子式为-{(CH2)2SiO}n的重复单元的线性硅氧烷聚合物组成,该线性硅氧烷聚合物用分子式为[(CH3)3SiO-]的三甲基甲硅烷氧基末端阻断单元来进行稳定。二甲基硅油是二甲聚硅氧烷和二氧化硅的混合物。为了实现本发明的目的,这两种材料可以互换使用。
本发明的第一个实施方案是一种水溶性的、基本上不含有明胶的、可用于片剂浸涂包衣或通过浸渍模塑过程制造胶囊的成膜组合物。一种组合物包含、组成和/或基本组成为成膜剂和增稠剂,其中所说的成膜剂如纤维素醚,例如羟丙基甲基纤维素;和增稠剂如水胶体,例如黄原胶或角叉菜胶。在另外一个实施方案中该组合物包含、组成和/或基本组成为成膜剂、增稠剂和增塑剂,其中所说的成膜剂如改性淀粉,该改性淀粉选自蜡状玉米淀粉、木薯淀粉糊精、以及它们的衍生物和混合物;其中所说的增稠剂选自蔗糖、葡萄糖、果糖、麦芽糖糊精、聚葡萄糖、以及其衍生物和混合物;其中所说的增塑剂如聚乙二醇、丙二醇、植物油如蓖麻油、甘油、以及它们的混合物。在又一个实施方案中该组合物包含、组成和/或基本组成为成膜剂如纤维素醚,例如羟丙基甲基纤维素;任选地含有一种增塑剂如植物油,例如蓖麻油;以及任选地可基本不含如水胶体之类的增稠剂,其中所说的水胶体如黄原胶。还是在另外一个实施方案中,该组合物包含、组成和/或基本组成为成膜剂如纤维素醚,例如羟丙基甲基纤维素;填充剂,如聚糖,例如麦芽糖糊精;可选择性地含有增塑剂,如二醇,例如聚乙二醇;可选择性地基本不含有增稠剂,如水凝胶,例如黄原胶。这里所说的“基本不含明胶”指的是组合物中的明胶少于1%,例如少于0.5%,“基本不含增稠剂”指的是组合物中的增稠剂少于1%,例如少于0.01%。
现有技术中已知的任何一种成膜剂都适用于本发明的成膜组合物。合适的成膜剂包括但不限于聚乙烯醇(PVA)、羟丙基淀粉、羟乙基淀粉、普鲁兰、甲基乙基淀粉、羧甲基淀粉、甲基纤维素、羟丙基纤维素(HPC)、羟乙基甲基纤维素(HEMC)、羟丙基甲基纤维素(HPMC)、羟丁基甲基纤维素(HBMC)、羟乙基乙基纤维素(HEEC)、羟乙基羟丙基甲基纤维素(HEMPMC)、预胶化淀粉、以及它们的聚合物、衍生物和混合物。
一种合适的羟丙基甲基纤维素是“HPMC 2910”,它是一种取代度为1.9的纤维素醚,其羟丙基克分子取代度为0.23,含有化合物总重量约29%至约30%的甲氧基和约7%至约12%的羟丙基基团。HPMC 2910可从Dow化学公司买到,其商品名为“Methocel E.”。“Methocel E5”是HPMC-2910适用于本发明的一个等级,用Ubbelohde粘度计测量,20℃下其2%水溶液的粘度为大约4至6cps(4至6毫帕-秒)。类似地,“Methocel E6”是HPMC-2910适用于本发明的另外一个等级,用Ubbelohde粘度计测量,20℃下其2%水溶液的粘度为大约5至7cps(5至7毫帕-秒)。“MethocelE15”是HPMC-2910适用于本发明的另一个等级,用Ubbelohde粘度计测量,20℃下其2%水溶液的粘度为大约15000cps(15毫帕-秒)。这里所说的“取代度”指的是连接在葡糖酐环上的取代基团的平均数目,“羟丙基克分子取代”指的是每摩尔葡糖酐中羟丙基的摩尔数。
这里所说的“改性淀粉”包括通过交联修饰、化学修饰以提高其稳定性或物理学修饰以改善其溶解性的淀粉。这里所说的“预胶化淀粉”或“速溶性淀粉”是被改性的淀粉,该淀粉先被湿润,然后干燥以提高其在冷水中的溶解度。合适的改性淀粉可以从一些供应商,如A.E.Staley制造公司和国家淀粉和化学公司那里得到可商用的品种。适合的改性淀粉包括可从国家淀粉和化学公司买到的、商品名称为“Purity Gum”和“FilmSet”的预胶化含蜡玉米衍生化淀粉,以及其衍生物、共聚物和混合物。这种蜡状玉米淀粉一般含有占淀粉总重量约0到约18%的直链淀粉和约100到约88%的支链淀粉。
合适的木薯淀粉糊精包括可从国家淀粉和化学公司买到的、商品名称为“Crystal Gum”或“K-4484”的商品,以及其衍生物,例如可以从国家淀粉和化学公司购得、其商品名称为“Purity Gum 40”的由木薯淀粉获得的改性食物淀粉,还有包括其共聚物和混合物。
现有技术中已知的任何一种增稠剂都适用于本发明的成膜组合物。这些增稠剂的例子包括但不仅限于水凝胶如藻酸盐、琼脂、瓜尔豆胶、槐树豆胶、角叉菜胶、他拉胶、阿拉伯胶、黄蓍胶、果胶、黄原胶、gellan、麦芽糖糊精、半乳甘露聚糖、石脐素、昆布糖、硬葡聚糖、阿拉伯胶、菊粉、果胶、whelan、rhamsan、zooglan、methylan、壳多糖、环糊精、壳聚糖、以及它们的衍生物和混合物。其它适宜的增稠剂包括蔗糖、葡萄糖、果糖、麦芽糖糊精、葡聚糖等,及其衍生物和混合物。
合适的黄原胶包括这些从C.P.Kelo公司购得的商品名为“Keltrol 1000”、“Xantrol 180”或“K9B310”商品。
在药学现有技术中任何已知的增塑剂均适用于本发明,该增塑剂包括但并不仅限于聚乙二醇;甘油;山梨醇;枸橼酸三乙酯;枸橼酸三丁酯;癸二酸二丁酯;植物油如蓖麻油;表面活性剂如聚山梨醇酯、十二烷基硫酸钠、和磺基琥珀酸二辛基钠;丙二醇;甘油单醋酸酯;甘油二醋酸酯;甘油三醋酸酯;天然胶及其混合物。在含有纤维素醚成膜剂的溶液中,可选择性地存在一定数量的增塑剂,其数量约为溶液总重量的0到约40%。
在一个实施方案中,用于浸渍涂布底物的成膜组合物可以基本不含有明胶,即例如含有少于约1%,或少于约0.01%的明胶。
在另一个实施方案中,用于浸渍涂布底物的成膜组合物可以基本不含有由牛类动物得到的材料,即例如含有少于约1%,或少于约0.01%由牛类动物得到的材料。
在组合物中使用纤维素醚成膜剂的实施方案中,用于浸渍涂布底物的成膜组合物可以基本不含有水凝胶,即例如含有少于约1%,或少于约0.01%的水凝胶。
在另外一个实施方案中,用于浸渍涂布底物的成膜组合物可以基本不含有增塑剂,即例如含有少于约1%,或少于约0.01%的增塑剂。
在一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约95%到少于约100%,例如约95%到约99.5%的成膜剂,如纤维素醚,纤维素醚的例子如羟丙基甲基纤维素;和约0.5%到约5%的增稠剂,如水凝胶,所说的水凝胶如黄原胶。
在另外一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约40%到约60%,例如约50%到约55%的改性淀粉,例如蜡状玉米淀粉、木薯淀粉糊精、和/或其混合物和衍生物;约15%到约30%,例如约20%到约25%的增塑剂,例如甘油、聚乙二醇、丙二醇、蓖麻油、及其混合物;和约5%到25%,例如约10%到约20%的增稠剂,例如蔗糖、葡萄糖、果糖、麦芽糖糊精、葡聚糖、及其混合物。
在另外一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约95%到约100%,例如约97%到约100%的成膜剂,如纤维素醚,例如羟丙基纤维素醚。
在另外一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约95%到约100%,例如约97%到约100%的成膜剂,如纤维素醚,其中所说的纤维素醚例如羟丙基甲基纤维素;和基本不含有水凝胶,即例如包含少于约1%,或少于约0.01%的水凝胶。
还是在一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约95%到约100%,例如约97%到约100%的成膜剂,如纤维素醚,其中所说的纤维素醚例如羟丙基甲基纤维素;和约0.1%到约1.0%,例如约0.25%到约0.5%的增塑剂,如植物油,例如蓖麻油。
还是在一个实施方案中,用于浸渍涂布底物的成膜组合物含有组合物总固体干重约5%到约99%,例如约50%到约90%,或约80%到约90%的成膜剂,如纤维素醚,其中所说的纤维素醚例如羟丙基甲基纤维素;约1%到约80%,例如约5%到约50%或约5%到约40%的填充剂,如聚糖,例如麦芽糖糊精;和约0.1%到约20%,例如约2.5%到约15%的增塑剂,如二醇,例如聚乙二醇。例如美国专利US5,470,581和US6,183,808中公开了合适的干组合物的例子,在这里它们被引入用作参考。
为了易于浸涂到底物上,这些成膜组合物的典型形态是分散体。这种分散体含有一定数量的溶剂,以分散体总重为基础,该分散体含有约30%到约97%的溶剂,例如含有约80%到约92%或约40%到约75%的溶剂。适合的溶剂包括但并不仅限于水;醇如甲醇、乙醇和异丙醇;有机溶剂如二氯甲烷、丙酮等等;及其混合物。在一个实施方案中,溶剂是水。所得的成膜分散体典型地含有一些固体,以成膜分散体的总重为基础,含有约3%到约70%,例如约8%到约20%或约25%到约60%的固体。
在一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总湿重约5%到约20%,例如约8%到15%或约10%到约14%的成膜剂,如羟丙基甲基纤维素;和约0.05%到约0.2%,例如约0.08%到约0.16%或约0.1%到约0.14%的增稠剂,如黄原胶。
在另外一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总湿重约20%到约35%,例如约25%到约30%的成膜剂,例如蜡状玉米淀粉、木薯淀粉糊精、和/或其衍生物和混合物;约5%到约20%,例如约10%到约15%的增塑剂,例如甘油、聚乙二醇、丙二醇、蓖麻油、及其混合物;和约5%到约15%的增稠剂,该增稠剂选自蔗糖、果糖、葡萄糖、麦芽糖糊精、葡聚糖、及其混合物。
还是在一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总湿重约5%到约25%,例如约8%到约20%或约10%到约16%的成膜剂,如纤维素醚,例如羟丙基甲基纤维素。
还是在一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总重约5%到约25%,例如约8%到约20%或约10%到约16%的成膜剂,如纤维素醚,例如羟丙基甲基纤维素;和基本不含有水凝胶,即含有少于约1%,或少于约0.01%的水凝胶。
还是在一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总湿重约5%到约25%,例如约8%到约20%或约10%到约16%的成膜剂,如纤维素醚,例如羟丙基甲基纤维素;和约0.001%到约0.1%,例如约0.01%到约0.09%的增塑剂,如植物油,例如蓖麻油。
还是在一个实施方案中,用于浸涂底物的成膜组合物含有浸涂分散组合物总湿重约1%到约21%,例如约10%到约19%或约16%到约19%的成膜剂,如纤维素醚,例如羟丙基甲基纤维素;约0.1%到约17%,例如约1%到约11%或约1%到约8%的填充剂,如聚糖,例如麦芽糖糊精;和约0.02%到约4%,例如约0.5%到约3%的增塑剂,如二醇,例如聚乙二醇。
浸涂组合物还可以任选地进一步含有其它组分,如以浸涂溶液的总重为基础,含有约0到约2%的防腐剂如尼泊金甲酯和尼泊金丙酯,约0到14%的不透明剂,如二氧化钛,和/或约0到约14%的着色剂。见Remington’s Practice of Pharmacy,Martin & Cook,17th ed.,pp.1625-30,该文献在这里被引入用作参考文献。
任何在药学上适用的着色剂都适用于本发明,这些着色剂包括但并不仅限于偶氮染料、quinopthalone染料、三苯甲烷染料、氧杂蒽染料、靛系染料、氧化铁、氢氧化铁、二氧化钛、天然染料、及其混合物。更特定地,适用的着色剂包括但并不仅限于V字广蓝、酸性大绿BS、红2G、偶氮玉红、鲜红4R、苋菜红、D&C红33、D+C红22、D+C红26、D+C红28、D+C黄10、FD+C黄5、FD+C黄6、FD+C红3、FD+C红40、FD+C蓝1、FD+C蓝2、FD+C绿3、亮黑BN、炭黑、氧化铁黑、氧化铁红、氧化铁黄、二氧化钛、核黄素、胡萝卜素、antyhocyanines、姜黄、胭脂虫提取物、叶绿素、鸡油菌黄素、酱色、甜菜红、及其混合物。
在一个实施方案中,片剂或胶囊的每头都用两种不同颜色的浸涂衣层包衣,这样可以为特定的产品提供有特色的外观。见US 4,820,524,在这里将其作为参考。
在一个实施方案中。药物制剂包含a)一个包含活性成分的核心;b)可选择存在的基本覆盖核心的构成包衣底层的第一层包衣;和c)位于第一层包衣层之外的第二包衣层,该第二包衣层含有本发明的浸涂组合物。这里所所的“基本覆盖”指的是至少约95%的核心表面积被包衣底层所覆盖。
在另一个的实施方案中,第一种活性成分可以被包含在第一包衣层中,核心中可以含有第二种活性成分和/或附加数量的第一种活性成分。在另外一个实施方案中,第一活性成分可以包含于第一包衣层中,核心中可以基本不含有,即少于约1%,例如少于约0.1%的活性成分。
包衣底的使用在现有技术中是公知的,并在US 3,185,626中被公开,这里将其作为参考。任何适用于片基薄膜包衣的组合物都可以适用于本发明的包衣底。适用的包衣底的实例在US 4,683,256、US 4,543,370、US 4,643,894、US4,828,841、US 4,725,441、US 4,802,924、US 5,630,871和US 6,274,162中进行了公开,它们在这里被引用作为参考。另外适用的包衣底包括一个或多个如下成分:纤维素醚如羟丙基甲基纤维素、羟丙基纤维素、以及羟乙基纤维素;聚糖如黄原胶、淀粉、以及麦芽糖糊精;增塑剂,例如甘油、聚乙二醇、丙二醇、癸二酸二丁酯、枸橼酸三乙酯、植物油如蓖麻油、表面活性剂,其中所说的表面活性剂如吐温80、十二烷基硫酸钠以及磺基琥珀酸二辛基钠;聚糖,色素和不透明剂。
在一个实施方案中,包衣底可以包含包衣底总重的约2%到约8%,例如约4%到约6%的水溶性纤维素醚和约0.1%到约1%的蓖麻油,其详细公开见US5,658,589,在这里引用其作为参考。在另外一个实施方案中,包衣底可以包含包衣底总重的约20%到约50%,例如约25%到约40%的HPMC;约45%到约75%,例如约50%到约70%的麦芽糖糊精;和约1%到约10%,例如约5%到约10%的PEG400。
以核心的干重为基础,典型的干燥包衣底存在量约为0到约5%。以核心和选择行存在的包衣底的干重为基础,干燥的浸涂层存在的重量为约1.5%到约10%。
典型的干燥的浸涂包衣层的平均厚度为约40到约400微米。但是,本领域熟练操作人员不需要过多的试验就能很容易的意识到浸涂包衣层的厚度可以有一定的变化,以得到光滑、易于吞咽的制剂或得到理想的溶出曲线。此外,在不同部位底物上浸涂包衣层的厚度可以根据其形状而有所不同。例如,底物较尖锐或边角处的包衣层厚度可能比底物主表面中心处的包衣层厚度少50%到70%。这种差异可以被减小,例如可以通过使用较厚的包衣底或使用能使底物获得更多增重点的浸涂组合物来减少这一差异。
在想要获得较厚浸涂层的实施方案中,我们发现可以向包含、组成或基本组成为成膜剂和可选择性的含有增稠剂的成膜组合物中加入有效量的增重增强剂,其中所说的增稠剂如水胶体,其中所说的增重增强剂选自二甲基硅油、吐温80以及其混合物。所用增重增强剂的量为能够增加包衣溶液增重量的有效量,例如至少为底物干重的约10%、约20%或约30%。获得的增重百分比是通过计算包衣底物和包含增重增强剂的包衣组合物的总重与相同的包衣底物总重间的差异来获得的,其中所说的相同的包衣底物是用不含有效量的增重增强剂的包衣组合物用同样的操作条件对底物进行包衣而获得的。
在一个实施方案中,成膜剂是纤维素醚如HPMC,增稠剂是水胶体如黄原胶,增重增强剂是二甲基硅油。
适合的能增加底物浸涂包衣增重的成膜组合物可以包含成膜组合物总重约40%到约99.9%。例如约95%到约99.5%,或约40%到60%的成膜剂;约0到约60%,例如约0到约10%,或约0.5%到约5%,或约10%到约25%的增稠剂;和约0.01%到约0.25%,例如约0.03%到约0.15%的增重增强剂。当特别关心最后所得片剂的美感时,建议不要使用高于约0.25%的量的增重增强剂。如上所述,适用于组合物的增稠剂的量将会依赖于诸如所选择的特定的增稠剂和所要的包衣膜的性质等因素而变化。例如,当选择黄原胶作为增稠剂时,以成膜组合物总的干重为基础,黄原胶增稠剂的量可以在约0.5%到约5%的范围之间变动。
本发明的成膜组合物可以通过将成膜剂,增稠剂,以及一些任选的组分如增塑剂、防腐剂、着色剂、不透明剂、增重增强剂、或一些其它的组分一起与溶剂混合来进行制备,在室温条件下用高速剪切混合机将其混合,直至达到均匀的状态。在用蜡状玉米淀粉衍生物作为成膜剂的实施方案中,可以将混合物加热到约60℃到约90℃以使组分迅速分散。或者,成膜剂和增稠剂可以以干粉末的形式先进行混合,然后将混和所得的粉末加入到水中,可以选择加入增重增加剂,然后高速混和。为了使所得的混合物基本没有泡沫,在降低混和速度以避免在混合物中产生漩涡的同时,可以将压力降低到约5英寸Hg。然后在恒速混合下可以向其中加入任何一种另外选择的组分。
令人吃惊的发现是底物可以通过使用与制造浸蘸成形的明胶包衣的片剂同样的装置和条件被浸入本发明的溶液中。例如,片剂和硬胶囊都可以通过用已知的明胶浸渍过程参数和设备,使用本发明的水分散体来进行包衣。该设备和操作的详细描述在现有技术都是已知的,例如US 4,820,524就对其进行了公开,在这里将其应用作为参考。其优点是,由于本发明的包衣溶液在室温下是液体,且与明胶组合物相比更不易遭受微生物生长的污染,所以浸涂操作可以在室温和常压的条件下进行操作。
用本发明的组合物浸涂包衣的片剂可以包含一种或多种活性成分。这里所使用的“活性成分”的定义是一个广义的概念,可以是在操作中包含在体系中的任何一种物质。例如,活性成分可以是药物、营养药、维生素、食品强化剂、营养物、草药、食物、染料、滋养物、矿物、添加剂、或矫味剂等等或其组合。
在这里有用的活性成分可以选自属于如下治疗各分类的物质:ACE-抑制剂;生物碱;抗酸剂;镇痛剂;同化剂;抗心绞痛药物;抗变态反应剂;抗心律失常药物;平喘药;抗生素;抗胆固醇血药;抗惊厥药;抗凝血药;抗抑郁药;止泻剂;止吐药;抗组胺药;抗高血压药;抗感染药;抗炎药;降脂药;抗狂躁药(antimanics);抗偏头痛药;止恶心药;精神抑制药;抗中风药;抗甲状腺制剂;同化药(anabolic drugs);抗肥胖药;抗寄生虫剂;精神抑制药;退热药;镇痉药;抗血栓形成药;抗肿瘤药;镇咳药;抗溃疡药;抗尿酸血症药;抗焦虑药;食欲促进剂;食欲抑制剂;β-受体阻断剂;支气管扩张药;心血管药;脑血管扩张药;鳌合剂;缩胆囊素拮抗剂;化疗药物;识别活化剂(cognitionactivators);避孕药;冠状血管扩张压药;咳嗽抑制剂;减充血剂;除臭剂;皮肤病药物;糖尿病药物;利尿药;软化剂;酶;红细胞生成药;祛痰药;生育药;杀真菌药;胃肠道药物;生长调节剂;激素替代物;促血糖增高药;降血糖药;离子交换树脂,轻泻药;偏头痛治疗药;矿物补充剂;粘液溶解剂;麻醉药;精神抑制药;神经肌肉药物;非甾体抗炎药(NSAIDs);营养添加剂;周边血管舒张药;多肽;前列腺素;治疗精神病药物;肾素抑制剂;呼吸促进剂;镇静药;类固醇;兴奋剂;交感神经阻滞剂;甲状腺制剂;安定药;子宫松弛剂;阴道制剂;血管收缩药;血管舒张药;眩晕药;维生素;伤口痊愈药等等。
本发明中的活性成分可以包括但不仅限于:对乙酰氨基酚;醋酸;乙酰水杨酸,包括其缓冲剂的形式;阿伐斯丁;沙丁胺醇及其硫酸盐;醇;生物碱磷酸盐;尿囊素;芦荟;醋酸铝、碳酸铝、水合氯化铝、氢氧化铝;阿普唑仑;氨基酸;氨基苯甲酸;阿莫西林;氨苄西林;安吖啶;amsalog;茴香脑;抗坏血酸;天门冬氨酯;阿司咪唑;阿替洛尔;阿扎他啶及其马来酸盐;枯菌肽;秘鲁香脂;BCNU(卡莫司汀);二丙酸倍氯美松;苯佐卡因;苯甲酸;二苯甲酮;过氧化苯甲酰;苯喹胺及其盐酸盐;氨基甲酰甲基胆碱;生物素;比沙可啶;次水杨酸铋;乙酰冰片酯;溴苯那敏及其马来酸盐;丁螺环酮;咖啡因;炉甘石;碳酸钙,酪蛋白酸盐(casinate)及其氢氧化物;樟脑;卡托普利;波西鼠李皮;蓖麻油;头孢克洛,头孢羟氨卞;头孢氨卞;centrizine及其盐酸盐;西替利嗪;十六醇;氯化十六烷基吡啶葎;螯合金属;氯霉素;盐酸氯环嗪;葡萄糖酸洗必太;对氯间二甲酚;choropentostatin;氯苯那敏及其马来酸盐及单宁酸盐;氯丙嗪;消胆胺;重酒石酸胆胺;软骨形成刺激蛋白;西米替丁;盐酸桂麻黄碱;西他罗仑;枸橼酸;甲红霉素;氯马斯丁及其富马酸盐;可乐定;clorfibrate;椰子油;鱼肝油;可待因及其富马酸盐和磷酸盐;醋酸可的松;盐酸环丙沙星;维生素B12;盐酸苯甲嗪;赛庚啶;丹蒽醌;右旋溴丙吡啶;右美沙芬及其氢卤酸盐;安定;二丁卡因;氯醛比林;双氯酚酸及其碱金属盐;双氯酚酸钠;地高辛;双氢麦角胺及其氢化物/甲磺酸盐;地尔硫卓;二甲聚氧硅烷;二羟苯宗;苯海拉明及其枸橼酸盐;苯海拉明及其盐酸盐;双丙戊酸及其碱金属盐;琥珀辛酯钙、钾和钠;多西环素水合物;琥珀酸杜克西拉明;屈大麻酚;依法克生;恩那普利;氟啶酸;麦角胺及其酒石酸盐;红霉素;estropipate;炔雌醇;麻黄素;重酒石酸肾上腺素;红细胞生成素;桉树脂;法莫替丁;非诺洛芬及其金属盐;富马酸亚铁、葡萄糖酸亚铁和硫酸亚铁;fexofenadine;氟西汀;叶酸;磷苯妥英;5-氟尿嘧啶(5-FU);氟西汀;氟比洛芬;呋塞米;加巴喷丁;庆大霉素;吉非贝齐;格列吡嗪;甘油;硬脂酸甘油酯;康泉;灰黄霉素;生长激素;愈创甘油醚;己霉锁辛;氢氯噻嗪;二氢可待酮及其酒石酸盐;氢化可的松及其醋酸盐;8-羟基喹啉硫酸盐;羟嗪及其双羟萘酸盐和盐酸盐;布洛芬;吲哚美辛;肌醇;胰岛素;碘;吐根;铁;异山梨醇及其单和二硝酸盐;伊索昔康;氯胺酮;高岭土;酮洛芬;乳酸;羊毛脂;卵磷脂;醋酸利普胺;利多卡因及其盐酸盐;lifinopril;liotrix;洛哌丁胺;氯雷他定;洛伐他丁;黄体生成素;LHRH(促黄体激素释放激素);碳酸镁、氢氧化镁、水杨酸镁及三硅酸镁;美克洛嗪;甲灭酸;甲氯灭酸;甲氯灭酸钠;甲孕酮;孟德立胺;薄荷醇;度冷丁;硫酸羟喘;甲东莨菪碱及其硝酸盐;methsergide及其马来酸盐;烟酸甲酯;水杨酸甲酯;甲基纤维素;甲琥胺;甲氧氯普胺及其卤化物/水合物;甲硝唑;酒石酸多美洛尔;硝酸咪康唑;矿物油;米诺地尔;吗啡;萘普生及其碱金属盐;硝苯地平;硫酸新霉素;烟酸;烟酰胺;烟碱;尼克酰胺;尼美舒利;硝酸甘油;壬丙醇醚-9;炔诺酮及其醋酸酯;制霉素;辛苯聚醇;辛苯聚醇-9;辛基二甲基PABA;辛基甲氧基桂皮酸酯;ω-3多不饱和脂肪酸;奥美拉唑;奥丹西隆及其盐酸盐;奥索利酸;羟甲氧苯酮;胆茶碱;对氨基苯甲酸(PABA);二甲氨苯甲酸辛酯;甲乙双酮;五肽抑制素;薄荷油;硝酸戊四醇酯;戊巴比妥钠;羟哌氯丙嗪;硫酸苯乙肼;苯茚胺及其酒石酸盐;马来酸苯吡丙胺;苯巴比妥;苯酚;酚酞;去氧肾上腺素及其丹宁酸盐和盐酸盐;苯丙醇胺;苯妥英;苯吡哌醇;炎痛喜康及其盐;硫酸多链丝霉素B;氯化钾和硝酸钾、普拉西泮;盐酸普鲁卡因胺;美喘清;异丙嗪及其盐酸盐;丙氯芬及其盐酸盐和萘磺酸盐;普拉西坦;丙马卡因及其盐酸盐;甲哌氯丙嗪及其马来酸盐;普奈洛尔及其盐酸盐;异丙嗪及其盐酸盐;普奈洛尔;假麻黄碱及其硫酸盐和盐酸盐;吡哆醇;pyrolamine及其盐酸盐和丹宁酸盐;喹那普利;奎尼丁葡萄糖酸盐和硫酸盐;炔雌酮;雷利托林;雷尼替丁;间苯二酚;核黄素;水杨酸;东莨菪碱;芝麻油;鲨肝油;二甲基硅油;碳酸氢钠、枸橼酸钠及氟化钠;单氟磷酸钠;硫糖铝;sulfanethoxazole;柳氮磺吡啶;硫;疏马曲坦及其琥珀酸盐;他克林及其盐酸盐;茶碱;丁苯哌丁醇,硫乙哌丙嗪及其马来酸盐;噻马洛尔及其马来酸盐;thioperidone;曲马多;曲美沙特;三唑仑;维A酸;盐酸四环素;托耳米丁;托萘酯;二氯苯氧氯酚;三甲氧苯酰胺及其烟酸盐;苄吡二胺及其盐酸盐;曲普利啶;及其盐酸盐;十一烯酸;去甲万古霉素;盐酸维拉帕米;硫酸阿糖腺苷;维生素A、B、C、D、B1、B2、B6、B12、E以及K;北美金缕梅(witch hazel);盐酸丁苄唑啉;锌;硫酸锌;十一烯酸锌。活性成分可以进一步包括但并不仅限于食品酸(food acids);水不溶性金属和矿物氢氧化物、碳酸盐、氧化物、聚丙烯酸树脂,及其盐;活性药物在三硅酸镁碱和硅酸镁铝碱上的吸附物,及其混合物。还可以使用这些组分的混合物和药学可用的盐以及一些其它的活性组分。
在一个实施方案中,用本发明的浸渍涂布的包衣制剂可以将活性成分立即释放,即制剂的溶出符合USP有关含有特定活性成分的快速释放片剂的规定。例如,对于对乙酰氨基酚片而言,USP 24规定其在pH5.8的硫酸缓冲液中,用USP装置2(浆法),50rpm,在将片剂放入缓冲液中30分钟内,制剂中所包含的对乙酰氨基酚至少有80%被释放出来,对布洛芬片而言,用USP 24所指定的pH7.2的磷酸缓冲液,用USP装置2(浆法),50rpm,在将片剂放入缓冲液中30分钟内,制剂中所包含的布洛芬至少有80%被释放出来。见USP 24,2000版,19-20和856(1999)。
我们意想不到地发现,将本发明的组合物应用于浸涂底物上形成的包衣层与明胶包衣形成的衣层相比具有更优良的性质,例如抗裂性(crack resistence)、硬度、厚度、色泽均一性、光滑度和光泽。更具有代表性的是,当用本发明实施例7所陈述的方法进行测定时,本发明的包衣的表面光泽度大于约150,例如大于约190或大于约210。
此外,用本发明的组合物浸涂包衣的片剂在一些重要的方面优于一般的以明胶为基础进行包衣的浸涂包衣片。首先,用本发明的组合物浸涂包衣的片剂的优点是其在较高的温度和湿度条件下,在保存期限和储藏期间仍能保持合意的溶出特性。特别地,本发明以纤维素醚为基础的组合物还有能抵抗微生物生长的优点,因而可以延长浸涂溶液的使用期限和储藏期限,从而降低制造成本。其次,与含有明胶的分散体相比,本发明的用糖增稠的浸涂分散体含有的水分量很少,因此可以缩短干燥周期。虽然本发明中其它浸涂分散体的水分含量可能会高于典型的以明胶为基质的浸涂溶液,但是与含有明胶的浸涂组合物相比,本发明以纤维素醚为基质的组合物所需要的干燥周期短得令人吃惊。第三,与干燥的、以明胶为基质的的浸涂组合物中出现的气泡数量相比,含有本发明组合物的干燥包衣具有令人吃惊的少的气泡。第四,与用含有明胶的组合物进行的浸涂操作过程不一样,在室温下就可以将底物浸入本发明的溶液中,这样在经济上就更为有利。第五,与现有技术中已知的经由喷雾包衣方法得到的类似的包衣相比,本发明的浸涂包衣组合物具有更好的光泽度。本发明的浸涂组合物具有与含有明胶的浸涂或包衣的包衣组合物类似的光泽度,后者在目前被认为是得到高光泽度包衣的工业基准。参见专利号为6,274,162的美国专利(典型的光泽读数(gloss reading)标准,凝胶浸涂或明胶包衣的片剂在约200到240光泽单位的范围之间,糖包衣的药剂商品在约177到209光泽单位的范围之间,新的、高光泽度的包衣体系的光泽读数在约148到约243光泽单位之间。
我们还意想不到的发现,向含有成膜剂和水凝胶的成膜组合物中加入有效量的增重增强剂,不仅可以显著的提高底物的浸涂包衣量,而且可以改善片剂的色泽均一度。
在这里通过举例公开对本发明在不存在本文中未特定公开得任何成分、组分、或步骤的情况下是可以实施的。下面通过一些实施例对本发明的本质和实施方式进行了进一步的阐述。但是并不应当认为本发明仅限于这些实施例的详细描述。
实施例
实施例1.)
包衣底分散体制剂
室温下,通过将所有的组分在大烧杯中进行混和,制备含有表A所描述的成分的水分散体。
表A:水分散体包衣底组合物
成分 | 份数 |
HPMC(2910,5mPs)购自Dow化学公司,商品名称为“Methocel E-5” | 20 |
蓖麻油 | 1 |
水 | 241.5 |
包衣溶液总重 | 262.5 |
包衣液中的固体含量% | 85 |
*除非特别指明均以重量份数来表示
用类似的方法制备含有表B所列组分的另外一种水分散体。
表B:水分散体包衣底组合物
*可以从Aqualon得到,商品名为“Natrosol 250L”**除非特别指出,所有的值都是以重量-份数来表示的用类似的方法制备含有表C所列组分的另外一种水分散体。表C:水分散体包衣底组合物
成分 | Ex 1A ** | Ex 1B | Ex 1C | Ex 1D | Ex 1E |
HPMC2910,5mPs | 20 | 40 | 40 | 28 | 28 |
蓖麻油 | 1 | 0 | 0 | 0 | 0 |
水 | 212.3 | 566.67 | 566.67 | 566.67 | 566.67 |
麦芽糖糊精 | 0 | 53 | 53 | 67 | 67 |
PEG400 | 0 | 7 | 7 | 5 | 5 |
羟乙基纤维素 | 0 | 0 | 0 | 0 | 0 |
包衣溶液总重 | 233.3 | 666.67 | 666.67 | 666.67 | 666.67 |
包衣溶液中所含固体重量% | 9% | 15% | 15 | 15 | 15 |
成分 | Ex 1F ** | Ex 1G | Ex 1H |
水 | 566.67 | 566.67 | 690.4 |
麦芽糖糊精 | 71 | 71 | 0 |
蓖麻油 | 0 | 0 | 0.13 |
HPMC(1910,5mPas) | 0 | 0 | 32.4 |
PEG400 | 5 | 5 | 0 |
羟乙基纤维素 | 24 | 24 | 0 |
包衣溶液总重 | 666.67 | 666.67 | 722.9 |
包衣溶液中所含固体重量% | 15% | 15% | 4.5% |
*可以从Aqualon得到,商品名为“Natrosol 250L”
**除非特别指出,所有的值都是以重量份数来表示的
实施例2.)包衣底片剂的制备
根据US 5,658,589(“589专利”)实施例1所描述的过程制备压制的片剂,该文献在这里被引用作为参考。
根据“589专利”实施例所描述的方法,通过喷雾将实施例1的分散体涂敷于所制备的片剂上。如下表D所示,与不含包衣底层的片剂相比,干的包衣底层平均增重2%到4%。
用实施例1中的1A到1H的包衣底分散体代替该专利实施例1分别重复该过程。所获得的干的包衣底片增重百分比见表D:
表D:
干的包衣底片增重%
实施例号 | 增重% |
1A | 2 |
1B | 2 |
1C | 4 |
1D | 2 |
1E | 4 |
1F | 2 |
1G | 4 |
1H | 4 |
实施例3)
HPMC包衣片的制备
制备含有如表E所示组分的HPMC浸涂水溶液:
表E:
HPMC浸涂溶液组合物
成分 | EX 3A * (g) | EX 3B(g) | EX 3C(g) | EX 3D(%) | EX 3E(%) | EX 3F(%) |
HPMC E5 | 32.5 | 0 | 32.5 | 10 | 11 | 14 |
水 | 200 | 200 | 200 | 89.89 | 88.879 | 85.85 |
HPMC(2910,15mPs) | 0 | 20 | 0 | 0 | 0 | |
黄原胶 | 0 | 0 | 0 | 0.11 | 0.121 | 0.15 |
PEG 400 | 0 | 0 | 8 | 0 | 0 | 0 |
包衣溶液中的固体%(重量) | 14 | 9 | 17 | 10.11 | 11.121 | 14.15 |
*除非特别指出,所有的值均以重量(g)来进行定义
实施例3A:实施例3A的浸涂溶液的制备:在70℃的温度下,将HPMC分散到200ml去离子水中。在向其中加入约1%重量的FD&C蓝染料后,将溶液搅拌均匀。然后将溶液冷却到约22℃。
实施例3B:实施例3B的浸涂溶液的制备:用HPMC(2910,15mPs)代替HPMC E5,重复实施例3A的操作。
实施例3C:实施例3C的浸涂溶液的制备:在70℃的温度下,将用MC分散到200ml去离子水中。在向其中加入PEG 400后,将溶液搅拌均匀。然后将溶液冷却到约22℃。
实施例3D:实施例3D的浸涂溶液的制备:在80℃的温度下,把HPMC和黄原胶加入到净化水中,直至粉末被分散。在停止加热后,将溶液分为两份。向第一份溶液中加入4.35%重量的购自Colorcon公司,商品名为“Opatint YellowDD-2115”的黄色分散体,低速搅拌直至将其分散。向第二份溶液中加入5.8%重量的购自Colorcon公司,商品名为“Opatint Green DD-11000”的绿色分散体,低速搅拌直至将其分散。然后将两种分散体溶液在室温下存放约12小时。
实施例3E:实施例3E的浸涂溶液的制备:使用实施例3E的组分,重复实施例3D的操作。
实施例3F:实施例3F的浸涂溶液的制备:使用实施例3F的组分,重复实施例3D的操作。
实施例3G:手动浸涂的浸涂包衣片的制备:将根据实施例2用实施例1H的包衣底制备的包衣底片剂在实施例3A的浸涂溶液中手动浸涂1秒钟,从浸涂溶液中取出,然后在环境条件下干燥。
分别用实施例3B和3C中的浸涂溶液代替实施例3A的浸涂溶液,重复上述操作。
观测到的包衣结果如下:
用实施例3A的包衣材料包衣的片剂:包衣光滑、坚硬、有光泽,没有气泡或裂缝。但是,包衣层薄,且不均匀,一部分区域未被充分覆盖。暴露于在环境条件下六个月,在包衣层上仍未观察到裂缝。
用实施例3B的包衣材料包衣的片剂:包衣有光泽,有少量的气泡,没有裂缝。与用实施例3A获得的包衣相比,该包衣更均匀和坚硬。但该包衣也有些薄,且有一定的破损,有些区域未被充分覆盖。暴露于在环境条件下六个月,在包衣层上仍未观察到裂缝。
用实施例3C的包衣材料包衣的片剂:包衣有光泽,有少量的气泡,没有裂缝。与用实施例3A获得的包衣相比,该包衣更均匀和坚硬。但该包衣也有些薄,且有一定的破损,有些区域未被充分覆盖。暴露于在环境条件下六个月,在包衣层上仍未观察到裂缝。
实施例3H:大规模生产浸涂片剂的制备:将用实施例1H的包衣底按照实施例2制备的包衣底片剂用实施例3D所得的浸涂溶液进行包衣,该包衣操作使用商品级凝胶浸涂机,根据美国专利4,820,524所描述的方法进行操作,该专利文献在此被引用作为参考。
分别用实施例3E和3F的浸涂溶液代替实施例3D的浸涂溶液重复该操作。
干浸涂包衣片剂的增重平均百分比见表F:
表F:
干浸涂包衣增重
实施例 | 干浸涂包衣增重%重量 * |
实施例3D | 0.75-2.26 |
实施例3E | 1.9-3.52 |
实施例3F | 3.2-5.8 |
*相对于干的包衣底和核心的重量
这一实施例表明,向HPMC浸涂溶液中加入黄原胶可以增加浸涂包衣液的粘度,从而可以增加片剂浸涂包衣时的增重量。
实施例3I:实施例3I浸涂溶液的制备
用实施例3I的组分代替实施例3D的组分,重复实施例3D的操作,实施例3I的组分如表M所列:
表M:
HPMC浸入溶液组合物
成分 | Ex 3I * (g) | Ex 3J(g) |
HPMC E5 | 14 | 12 |
水 | 85.89 | 87.88 |
HPMC(2910,15mPs) | 0 | 0 |
黄原胶 | 0.11 | 0.12 |
PEG 400 | 0 | 0 |
浸涂溶液中固体%(重量) | 14.11 | 12.12 |
*除非特别指出,所有的值均以重量(g)来进行定义
实施例3J:实施例3J浸涂溶液的制备
用实施例3J的组分代替实施例3D的组分,重复实施例3D的操作,实施例3J的组分如上表M所列。
实施例4)
包含预胶化淀粉的浸涂包衣溶液的制备
周围环境下,将75g的改性蜡状玉米淀粉分散到200ml水中,混和,制得包含如表G所述组分的浸涂溶液:
表G:
包含预胶化淀粉的浸涂溶液
组分/其它 | 实施例4A * | 实施例4B |
改性的蜡状玉米淀粉(PurityGum 59) | 75 | 125 |
水 | 200 | 200 |
溶液总重 | 275 | 325 |
浸涂溶液中固体%重量 | 27 | 39 |
*除非特别指出,所有的值均以重量(g)来进行定义
周围环境下,将表H所列的所有组分分散到200ml水中,混和,直至所得的溶液变清澈,这样就制得包含表H所述组分的浸涂溶液表H:
包含预胶化淀粉的浸涂溶液和实施例4C的包含二甲基硅油的浸涂溶液
组分 | 商品名 | 供应商 | 使用数量 * |
改性蜡状玉米淀粉 | PurityGum 59 | NationalStarch&ChemicalCo. | 125 |
二甲基硅油 | Antifoam | 2 | |
二氧化硅胶体 | AerosilA200 | 6 | |
甘油 | - | - | 63.5 |
蔗糖 | - | - | 38 |
着色剂 | Opatint | 6.9 | |
水 | - | - | 200 |
总固体量 | 241.4 | ||
溶液总重(w/55%固体) | 441.1 |
*除非特别指出,所有的值均以重量(g)来进行定义
将根据实施例2用实施例1H得包衣层制得的包衣底片手动浸入实施例4A的浸涂液中,停留约1秒,取出,在周围环境下干燥。
用实施例4B的浸涂溶液替代实施例4A的浸涂溶液,重复上述操作过程,完成浸涂溶液的制造和开始浸涂包衣操作之间需要约3天的时间。
用实施例4C的浸涂溶液替代实施例4A的浸涂溶液,重复上述操作过程,完成浸涂溶液的制造和开始浸涂包衣操作之间需要约12小时的时间。
所得包衣的观察结果如下:
用实施例4A的浸涂溶液包衣的片剂:包衣很有光泽,坚硬,光滑,平坦,没有破损或裂缝。但是该包衣太薄,有些区域未被包覆。在周围条件下放置6个月后未出现裂缝。
用实施例4B的浸涂溶液包衣的片剂:包衣光滑,有光泽。所有的表面均被覆盖;但是,在周围条件下放置6个月后出现裂缝。
用实施例4C的浸涂溶液包衣的片剂:包衣具有很好的光泽和包覆度,并且光滑,没有裂缝。在周围条件下放置2个月后未出现裂缝。
实施例5)
包含预胶化淀粉的浸涂溶液的制备
重复实施例4C的操作,但是不加入二甲基硅油。在对底物进行包衣之前,将溶液置于5英寸Hg的真空压力之下,以基本除去溶液中可见的气泡。所得包衣有极好的光泽和覆盖度,且光滑、没有裂缝。
实施例6)
二甲基硅油对包衣增重的作用
制备下面表I所列的浸涂溶液,以说明二甲基硅油作为增重增强剂的作用。数量是以包衣溶液总重的百分比为基础的。
表I浸涂溶液
成分 | 6A | 6B | 6C | 6D | 6E |
HPMC2910,5mPs | 12 | 12 | 12 | 12 | 12 |
黄原胶 | 1 | 1 | 1 | 1 | 1 |
二甲基硅油 | 0 | 0.035 | 0.07 | 0.14 | 0.25 |
黄色分散体*** | 6 | 6 | 6 | 6 | 6 |
水 | 81 | 80.965 | 80.93 | 80.86 | 80.75 |
***黄色分散体是从Colorcon公司购得的“Opatint”No.DD2125
用下面的方法制备上述浸涂溶液A到E:将净化水加热到约35℃。在用实验室规模的螺旋浆叶电子搅拌器(Janke and Kunkel,IKA Labortechnik,Staufen,德国)以1000rpm混和时加入HPMC和黄原胶,直至看起来粉末已经被均匀分散。停止加热,然后将所得的分散体室温下静置过夜。在约500rpm的搅拌速度下加入二甲基硅油和黄色分散体。
将根据实施例1A的方法制备的包衣底核心预先称重,然后浸入上述溶液A、B、C、D以及E中,停留约2秒,取出,然后在周围环境下干燥(约22℃)。7个核心被同时浸入。将7个核心浸到A至E各溶液中,核心一式三份。用从每一包衣溶液获得的3个被浸渍的核心测定平均增重。
所得增重结果见表J:
表J-平均增重
浸涂溶液 | 6A | 6B | 6C | 6D | 6E |
浸涂包衣的平均增重(mg/片) | 13.3 | 20.8 | 22.3 | 23.7 | 19.1 |
实施例7)
包衣片剂表面光泽的测定
使用由TriCor System公司(Elgin IL)购得的、商品名为“Tri-Cor Model805A/806H表面分析体系”,根据“TriCor Systems WGLOSS 3.4 Model805A/806H Surface Analysis System操作手册”(1996)所描述的方法,测定根据前面的实施例制得的片剂的表面光泽度,该操作手册在这里被引用作为参考,在下面所作的修改除外。
该装置利用CCD摄影检测器,使用扁平的弥散广光源,用对照片作为参照,在60度入射角测定平均光泽度值。在操作过程中,装置产生灰度等级的影像,其中出现的较亮的像素表示所选定的位置的光度更高。
本装置也结合利用分组的方法定量测定光泽度的软件,即可以将相似亮度的像素结合成组来求均值。
“满刻度百分比”或“理想百分比”设置(也称作“样品组百分比”设置)被用于确定在阈值之上的最亮的像素,它们被当作一组,在组内求均值。这里所说的“阈值”是指所定义的不包括在平均光泽度值计算中的最大光泽度值。因此,背景或样品没有光泽的区域不包括在平均光泽度值的计算之中。该方法公开在K.Fegley和C.Vesey,“片剂形状对获取高光泽度膜衣系统的影响”中,该文章可以从2002年三月18号的
www.colorcon.com上获得,该方法是为了将由于片剂形状的不同而产生的影响最小化,从而可以得到在工业上可比的计量。(将所选择的50%样品组定位作为片剂表面硬度测定所得的估计近似数据定位。)
在开始时用一个校准参照版对仪器进行校准后(190-228;294度标准;没有屏蔽,旋转度0,深度0),用凝胶包衣的囊片进行标准表面光泽度测定,该凝胶包衣的囊片购自McNEIL-PPC公司,商品名为“Extra Strength Tylenol Gelcaps”。使用25mm全视图屏蔽(190-280)时测得的该凝胶包衣的平均光度值为112,然后对仪器选择如下的配置:
旋转:0
深度:0.25英寸
光泽度阈值:95
%满刻度:50%
折射指数:1.57
使用50%理想(50%满刻度)设置,测得对照物的平均表面光泽度为269。
然后用相同的方法测定根据前面的实施例制得的包衣片样品。在50%理想设置下得到的表面光泽度值见下面的表K。
表K:包衣片的光泽度值
实施例号 | 3D | 3I | 3J | 4C | 6B |
包衣种类 | 浸涂 | 浸涂 | 浸涂 | 浇膜 | 浸涂 |
测试片数目 | 48 | 48 | 51 | 板 | 3 |
光泽度值(50%理想设置) | 234 | 247 | 229 | 259 | 221 |
此外,还对其它可买到的凝胶包衣片剂用同样的方法和同样的对照品进行了测试,测试结果见下面的表L。
表L:商业上可以得到的包衣片的光泽度
*由McNEIL-PPC公司获得**由Bristol-Myers,Squibb公司获得
产品 | MotrinIB*囊片(白色) | Excedrin**不含阿司匹林囊片(红色) | Excedrin**治疗偏头痛的明胶衣片(绿色侧面) | Excedrin**治疗偏头痛的明胶衣片(白色侧面) | 高强度Tylenol明胶衣片*(黄色侧面) | 高强度Tylenol明胶衣片*(红色侧面) |
包衣种类 | 喷雾膜 | 喷雾膜 | 明胶包衣 | 明胶包衣 | 浸涂 | 浸涂 |
测试片剂数 | 41 | 40 | 10 | 10 | 112 | 112 |
光度值(50%理想) | 125 | 119 | 270 | 264 | 268 | 268 |
这些实施例表明,用本发明的组合物包衣的片剂具有可与可在商业上获得的明胶包衣的片剂相当的和或更优的高表面光泽度值。与之相反,在本实施例中,典型的喷雾膜均有较低的表面光泽度,例如在本实施例中为119到125。
实施例8:包衣片的制备
实施例8A:用OpadryII包衣底喷雾包衣片剂的制备
在常压罐中,将制得的含HPMC 2910-6cP、麦芽糖糊精、HPMC2910-3cP、HPMC2910-50cP和PEG 400(购自Colorn公司,West Point,PA为“OpadryII”的122.8kg(18%w/w)的混合物在搅拌下被加入到559.7kg(82%w/w)的35℃的净化水中,用空气驱动的螺旋桨式Lightnin搅拌器以500rpm的转速进行混合。在加入所有的粉末之后,将分散体用500rpm觉拌2小时,然后不搅拌,在周围环境下放置12小时。
然后将所得的包衣分散体应用于压制的对乙酰氨基酚片上,该片剂是根据US5,658,589(“589专利”)实施例1中所描述的方法进行制备的,该文献在这里被引用作为参考,应用的方法是589专利所描述的喷雾法。与未包衣的片剂核心相比,所得的喷雾包衣片剂获得4%的增重量。
实施例8B:用HPMC/蓖麻油包衣底喷雾包衣片剂的制备
在搅拌机(Lee Industries)转速为1750rpm的条件下,向装有593.8kg(91%w/w)35℃的净化水的容器中加入88.4kg(9%w/w)的羟丙基纤维素2910,5mPs和0.347kG(0.04%w/w)的蓖麻油。在加入所有的粉末之后,将搅拌速度提高到3500rpm,搅拌15分钟。然后将搅拌速度降低到1750rpm,同时将压力降低到15英寸水柱,搅拌2小时以使分散体脱气。
然后通过喷雾法将制得的成膜分散体应用于实施例8A压制的对乙酰氨基酚片上,其操作过程同上述实施例8A所描述的。与未包衣的片剂核心相比,所得的喷雾包衣片剂获得4%的增重量。
实施例8C:使用HPMC/蓖麻油浸涂溶液的浸涂包衣片剂的制备
制备含表M所列组分的浸涂溶液:
表M:HPMC/蓖麻油澄清包衣溶液
实施例 | A&B | C&D | E&F |
HPMC 2910 5mPs | 9% | 13% | 13% |
蓖麻油 | 0.04% | 0.05% | 0.05% |
净化水 | 90.96% | 86.95% | 86.95% |
将净化水加热到80℃,然后在1750rpm的搅拌速度下将其加入到Lee夹套混和罐中。混合下向其中加入HPMC 2910,5mPs和蓖麻油,然后将混和器的速度增加到3500rpm,搅拌15分钟。然后当分散体的温度降低到35℃时,将混合器的速度降低到1750rpm,压力降低到15英寸水柱,脱气。在将分散体混合2小时之后,将所得的分散体在常压下不搅拌地放置3小时。
然后在1750rpm的搅拌速度下向所得的96kg澄清的浸涂溶液中加入实施例8C-a的着色剂,加入的量如表N所述:
表N:HPMC/蓖麻油彩色浸涂溶液
实施例 | 8C-a | 8C-b | 8C-c | 8C-d | 8C-e | 8C-f |
着色剂 | Opatint(DD-1761) | Opatint(DD-2125) | Opatint(DD-1761) | Opatint(DD-2125) | Opatint(DD-10516) | Opatint(DD-18000) |
着色剂数量(kg) | 2.700 | 2.570 | 2.700 | 2.570 | 4.072 | 2.175 |
颜色 | 红色 | 黄色 | 红色 | 黄色 | 蓝色 | 白色 |
粘度/温度 | 490cps@40C | 518cps@40C | 612cps@30C | 457cps@30C | 351cps@40C | 319cps@40C |
浸涂温度 | 40C | 40C | 30C | 30C | 40C | 40C |
浸入增重(mg/片) | 16* | 16* | 26** | 26** | 20*** | 20*** |
光泽度 | 229 | 229 | 249 | 228 | 238 | 233 |
* 表明8Ca包衣一半和8Cb包衣另一半的片剂获得的总增重量
** 表明8Cc包衣一半和8Cd包衣另一半的片剂获得的总增重量
***表明8Ce包衣一半和8Cf包衣另一半的片剂获得的总增重量
对表N中所列的着色剂分别重复此操作。
用商品级的凝胶浸涂机,使用US4,820,524所描述的方法,根据上面表N所列的浸涂溶液温度,将根据上面实施例8A所述的方法制备的包衣底片用实施例8C-a和8C-b所制得的浸涂包衣溶液进行浸涂包衣,该文献在这里被引用作为参考。对根据实施例8B的过程制得的包衣底片分别使用表N所列的8C-c到8C-f的彩色浸涂溶液重复进行上述操作。
将根据实施例8C-a和8C-b制备的浸涂包衣片剂与根据实施例8C-c到8C-f制备的浸涂包衣片进行视觉上的比较,前者在片剂的边缘没有完全包衣。与之相反,根据实施例8C-c到8C-f制备的浸涂包衣片在片剂的边缘具有十分优良的包衣覆盖。这表明,对HPMC/蓖麻油制剂而言,每一明胶囊片(如实施例8C-a和8C-b用9%的HPMC制造的)获得16mg的增重是不够的,而每一明胶囊片/明胶衣片(如实施例8C-c和8C-f用13%的HPMC制造的)获得20到26mg的增重就可以提供很好的包衣覆盖度。
此外,将根据实施例8C-c到8C-f制备的HPMC/蓖麻油浸涂包衣片与根据实施例3I和3J制备的HPMC/黄原胶浸涂片剂进行视觉上的比较,结果表明前者具有优良的光泽度和表面光滑度。该优良的光泽度和光滑度可能得益于浸涂包衣液中含有的蓖麻油。
实施例9:
用HPMC/麦芽糖糊精/PEG浸涂溶液包衣的浸涂片剂的制备
在3500rpm的搅拌速度下,将实施例8A的OpadryII混合物143.3kg(21%w/w)加入到539.2kg(79%w/w)的35℃的净化水中,搅拌15分钟。然后将搅拌速度降低到1750rpm,然后将罐子抽真空到30PSIA对溶液脱气5小时。然后,在1750rpm的搅拌速度下,将2.70kg的Colorant(OpatintRed DD-1761,购自Colorcon公司)加入到96kg的澄清的浸涂溶液中。在1750rpm的搅拌速度下,将2.570kg的Colorant(OpatintYellow DD-2125,购自Colorcon公司)加入到96kg份的澄清的浸涂溶液中直至其被分散。
将根据上述实施例8B所用的方法和材料制备的包衣底片剂用根据该实施例制备的浸涂包衣溶液进行浸涂包衣,使用的设备是商用级的凝胶浸涂机,所用的方法是US 4,820,524所描述的方法,该文献在这里被引用作为参考文献,使用的浸涂溶液的温度为30℃。浸涂溶液在30℃下的粘度:黄色溶液为607cPs,红色溶液为677cPs。平均增重为约27mg/明胶囊片。
根据实施例7所描述的方法对根据本实施例的方法制备的72个浸涂凝胶片进行了表面光泽度的测定。这些浸涂明胶囊片的平均表面光泽度为258光泽单位。
实施例10:
使用HPMC/角叉菜胶浸涂溶液的浸涂片的制备
在1750rpm的搅拌速度下,将88.4kg(13%w/w)的HPMC 2910-5mPs,0.347kg的蓖麻油(0.05%w/w),以及0.68kg(0.1%w/w)的卡帕角叉菜胶-911加入到含有590kg(87%w/w)80℃净化水的罐子中。在所有的物质都被加进去之后,将搅拌速度提高到3500rpm,搅拌15分钟。然后将混合器的速度降低到1750rpm,将罐抽真空到15英寸水柱脱气2小时。然后停止混合,将分散体在常压下静置3小时。然后在1750rpm的速度下,将2.175kg的着色剂(OpatintWhite DD-18000,购自Colorcon公司)加入到96kg的澄清浸涂溶液中。在1750rpm的速度下,将4.072kg的着色剂(OpatintBlue DD-10516,购自Colorcon公司)加入到96kg的澄清浸涂溶液中,直至其被分散。
将根据上述实施例8B所用的方法和材料制备的包衣底片剂用根据该实施例制备的浸涂包衣溶液进行浸涂包衣,使用的设备是商用级的凝胶浸涂机,所用的方法是US 4,820,524所描述的方法,该文献在这里被引用作为参考文献,使用的浸涂溶液的温度为40℃。平均增重为约27mg/明胶囊片。
根据实施例7所描述的方法对根据本实施例的方法制备的88个浸涂凝胶片进行了表面光泽度的测定。这些浸涂明胶囊片的平均表面光泽度为232光泽单位。
Claims (12)
1.一种成膜组合物,改组合物含有:
a)成膜剂;
b)增重增强剂,该增重增强剂选自二甲基硅油、吐温80和它们的组合物,当应用于底物时其用量足以增加底物所获得的成膜组合物的增重量。
2.一种如权利要求1所述的成膜组合物,该组合物进一步含有水凝胶,该水凝胶选自海藻酸盐、琼脂、瓜尔豆胶、槐树豆胶、角叉菜胶、他拉胶、阿拉伯胶、黄蓍胶、果胶、黄原胶、gellan、麦芽糖糊精、半乳甘露聚糖、石脐素、昆布糖、硬葡聚糖、阿拉伯胶、菊粉、果胶、whelan、rhamsan、zooglan、methylan、壳多糖、环糊精、壳聚糖、以及它们的衍生物和混合物。
3.如权利要求1所述的组合物,其中所说的成膜剂选自聚乙烯醇、羟丙基淀粉、羟乙基淀粉、普鲁兰、甲基乙基淀粉、羧甲基淀粉、甲基纤维素、羟丙基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素、羟丁基甲基纤维素、羟乙基乙基纤维素、羟乙基羟丙基甲基纤维素、预胶化淀粉、以及它们的聚合物、衍生物和混合物。
4.如权利要求2所述的组合物,以组合物的总重为基础,该组合物包含:
a) 约40%到约99.9%的羟丙基甲基纤维素成膜剂;
b) 约0.5%到约5%的黄原胶水凝胶;和
c) 约0.01%到约0.25%的二甲基硅油。
5.一种含有如权利要求1所述的组合物,以组合物总重量为基础,该组合物进一步包含不超过约14%的着色剂,其中着色剂选自偶氮染料、quinopthalone、三苯甲烷染料、氧化铁、氢氧化铁、二氧化钛、天然染料及其混合物。
6.一种包含如权利要求4所述的组合物的外包衣层的药物制剂。
7.一种药物制剂,其中包含一个核心、基本包覆所说核心的包衣底、以及基本包覆所说的包衣底的外层,其中的外层包衣包含如权利要求4所说的组合物。
8.一种如权利要求6所说的制剂,该制剂进一步包含有效量的药物活性成分,其中所说的制剂符合美国药典对包含所说药物活性成分的立即释放剂型溶出度的要求。
9.一种包含核心和包衣层的药物制剂,当通过浸渍涂布应用于底物上时,所说的包衣基本包覆所说的核心,且具有至少150的表面光泽度,其中所说的包衣包含如权利要求1所述的组合物。
10.一种类似胶囊的药物制剂,该药物制剂包含:
a 有第一端和第二端的核心;
b 可以为所说核心的第一端提供第一种颜色的第一包衣层;
c 可以为所说的第二端提供第二种颜色的第二包衣层,所说的第一包衣层和第二包衣层的颜色不同;
所说的第一包衣层和第二包衣层中的至少一种包含一种含有如权利要求1所述组合物的包衣层。
11.一种增加浸蘸成形底物上所获得的干的包衣层增重的方法,该方法包括:
当包衣组合物中含有成膜剂时,向该包衣材料中加入有效量的增重增强剂,该增重增强剂选自二甲基硅油、吐温80和它们的混合物。
12.一种改善浸蘸底物上干的包衣组合物层色泽均一度的方法,该方法包括:
当该包衣组合物中包含成膜剂和着色剂时,向该包衣组合物的水分散体中加入有效量的二甲基硅油、吐温80、或它们的混合物。
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US29112701P | 2001-05-15 | 2001-05-15 | |
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US32572601P | 2001-09-28 | 2001-09-28 | |
US60/325,726 | 2001-09-28 | ||
US10/122,999 US20030070584A1 (en) | 2001-05-15 | 2002-04-12 | Dip coating compositions containing cellulose ethers |
US10/122,999 | 2002-04-12 | ||
US10/122,498 | 2002-04-15 | ||
US10/122,498 US20030072729A1 (en) | 2001-05-15 | 2002-04-15 | Simethicone as weight gain enhancer |
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CN1429545A true CN1429545A (zh) | 2003-07-16 |
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CN02121867A Pending CN1429545A (zh) | 2001-05-15 | 2002-05-15 | 作为增重增强剂的二甲基硅油 |
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EP (1) | EP1260217A3 (zh) |
JP (1) | JP2003012560A (zh) |
KR (1) | KR20020087380A (zh) |
CN (1) | CN1429545A (zh) |
AR (1) | AR036998A1 (zh) |
CA (1) | CA2386430A1 (zh) |
Cited By (1)
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CN1297319C (zh) * | 2003-09-22 | 2007-01-31 | 王玉万 | 以硅油为介质制备含抗微生物药物的制剂 |
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KR100442174B1 (ko) * | 2001-09-25 | 2004-07-30 | (주)다산메디켐 | 이산화규소, 폴리소르베이트류 및디메칠폴리실록산(디메치콘, 시메치콘)을 함유하는소화기장애에 사용되는 고형의 신규의약조성물 |
CA2519228C (en) * | 2003-03-20 | 2014-10-14 | Galephar M/F | Improved dry powder inhaler system |
DK1841332T4 (da) * | 2004-11-18 | 2013-05-06 | Nutricia Nv | Fortykningsmiddelsammensætning til dysfagipatienter |
US20070077300A1 (en) * | 2005-09-30 | 2007-04-05 | Wynn David W | Oral compositions containing a salivation inducing agent |
MX2010009067A (es) * | 2008-02-19 | 2010-09-14 | Mcneil Ppc Inc | Composiciones recubiertas por inmersion que contienen un almidon que tiene alto contenido de amilosa. |
PT2418969E (pt) | 2009-04-15 | 2013-06-05 | Nutricia Nv | Nutrição para bebés anti-refluxo |
US8420057B2 (en) | 2011-09-01 | 2013-04-16 | Qualicaps, Inc. | Capsule having broad color spectrum |
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EP3236954B1 (en) * | 2014-12-23 | 2022-03-23 | DuPont Nutrition USA, Inc. | Enteric film coating compositions, method of coating, and coated forms |
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- 2002-05-14 EP EP02253340A patent/EP1260217A3/en not_active Withdrawn
- 2002-05-14 CA CA002386430A patent/CA2386430A1/en not_active Abandoned
- 2002-05-14 JP JP2002139178A patent/JP2003012560A/ja active Pending
- 2002-05-14 AR ARP020101762A patent/AR036998A1/es unknown
- 2002-05-15 KR KR1020020026834A patent/KR20020087380A/ko not_active Application Discontinuation
- 2002-05-15 CN CN02121867A patent/CN1429545A/zh active Pending
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CN1297319C (zh) * | 2003-09-22 | 2007-01-31 | 王玉万 | 以硅油为介质制备含抗微生物药物的制剂 |
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CA2386430A1 (en) | 2002-11-15 |
JP2003012560A (ja) | 2003-01-15 |
US20030072729A1 (en) | 2003-04-17 |
KR20020087380A (ko) | 2002-11-22 |
AR036998A1 (es) | 2004-10-20 |
EP1260217A2 (en) | 2002-11-27 |
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