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CN100486643C - 包括非甾体抗炎药,并且具有良好可口性的药物口服剂型 - Google Patents

包括非甾体抗炎药,并且具有良好可口性的药物口服剂型 Download PDF

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CN100486643C
CN100486643C CNB2004800378753A CN200480037875A CN100486643C CN 100486643 C CN100486643 C CN 100486643C CN B2004800378753 A CNB2004800378753 A CN B2004800378753A CN 200480037875 A CN200480037875 A CN 200480037875A CN 100486643 C CN100486643 C CN 100486643C
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dosage form
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nsaid
steroidal anti
inflammatory drug
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CN1893922A (zh
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L·马尔基托
F·马里奥蒂
L·拉尼
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones

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Abstract

口服药物剂型，包括氨丁三醇和选自包括布洛芬、萘普生和氟比洛芬的组的NSAID，特征在于它还包括选自包括甘氨酸、维生素B6和其混合物的组的化合物。

Description

包括非甾体抗炎药，并且具有良好可口性的药物口服剂型
本发明涉及包括非甾体抗炎药(NSAID)，并且具有良好可口性的药物口服剂型。
更特别地，本发明涉及口服剂型，包括
-选自包括布洛芬、萘普生和氟比洛芬的组的NSAID
-氨丁三醇，和
-选自包括甘氨酸、维生素B6、及其混合物的组的化合物。
在本说明书及权利要求中，术语“NSAID”和“非甾体抗炎药”指为消旋物混合物形式的或精制的或富集的对映异构体形式的布洛芬、萘普生以及氟比洛芬及药学上可接受的盐。
众所周知许多非甾体抗炎药(NSAIDs)例如布洛芬对口腔，咽喉和喉咽部具有“chemesthetic作用”(刺激作用)(Breslin等人.“ibuprofen as a chemesthetic stimulus：evidence of a novelmechanism of throat irritation”，Chem.Sens.26：55-65，2001)。
这使得用于口服使用的包含布洛芬，萘普生，氟比洛芬或其对映异构体和/或盐的药物剂型，例如，当此类药物剂型是部分吞服或咀嚼的片剂，或口溶(orosoluble)片，施用前混悬或溶解的颗粒和粉末，漱口剂，喷雾剂，止咳滴剂，锭剂，糖浆剂，滴剂，口服凝胶等时具有刺激性和使人不愉快。
在本说明书和权利要求中，术语“口服使用”包括全身性口服施用和局部性口服施用，术语“口服形式”指用于口服使用的药物剂型。
迄今为止已经进行了许多研究以提高患者对基于布洛芬、萘普生和氟比洛芬的口服形式的耐受性。
然而，还发现所发现的能够减少对口腔、咽喉和喉咽部刺激性刺激的成分会使口服形式具有味觉特性，例如苦味、盐味和碱味，这导致其不被接受。
因此，仍然非常需要不但能够消除咽喉-刺激性刺激，而且能使其具有可接受的味觉，也就是良好可口性的基于布洛芬、萘普生或氟比洛芬的口服形式。
现在令人惊讶地发现当将选自包括甘氨酸、维生素B6和其混合物的组的化合物加到包括氨丁三醇和选自包括布洛芬、萘普生和氟比洛芬的组的NSAID的口服形式中时可实现该目标。
因此，在第一方面本发明涉及包括氨丁三醇和选自包括布洛芬、萘普生和氟比洛芬的组的NSAID的口服形式，特征在于它还包括选自包括甘氨酸、维生素B6和其混合物的组的化合物。
优选地，相对于每1重量份的NSAID，氨丁三醇的量的范围为0.2至50重量份。更优选地，相对于每1重量份的NSAID，氨丁三醇的量的范围为1.4至2.5重量份，甚至更优选为1.4至2.2重量份。
优选地，相对于每1重量份的NSAID，甘氨酸的量的范围为0.01至20重量份。更优选地，相对于每1重量份的NSAID，甘氨酸的量的范围为0.0125至10重量份。
依次，相对于每1重量份的NSAID，维生素B6的量的范围为0.01至20份，更优选地为0.0125至10重量份。
通过下文所描述的比较试验在人体内对本发明口服形式的耐受性和可口性进行了研究。
以下实例旨在进一步阐述本发明，而不是以任何方式限制本发明。
比较实施例1
溶液A
 
组分 数量(g)
布洛芬钠 0.400
软化水 适量100ml
pH7.0-7.5
比较实施例2
溶液B
 
组分 数量(g)
氟比洛芬钠 0.250
软化水 适量100ml
pH7.0-7.5
比较实施例3
溶液C
 
组分 数量(g)
萘普生钠 0.220
软化水 适量100ml
比较实施例4
溶液D
 
组分 数量(g)
布洛芬钠 0.400
氨丁三醇 0.600
软化水 适量100ml
比较实施例5
溶液E
 
组分 数量(g)
氟比洛芬钠 0.250
氨丁三醇 0.500
软化水 适量100ml
比较实施例6
溶液F
 
组分 数量(g)
萘普生钠 0.220
氨丁三醇 0.400
软化水 适量100ml
发明实施例1
溶液G
 
组分 数量(g)
布洛芬 0.400
氨丁三醇 0.600
甘氨酸 0.200
软化水 适量100ml
发明实施例2
溶液H
 
组分 数量(g)
氟比洛芬 0.250
氨丁三醇 0.500
甘氨酸 0.010
软化水 适量100ml
发明实施例3
溶液I
 
组分 数量(g)
萘普生钠 0.220
氨丁三醇 0.400
甘氨酸 0.145
软化水 适量100ml
发明实施例4
水溶性颗粒(L)
 
组分 数量(g)
布洛芬80BP 0.400
糖精钠 0.030
氨丁三醇 0.600
柠檬调味剂Givaudan96833-51 0.100
丁磺氨K 0.030
维生素B6 0.150
压片用糖 3.000
蔗糖单棕榈酸酯 0.020
发明实施例5
口腔喷雾剂(M)
 
组分 数量(g)
氟比洛芬 0.250
甘油FU IX 10.000
95°乙醇 10.000
山梨醇70 7.000
糖精钠 0.150
氨丁三醇 0.500
苯甲酸钠 0.150
吐温20 1.000
Mint cool flavor 0.195
Blu patent 0.0006
甘氨酸 0.010
软化水 qs100ml
发明实施例6
水溶性颗粒(N)
 
组分 数量(g)
萘普生钠 0.220
糖精钠 0.032
Peppermint flavoringGivaudan           0.093
丁磺氨K 0.030
麦芽糖醇 1.500
甘氨酸 0.145
蔗糖 1.500
氨丁三醇 0.400
可口性试验
由于NSAIDs导致的口腔粘膜刺激表现出极大的个体差异性，因此要适当选择适合于评价口服形式的可口性(掩味(taste masking))的小组人员。毫无疑问地，对于某些人来说刺激可以“忽略不计”，而其他人却描述为是“强烈的”或“非常强烈的”(Breslin等.“Ibuprofen as a chemesthetic stimulus：evidence of a novelmechanism of throat irritation”，Chem.Sens.26：55-65，2001).
因此在下文所公开的试验中选择被证明是对NSAIDs的刺激作用明显敏感的个体。
给40名20至40岁之间的人员施用溶液A至C，以如下所述的指征正确地定义感觉到的刺激性刺激：
 
刺激作用 描述
烧灼感 由擦破皮肤或暴露于高温，或暴露于酒精的刺激作用所引起的感觉。    
螫刺痛(stinging) 昆虫叮咬或荆棘引起的短暂感觉。
针刺痛(prickling) 与由小尖针的作用所引起的感觉相似的感觉                      
麻木 与麻醉剂作用开始时的感觉相似的弥散性感觉(不是没有感觉)      
另外，就以下操作程序对40名人员进行说明：
-如何根据前述表格所定义的术语来描述所感觉到的感觉，
-如何进行制剂的漱洗，吞咽和喷雾操作以及如何识别不含有效成分的制剂所引起的背景感觉。
当服用制剂时还要求40名人员遵循下文的标准程序：
-喝10ml的软化水，使其在口中保持10秒然后咽下，
-喝10ml的溶液，使其在口中保持10秒然后咽下。
接下来，要求40名人员对施用后0、30秒、1分钟和5分钟时的口腔刺激强度和感觉到的味觉进行评价，给那些将感觉描述为“强烈”的人员赋予3分，给那些将定义的感觉描述为“中度”的人员赋予2分，给那些将感觉描述为“轻徽”的人员赋予1分，给那些将制剂描述为没有感觉的人员赋予0分。
因此仅选择了得分超过40，并且因此对由NSAIDs所产生的令人不愉快的感觉具有更强的感觉敏感性的18名人员。
要求这18名人员评价溶液D至F以及颗粒L和N的水溶液和口服喷雾剂M的可口性。
所遵循的方法和赋予的分数如上文所述，除了在喷雾剂的情况下，患者在口中喷射两股(puffs)200μl，然后将喷射的喷雾剂咽下，而在颗粒的情况下，给每个患者施用溶解在100ml水中并搅拌30秒的囊剂内容物(平均重量＝4.33g)。
另外，由于要求这18名人员对施用后0时、30秒、1分钟、2分钟、3分钟、5分钟、10分钟和15分钟对口中的刺激强度和感觉到的味觉进行评价，因此评价时间更长。
分别计算每名人员烧灼感、螫刺痛、针刺痛和麻木等的评价值的总和(0-15分钟)，连同所有感觉的评价值(0-15分钟)的总和。通过Wilcoxon“符号秩”方法比较包含相同活性成分的溶液和口服形式。最后得分如下表所示。
表
 
组合物 活性成分 分数
溶液A 布洛芬 21
溶液D “ 16
溶液G “ 11
颗粒L “ 8
溶液B 氟比洛芬 15
溶液E “ 12
溶液H “ 9
口服喷雾剂M “ 6
溶液C 萘普生 20
溶液F “ 17
溶液I “ 10
颗粒N “ 7
包含布洛芬的组合物的评价值表明与比较溶液A和D相比，本发明的溶液G和颗粒L的溶液的刺激性和使人不愉快的感觉更小，并且具有更好的可口性。不仅所考虑的各单独的感觉的评价值是这样，而且所得到的所有感觉的评价值的总和也是这样。
包含氟比洛芬的组合物的评价值表明与比较溶液B和E相比，本发明的溶液H和口服喷雾剂M的刺激性和使人不愉快的感觉更小，并且具有更好的可口性，不仅所考虑的各单独的感觉的评价值是这样，而且所得到的所有感觉的评价值的总和也是这样。
包含萘普生的组合物的评价值表明与比较溶液C和F相比，本发明的溶液I和颗粒N的溶液的刺激性和使人不愉快的感觉更小，并且具有更好的可口性，不仅所考虑的各单独的感觉的评价值是这样，而且所得到的所有感觉的评价值的总和也是这样。

Claims (4)

1、药物口服剂型，包括氨丁三醇和选自由布洛芬、萘普生和氟比洛芬组成的组的非甾体抗炎药，特征在于相对于每1重量份的非甾体抗炎药，其包括1.4至2.5重量份的氨丁三醇；且相对于每1重量份的非甾体抗炎药，其还包括0.0125至10重量份的选自由甘氨酸、维生素B6和其混合物组成的组的化合物。
2、根据权利要求1的药物口服剂型，特征在于相对于每1重量份的非甾体抗炎药，其包括1.4至2.2重量份的氨丁三醇。
3、根据权利要求1或2的药物口服剂型，特征在于其为水溶性颗粒。
4、根据权利要求1或2的药物口服剂型，特征在于其为喷雾剂。
CNB2004800378753A 2003-12-19 2004-12-16 包括非甾体抗炎药,并且具有良好可口性的药物口服剂型 Expired - Fee Related CN100486643C (zh)

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