CN1325306A - 莫西沙星药物制剂 - Google Patents

莫西沙星药物制剂 Download PDF

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CN1325306A
CN1325306A CN99813124A CN99813124A CN1325306A CN 1325306 A CN1325306 A CN 1325306A CN 99813124 A CN99813124 A CN 99813124A CN 99813124 A CN99813124 A CN 99813124A CN 1325306 A CN1325306 A CN 1325306A
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moxifloxacin
oral drug
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lactose
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CN1149993C (zh
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P·博舍
H·F·马勒
C·维瑟曼
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Bayer Intellectual Property GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Abstract

本发明涉及含有莫西沙星、其盐和/或水合物以及乳糖的口服药物制剂。本发明还涉及所述制剂的制备方法以及该制剂在对抗人或动物细菌感染中的应用。

Description

莫西沙星药物制剂
本发明涉及含有莫西沙星(moxifloxacin)、其盐和/或水合物以及乳糖的口服药物制剂，其制备方法以及该制剂在防治人或动物细菌感染中的应用。
莫西沙星(INN-国际非专利药名)是具有下列结构式的抗菌药：1-环丙基-7-([S,S]-2,8-二氮杂双环[4.3.0]壬-8-基)-6-氟-1,4-
       二氢-8-甲氧基-4-氧代-3-喹诺酮甲酸
这是高度有效的抗感染剂，并且是在EP-A-0350733中首次描述的。EP-A-0350733描述了含有该活性化合物、微晶纤维素、玉米淀粉、聚-(1-乙烯基)-2-吡咯烷酮(不溶)、细分散的二氧化硅和硬脂酸镁的药物制剂。
此外，EP-A-0230881描述了环丙沙星的药物制剂，环丙沙星同样是喹诺酮甲酸类的抗菌素。在该专利公开中描述的环丙沙星制剂与EP-A-0350733中描述的制剂相应。然而，如果将现有技术的制剂用于莫西沙星，则出人意料地发现，用该制剂制备的片剂具有在某些情况下、例如当制成泡囊包装的片剂时可以得到改善的硬度和断裂载荷(breaking load)，同时还使其释放性质得到一定范围的改进。因此本发明的目的是提供药物制剂，该制剂可用于制备具有足够硬度或断裂载荷的片剂，并且同时该片剂具有出色的释放性质。
我们出人意料地发现，上述目的可以通过使药物制剂包含一定量的乳糖得以实现。
因此本发明提供了口服给药的药物制剂，该制剂含有莫西沙星、至少一种无水粘合剂、至少一种崩解剂和任选地含有润滑剂，其特征在于该制剂含有2.5％-25％的乳糖(所有的百分数均以药物制剂的重量为基础计算)。
此外，本发明提供了含有该制剂的片剂的制备方法。
本发明的药物制剂是供口服给药的制剂。
莫西沙星的盐包括例如酸加成盐如盐酸盐、硫酸盐、乙酸盐、乳酸盐等，以及与碱例如氢氧化钠、氢氧化钾等的盐，和/或其水合物，例如本发明特别优选的莫西沙星盐酸盐或其一水合物。
本发明的制剂优选含有50-85％、特别优选60-80％莫西沙星或其盐和/或其水合物。
以单一剂量为基础，本发明该药物制剂通常含有50-800mg莫西沙星，优选100-600mg，特别优选200-400mg(每种情况下均以内铵盐(betaine)形式为基础)。
出人意料的是，使用本发明所述用量范围的乳糖可以使由本发明药物制剂制备的片剂具有出色的硬度和断裂载荷，同时具有出色的释放性质。本发明药物制剂的其他优点包括可以以简单的方式制粒，可以使用微粉化和非微粉化的活性化合物，无论在哪种情况下，均可以得到生物等价的制剂。
该药物制剂含有作为达到本发明目的所必需成分的2.5-25％乳糖，优选5-20％乳糖，特别优选7.5-16％乳糖。根据本发明，在此优选使用常用的乳糖一水合物。
本发明药物制剂含有至少一种无水粘合剂，该粘合剂选自例如：微晶纤维素、纤维状纤维素、磷酸钙和甘露糖醇。本发明特别优选的是微晶纤维素。微晶纤维素可以购买到，例如Avicel。该药物制剂有利地含有5-30％、优选6.9-30％、特别优选12-15％无水粘合剂。
本发明药物制剂含有至少一种崩解剂，所述崩解剂选自例如淀粉、预胶凝淀粉、淀粉羟乙酸盐、交联聚乙烯吡咯烷酮和羧甲基纤维素钠(=Croscarmellose sodium)。本发明尤其优选的是使用羧甲基纤维素钠。该药物制剂有利地含有1-10％、优选1.5-8％、特别优选2-6％的崩解剂。
本发明药物制剂含有至少一种润滑剂，该润滑剂选自脂肪酸及其盐。本发明特别优选使用硬脂酸镁。润滑剂的用量有利地是0.3-2.0％、特别优选的是0.4-1.5％、最优选0.5-1.1％。
特别优选的本发明药物制剂含有：
60-70％莫西沙星或其盐和/或其水合物，
7.5-16％乳糖，
2-6％羧甲基纤维素钠，
0.5-1.1％硬脂酸镁，和
最多30％微晶纤维素。
通过下述方法可以有利地制备本发明药物制剂，其中将莫西沙星、其盐和/或水合物、至少一种无水粘合剂和乳糖用水制粒，然后将该颗粒与至少一种崩解剂和至少一种润滑剂混合，并任选地压片和包衣。
使用高速混合器制粒方法制粒。用水进行制粒，而无需加入粘合剂。
本发明药物制剂尤其优选以片剂形式使用，可以任选地对该片剂进行包衣(如上所述，本专利申请中的重量百分数以药物制剂的总重量为基础计算，而不包括任选的包衣的重量)。对于包衣来说，可以使用药学领域常规的包衣制剂，例如以各种分子量的羟丙基甲基纤维素(HPMC)和/或聚乙二醇为基础。此外，该包衣可以含有常规的色素，例如二氧化钛或氧化铁红。
本发明的药物制剂优选用于治疗或预防人或动物的细菌感染。
实施例
实施例1
含有50mg莫西沙星作为微粉化的活性化合物的片剂，活性化合物的含量约为66％(以未包衣片为基础计算)：莫西沙星盐酸盐，微粉化的           54.6mg微晶纤维素                         17.0mg乳糖                               8.5mg羧甲基纤维素钠                     2.0mg硬脂酸镁                           0.6mgHPMC包衣                          3.2mg
实施例2
含有50mg莫西沙星作为微粉化的活性化合物的片剂，活性化合物的含量约为80％(以未包衣片为基础计算)：莫西沙星盐酸盐，微粉化的          54.6mg微晶纤维素                        7.1mg乳糖                              3.55mg羧甲基纤维素钠                    2.7mg硬脂酸镁                          0.4mg
实施例3
含有50mg莫西沙星作为微粉化的活性化合物的片剂，活性化合物的含量约为65％(以未包衣片为基础计算)：莫西沙星盐酸盐，微粉化的         54.6mg微晶纤维素                       12.8mg乳糖                             12.8mg羧甲基纤维素钠                   3.4mg硬脂酸镁                         0.5mg
实施例4
含有200mg莫西沙星作为微粉化的活性化合物的片剂：莫西沙星盐酸盐，微粉化的         218.4mg微晶纤维素                       68.0mg乳糖                             34.0mg羧甲基纤维素钠                   8.0mg硬脂酸镁                         2.4mgHPMC包衣                         9.0mg实施例5
含有400mg莫西沙星作为微粉化的活性化合物的片剂：莫西沙星盐酸盐，微粉化的        436.8mg微晶纤维素                      136.0mg乳糖                            68.0mg羧甲基纤维素钠                  16.0mg硬脂酸镁                        4.8mgHPMC包衣                        14.0mg
实施例6
含有400mg莫西沙星作为非微粉化的活性化合物的片剂：莫西沙星盐酸盐                  436.8mg微晶纤维素                      136.0mg乳糖                            68.0mg羧甲基纤维素钠                  32.0mg硬脂酸镁                        6.0mgHPMC包衣                        21.0mg
图1所示为本发明实施例6的片剂与EP-A-0350733制剂(第53页)断裂强度的比较。
图2所示为从本发明实施例6的片剂与从EP-A-0350733制剂中释放莫西沙星盐酸盐的比较。
在每种情况下，均使用可比较的制粒和压片条件、以实验室规模制备片剂。
图1清楚地表明本发明制剂的片剂硬度得以改善。无论如何，活性化合物如图2所示更快地释放。
图3所示为实施例5和6的片剂的血液浓度曲线的比较。
通过对实施例5片剂(微粉化的莫西沙星盐酸盐)与实施例6片剂(非微粉化的莫西沙星盐酸盐)的生物等价性进行比较，本发明其他出人意料的优点将变得显而易见，其中包括，尽管活性化合物颗粒的大小明显不同，但是两种制剂随着时间推移的血液浓度是相同的。因此，在本发明制剂中微粉化步骤不是必需的，这就有利于降低成本。

Claims (10)

1．口服药物制剂，含有
莫西沙星或其盐和/或其水合物，
至少一种无水粘合剂，
至少一种崩解剂，和
至少一种润滑剂，
其特征在于该制剂含有2.5％-25％的乳糖。
2．权利要求1的口服药物制剂，其特征在于该制剂以单一剂量为基础含有50-800mg莫西沙星或其盐和/或其水合物。
3．权利要求1或2的口服药物制剂，其特征在于无水粘合剂是微晶纤维素。
4．权利要求1-3中任何一项的口服药物制剂，其特征在于崩解剂是羧甲基纤维素钠。
5．权利要求1-4中任何一项的口服药物制剂，其特征在于润滑剂是硬脂酸镁。
6．权利要求1-5中任何一项的口服药物制剂，其特征在于它含有：
60-76％莫西沙星或其盐和/或其水合物，
7.5-16％乳糖，
2-6％羧甲基纤维素钠，
0.5-1.1％硬脂酸镁，和
最多30％微晶纤维素。
7．口服片剂，包括权利要求1-6中任何一项的药物制剂片芯和膜包衣。
8．权利要求1-7中任何一项的口服药物制剂，其特征在于它含有莫西沙星盐酸盐。
9．权利要求1-8中任何一项的口服药物制剂，用于防治人或动物细菌感染。
10．制备权利要求1-8中任何一项的口服药物制剂的方法，其特征在于将莫西沙星、其盐和/或水合物、至少一种无水粘合剂和乳糖用水制粒，然后将该颗粒与至少一种崩解剂和至少一种润滑剂混合，并任选地压片和包衣。
CNB998131245A 1998-11-10 1999-10-29 莫西沙星药物制剂 Expired - Lifetime CN1149993C (zh)

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WO2006015545A1 (fr) * 2004-08-11 2006-02-16 Shenzhen Tys R & D Co., Ltd. Capsule de gelatine de moxifloxacin et procede pour sa preparation
WO2007033515A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation orale contenant de la moxifloxacine et son procédé de préparation
WO2007033522A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation de gélule contenant de la moxifloxacine et son procédé de préparation
CN1330306C (zh) * 2004-08-11 2007-08-08 深圳市天一时科技开发有限公司 莫西沙星明胶胶囊剂及其制备方法
CN102247314A (zh) * 2011-01-12 2011-11-23 北京润德康医药技术有限公司 一种以莫西沙星为活性成分的口服固体制剂
CN102525982A (zh) * 2012-02-21 2012-07-04 天津市汉康医药生物技术有限公司 一种稳定的盐酸莫西沙星药物组合物
CN102600093A (zh) * 2012-04-11 2012-07-25 南京优科生物医药有限公司 一种莫西沙星片剂及其制备方法
CN101890169B (zh) * 2009-11-16 2013-09-11 江苏亚邦强生药业有限公司 莫西沙星口服制剂及其制备方法
CN103768063A (zh) * 2012-10-19 2014-05-07 深圳信立泰药业股份有限公司 一种盐酸莫西沙星药物组合物及其制备方法

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DE19937116A1 (de) * 1999-08-06 2001-02-08 Bayer Ag Moxifloxacin Kochsalzformulierung
GB0209265D0 (en) 2002-04-23 2002-06-05 Novartis Ag Organic compounds
WO2005020998A1 (en) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Pharmaceutical compositions of moxifloxacin and processes for their preparation
CN100363001C (zh) * 2005-09-21 2008-01-23 深圳市天一时科技开发有限公司 一种莫西沙星胶囊剂及其制备方法
EA201170545A1 (ru) * 2008-10-09 2012-01-30 Абды Ибрахым Иладж Санайи Ве Тыджарет Аноным Сыркеты Применение органических растворителей в способе влажного гранулирования моксифлоксацина
ES2467105T5 (es) 2008-12-08 2017-12-05 Ratiopharm Gmbh Moxifloxacino compactado
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CN1330306C (zh) * 2004-08-11 2007-08-08 深圳市天一时科技开发有限公司 莫西沙星明胶胶囊剂及其制备方法
WO2007033515A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation orale contenant de la moxifloxacine et son procédé de préparation
WO2007033522A1 (fr) * 2005-09-21 2007-03-29 Shenzhen Tys R & D Co., Ltd. Formulation de gélule contenant de la moxifloxacine et son procédé de préparation
CN101890169B (zh) * 2009-11-16 2013-09-11 江苏亚邦强生药业有限公司 莫西沙星口服制剂及其制备方法
CN102247314A (zh) * 2011-01-12 2011-11-23 北京润德康医药技术有限公司 一种以莫西沙星为活性成分的口服固体制剂
CN102525982A (zh) * 2012-02-21 2012-07-04 天津市汉康医药生物技术有限公司 一种稳定的盐酸莫西沙星药物组合物
CN102600093A (zh) * 2012-04-11 2012-07-25 南京优科生物医药有限公司 一种莫西沙星片剂及其制备方法
CN102600093B (zh) * 2012-04-11 2013-06-05 南京优科生物医药有限公司 一种莫西沙星片剂及其制备方法
CN103768063A (zh) * 2012-10-19 2014-05-07 深圳信立泰药业股份有限公司 一种盐酸莫西沙星药物组合物及其制备方法
CN103768063B (zh) * 2012-10-19 2016-04-20 深圳信立泰药业股份有限公司 一种盐酸莫西沙星药物组合物及其制备方法

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