CN103860540A - 奥洛他定在治疗鼻子过敏或发炎状态的制剂制备中的用途 - Google Patents
奥洛他定在治疗鼻子过敏或发炎状态的制剂制备中的用途 Download PDFInfo
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Abstract
本发明公开了奥洛他定在治疗鼻子过敏或发炎状态的制剂制备中的用途。提供一种喷雾器,所述喷雾器具有包括奥洛他定的制剂。将制剂的喷雾输送到对象的鼻子中。喷雾可以具有喷雾特点,所述喷雾特点包括喷流型,该喷流型具有最长轴线为20-45mm,最短的轴线为14-20μm,和椭圆度为1-1.8。喷雾还可以具有喷雾特点,所述喷雾特点包括液滴大小分布,该液滴大小分布具有D10为15-30μm,D50为30-60μm,D90为50-150μm,SPAN为不大于3,和<10μm的体积百分数为小于4%。
Description
本发明是国际申请日为2005年10月31日、国际申请号为PCT/US2005/039268、中国国家申请号为200580040226.3、发明名称为“输送鼻孔喷雾剂的方法”的发明专利申请的分案申请。
本申请要求2004年11月24日发布的美国临时申请No.60/630886的优先权。
技术领域
本发明一般涉及鼻孔喷雾剂的输送,而更具体地说,涉及含有奥洛他定的鼻孔喷雾剂的输送。
相关技术说明
各种鼻孔喷雾剂可用于治疗过敏性鼻炎。示例性的产品包括从United Kingdom的GlaxoSmithKline购买的鼻孔喷雾剂;从Kennilworth,New Jersey的Schering Corporation购买的鼻孔喷雾剂;及从Somerset,New Jersey的MedPointePharmaceuticals购买的鼻孔喷雾剂。所有这些产品都是通过从供应商如德国的Pfeiffer,法国的Saint-Gobain Calmar,或法国的Valois购买的普通泵-喷雾器输送局部用制剂。
美国专利Nos.4871865和4923892二者都转让给了BurroughsWellcome Co.(“Burroughs Wellcome专利”),上述专利公开了某些多塞平的羧酸衍生物,其中包括奥洛他定(化学名称:Z-11-(3-二甲氨基亚丙基)-6,11-二氢二苯[b,e]更英-2-乙酸),上述多塞平的羧酸衍生物具有抗组胺和镇喘活性。Burroughs Wellcome专利说明了各种含多塞平羧酸衍生物的药物制剂,其中包括鼻孔喷雾剂和眼科制剂。例如见专利4871865的第7项7-26行,和实施例的8(H)和8(I)。
已转让给Hakko Kogyo Co.,Ltd.,(Kyowa专利)的美国专利No.5116863讲述了多塞平的乙酸衍生物,尤其是奥洛他定具有抗过敏和消炎活性。由Kyowa专利对于多塞平的乙酸衍生物所讲述的药物形式包括很大范围的可容许的载体,然而,只提到口腔和注射给药形式。
已转让给Alcon Laboratories,Inc.和Kyowa Hakko Kogyo Co.,Ltd.,的美国专利5641805讲述了用于治疗眼疾的含有奥洛他定的局部眼科制剂。按照美国专利5641805,局部制剂可以是溶液、悬浮体或凝胶。
来自Fort Worth,Texas的Alcon Laboratories,Inc.的(盐酸奥洛他定眼科溶液)0.1%目前是唯一在市场上出售的供眼科使用的奥洛他定产品。根据上述产品的标签信息,产品含有与0.1%奥洛他定等效的盐酸奥洛他定,0.01%的苯扎氯胺,及未规定量的氯化钠,磷酸氢二钠,盐酸和/或氢氧化钠(调节pH用)和纯水。
由Alcon,Inc.所申请的美国专利申请公报No.20030055102公开了局部用奥洛他定制剂,所述制剂对治疗和/或防止眼或鼻子过敏症或炎症有效。公开了含有约0.2-0.6%奥洛他定的水溶液制剂。
美国专利Nos.4871865;4923892;5116863;和5641805及美国专利申请公报No.20030055102都整体包括在本文中作为参考。
改进的输送局部用奥洛他定制剂的方法对治疗鼻子的过敏或发炎状态是有效的,所述方法仍然是理想的。
发明内容
本发明的一个方面是输送鼻孔喷雾剂的方法。提供具有含奥洛他定的制剂的喷雾器。将制剂的喷雾输送到患者的鼻子中。喷雾剂具有喷雾特点,所述喷雾特点包括喷流型(spray pattern),喷流型具有最长的轴线为20-45mm,最短的轴线为14-20mm,及椭圆度为1-1.8。
另一方面,本发明是输送鼻孔喷雾剂的方法。提供具有含奥洛他定的制剂的喷雾。将制剂的喷雾输送到患者的鼻子中。喷雾剂具有喷雾特点,所述喷雾特点包括液滴大小分布,液滴大小分布具有D10为15-30μm,D50为30-60μm,D90为50-150μm,跨度(SPAN)不大于3,和<10μm的体积百分数为小于4%。
附图说明
为了更完全的理解本发明,及对于本发明的另一些目的和优点,参照下面结合附图所作的说明,其中:
图1是按照本发明的优选实施例所述的鼻孔喷雾器的前面剖视图。
具体实施方式
本发明的一些优选实施例及其优点最好是参照附图的图1理解,对于各附图中相同和对应的部件采用相同的标号。
除非另有说明,否则所有组分的量都是以%(W/V)为基础表示,并且所有涉及奥洛他定的都是涉及奥洛他定自由基。
图1示出按照本发明的优选实施例所述的鼻孔喷雾器10。鼻孔喷雾器10一般包括瓶12、泵16、启动机构18和盖20,上述瓶12装有制剂14,上述泵16与瓶12密封式接合,上述启动机构18可拆卸地容纳泵16的顶部16a,而上述盖20可拆卸地与瓶12接合,并用于盖住启动机构18。瓶12和盖20优选的是用高密度聚乙烯制成。用于泵16的优选的泵是Valois VP7/100S CS20型泵。启动机构18优选的是用聚丙烯制成。制剂14优选的是水溶液制剂,所述水溶液制剂含有奥洛他定这对于在鼻子中治疗和/或防止过敏或发炎状态是有效的。制剂14优选的是含0.38-0.62%奥洛他定。制剂14最优选的是含0.6%奥洛他定。在取下盖20并将启动机构18的喷嘴18a插入他或她的鼻子中后,用户可以通过朝箭头22的方向移动启动机构18的表面18b,经由泵16的管道16b和启动机构18,从瓶12输送一次制剂14的喷雾。鼻子喷雾器10可以用常规技术制造。
现已发现,对于含有0.6%奥洛他定和粘度为1-2cps(优选的是1.7cps)的制剂14,从喷嘴18a喷出的某些喷雾特点产生意想不到有效的临床性能。更具体地说,优选的是喷雾特点具有下列参数中的一个或多个参数:散粒(Shot)重量为90-110mg,而最优选的是100mg;喷流型具有最长的轴线为20-45mm,而最优选的是23.5mm;喷流型具有最短的轴线为14-20mm,而最优选的是17.5mm;喷流型具有椭圆度为1-1.8,更优选的是为1-1.4,而最优选的是1.24;及下列液滴大小分布:
D10=15-30μm,更优选的是18-25μm,而最优选的是22μm;
D50=30-60μm,更优选的是39-53μm,而最优选的是47μm;
D90=50-150μm,更优选的是83-128μm,而最优选的是106μm;
跨度=不大于3,更优选的是1.6-2.1,而最优选的是1.8;
<10μm的体积百分数=小于4%,更优选的是0.8-2.4%,而最优选的是1.6%,
此处,D10是10%液滴的液滴大小分布,D50是50%液滴的液滴大小分布,D90是90%液滴的液滴大小分布;跨度是(D90-D10)/D50的比值;而<10μm的体积百分数是直径小于10μm的液滴的百分率。D10、D50和D90是微滴直径的量度。当把具有上述喷雾特点的所有优选或更优选的参数的含0.6%奥洛他定的制剂14的两个喷雾/鼻孔在对4000多个患者的临床试验中每天输送两次时,药物动力学测试显示出,这种输送方法产生特别有利的奥洛他定利用率。更具体地说,观察到在0.5-2小时内后剂量(post-dose)用高效液相色谱法测量所得的最大奥洛他定血浆浓度(Cmax)为14.4-35.3ng/ml(平均为23.3±6.1ng/mL)。该浓度范围可与通过系统的(比如口腔)剂量形式预期得到的浓度相一致。
下面说明用于表征喷流型的优选操作。获得了TLC(薄层色谱法)板(比如硅凝胶60,F254(荧光指示剂),在玻璃上250μm厚的层)和TLC板夹持器,购自Gibbstown,N.J的EM Science;254nm经过滤光的紫外光源;和适合于在紫外光中拍摄照片的照像机(比如数字照像机)。喷雾器10装满制剂14,并由驱动泵16通过启动机构18提供,直至细雾出现排出喷嘴18a为止。喷雾器10和TLC板夹持器如此安装,以便喷嘴18a距TLC板约3cm。泵16通过常规机械启动机构用恒定的力(优选为5kg)驱动。所产生的制剂14的喷雾能渗进TLC板中。将TLC板移动到干的部分,并重复操作手续。为了得到最好结果,从5个独立的喷雾器10单元得到两个喷流型。将所述两个喷流型在254nm经过滤光的紫外光中观察,并拍摄每个喷流型的照片。
若采用打印的照片,则每个喷流型都用铅笔划圆。画一条线包围全部喷流型,其中包括任何似乎与喷流型其余部分无关的密度区。“外环”应不变成圆形,上述“外环”有时可看到,并且是接触之后液体散布在板上的结果。里面较暗的喷流型是起始待测量的喷流型。用铅笔画出最长的轴线,所述最长的轴线可以在每个变圆的喷流型内找到。画出最短的轴线,所述最短的轴线穿过每个最长的轴线的中心。每个轴线都测量到最接近0.5mm。每个喷流型的椭圆度(形状)按下式计算:椭圆度=最长的轴线/最短的轴线。椭圆度报导是最接近1/10。将每个喷雾器10的每个喷流型的最长轴线、最短轴线和椭圆度取平均值,以便为每个喷雾器10提供一组参数。然后将所有5个喷雾器10的单元取平均值,以便求出规定制剂14的一组喷流型参数。
下面说明表征液滴大小分布的优选操作。喷雾器10装满制剂14,并由驱动泵16通过启动机构18提供,直至出现细雾从喷嘴18a出来为止。将喷雾器10和市场上购买的激光衍射仪如此安装,以使喷嘴18a在激光衍射仪的激光束下方约5cm。泵16通过常规的机械启动机构用恒定的力(优选的是5kg)驱动。所产生的制剂14的喷雾横跨激光束。将数据收集用于D10、D50、D90、跨度和<10μm的体积百分数。对这些参数当中的每个参数计算平均值用于两个喷雾。
从上述情况,可以理解,本发明提供改进的输送局部用奥洛他定制剂的方法,上述制剂对处理鼻子的过敏或发炎状态是有效的。可以认为,本发明的操作和结构从上面的说明将是显而易见的。尽管上面所显示和说明的方法可以称为是优选的,但在不脱离如所附权利要求书所述的精神和范围的情况下,其中可以进行各种修改和改变。
Claims (16)
1.奥洛他定在制备用于治疗鼻子的过敏或发炎状态的制剂中的用途,所述制剂被制备成通过喷雾器形成喷雾,其特征在于,
所述制剂中包括0.38-0.62%的奥洛他定,当将所述制剂的喷雾输送到患者的鼻子中时,所述喷雾具有喷雾特点,上述喷雾特点包括喷流型,所述喷流型具有最长轴线为20-45mm,最短轴线为14-20mm,并且椭圆度为1-1.8。
2.如权利要求1所述的用途,其中上述最长的轴线为23.5mm。
3.如权利要求1所述的用途,其中上述最短的轴线为17.5mm。
4.如权利要求1所述的用途,其中上述椭圆度为1-1.4。
5.如权利要求1所述的用途,其中上述制剂包括0.6%的奥洛他定。
6.如权利要求1所述的用途,其中上述喷雾特点还包括散粒重量为90-110mg。
7.如权利要求1所述的用途,其中上述最长的轴线是23.5mm,上述最短的轴线是17.5mm,上述椭圆度是1-1.4,上述制剂包括0.6%的奥洛他定,并且上述喷雾特点还包括散粒重量为90-110mg。
8.奥洛他定在制备用于治疗鼻子的过敏或发炎状态的制剂中的用途,所述制剂被制备成通过喷雾器形成喷雾,其特征在于,
所述制剂中包括0.38-0.62%的奥洛他定,当将上述制剂的喷雾输送到患者的鼻子中时,所述喷雾具有喷雾特点,上述喷雾特点包括具有D10为15-30μm,D50为30-60μm,D90为50-150μm的液滴大小分布,跨度不大于3,并且<10μm的体积百分数为小于4%。
9.如权利要求8所述的用途,其中上述制剂包括0.6%的奥洛他定。
10.如权利要求8所述的用途,其中上述喷雾特点还包括散粒重量为90-110mg。
11.如权利要求8所述的用途,其中D10是18-25μm,D50是39-53μm,D90是83-128μm,跨度是1.6-2.1,并且<10μm的体积百分数是0.8-2.4%。
12.如权利要求8所述的用途,其中:
上述液滴大小分布具有D10为18-25μm,D50为39-53μm,D90为83-128μm,跨度为1.6-2.1,并且<10μm的体积百分数为0.8-2.4%;
上述制剂包括0.6%的奥洛他定;并且
上述喷雾特点还包括散粒重量为90-110mg。
13.奥洛他定在制备用于治疗鼻子的过敏或发炎状态的制剂中的用途,所述制剂被制备成通过喷雾器形成喷雾,其特征在于,
所述制剂中包括0.38-0.62%的奥洛他定,当将上述制剂的喷雾输送到患者的鼻子中时,所述喷雾具有喷雾特点,包括:
喷流型,所述喷流型具有最长的轴线为20-45mm,最短的轴线为14-20mm,并且椭圆度为1-1.8;以及
液滴大小分布,所述液滴大小分布具有D10为15-30μm,D50为30-60μm,D90为50-150μm,跨度为不大于3,并且<10μm的体积百分数为小于4%。
14.如权利要求13所述的用途,其中上述制剂包括0.6%的奥洛他定。
15.如权利要求13所述的用途,其中上述喷雾特点还包括散粒重量为90-110mg。
16.如权利要求13所述的用途,其中上述最长的轴线是23.5mm,上述最短的轴线是17.5mm,上述椭圆度是1-1.4,D10是18-25μm,D50是39-53μm,D90是83-128μm,跨度是1.6-2.1,<10μm的体积百分数是0.8-2.4%,上述制剂包括0.6%的奥洛他定,并且上述喷雾特点还包括散粒重量为90-110mg。
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US20140227326A1 (en) | 2014-08-14 |
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KR101158603B1 (ko) | 2012-07-09 |
US20170172974A1 (en) | 2017-06-22 |
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US20060110328A1 (en) | 2006-05-25 |
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ES2331619T3 (es) | 2010-01-11 |
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AU2005309951B2 (en) | 2011-07-07 |
CA2586553A1 (en) | 2006-06-01 |
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