CN1224610A - 布洛芬组合物 - Google Patents

布洛芬组合物 Download PDF

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CN1224610A
CN1224610A CN98126749A CN98126749A CN1224610A CN 1224610 A CN1224610 A CN 1224610A CN 98126749 A CN98126749 A CN 98126749A CN 98126749 A CN98126749 A CN 98126749A CN 1224610 A CN1224610 A CN 1224610A
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F·J·布尼克
林峰
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Johnson and Johnson Consumer Inc
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Abstract

以足以减少通常与丙酸衍生物有关的烧灼感余味的量加入富马酸。

Description

布洛芬组合物
本发明涉及布洛芬组合物，更具体地讲涉及减少烧灼特性的布洛芬组合物。
人们向药物中加入多种矫味剂和甜味剂，以便使其更适口并掩蔽许多药物中常有的烧灼感。尽管人们为发现更有效的减少这种烧灼感的方法付出了大量的努力，但是仍然需要有效减少药物的烧灼感的方法，优选可以将烧灼感降低至这样一个水平，以可以提供可咀嚼的组合物。
布洛芬是熟知的在摄入后，在口和咽喉中具有味道差的烧灼感的药物。
日本专利申请9(1997)-2949(转让给Amencan Home Products)通过仅仅提供一种对映体以试图消除令人不快的余味。该专利申请公开从其外消旋的混合物中分离布洛芬，以形成仅仅含有S(+)-布洛芬而基本上不含有R(-)-布洛芬的口服药物组合物。尽管该途径可以提供更适口形式的布洛芬，但是所述对映体的分离和纯化是很困难的。
美国专利4762702公开用水胶体和富马酸包衣物包封的布洛芬颗粒。优选的水胶体组合物含有黄原胶和/或麦芽糖糊精。得到的产物为真空干燥的泡腾混合物。该专利公开的此方法由于在富马酸存在下用水胶体包封布洛芬颗粒，因此克服了先有技术制剂的缺点。
尽管有上述专利和申请的公开内容，但是一种更简单、费用更低廉的方法可以提供掩蔽味道的布洛芬组合物。
本发明提供丙酸衍生物及为该丙酸衍生物量的约50-约150％量的富马酸。本发明提供在不存在水胶体试剂时足以减少丙酸的烧灼感余味的富马酸。在优选的实施方案中，所述丙酸衍生物-富马酸组合物是以可咀嚼形式提供的。
本发明也提供通过提供有效量的富马酸抑制丙酸衍生物烧灼感余味的方法。
丙酸衍生物是一类熟知的镇痛化合物。如在此所用，可以理解丙酸衍生物包括(但不限于)布洛芬、萘普生、苯噁丙酸、萘普生钠、氟苯布洛芬、苯氧苯丙酸、fenbuprofen、苯酮苯丙酸、茚酮苯丙酸、吡丙吩、卡布洛芬、oxaprofen、双吡苯丙酸、microprofen、苯噁硫丙酸、suproprofen、烯氨苯丙酸、苯噻丙酸、氟联苯丙酸和氯环己苯酰丙酸。其结构式在美国专利4923898中提出，在此引入作参考。如在此所定义的丙酸衍生物定义为具有游离的-CH(CH3)COOH或-CH2CH2COOH或药学上可接受的盐基团例如-CH(CH3)COO-Na+或CH2CH2COONa+(一般直接或通过羰基官能度连接于芳环体系)的药学上可接受的镇痛/非甾体抗炎药物。
在此所用的乙酸衍生物包括(但不限于)消炎痛、舒林酸、甲苯酰吡酸、双氯酚酸钠、二氯苯氧苯乙酸、alsoclofenac、异丁苯乙酸、氧乙酸、乙氧茚乙酸、噻庚乙酸、叠氮吲酸、acemmetacm、双苯噻酸、环氯茚酸和噁庚乙酸。包括在本发明范围内具有类似镇痛和抗炎性质的结构相关的乙酸衍生物包括甲苯酰吡酸、舒林酸、消炎痛、双氯酚酸钠、阿氯芬酸、氯苯噻唑乙酸和异丁苯乙酸。
丙酸衍生物每天给药的量一般为约50-约2000mg，优选约100-1600mg，更优选约200-约1200mg。
布洛芬为广泛使用、熟知的非甾体抗炎的已知丙酸衍生物。布洛芬的化学名称为2-(4-异丁基苯基)丙酸。如在此所用，布洛芬可以理解为包括2-(4-异丁基苯基)丙酸以及其药学上可接受的盐。适当的布洛芬盐包括精氨酸盐、赖氨酸盐、hystadine盐以及美国专利4279926、4873231、5424075、5510385(在此引入其内容作参考)中所述的其它的盐。
富马酸是广泛使用的药学上可接受的酸。存在的抑制丙酸衍生物烧灼感的富马酸的浓度根据所需减少烧灼感的量而变化。富马酸的量通常为丙酸衍生物剂量的约50-约150％(重量)。一般而言，富马酸的量为丙酸衍生物剂量的约60-约100％(重量)，最优选为丙酸衍生物剂量的约70-约90％(重量)。
与以前公开的内容相反，本发明不需要加入水胶体物质以使其更有效。本发明可以结合到下列实施方案中。
最简单和优选的实施方案为在基质中加入富马酸，即以混合物的形式自由和随意地提供富马酸。在该实施方案中，所述丙酸衍生物优选布洛芬和富马酸以在caplet、片剂或胶囊剂中的基质形式提供。
在本发明的另一个实施方案中，以颗粒形式提供布洛芬和富马酸。一般而言，这包括用本领域熟知的设备将丙酸衍生物、富马酸以及糖、粘合剂、水和其它成分一起混合。例如，美国专利5429825号公开旋转熔融(rotomelt)制粒的方法，在此引入其全部内容作参考。然后将该混合物干燥并研磨。接着将适当形式的研磨产物压成片剂。优选向所述混合物中加入崩解剂，以帮助活性成分释放给使用者。在其更优选的实施方案中，将丙酸和富马酸以可咀嚼片剂的形式提供给那些吞咽片剂困难的患者。
在本发明的另一个实施方案中，在存在非-水胶体粘合剂的情况下提供富马酸/丙酸。优选非-水胶体粘合剂为药学上可接受的蜡或脂肪。适当的蜡和脂肪包括一硬脂酸甘油酯、氢化的牛脂、十四烷醇、十四酸、十八醇、取代的一甘油酯、取代的二甘油酯、取代的三甘油酯、蜂蜡、巴西棕榈蜡、日本蜡乙酰化一甘油酯等。可以使用二种或多种非-胶体粘合剂的混合物。优选本发明非-胶体粘合剂的熔点为约30-约100℃，最优选约40-约85℃。
可以通过首先将蜡或脂肪融化，然后与布洛芬和富马酸的组合物混合制备所述非-水胶体粘合剂。接着将所述组合物研磨成适当大小，然后用本领域技术人员熟知的技术压制成片剂。
本发明的制剂也可以含有药学上可接受的赋形剂、填充剂、矫味剂、稀释剂、润滑剂、崩解剂、悬浮剂、稳定剂、粘合剂、着色剂、载体等。
例如适当的载体包括乳糖、淀粉、磷酸二钙(disclaim phosphate)、硫酸钙、高岭土、甘露醇和粉状蔗糖。一般粘合剂包括淀粉明胶、糖如葡萄糖、甘露醇、木糖醇、山梨醇、麦芽糖糊精、果糖、蔗糖、糖蜜、天然和合成树胶、羧甲基纤维素、甲基纤维素、聚乙烯吡咯烷酮、聚乙二醇、乙基纤维素和蜡。润滑剂包括硼酸、苯甲酸钠、乙酸钠、氯化钠、亮氨酸、聚乙二醇等。一般的崩解剂包括来自木头、玉米、马铃薯和大米的淀粉、甲基纤维素、硅酸镁、硅酸铝、蔗糖、葡萄糖、malodextrose、琼脂、benoite、藻酸、木产物、瓜尔胶、柠檬酸浆、十二烷基硫酸钠等。
本发明也可以以液体形式，如酏剂、悬浮剂或糖浆提供。用本领域已知的生产方法和药学上可接受的表面活性剂、分散剂和稀释剂可以制备液体制剂。本发明优选以caplet、胶囊剂和片剂形式提供，最优选以可咀嚼形式提供。
如在整个说明书中所用，烧灼感理解为指服用布洛芬时的余味，常常鉴定为金属样的、显著的感觉。该余味不同于苦味，因为加入甜味剂不能有效地减少余味。
或者，可以将所述布洛芬、富马酸组合物以适当的浓度加至饮料、食品和其它需要的可食用组合物中。也预期本发明的布洛芬/富马酸组合物也可以用作兽用。
不希望受缚于任何理论，向丙酸衍生物中加入富马酸可以通过酸化唾液以足以维持丙酸衍生物为质子化形式来减少余味烧灼感的特性。丙酸衍生物的质子化形式溶解性低，因此对于咽喉粘膜刺激性低。与其它的酸化剂不同，富马酸溶解很慢，因此在口中的酸味很小，但是却足以酸化咽喉。其它药学上可接受的酸如柠檬酸、苹果酸、酒石酸比富马酸更易溶解。这些酸和其它的酸在口中可以很快地产生不能接受的酸味。其溶出太快以致于在唾液充分酸化前已经觉察到酸味。
通过下列实施例说明本发明，但是不用于限制本发明。在这些实施例中，除另外指明外，可以理解所有的份数均指重量百分比。
实施例1
用70mg富马酸或不用富马酸制备含有100mg布洛芬的可咀嚼片剂。将不含富马酸的可咀嚼片剂用作对照。请由18个受试者组成的品尝组咀嚼两个对照片剂，并以1-9(最高水平)的等级记录咽喉的烧灼感。1小时后，咀嚼含有布洛芬/富马酸组合物的片剂，并请受试者用相同的1-9等级记录结果。
所述受试者记录的对照片剂为中等高度，在9个点等级中为7，而含有布洛芬/富马酸组合物的片剂等级为中等低度，在9个点等级中为3或4。
实施例2
发现下列制剂在去除烧灼感时有效：布洛芬100mg、着色剂1.76mg、微晶纤维素84mg、甜味剂11mg、第二种甜味剂4mg、矫味剂2mg、润滑剂6mg、赋形剂465mg、富马酸65mg。
实施例3
用两个受试者评价对100mg剂量的布洛芬有效的富马酸水平。用下列等级使受试者对布洛芬/富马酸组合物进行评定。烧灼感强度：极高：9；非常高：8；中高：7；微高6；不高不低：5；微低：4；中低：3；很低：2；极低：1；无苦味或烧灼感：0。将实验的平均结果报道如下：
30mg富马酸7
40mg富马酸6
50mg富马酸3
60mg富马酸1
该实施例证明每100mg布洛芬用50mg富马酸可有效减少布洛芬烧灼感的余味。

Claims (9)

1．口服给药的组合物，它在不存在水胶体下，包含镇痛有效量的丙酸和约50-约150％(重量)的富马酸。
2．权利要求1的组合物，其中所述丙酸为布洛芬。
3．权利要求1的组合物，其中富马酸/丙酸是以可咀嚼片剂的形式提供的。
4．权利要求2的组合物为可咀嚼片剂的形式。
5．权利要求1的组合物，其中布洛芬和富马酸以液体形式摄入。
6．减少丙酸组合物余味烧灼感的方法，该方法包括：
提供镇痛有效量的丙酸衍生物；
根据丙酸衍生物的重量混入约50-约150％(重量)的富马酸；
其中所述富马酸和丙酸衍生物在不存在水胶体下混合。
7．权利要求6的方法，其中所述丙酸衍生物为布洛芬。
8．权利要求6的方法，其中所述富马酸和丙酸衍生物在制粒过程中混合。
9．权利要求8的方法，其中所述制粒过程用非-水胶体粘合剂进行。
CN981267491A 1998-01-02 1998-12-31 布洛芬组合物 Expired - Fee Related CN1224610B (zh)

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US6627214B1 (en) 2003-09-30
ATE265850T1 (de) 2004-05-15
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US8025897B2 (en) 2011-09-27
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PL330634A1 (en) 1999-07-05
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EP0945132A2 (en) 1999-09-29
AR014230A1 (es) 2001-02-07
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