CN117042629A - 胃滞留药物递送系统 - Google Patents
胃滞留药物递送系统 Download PDFInfo
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- CN117042629A CN117042629A CN202280009860.4A CN202280009860A CN117042629A CN 117042629 A CN117042629 A CN 117042629A CN 202280009860 A CN202280009860 A CN 202280009860A CN 117042629 A CN117042629 A CN 117042629A
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- sodium alginate
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Abstract
提供了具有筏形成特性的药物组合物或营养组合物,该药物组合物或营养组合物包含:(a)海藻酸钠,(b)胶体微晶纤维素,(c)碳酸氢盐,和(d)碳酸盐。
Description
技术领域
本发明涉及包含海藻酸钠和微晶纤维素的具有筏形成特性的组合物。该组合物可用于治疗胃食管障碍并作为胃滞留药物递送系统提供对活性成分的调节释放。
背景技术
胃食管反流障碍是全世界不适的主要来源,并且已经用抗酸药、H2受体拮抗剂和质子泵抑制剂以及含有海藻酸盐和碳酸氢盐/碳酸盐的抗反流组合物进行医学治疗,当摄入该抗反流组合物后暴露于胃液中的酸时,该抗反流组合物形成漂浮在胃内容物顶部的筏。该筏防止胃内容物进入食管,从而保护食管黏膜免受刺激。已知的包括海藻酸钠、碳酸氢钠和碳酸钙的筏形成抗反流组合物包括和/>Advance,两者均可购自利洁时健康护理有限公司(Reckitt Benckiser Healthcare)。
漂浮组合物还被提议作为缓释药物递送系统,因为它们在胃中的停留时间长,在胃中它们缓慢地将活性成分释放到胃肠环境中,确保改善活性成分的生物利用度并降低给药频率。各种漂浮药物递送选择的概述见于S.Sharma等人,International Journal ofResearch in Pharmaceutical and Biomedical Sciences[国际药物和生物医学科学研究杂志]2(3),2011年7月至9月,第954-958页中。一种选择是包含海藻酸钠或另一种凝胶形成水胶体和碳酸氢盐或碳酸盐的凝胶形成溶液。与胃液接触时,形成粘性凝胶,其中含有漂浮在胃内容物顶部的截留的二氧化碳气泡。
为了确保延长的胃停留时间和良好的弹性,重要的是提供赋予在胃中形成的筏有利特性的组合物。因此,本发明的目的是提供包含海藻酸钠作为凝胶形成剂的胃滞留药物递送系统,该凝胶形成剂表现出改善的筏强度和/或筏弹性。
发明内容
令人惊讶地发现,当进行模拟胃中条件的体外测试时,向海藻酸钠组合物中添加胶体微晶纤维素导致在筏厚度、强度和/或弹性方面增强的筏特性。
因此,本发明涉及具有筏形成特性的药物组合物或营养组合物,该组合物包含
(a)海藻酸钠,
(b)胶体微晶纤维素
(c)碳酸氢盐,和
(d)碳酸盐。
在另一方面,本发明涉及组合物,其包含用于在提供药学或营养学活性成分的缓释或靶向释放中使用的组分(a)-(d)。
附图说明
图1是TA-XT2装置的示意图,该装置用于测量由本发明的组合物形成的筏在模拟胃液中的凝胶强度。
图2A和2B示出了用于确定筏弹性的实验装置,图2A示出了筏的形成,图2B示出了筏在其中进行混合的滚筒混合器。
图3示意性地示出了用于制备本发明的组合物的方法的步骤。
具体实施方式
定义
在本文中,术语“筏形成特性”旨在意指本发明组合物在与胃酸接触时在胃内容物顶部形成漂浮阻挡层的能力。
术语“筏强度”被确定为使用图1所示的装置将探针向上拉使其穿过在模拟胃液中形成的筏所需的力(以g为单位)。
术语“筏弹性”旨在意指在实验装置中经受物理运动时,如在滚筒混合器中经受剧烈运动时,筏对破裂的抵抗力,参见图2B。筏弹性通常随着筏强度的增加而提高。
术语“胶体微晶纤维素”(下文中的胶体MCC或cMCC)旨在意指经受磨碎的MCC,其中MCC颗粒的D50为约0.1-10微米(如在粒度分析仪中通过静态光散射测量的),其中小颗粒以大角度散射光,并且大颗粒以小角度散射光。记录cMCC样品产生的散射图案,并且通过应用Mie散射理论可以计算粒度的分布。
如关于粒度分布使用的术语“D50”表示颗粒的直径,样品体积的50%小于该直径,并且样品体积的50%大于该直径。
术语“漂浮”用于表示筏漂浮在胃液顶部的能力。当所有不溶性物质上升到胃液表面时,实现完全漂浮,并且当在将组合物添加到胃液的约1分钟内发生时,评估为快速漂浮。
当筏可以以基本上一团的形式从测试胃液中移除时,表明由组合物形成的筏是“连贯的”。
实施例
海藻酸钠作为凝胶形成剂包括在本发明组合物中。
海藻酸盐是广泛不同的组成和序列的(1→4)-连接的β-D-甘露糖醛酸(M)和α-L-古罗糖醛酸(G)残基的直链二元共聚物的家族。对海藻酸盐的顺序结构的工作揭示了广泛不同的组成的许多部分:古罗糖醛酸和甘露糖醛酸的均聚分子,近似相等比例的含有大量的MG或GM二聚物残基的两种单体(仅仅指定几个主要的部分)。因此,海藻酸盐是由M和G(分别被称为M-嵌段和G-嵌段)的均聚物区域构成的真嵌段共聚物,并且穿插有交替结构MG-嵌段或GM-嵌段的区域。
商业的海藻酸盐主要从选自以下的海藻物种中生产:极北海带(Laminariahyperborea)、巨藻(Macrocystis pyrifera)、掌状海带(Laminaria digitata)、泡叶藻(Ascophyllum nodosum)、海带(Laminaria japonica)、南非褐藻(Eclonia maxima)、淡黑巨海藻(Lessonia nigrescens)和南极洲丛梗藻(Durvillea Antarctica)。在工业设置中,除了海藻酸盐产品的规格单上的粘度和pH外,还在限定条件下典型地测量了胶凝强度以评估M-嵌段/G-嵌段的比率。
优选地,海藻酸盐是包含至少50%古罗糖醛酸残基(G),更优选65%-75% G的海藻酸钠。已经发现这样的海藻酸盐与二价阳离子(例如Ca2+)形成强凝胶。可以从极北海带中提取G含量为65%-75%的海藻酸盐。
海藻酸钠优选地具有低粘度,如其1%(按重量计)水溶液在20℃时的粘度在3-10mPa.s范围内,该粘度通过使用Brookfield转子2的Brookfield型RV粘度计测量。
包括在本发明组合物中的特别优选的海藻酸钠是LFR 5/60,其1%(按重量计)水溶液在20℃时的G含量为65%-75%,并且粘度为3.5-7mPa.s,该粘度通过使用Brookfield转子2的Brookfield型RV粘度计测量。
海藻酸钠能够以25%-50%(按组合物中固体的干重计)的浓度存在。
微晶纤维素(MCC)是白色、无臭、无味、相对自由流动的结晶性粉末,实际上没有有机和无机污染物。它是通过使如从纤维状植物材料作为浆获得的α纤维素经受典型地用矿物酸进行的水解降解而制得的纯化的、部分解聚的纤维素。其是高度结晶的微粒纤维素,主要由通过去除纤维素原纤维的无定形区域(或次晶区域)获得的结晶聚集体组成。MCC用于各种应用,包括食品、营养品、药物和化妆品。
用于制备胶体MCC的合适的起始材料包括例如木浆(如漂白的亚硫酸盐和硫酸盐浆)、玉米壳、甘蔗渣、秸秆、棉、棉短绒、亚麻、大麻、苎麻、发酵纤维素等。微晶纤维素可以通过用矿物酸,优选盐酸来处理纤维素源,优选来自纤维状植物材料的呈浆的形式的α纤维素而产生。该酸选择性地攻击纤维素聚合物链的较低有序区域,由此暴露并释放形成微晶聚集体的结晶位点,这些微晶聚集体构成微晶纤维素。然后将它们从反应混合物中分离出来并洗涤以去除降解的副产物。所得的通常含有40至75百分比水分的湿物料在本领域中被称作多个名称,包括水解纤维素、水解纤维素湿饼、平衡聚合度(level-off DP)的纤维素、微晶纤维素湿饼或简称湿饼。优选地,聚集的MCC是经酸水解的,并且为在水中25-60%wt.。
将湿饼干燥并去除水后,所得产品微晶纤维素为白色、无臭、无味、相对自由流动的粉末,不可溶于水、有机溶剂、稀碱和酸。关于微晶纤维素的描述以及其制造,参见美国专利号2,978,446。
为了本发明目的,可以通过以下方式来制备胶体MCC:使水解的MCC聚集的微晶(呈高固体水性混合物的形式,通常称为“湿饼”)经受磨碎工艺,例如挤出,这将聚集的纤维素微晶基本上细分成更精细分离的微晶颗粒。为了防止角化,可以在磨碎之前、期间或之后但在干燥之前添加保护性水胶体。保护性水胶体将较小尺寸颗粒之间的氢键或其他吸引力全部或部分地筛除,以便提供可容易地分散的粉末。胶体MCC将典型地形成稳定的悬浮液,其几乎没有分散的固体的沉降。羧甲基纤维素是用于这些目的的常见水胶体(参见例如美国专利号3,539,365(Durand等人)),以及例如由杜邦公司(DuPont)以商标名出售的胶体MCC产品。包含在本发明组合物中的特别有利的胶体MCC是以MCC与CMC的比率在85:15至90:10范围内与CMC共磨碎的MCC(例如/>RC-591)和/>CE15(其中MCC与瓜尔胶共加工)。后一种MCC产品特别适用于配制咀嚼片。
在本发明组合物中,胶体MCC作为稳定剂和悬浮剂。
胶体MCC能够以8%-20%(按组合物中固体的干重计)的浓度存在。
本发明组合物进一步包含碳酸氢盐和碳酸盐,在与胃酸接触时其量使得产生足够量的二氧化碳,以使组合物漂浮在胃内容物顶部。碳酸氢盐优选以15%-30%,更优选18%-25%(按组合物中固体的干重计)的浓度存在。碳酸氢盐可以选自碳酸氢钾或碳酸氢钠,优选碳酸氢钠。
碳酸盐优选以8%-20%(按组合物中固体的干重计)的浓度存在。碳酸盐可以选自碳酸钙、碳酸镁或碳酸铝,优选碳酸钙。钙离子在胃酸中释放并与海藻酸钠相互作用以形成不溶于水的海藻酸钙,从而有助于筏形成并增加筏强度。
令人惊讶地发现,可以通过添加高分子量(100,000-7,000,000道尔顿)的聚环氧乙烷来改变组合物的筏特性。向包含海藻酸钠和与CMC共加工的胶体MCC的本发明的组合物中添加高分子量聚环氧乙烷导致筏强度和弹性增加,参见下文的实例2。高分子量聚环氧乙烷还作为组合物中水不溶性组分(如胶体MCC)和水不溶性活性成分的悬浮剂。适用于本发明目的的聚环氧乙烷的实例是可购自杜邦公司的POLYOXTM Sentry。聚环氧乙烷能够以1%-10%(按组合物中固体的干重计)的浓度存在。
也可以通过添加羟丙基甲基纤维素(HPMC)来改变本发明组合物的筏特性。HPMC是纤维素醚,其在水性组合物中用作增稠剂并增加其粘度。粘度增加取决于水中HPMC的分子量和浓度。HPMC也可以作为组合物中水不溶性组分的悬浮剂。合适的HPMC的实例是METHOCELTM K级,特别是METHOCELTM K100M(其是甲氧基取代为19.0%-24.4%、羟基丙氧基取代为7.0%-12.0%、粘度为75,000-140,000mPa.s的HPMC,该粘度是根据ASTM 2363-79(2006年重新批准)在Ubbelohde粘度计中在20℃下以2%水溶液测定的)。METHOCELYM K级HPMC可商购自杜邦公司。HPMC能够以1.5%-10%(按组合物中固体的干重计)的浓度存在。
本发明组合物可以原样使用以提供对胃食管反流障碍的治疗或作为胃滞留药物递送系统(GRDDS)以提供药学或营养学活性成分的缓释或靶向释放。GRDDS可以适当地呈水性悬浮液或胶囊、片剂、粉末或颗粒的形式,优选地呈水性悬浮液或咀嚼片的形式。可以有利地作为GRDDS施用的活性成分的实例是膳食补充剂,如姜黄素、维生素(如维生素D或叶酸)、益生元或益生菌、和矿物质(如镁、锌或铁)、或选自抗糖尿病药(如盐酸二甲双胍)的活性药物成分;抗生素,如红霉素、头孢菌素、米诺环素、阿莫西林和环丙沙星;镇痛药和抗炎剂,如对乙酰氨基酚、布洛芬、酮洛芬、吲哚美辛或萘普生;抗酸药,如氢氧化铝和氢氧化镁;H2受体拮抗剂,如雷尼替丁、西咪替丁和法莫替丁;抗组胺药,如马来酸氯苯那敏、盐酸苯海拉明和盐酸曲普利啶;酸性药物和极弱碱性药物,如水杨酸、阿司匹林、硫喷妥钠、司可巴比妥、安替比林等。
本发明组合物可以如图3所概述通过以下步骤制备:在第一容器中将碳酸氢盐和碳酸盐分散在水和任选的水溶性组分和/或活性成分中,并且在混合下添加海藻酸钠;
在第二容器中将胶体MCC分散在水中并将其在水中活化;
将来自第一容器的碳酸氢盐、碳酸盐和海藻酸钠分散体添加到来自第二容器的胶体MCC的分散体中;以及
任选地添加防腐剂和调味剂并用水补充体积。
为了制备固体剂型(如片剂),将所需成分在合适的滚筒混合器中共混,并将片剂压缩至所需尺寸。
在以下实例中进一步描述本发明。
实例
方法
根据F.C.Hampson等人,International Journal of Pharmaceutics[国际药剂学杂志]294,2005,第137-147页,通过在200ml玻璃瓶中将本发明组合物作为水性悬浮液添加至预先于37℃平衡的150ml的0.1M HCl中形成筏来测定筏弹性。使筏形成30min(图2A),然后将瓶子盖上并放置在设置为以20rpm旋转的滚筒混合器(连接到V型搅拌器)中,以模拟胃搅动,如图2B所示。在总搅动时间为2、5、10、20、30、45和最多60min后,或直到无法再检测到筏的这个时候,目视评估筏的厚度、连贯性和完整性。为了目视评估,筏定义为两个或更多直径为至少15mm的漂浮凝胶。筏弹性定义为观察到筏的最后时间点。
根据F.C.Hampson,同上,通过将本发明组合物添加到250ml玻璃烧杯中保持于37℃的150ml的0.1M HCl中,测定筏强度。在筏形成整个时间段,每个筏都围绕直立在烧杯中的L形不锈钢金属丝探针形成。筏形成30min后,将烧杯放置在TA-XT质构分析仪(英国稳定微系统公司(Stable Micro Systems,UK))的工作台上,将金属丝探针挂在质构分析仪臂上,并以5mm/秒的速度垂直向上拉穿过筏。通过质构分析仪记录将金属丝探针向上拉穿过筏所需的力(g)。TA-XT装置的示意图示出于图1中。
实例1
海藻酸钠和胶体MCC的水性悬浮液
如图3所概述,由以下成分制备水性悬浮液。
当根据上文所讨论的方法进行测试时,发现该组合物具有以下筏特性
序号 | 测试参数 | 结果 |
1 | 筏强度 | 19g |
2 | 粘度 | 2cps |
3 | 筏弹性 | 长达30min |
4 | 筏厚度 | 32mm |
5 | 筏漂浮 | LT 1min |
6 | 筏连贯性 | 良好 |
将这些结果与对比实例A(商业的组合物(Advance))在类似条件下获得的筏特性进行比较。对比实例A包括以下成分。
当根据上文所讨论的方法进行测试时,发现该组合物具有以下筏特性。
序号 | 测试参数 | 结果 |
1 | 筏强度 | 16g |
2 | 粘度 | 6cps |
3 | 筏弹性 | 长达45min |
4 | 筏厚度 | 20mm |
5 | 筏漂浮 | LT 1min |
6 | 筏连贯性 | 良好 |
从结果看出,在筏板强度和筏厚度方面,含有胶体MCC的实例1的本发明组合物优于对比实例A,而对比实例A中筏弹性略高。
实例2
海藻酸钠、胶体MCC和聚环氧乙烷的水性悬浮液
如图3所概述,由以下成分制备水性悬浮液。
当根据上文所讨论的方法进行测试时,发现该组合物具有以下筏特性。
序号 | 测试参数 | 结果 |
1 | 筏强度 | 17g |
3 | 筏弹性 | 60min |
4 | 筏重量 | 53.7g |
5 | 筏厚度 | 30.4mm |
6 | 筏漂浮 | 又快又好 |
从结果看出,在筏强度、筏弹性和筏厚度方面,含有胶体MCC和聚环氧乙烷两者的实例2的本发明组合物优于对比实例A。
实例3
含有海藻酸钠、胶体MCC和任选地聚环氧乙烷的咀嚼片
制备含有以下成分的咀嚼片。
当根据上文所讨论的方法进行测试时,发现片剂配制品具有以下筏特性。
序号 | 测试参数 | 含Polyox | 不含Polyox |
1 | 筏强度 | 6.6g | 12.9g |
4 | 筏重量(gm) | 50.4 | 59.2 |
5 | 筏厚度(mm) | 26.05 | 27.01 |
6 | 漂浮 | 快 | 快 |
尽管观察到含有Polyox的组合物的筏强度较低,但发现其悬浮稳定性良好,同时快速漂浮,具有良好的筏厚度和重量。
实例4
海藻酸钠和胶体MCC的含有盐酸二甲双胍的水性悬浮液
如图3所概述,由以下成分制备水性悬浮液。
当根据上文所讨论的方法进行测试时,发现实例4的水性悬浮液具有以下筏特性。
筏特征 | 值 | |
1 | 筏强度 | 17.83g |
2 | 筏弹性 | 90min |
3 | 漂浮 | 又好又快 |
将这些结果与对比实例B(含有盐酸二甲双胍的商业的组合物(Advance))在类似条件下获得的筏特性进行比较。对比实例B包括以下成分。
当根据上文所讨论的方法进行测试时,发现对比实例B的水性悬浮液具有以下筏特性。
筏特征 | 值 |
筏强度 | 15.70g |
筏弹性 | 60min |
漂浮 | 又好又快 |
从结果看出,在筏强度和筏弹性方面,含有胶体MCC的实例4的本发明组合物优于对比实例B。
Claims (18)
1.一种具有筏形成特性的药物组合物或营养组合物,所述组合物包含
(a)海藻酸钠,
(b)胶体微晶纤维素,
(c)碳酸氢盐,和
(d)碳酸盐。
2.如权利要求1所述的组合物,其中所述海藻酸钠的按重量计1%水溶液在20oC时的粘度在3-10mPa.s范围内,所述粘度通过使用Brookfield转子2的Brookfield型RV粘度计测量。
3.如权利要求1或2所述的组合物,其中所述海藻酸钠的古罗糖醛酸含量≥50%,优选65%-75%。
4.如权利要求1-3中任一项所述的组合物,其中按所述组合物中固体的干重计,海藻酸钠的浓度在25%-50%范围内。
5.如权利要求1-4中任一项所述的组合物,其中所述胶体微晶纤维素是与羧甲基纤维素或瓜尔胶共加工的纤维素。
6.如权利要求5所述的组合物,其中所述共加工的胶体微晶纤维素中微晶纤维素与羧甲基纤维素的比率在85:15至90:10范围内。
7.如权利要求1-6中任一项所述的组合物,其中按所述组合物中固体的干重计,胶体微晶纤维素的浓度在8%-20%范围内。
8.如权利要求1-7中任一项所述的组合物,其中所述碳酸氢盐是碳酸氢钠。
9.如权利要求1-8中任一项所述的组合物,其中按所述组合物中固体的干重计,所述碳酸氢盐的浓度在15%-30%范围内。
10.如权利要求1-9中任一项所述的组合物,其中所述碳酸盐是碳酸钙。
11.如权利要求1-10中任一项所述的组合物,其中按所述组合物中固体的干重计,所述碳酸盐的浓度为8%-20%。
12.如权利要求1-10中任一项所述的组合物,其进一步包含分子量为100,000-7,000,000道尔顿的聚环氧乙烷。
13.如权利要求12所述的组合物,其中按所述组合物中固体的干重计,聚环氧乙烷的浓度在1%-10%范围内。
14.如权利要求1-13中任一项所述的组合物,其进一步包含羟丙基甲基纤维素。
15.如权利要求14所述的组合物,其中按所述组合物中固体的干重计,羟丙基甲基纤维素的浓度为1.5%-10%。
16.如权利要求1-15中任一项所述的组合物,其呈水性悬浮液或胶囊、片剂、粉末或颗粒的形式,优选地水性悬浮液或咀嚼片。
17.如权利要求1-16中任一项所述的组合物,其进一步包含药学或营养学活性成分。
18.如权利要求1-17中任一项所述的组合物,其用于在提供药学或营养学活性成分的缓释或靶向释放中使用。
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PCT/EP2022/050524 WO2022152741A1 (en) | 2021-01-13 | 2022-01-12 | A gastroretentive drug delivery system |
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US (1) | US20240065976A1 (zh) |
EP (1) | EP4277605A1 (zh) |
JP (1) | JP2024502378A (zh) |
KR (1) | KR20230131480A (zh) |
CN (1) | CN117042629A (zh) |
CA (1) | CA3204777A1 (zh) |
IL (1) | IL304391A (zh) |
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US3539365A (en) | 1967-02-13 | 1970-11-10 | Fmc Corp | Dispersing and stabilizing agent comprising beta-1,4 glucan and cmc and method for its preparation |
ATE396710T1 (de) * | 2005-07-19 | 2008-06-15 | Ethypharm Sa | Gastroretentive zusammensetzungen und verfahren zur herstellung |
US11110118B2 (en) * | 2018-03-02 | 2021-09-07 | Pharagen Llc | Formulations for treating acid reflux comprising sodium alginate |
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2022
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- 2022-01-12 CA CA3204777A patent/CA3204777A1/en active Pending
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IL304391A (en) | 2023-09-01 |
KR20230131480A (ko) | 2023-09-13 |
JP2024502378A (ja) | 2024-01-18 |
MX2023008206A (es) | 2023-09-25 |
US20240065976A1 (en) | 2024-02-29 |
EP4277605A1 (en) | 2023-11-22 |
WO2022152741A1 (en) | 2022-07-21 |
CA3204777A1 (en) | 2022-07-21 |
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