CN1297275C - 抗过敏剂和类固醇用于治疗过敏性鼻炎的用途 - Google Patents

抗过敏剂和类固醇用于治疗过敏性鼻炎的用途 Download PDF

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CN1297275C
CN1297275C CNB2003801029346A CN200380102934A CN1297275C CN 1297275 C CN1297275 C CN 1297275C CN B2003801029346 A CNB2003801029346 A CN B2003801029346A CN 200380102934 A CN200380102934 A CN 200380102934A CN 1297275 C CN1297275 C CN 1297275C
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G·D·卡格尔
G·M·沃尔
J·M·扬尼
R·贾尼
H·G·巴哈盖特
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Abstract

本发明披露了用于治疗鼻炎的含有某些抗过敏剂和类固醇组合的组合物和用其治疗鼻炎的方法。

Description

抗过敏剂和类固醇用于治疗过敏性鼻炎的用途
本发明涉及抗过敏剂和类固醇组合用于治疗鼻部病症、尤其是鼻炎的用途。
发明背景
过去一直用口服抗组胺药和/或口服类固醇的方案治疗过敏性鼻炎。全身性治疗通常要求所施用的药物化合物具有更高浓度以便使有效的浓度到达必要的治疗部位。已知抗组胺化合物具有中枢神经系统(CNS)活性，表现为嗜睡。它们还具有抗胆碱能活性，表现为粘膜发干。
鼻内组合治疗是已知的。例如，WO 97/01337披露了用于治疗鼻炎的局部鼻用抗组胺药和局部鼻用类固醇的组合。但是该专利没有披露本发明的抗过敏剂和类固醇组合的用途。WO 97/46243披露了含有类固醇和抗组胺药的鼻腔喷雾剂。但是该专利也没有披露本发明的组合。在美国境外有含类固醇和抗组胺药的鼻内产品上市销售，例如：Pharmacobel的Cortinasal，其含有安他心和氢化可的松；SmithKline Beecham的Rinosular，其含有苯海拉明和泼尼松龙；以及AlconCusi的Rinocusi，其含有苯海拉明和氢化可的松。
发明概述
本发明涉及用于治疗鼻炎的含有某些抗过敏剂和类固醇组合的鼻内组合物。所述的抗过敏剂选自依美司汀或奥洛他定。所述的类固醇选自氟地松、莫美达松、布地缩松或倍氯米松。本发明还涉及在哺乳动物中使用所述组合物的方法。
优选实施方案描述
本发明包括依美司汀或奥洛他定和所选择的类固醇的组合物，所述组合物用于治疗与过敏性鼻炎有关的喷嚏、鼻液溢、充血和瘙痒。
依美司汀和奥洛他定是已知的抗过敏化合物。依美司汀在美国专利No.4,430,343中有披露。奥洛他定在美国专利No.5,116,863中有披露；其用于治疗眼科过敏性病症的用途在美国专利No.5,641,805中有披露。本发明的组合物中抗过敏剂的浓度为0.01-0.8％(w/v)，优选地，奥洛他定的浓度为0.1-0.8％(w/v)，依美司汀的浓度为0.01-0.1％(w/v)。依美司汀优选以二富马酸依美司汀形式被加入本发明的组合物中。奥洛他定优选以盐酸奥洛他定形式被加入。
本发明的组合产品包含选自以下的类固醇：氟地松、莫美达松、布地缩松和倍氯米松。已知这些类固醇中的每一种均用于治疗鼻炎。本发明的组合物中类固醇的浓度为0.01-1.0％(w/v)，优选为0.02-0.5％(w/v)。优选地，氟地松以丙酸氟地松形式被加入本发明的组合物中，莫美达松以糠酸莫美达松一水合物形式被加入，倍氯米松以二丙酸倍氯米松形式被加入。在一个实施方案中，用已知技术调整类固醇的大小以便使其具有2.5-5μm的平均粒度。在另一个实施方案中，用已知的纳米化技术获得了平均粒度小于0.8μm、优选0.5μm或更小的类固醇颗粒。
本发明中的组合可被掺入多种用于向鼻递送的鼻内制剂中。例如，制剂可以采用被设计作为气雾剂、水性喷雾剂或滴剂施用的溶液或混悬液形式。优选地，制剂是被包装成鼻腔喷雾剂的水性组合物。给药方案可根据熟练临床医生的常规考虑来确定，但通常是将1至2喷的这些制剂递送至鼻孔，每天不超过两次，每喷递送25-100μL制剂。
除了抗过敏剂和类固醇之外，制剂还可以含有鼻用制剂领域中已知的赋形剂，包括抗微生物剂、抗氧化剂、增粘剂、张力调节剂、缓冲剂、增溶剂、表面活性剂等。例如，水性鼻内制剂可以含有防腐剂和防腐辅剂，如季铵类防腐剂例如苯扎氯铵和聚季铵盐-1(Polyquaternium-1)以及EDTA；粘度调节剂，如羟丙基甲基纤维素(HPMC)、聚乙烯吡咯烷酮和羧甲基纤维素；张力调节剂，如氯化钠、氯化钾、甘露醇、山梨醇和甘油；湿润剂/表面活性剂，如四丁酚醛或聚山梨酯80；以及pH调节剂，如NaOH或HCl。本发明的制剂中季铵类防腐剂的量通常为0.001-0.03％(w/v)。本发明的组合物优选被配制成具有约3.5-8.0的pH和1-50cps的粘度。
以下实施例是本发明的组合物的举例说明，但绝不限制本发明。
                    实施例1
  成分   ％(w/v)
  二富马酸依美司汀   0.05
  丙酸氟地松   0.05
  苯扎氯铵   0.001-0.03
  EDTA二钠   0.01
  氯化钠(调节张力至250-350mOsmols/kg)   0.1-0.8
  HPMC   0.1-0.5
  四丁酚醛   0.05
  氨基丁三醇   0.5
  NaOH和/或HCl   适量至pH 4-7.7
  纯化水   适量至100
                    实施例2
  成分   ％(w/v)
  奥洛他定   0.4-0.6
  丙酸氟地松   0.05
  苯扎氯铵   0.001-0.03
  聚维酮K-29/32   1.8
  EDTA二钠   0.01
  氯化钠(调节张力至250-350mOsmols/kg)   0.1-0.8
  四丁酚醛   0.05
  磷酸氢二钠   0.5
  NaOH和/或HCl   适量至pH 4-7.7
  纯化水   适量至100
                    实施例3
  成分   ％(w/v)
  奥洛他定   0.4-0.8
  丙酸氟地松   0.05
  苯扎氯铵   0.001-0.03
  磷酸氢二钠   0.5
  EDTA二钠   0.01
  氯化钠(调节张力至250-350mOsmols/kg)   0.6-0.8
  四丁酚醛   0.05
  NaOH和/或HCl   适量至pH 4-7.7
  纯化水   适量至100
                    实施例4
  成分   ％(w/v)
  奥洛他定   0.4-0.6
  丙酸氟地松   0.05
  聚季铵盐-1   0.001-0.03
  聚维酮K-29/32   1.8
  EDTA二钠   0.01
  甘露醇(调节张力至250-350mOsmols/kg)   0.5-5
  四丁酚醛   0.05
  硼酸   0.5
  NaOH和/或HCl   适量至pH 4-7.7
  纯化水   适量至100
                    实施例5
  成分   ％(w/v)
  奥洛他定   0.4-0.8
  丙酸氟地松   0.05
  聚季铵盐-1   0.001-0.03
  磷酸氢二钠   0.5
  EDTA二钠   0.01
  氯化钠(调节张力至250-350mOsmols/kg)   0.1-0.8
  硼酸   0.5
  四丁酚醛   0.05
  NaOH和/或HCl   适量至pH 4-7.7
  纯化水   适量至100
                                                             实施例6
                                               奥洛他定和类固醇的鼻腔喷雾制剂
  制剂  1  2  3   4  5  6  7  8  9  10
  成分                                                       ％(w/v)
  盐酸奥洛他定  0.665  0.665  0.665   0.665  0.665  0.665  0.665  0.665  0.665  0.665
  丙酸氟地松  0.05  0.05  0   0  0.05  0  0.05  0  0.05  0
  布地缩松  0  0  0.03   0.03  0  0.03  0  0.03  0  0.03
  聚维酮  1.8  0.5  1.8   0.5  0  0  1.0  1.0  0  0
  微晶纤维素  0  0  0   0  0.9  0.9  0  0  0.9  0.9
  羧甲基纤维素钠  0  0  0   0  0.1  0.1  0  0  0.1  0.1
  苯扎氯铵  0.001-0.03  0.001-0.03  0.001-0.03   0.001-0.03  0.001-0.03  0.001-0.03  0.001-0.03  0.001-0.03  0.001-0.03  0.001-0.03
  四丁酚醛  0  0  0   0  0  0  0.05  0.05  0.05  0.05
  聚山梨酯80  0.005  0.005  0.005   0.005  0.005  0.005  0  0  0  0
  磷酸氢二钠，无水  0.5  0.5  0.5   0.5  0.5  0.5  0.5  0.5  0.5  0.5
  氯化钠  适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg   适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg  适量至250-350mOsm/kg
  依地酸二钠  0.01  0.01  0.01   0.01  0.01  0.01  0.01  0.01  0.01  0.01
  NaOH/HCl  适量至pH4-7.7  适量至pH 4-7.7  适量至pH 4-7.7   适量至pH 4-7.7  适量至pH 4-7.7  适量至pH 4-7.7  适量至pH 4-7.7  适量至pH 4-7.7  适量至pH 4-7.7  适量至pH 4-7.7
  纯化水，适量至  100  100  100   100  100  100  100  100  100  100

Claims (7)

1.用于治疗哺乳动物过敏性鼻炎的鼻内组合物，其包含0.4-0.8％w/v奥洛他定和0.02-0.5％w/v类固醇，所述类固醇选自氟地松、莫美达松、布地缩松和倍氯米松，其中组合物具有3.5-8.0的pH值和1-50cps的粘度。
2.权利要求1中所述的组合物，其中类固醇是氟地松。
3.权利要求1中所述的组合物，其中类固醇具有2.5-5μm的平均粒度。
4.权利要求1中所述的组合物，其中类固醇具有小于0.8μm的平均粒度。
5.权利要求4中所述的组合物，其中类固醇具有0.5μm或更小的平均粒度。
6.权利要求1中所述的组合物，其中组合物是包装成鼻腔喷雾剂的水性组合物。
7.权利要求1至6中任一项所述的组合物在制备用于治疗哺乳动物过敏性鼻炎的药物中的用途。
CNB2003801029346A 2002-11-12 2003-11-12 抗过敏剂和类固醇用于治疗过敏性鼻炎的用途 Expired - Fee Related CN1297275C (zh)

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BR0316203A (pt) 2005-10-04
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AU2003291497A1 (en) 2004-06-03
AU2003291497B2 (en) 2007-12-20
CA2504200A1 (en) 2004-05-27
US20040097474A1 (en) 2004-05-20
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PL376970A1 (pl) 2006-01-23

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