CN1148177C - 含氟比洛芬的药物组合物 - Google Patents

含氟比洛芬的药物组合物 Download PDF

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CN1148177C
CN1148177C CNB96199729XA CN96199729A CN1148177C CN 1148177 C CN1148177 C CN 1148177C CN B96199729X A CNB96199729X A CN B96199729XA CN 96199729 A CN96199729 A CN 96199729A CN 1148177 C CN1148177 C CN 1148177C
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flurbiprofen
lozenge
patient
solid dosage
oral cavity
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CN1207677A (zh
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D·M·巴雷特
ʷ
C·S·史密斯
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D·M·图尔古德
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Reckitt Benckiser Healthcare UK Ltd
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Boots Co PLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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]

Abstract

本发明涉及氟比洛芬在治疗咽喉疼痛中的应用，包括对需此治疗的患者施用可咀嚼或可吮吸的固体剂量形式或喷雾剂形式的、含有治疗有效量的氟比洛芬的药物组合物，所述组合物在口腔中释放氟比洛芬，以使氟比洛芬运送到疼痛的咽喉表面。

Description

含氟比洛芬的药物组合物
本发明涉及氟比洛芬的新医药用途。氟比洛芬[2-(2-氟-4-联苯基)丙]酸是一种熟知的非甾类抗炎药，它还具有镇痛和解热活性。氟比洛芬分子以两种对映体形式存在，本文采用的术语氟比洛芬包括其各种对映体和它们的任何比例的混合物，包括1∶1混合物，本文称之为外消旋氟比洛芬。氟比洛芬可以可药用药盐或衍生物如酯形式存在，本文采用的术语“氟比洛芬”包括这类盐和酯。
氟比洛芬和其S(+)对映体被建议用于治疗牙龈适应症。
EP 137668-A(Up john)描述了氟比洛芬用于防止或抑制牙槽骨吸收的应用。
EP 486561-A(Sepracor)描述了S(+)-氟比洛芬治疗牙周疾病和促进与该疾病有关的骨再生的用途。所述的牙周疾病包括牙周炎、牙龈炎和牙周变性。
这两篇文献具体描述了牙龈的治疗，但未涉及口腔的任何其它部位的治疗。
本发明的其中一个方面提供了一种药物组合物，该组合物的形式为可吮吸的固体剂量，该组合物含有2.5-20mg的氟比洛芬，氟比洛芬存在于锭剂基质中，该锭剂基质是通过冷却糖基或糖醇基的熔融基质而形成的，上述组合物的特征在于：当将所述剂量形式给药到有需要的病人的口腔中，并且所述剂量形式被吮吸时，所述固体剂量形式将治疗有效量的氟比洛芬释放到口腔中以将所述氟比洛芬运送到该病人的咽喉表面，从而治疗咽喉疼痛。
本发明的另一个方面涉及所述药物组合物在制造用于治疗咽喉疼痛的药物上的用途，当将所述药物给药到有需要的病人的口腔中时，该药物将治疗有效量的氟比洛芬释放到口腔中，从而将所述氟比洛芬运送到该病人的咽喉表面。
所述的固体剂量形式优选含有5-12.5mg的氟比洛芬。
固体剂量形式可以是锭剂。本文采用的术语“锭剂”包括所有通过冷却含活性成分的糖基或糖醇基(如山梨糖醇)的熔融基质形成的产品剂型。优选的固体剂量形式是通过冷却含糖、液体葡萄糖、氟比洛芬和其它赋形剂的热的锭剂基质形成固体锭剂而制成的锭剂。
已发现，治疗有效量为普通成人剂量的5％-40％，该剂量是指通过摄入获得全身性抗炎和/或镇痛作用的剂量。因此，氟比洛芬在药物组合物中的存在量可以为2.5-20mg，优选5-12.5mg。使用氟比洛芬的可药用盐时，使用的盐量应是能提供所需量氟比洛芬的量。适合的盐包括氟比洛芬的碱金属盐如钠盐或氨基酸盐如赖氨酸、精氨酸或葡甲胺盐。
预期氟比洛芬会与其它非甾类抗炎药一样，留在口中时会在口后部产生令人不快的灼烧感。显然，这是患者所不能接受的。本申请人出人意料地发现当使用本发明的组合物治疗咽喉疼痛时患者并未经历无法接受的灼烧感，而是确实感到了咽喉疼痛症状的缓解。
固体剂型可采用本领域生产锭剂的熟知方法制备，这类制剂中可含有已知的其它成分，如酸性调节剂、遮光剂、稳定剂、缓冲剂、芳香剂、甜味剂、着色剂和防腐剂。例如，优选的本发明固体制剂可通过在真空下加热锭剂基质(如糖和液体葡萄糖的混合物)除去过量水份，然后将剩余的成分混入该混合物中制备成锭剂。再将所得混合物抽制为长柱状物，由此形成单个锭剂。然后将锭剂冷却，随后用肉眼检查并进行适当包装。一种适当的包装形式是由金属如铝箔密封的防水塑料材料(聚氯乙烯)泡罩包装。患者通过对泡罩加压使锭剂将金属箔封压破并由此取出锭剂。锭剂通常为患者吮吸而释放氟比洛芬。
用于本发明的优选制剂的形式是可为患者吮吸的并且可缓慢释放氟比洛芬的组合物。氟比洛芬经过咽喉粘膜被部分吸收，提供局部缓解作用。未被吸收的氟比洛芬经患者消化吸收进入血流。除氟比洛芬对咽喉粘膜的局部应用产生的缓解作用外，经吸收的氟比洛芬还可全身性地发挥作用，提供镇痛、抗炎和解热活性。
本发明将通过仅以举例方式给出的下列实施例加以说明。
实施例1-4
制备含下列成分的锭剂，各成分量以就每个锭剂而言的毫克重量表示。
                         实施例1 实施例2 实施例3 实施例4
外消旋氟比洛芬           2.5     5       8.75    12.5
芳香剂(樱桃)             7.05    7.05    7.05    7.05
碳酸钙                   7.5     7.5     7.5     7.5
二氧化硅(Aerosil 300)    0.75    0.938   0.94    1.5
糖和液体葡萄糖的         至2350至2350至2350至2350
1∶1混合物固体
将糖和液体葡萄糖的混合物加热到140°并施加真空降低该混合物的水含量。在密封容器中加入芳香剂。将氟比洛芬、二氧化硅(助流剂)和碳酸钙混合，将该混合物加到剩余组分中。将所得混合物冷却形成长柱状物，由此形成各个锭剂。该各个锭剂经肉眼检查，然后包装。
发现所得锭剂对咽喉镇痛提供了令人愉快、稳定的和有效的治疗。
实施例5-7
以类似于上面实施例1-4描述的方式，制备含下列成分的锭剂，各成分的量以就每个锭剂而言的毫克重量表示。
                         实施例5  实施例6  实施例7
外消旋氟比洛芬           5        8.75     12.5
左旋薄荷醇               4        4        4
芳香剂(橙)               1.645    1.645    1.645
芳香剂(葡萄)             2.5      2.5      2.5
糖精钠                   2        2        2
碳酸钙                   7.5      7.5      7.5
二氧化硅(Aerosil 300)    0.94     1.22     1.5
糖和液体葡萄糖的         至2350   至2350   至2350
1∶1混合物固体
实施例8和9
以类似于上面实施例1-4描述的方式，制备含下列成分的锭剂，各成分的量以就每个锭剂而言的毫克重量表示。
                         实施例8    实施例9
外消旋氟比洛芬           5          12.5
左旋薄荷醇               1.551      1.551
芳香剂(橙)               1.645      1.645
薄荷油                   2          2
天冬酰苯丙氨酸甲酯       4          4
碳酸钙                   7.5        7.5
二氧化硅(Aerosil 300)    0.94       1.5
糖和液体葡萄糖的         至2350     至2350
1∶1混合物固体
实施例10和11
以类似于上面实施例1-4描述的方式，制备含下列成分的锭剂，各成分的量以就每个锭剂而言的毫克重量表示。
                         实施例10    实施例11
外消旋氟比洛芬           5           12.5
左旋薄荷醇               4           4
芳香剂(橙)               1.645       1.645
芳香剂(酸柚)             2.5         2.5
天冬酰苯丙氨酸甲酯       4           4
碳酸钙                   7.5         7.5
二氧化硅(Aerosil 300)    0.94        1.5
糖和液体葡萄糖的         至2350      至2350
1∶1混合物固体
实施例12和13
以类似于上面实施例1-4描述的方式，制备含下列成分的锭剂，各成分的量以就每个锭剂而言的毫克重量表示。
                         实施例12    实施例13
外消旋氟比洛芬           5           12.5
左旋薄荷醇               4           4
芳香剂(酸柚)             2.5         2.5
天冬酰苯丙氨酸甲酯       4           4
碳酸钙                   7.5         7.5
二氧化硅(Aerosil 300)    0.94        1.5
糖和液体葡萄糖的         至2350      至2350
1∶1混合物固体
经临床试验证实了疗效，在试验中，对咽喉疼痛患者施用实施例2、3和4之一描述的制剂或安慰剂。询问患者与咽喉疼痛有关的疼痛缓解、咽喉肿胀减轻和/或治疗后吞咽改善方面的因素，评价疗效。患者还经临床医师检查确定扁桃体咽炎(tonsillopharyngitis)的量。

Claims (4)

1.一种治疗咽喉疼痛的可吮吸的固体剂型，含有2.5-20mg的氟比洛芬，该氟比洛芬存在于锭剂基质中，是通过冷却糖基或糖醇基的熔融基质而形成的，从而当将所述剂型给药到有需要的病人的口腔中并且被吮吸时，所述固体剂型将治疗有效量的氟比洛芬释放到口腔中以将所述氟比洛芬运送到该病人的咽喉表面。
2.权利要求1的固体剂型，其含有5-12.5mg的氟比洛芬。
3.权利要求1的固体剂型在制造用于治疗咽喉疼痛的药物上的用途，当将所述药物给药到有需要的病人的口腔中时，该药物将治疗有效量的氟比洛芬释放到口腔中，从而将所述氟比洛芬运送到该病人的咽喉表面。
4.权利要求3的用途，其中所述的固体剂型含有5-12.5mg的氟比洛芬。
CNB96199729XA 1995-11-22 1996-11-21 含氟比洛芬的药物组合物 Expired - Lifetime CN1148177C (zh)

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SK66598A3 (en) 1998-12-02
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UA46807C2 (uk) 2002-06-17
EP0862424B1 (en) 2003-10-22
AU707749B2 (en) 1999-07-22
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NO982294D0 (no) 1998-05-20
CA2238271C (en) 2008-08-12
AU2611997A (en) 1997-06-11
GB9523833D0 (en) 1996-01-24
HU225235B1 (en) 2006-08-28
HUP0000180A2 (hu) 2000-08-28
CN1207677A (zh) 1999-02-10
ATE252382T1 (de) 2003-11-15
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US5889057A (en) 1999-03-30
US6166083A (en) 2000-12-26
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CZ289643B6 (cs) 2002-03-13
EP0862424A1 (en) 1998-09-09
NO982294L (no) 1998-07-20
BG102526A (en) 1999-02-26
SK284092B6 (sk) 2004-09-08
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PT862424E (pt) 2004-02-27

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