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CN101861139A - 含有盐酸莫西沙星和磷酸地塞米松的局部眼或耳用溶液制剂 - Google Patents

含有盐酸莫西沙星和磷酸地塞米松的局部眼或耳用溶液制剂 Download PDF

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CN101861139A
CN101861139A CN200880116678A CN200880116678A CN101861139A CN 101861139 A CN101861139 A CN 101861139A CN 200880116678 A CN200880116678 A CN 200880116678A CN 200880116678 A CN200880116678 A CN 200880116678A CN 101861139 A CN101861139 A CN 101861139A
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moxifloxacin
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O·N·辛格
S·C·迪克西
M·沃尔
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Abstract

本发明公开了莫西沙星和磷酸地塞米松的局部眼耳用溶液组合物。

Description

含有盐酸莫西沙星和磷酸地塞米松的局部眼或耳用溶液制剂
发明背景
本发明涉及适用于眼睛或耳局部施用的莫西沙星和磷酸地塞米松溶液制剂。
莫西沙星是一种已知的抗生素化合物。参见例如美国专利US 4,990,517和US 5,607,942。含有莫西沙星的供局部施用的眼用溶液剂可商购获得，其商品名为
Figure GPA00001138906900011
(盐酸莫西沙星眼用溶液剂)，以碱计浓度为0.5％，为爱尔康公司的产品。参见美国专利US 6,716,830。该′830专利公开了专门用于眼、耳和鼻组织局部施用的特别处方组合物。该′830专利公开了莫西沙星组合物，其任选含有抗炎剂。公开的抗炎剂包括甾类和非甾类抗炎剂。根据该′830专利，优选的眼和耳用甾类抗炎剂包括地塞米松、氯替泼诺、利美索龙、泼尼松龙、氟甲松龙和氢化可的松。′830专利的实施例2提供了pH为5.5的含有莫西沙星和地塞米松(微粉)的混悬液组合物。′830专利没有具体公开任何含有莫西沙星和磷酸地塞米松的溶液组合物。
磷酸地塞米松是一种已知形式的地塞米松。参见例如美国专利US2,939,873。该形式的地塞米松已被用于局部眼和耳用组合物中。参见例如美国专利US 5,679,665。
需要稳定、防腐、多剂量、适用于局部施用于眼和耳的莫西沙星和地塞米松溶液组合物。
发明内容
本发明的组合物是莫西沙星和地塞米松的水性组合物。该组合物是稳定、防腐的多剂量溶液组合物。该组合物可局部施用于眼或耳，基本上由盐酸莫西沙星、磷酸地塞米松、依地酸二钠、离子渗透压调节剂、硼酸、非离子表面活性剂以及苯扎氯铵或山梨糖醇组成。该组合物pH为7.5-8.1。
发明详述
若非另外说明，所有成分的浓度单位为％重量/体积(％w/v)。
在本发明的组合物中，莫西沙星优选以可药用盐的形式存在。更优选莫西沙星以盐酸莫西沙星的形式存在。该组合物含有的莫西沙星量相当于约0.5％的游离碱。本发明的组合物中盐酸莫西沙星的量为0.5-0.6％、最优选为0.545％，相当于0.5％的碱形式的莫西沙星。
除了莫西沙星，本发明的水性组合物还含有磷酸地塞米松。地塞米松的形式必须是磷酸地塞米松。地塞米松的其它已知形式例如21-醇或21-乙酸酯形式无法使组合物成为溶液组合物形式。供局部施用于眼或耳的溶液组合物不期望是混悬剂组合物形式，因为混悬剂无法象溶液剂那样穿透眼或耳组织。本发明的组合物含有磷酸地塞米松的量约为0.1-0.12％。优选本发明的组合物含有的磷酸地塞米松可药用盐的量相当于约0.1-0.12％的磷酸地塞米松。例如，本发明的组合物可含有的地塞米松磷酸钠的量为0.10-0.132％。最优选本发明的组合物含有0.11％的地塞米松磷酸钠，相当于0.1％的磷酸地塞米松。优选本发明的组合物含有地塞米松磷酸钠形式的地塞米松。
本发明的组合物含有硼酸的量为0.2-0.4％，优选0.3％。
本发明的组合物中依地酸二钠的含量为0.005-0.02％。最优选依地酸二钠的量为0.01％。
本发明的组合物中加入离子渗透压调节剂的量足以使终组合物的渗透压为270-330mOsm/Kg。优选离子渗透压调节剂是氯化钠，其量优选为0.5-0.75％。最优选本发明的组合物含有0.62％的NaCl。
本发明的组合物含有眼和耳可接受的非离子表面活性剂例如聚山梨醇酯表面活性剂、聚氧乙烯和聚氧丙烯嵌段共聚物表面活性剂(例如普朗尼克或Tetronic表面活性剂)或四丁酚醛。优选本发明的组合物含有非离子表面活性剂的量为0.04-0.06％。最优选本发明组合物中的非离子表面活性剂是四丁酚醛，且其量为0.05％。
本发明组合物含有防腐成分或加强防腐作用的成分，其选自于苯扎氯铵和山梨糖醇。若本发明的组合物用于局部耳部施用，则优选含有苯扎氯铵，若用于局部眼部施用，则优选含有山梨糖醇。存在时，苯扎氯铵在组合物中的量为0.005-0.015％、优选0.01％。若存在，山梨糖醇在本发明组合物中的量为0.1-0.3％，优选0.2％。
用眼科可接受的pH调节剂调节本发明水性溶液剂的pH。眼科可接受的pH调节剂是已知的，包括但不限于盐酸(HCl)和氢氧化钠(NaOH)。本发明的组合物优选含有NaOH或HCl以获得期望的pH。本发明的组合物在较窄的pH范围内配制和保存以使其在商业上可接受的货架寿命期间内保持稳定。本发明的组合物的pH为7.5-8.1，最优选为7.8-8.0。
本发明的组合物优选包装在为递送滴眼剂或滴耳剂而设计的多剂量塑料容器中。优选所述塑料是低密度聚乙烯(LDPE)或聚丙烯。最优选所述塑料是LDPE。
以下实施例旨在举例说明本发明而非限制本发明。
实施例1
局部眼用溶液剂
  成分   处方A(％w/v)
  盐酸莫西沙星   0.5-0.6
  地塞米松磷酸钠   0.10-0.12
  依地酸二钠   0.005-0.02
  NaCl   0.5-0.75
  硼酸   0.2-0.4
  山梨糖醇   0.1-0.3
  四丁酚醛   0.04-0.06
  成分   处方A(％w/v)
  NaOH/HCl   调至pH 7.5-8.1
  纯水   加至100
实施例2
优选的局部眼用溶液剂
  成分   处方B(％w/v)
  盐酸莫西沙星   0.545a
  地塞米松磷酸钠   0.11b
  依地酸二钠   0.01c
  NaCl   0.62
  硼酸   0.3
  山梨糖醇   0.2
  四丁酚醛   0.05
  NaOHd/HCl   调至pH 7.8-8.0
  纯水   加至100
a 0.545％相当于0.5％的碱形式的莫西沙星
b 0.11％相当于0.1％的磷酸地塞米松
c使用依地酸二钠的无水形式
d加入相当于0.0972％的氢氧化钠以促进盐酸莫西沙星的溶解。若调节pH需要可加入额外的NaOH
实施例3
局部耳用溶液剂
  成分   处方C(％w/v)
  盐酸莫西沙星   0.5-0.6
  成分   处方C(％w/v)
  地塞米松磷酸钠   0.10-0.12
  依地酸二钠   0.005-0.02
  NaCl   0.5-0.75
  硼酸   0.2-0.4
  苯扎氯铵   0.005-0.015
  四丁酚醛   0.04-0.06
  NaOH/HCl   调至pH 7.5-8.1
  纯水   加至100
实施例4
优选的局部耳用溶液剂
  成分   处方D(％w/v)
  盐酸莫西沙星   0.545a
  地塞米松磷酸钠   0.11b
  依地酸二钠   0.01c
  NaCl   0.62
  硼酸   0.3
  苯扎氯铵   0.01
  四丁酚醛   0.05
  NaOHd/HCl   调至pH 7.8-8.0
  纯水   加至100
a 0.545％相当于0.5％的碱形式的莫西沙星
b 0.11％相当于0.1％的磷酸地塞米松
c使用依地酸二钠的无水形式
d加入相当于0.0972％的氢氧化钠以促进盐酸莫西沙星的溶解。若调节pH需要可加入额外的NaOH
实施例5
对实施例4的三批组合物进行物理稳定性研究(澄明度、目测沉淀物、pH稳定性)。将组合物样品在8ml不透明LDPE瓶中储存，条件如下：4℃/35％相对湿度；25℃/40％相对湿度；25℃/40％相对湿度(瓶子水平方向储存)；30℃/65％相对湿度；40℃/＜25％相对湿度；光照箱(25℃/40％相对湿度，总照明量不低于120万lux小时，总近紫外能量不低于200瓦特小时/平方米)；光照箱和LDPE瓶在硬纸箱中；循环条件(CY)一周在-20℃下冷冻28小时，然后在30℃下融化28小时，每周共3个循环。结果见表1-3。
Figure GPA00001138906900081
Figure GPA00001138906900091
实施例6
在冷冻融化循环实验中研究实施例4的组合物中各种浓度的四丁酚醛的稳定作用。每个循环的构成为：-20℃下24小时然后在室温下24小时。组合物储存在经环氧乙烷气体灭菌的LDPE容器中或玻璃容器中。结果见表4(LDPE容器)和5(玻璃容器)。
表4
(LDPE容器)
Figure GPA00001138906900101
表5
(玻璃容器)
Figure GPA00001138906900111
实施例7
测试标示莫西沙星和磷酸地塞米松溶液组合物的物理稳定性，结果见下表6-9。
Figure GPA00001138906900121
Figure GPA00001138906900131
Figure GPA00001138906900141
Figure GPA00001138906900151
实施例10
测试实施例2的组合物的防腐效果。根据美国药典(USP)和欧洲药典(Ph.Eur.)中所述的方法进行微生物挑战试验以确定抗微生物防腐效果。用已知水平的一种或多种以下微生物接种样品：革兰氏阳性菌(金黄色葡萄球菌ATCC 6538)和革兰氏阴性菌(绿脓杆菌ATCC 9027和大肠杆菌ATCC8739)繁殖体、酵母菌(白色念珠菌ATCC 10231)和霉菌(黑曲霉ATCC16404)。然后在特定时间间隔检测样品，观察抗微生物防腐系统是否能够杀死故意引入处方中的微生物或抑制其繁殖。抗微生物活性速率或水平决定其与美国药典和/或欧洲药典中眼用制剂防腐效果标准的顺应性。
眼用制剂防腐标准简要如下：
对于细菌：
Figure GPA00001138906900161
对于真菌：
Figure GPA00001138906900162
NR＝未发现微生物
NI＝该检测时间点或其后任何检测时间点均未增加
-＝不要求在该时间检测
微生物挑战试验结果如下表10所示。
表10
 组合物   USP   Ph.Eur.B   Ph.Eur.A
 实施例2   通过   通过   未通过
实施例11
如实施例10所述，对实施例4的组合物进行同样的防腐效果检测。此外，还对含有不同浓度苯扎氯铵的相似组合物进行检测。各组合物及其防腐效果检测结果见表11。
Figure GPA00001138906900181
通过参考某些优选实施方案对本发明进行了描述；但是应该理解，本发明可以以其它具体形式或其变体形式实施而不偏离其精神或基本特征。因此，上述实施方案从各方面而言均应被看作是为了举例说明的目的而不是限制性的。本发明的范围由所附的权利要求书定义而不由上述说明书定义。

Claims (3)

1.一种防腐的可局部施用的多剂量眼或耳用水溶液组合物，其基本上由如下成分组成
a)0.5-0.6％(w/v)的莫西沙星或其可药用盐；
b)0.10-0.12％(w/v)的磷酸地塞米松或其量相当于0.10-0.12％(w/v)磷酸地塞米松的其可药用盐；
c)0.005-0.02％(w/v)的依地酸二钠；
d)0.5-0.75％(w/v)的氯化钠；
e)0.2-0.4％(w/v)的硼酸；
f)0.1-0.3％(w/v)的山梨糖醇或0.005-0.015％(w/v)的苯扎氯铵；
g)0.04-0.06％(w/v)的非离子表面活性剂；
h)pH调节剂，其量足以使组合物的pH为7.5-8.1；和
i)水。
2.权利要求1的组合物，其中所述组合物是眼用组合物并且该组合物基本上由如下成分组成
a)0.545％(w/v)的盐酸莫西沙星；
b)0.11％(w/v)的地塞米松磷酸钠；
c)0.01％(w/v)的依地酸二钠；
d)0.5-0.75％(w/v)的氯化钠；
e)0.3％(w/v)的硼酸；
f)0.2％(w/v)的山梨糖醇；
g)0.05％(w/v)的四丁酚醛；
h)NaOH或HCl，其量足以使组合物的pH为7.8-8.0；和
i)水。
3.权利要求1的组合物，其中所述组合物是耳用组合物并且该组合物基本上由如下成分组成
a)0.545％(w/v)的盐酸莫西沙星；
b)0.11％(w/v)的地塞米松磷酸钠；
c)0.01％(w/v)的依地酸二钠；
d)0.5-0.75％(w/v)的氯化钠；
e)0.3％(w/v)的硼酸；
f)0.01％(w/v)的苯扎氯铵；
g)0.05％(w/v)的四丁酚醛；
h)NaOH或HCl，其量足以使组合物的pH为7.8-8.0；和
i)水。
CN200880116678A 2007-11-27 2008-11-24 含有盐酸莫西沙星和磷酸地塞米松的局部眼或耳用溶液制剂 Pending CN101861139A (zh)

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