JP4976139B2 - 処置方法 - Google Patents
処置方法 Download PDFInfo
- Publication number
- JP4976139B2 JP4976139B2 JP2006551345A JP2006551345A JP4976139B2 JP 4976139 B2 JP4976139 B2 JP 4976139B2 JP 2006551345 A JP2006551345 A JP 2006551345A JP 2006551345 A JP2006551345 A JP 2006551345A JP 4976139 B2 JP4976139 B2 JP 4976139B2
- Authority
- JP
- Japan
- Prior art keywords
- mometasone
- day
- mometasone furoate
- composition
- amount
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0043—Nose
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
-
- 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
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Adhesives Or Adhesive Processes (AREA)
Description
事実上すべての人々は、時折、急性上気道感染、鼻の急性または慢性アレルギー発症、および/または急性または慢性の非アレルギー性鼻副鼻腔炎に襲われる。このような症状を罹患した人々によって、通常、顕著な不快および不自由が被られる。これらの疾患のすべては、鼻粘膜の強い炎症によって特徴付けられる。一般に風邪またはその他の副鼻腔炎症状をともなう不快および不自由に少なくとも一部寄与する多くの症状としては、しばしば、以下の1つ以上が挙げられる:鼻づまり、後部鼻汁、臭覚減少、耳つまり(ear fullness)、頭痛、咽頭炎、倦怠感、筋肉および関節の痛み、疲労、咳、胸部鬱血、熱、悪寒および消化管疾患。
Nayakら、Ann.All.Asthma Immunol.2002 9月:89(3):271〜8 Charousら、J.All.Clin.Immunology、(2000)、(105)S210
従って、抗生物質を同時投与せずに、鼻副鼻腔炎に罹患した患者における上部気道の急性鼻副鼻腔炎を処置する方法が開示され、この方法は、患者の上記通路の表面に、少なくとも一日一回、この疾患を処置するために有効な量のフランカルボン酸モメタゾンのエアロゾル化粒子を投与する工程を包含する。
フランカルボン酸モメタゾンは、コルチコステロイド応答性の皮膚疾患の炎症性および/またはかゆみ性症状を処置するための局所的皮膚科使用のために認可されたコルチコステロイドである。この化合物は、米国特許第4,472,393号、同第4,731,447号、同第4,873,335号、同第5,837,699号および同第6,127
353号に開示される手順に従って調製され得、これらはすべて、本明細書によって、それらの全体が参考として援用される。モメタゾンは、容易に生体利用可能でない局所的に活性なステロイドであり、より全身的に生体利用可能であるその他の局所的に活性であるコルチコステロイドに対し治療的利点を提供し、そしてそれはまた、例えば、溶液、錠剤またはカプセルの経口嚥下によって経口的に投与される任意のコルチコステロイドより優れている。それは、Nasonex(登録商標)の名の下、鼻内投与のためのスプレーとして市販される。気道および肺疾患の処置のためのモメタゾンの使用は、米国特許第6,677,323号、同第6,677,322号、同第6,365,581号、同第6,187,765号、同第6,068,832号、同第6,057,307号、同第5,889,015号、同第5,837,699号、および同第5,474,759号に開示され、これらのすべては、それらの全体が参考として援用される。
4つの平行する群で、フェーズ2、投薬量範囲、二重盲検、二重ダミー、ランダム化、複数中心、多国籍研究を実施した。3つの処置レジメンが存在した:フランカルボン酸モメタゾン鼻内スプレー200μgを一日1回投与;フランカルボン酸モメタゾン鼻内スプレー200μgをまた一日2回投与;アモキシリン500mgを一日3回投与。3つすべてを、偽薬に対して投与した。これらのレジメンは、年齢12才またはそれ以上の、7日以上および28日以下で存在する症状を有すると臨床的に診断された急性鼻副鼻腔炎の被験体に投与された。5以上そして12以下の主要症状スコア(症状の合計−顔の痛み、鼻漏、後部鼻汁、鼻風邪にともなう頭痛、鼻鬱血−各々は0−なし〜3−重篤でスコアされた)の被験体を、重篤とスコアされた3以下の症状ベースラインで含めた。101゜F/38.3℃以上の熱、持続する重篤な片側顔面痛/歯痛、眼窩または眼窩周囲顔面の腫れ、歯痛併発の存在について疑われる細菌性鼻副鼻腔炎;および/または初期改善の後、悪化する症状をもつ被験体を、この研究から排除した。
Claims (12)
- 上部気道通路の急性鼻副鼻腔炎を罹患した患者において、抗生物質の併用投与なくして該疾患を処置するための組成物であって、該組成物は、該患者の該通路の表面に、少なくとも一日1回投与され、該組成物は、該疾患を処置するために有効な量のフランカルボン酸モメタゾンのエアロゾル化粒子を含む、組成物。
- 前記フランカルボン酸モメタゾンの量が、25μg〜1600μgの範囲であり、該フランカルボン酸モメタゾンはエアロゾル化粒子の形態である、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンの量が、25μg〜800μgの範囲である、請求項2に記載の組成物。
- 前記フランカルボン酸モメタゾンの量が、25μg〜400μgの範囲である、請求項3に記載の組成物。
- 前記フランカルボン酸モメタゾンの量が、25μg〜200μgの範囲である、請求項4に記載の組成物。
- 前記フランカルボン酸モメタゾンの量が、25μg〜100μgの範囲である、請求項5に記載の組成物。
- 前記フランカルボン酸モメタゾンの量が、100μg、200μgまたは400μgである、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンが、一日2回投与される、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンが、フランカルボン酸モメタゾン一水和物である、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンが、水性懸濁物の形態である、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンが、乾燥粉末の形態である、請求項1に記載の組成物。
- 前記フランカルボン酸モメタゾンが、無水物である、請求項11に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US53783004P | 2004-01-21 | 2004-01-21 | |
US60/537,830 | 2004-01-21 | ||
PCT/US2005/002105 WO2005072704A2 (en) | 2004-01-21 | 2005-01-19 | Method of treating acute rhinosinusitis |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008016970A Division JP2008110991A (ja) | 2004-01-21 | 2008-01-28 | 処置方法 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2007518817A JP2007518817A (ja) | 2007-07-12 |
JP2007518817A5 JP2007518817A5 (ja) | 2008-03-13 |
JP4976139B2 true JP4976139B2 (ja) | 2012-07-18 |
Family
ID=34825945
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006551345A Expired - Fee Related JP4976139B2 (ja) | 2004-01-21 | 2005-01-19 | 処置方法 |
JP2008016970A Pending JP2008110991A (ja) | 2004-01-21 | 2008-01-28 | 処置方法 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008016970A Pending JP2008110991A (ja) | 2004-01-21 | 2008-01-28 | 処置方法 |
Country Status (16)
Country | Link |
---|---|
US (2) | US20050186144A1 (ja) |
EP (2) | EP2201936B1 (ja) |
JP (2) | JP4976139B2 (ja) |
AT (1) | ATE461693T1 (ja) |
CA (1) | CA2554064A1 (ja) |
CY (1) | CY1110620T1 (ja) |
DE (1) | DE602005020113D1 (ja) |
DK (1) | DK1711164T3 (ja) |
ES (2) | ES2426957T3 (ja) |
HR (1) | HRP20100208T8 (ja) |
MX (1) | MXPA06008240A (ja) |
PL (1) | PL1711164T3 (ja) |
PT (1) | PT1711164E (ja) |
RS (1) | RS51335B (ja) |
SI (1) | SI1711164T1 (ja) |
WO (1) | WO2005072704A2 (ja) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PL1711164T3 (pl) * | 2004-01-21 | 2010-09-30 | Merck Sharp & Dohme | Sposób leczenia ostrego zapalenia zatok przynosowych |
AU2007311607A1 (en) * | 2006-10-19 | 2008-04-24 | Cipla Limited | Pharmaceutical compositions and nasal spray incorporating anhydrous mometasone furoate |
TWI411121B (zh) * | 2010-03-11 | 2013-10-01 | Ind Tech Res Inst | 光吸收層之製造方法及應用其之太陽能電池結構 |
EP3789022A1 (en) * | 2012-12-27 | 2021-03-10 | Massachusetts Eye & Ear Infirmary | Treatment of rhinosinusitis with p-glycoprotein inhibitors |
US11408900B2 (en) | 2016-01-15 | 2022-08-09 | Massachusetts Eye And Ear Infirmary | Secreted P-glycoprotein is a non-invasive biomarker of chronic rhinosinusitis |
CN116209449A (zh) * | 2020-06-21 | 2023-06-02 | 麻省眼耳科医院 | 用于慢性鼻窦炎治疗的维拉帕米和莫米松联合疗法 |
JP2024049405A (ja) * | 2021-02-22 | 2024-04-10 | 興和株式会社 | 新規吸入剤 |
Family Cites Families (25)
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CY1359A (en) | 1981-02-02 | 1987-08-07 | Schering Corp | Aromatic heterocyclic esters of steroids, their preparation and pharmaceutical compositions containing them |
US4731447A (en) | 1985-05-13 | 1988-03-15 | Schering Corporation | Process for preparing piperidylidene dihydro-dibenzo(a,d)-cycloheptenes or aza-derivatives thereof |
US4873335A (en) * | 1986-03-12 | 1989-10-10 | Schering Corporation | 3-phenethyl-2-benzene-amides or aza-derivatives thereof |
PT656207E (pt) | 1991-06-10 | 2001-11-30 | Schering Corp | Formulacoes de aerossois sem clorofluorocarbonetos |
DE69231991T2 (de) * | 1991-06-10 | 2002-04-04 | Schering Corp | Fluorchlorkohlenwasserstofffreie Aerosolformulierungen |
US6127353A (en) * | 1991-09-06 | 2000-10-03 | Schering Corporation | Mometasone furoate monohydrate, process for making same and pharmaceutical compositions |
PE44995A1 (es) * | 1994-01-27 | 1995-12-18 | Schering Corp | Furoato de mometasona para el tratamiento de las enfermedades pulmonares y de las vias respiratorias |
US5837699A (en) * | 1994-01-27 | 1998-11-17 | Schering Corporation | Use of mometasone furoate for treating upper airway passage diseases |
US6068832A (en) | 1996-08-29 | 2000-05-30 | Schering Corporation | Chlorofluorocarbon-free mometasone furoate aerosol formulations |
US5837713A (en) * | 1997-02-26 | 1998-11-17 | Mayo Foundation For Medical Education And Research | Treatment of eosinophil-associated pathologies by administration of topical anesthetics and glucocorticoids |
US6503537B2 (en) * | 1997-03-20 | 2003-01-07 | Schering Corporation | Preparation of powder agglomerates |
US6495167B2 (en) * | 1997-03-20 | 2002-12-17 | Schering Corporation | Preparation of powder agglomerates |
US6187765B1 (en) | 1997-10-09 | 2001-02-13 | Schering Corporation | Mometasone furoate suspensions for nebulization |
US6297227B1 (en) * | 1998-09-10 | 2001-10-02 | Schering Corporation | Methods and compositions for treating sinusitis, otitis media and other related disorders using antihistamines |
SE9803770D0 (sv) * | 1998-11-05 | 1998-11-05 | Astra Ab | Dry powder pharmaceutical formulation |
US6465581B1 (en) * | 2001-01-24 | 2002-10-15 | The Goodyear Tire & Rubber Company | Silica reinforced rubber composition which contains stabilized unsymmetrical coupling agents and article of manufacture, including a tire, having at least one component comprised of such rubber composition |
AR036358A1 (es) * | 2001-08-28 | 2004-09-01 | Schering Corp | Un inhalador de dosis medidas que contiene una formulacion de suspension en aerosol para inhalacion, un proceso para la produccion de la formulacion, el producto y el uso de una formulacion para la manufactura de un medicamento de asma |
AU2003259986A1 (en) * | 2002-08-23 | 2004-03-11 | Schering Corporation | Pharmaceutical compositions |
US20040081625A1 (en) * | 2002-10-21 | 2004-04-29 | Schering Corporation | Nasal formulations for the treatment of allergies |
US8912174B2 (en) * | 2003-04-16 | 2014-12-16 | Mylan Pharmaceuticals Inc. | Formulations and methods for treating rhinosinusitis |
US20040235807A1 (en) * | 2003-05-21 | 2004-11-25 | Weinrich Karl P. | Formulations including a topical decongestant and a topical corticosteroid suitable for nasal administration and method for treating obstructive sleep apnea |
JP2007509147A (ja) * | 2003-10-20 | 2007-04-12 | シェーリング コーポレイション | 薬学的エアロゾル組成物 |
PL1711164T3 (pl) * | 2004-01-21 | 2010-09-30 | Merck Sharp & Dohme | Sposób leczenia ostrego zapalenia zatok przynosowych |
EP2651494B1 (en) | 2010-12-13 | 2017-02-15 | Pacesetter, Inc. | Delivery catheter |
US9106249B1 (en) | 2014-09-04 | 2015-08-11 | Semtech Corporation | Calibration of a time-interleaved analog-to-digital converter |
-
2005
- 2005-01-19 PL PL05711867T patent/PL1711164T3/pl unknown
- 2005-01-19 DE DE602005020113T patent/DE602005020113D1/de active Active
- 2005-01-19 EP EP10003076.6A patent/EP2201936B1/en not_active Revoked
- 2005-01-19 SI SI200531000T patent/SI1711164T1/sl unknown
- 2005-01-19 WO PCT/US2005/002105 patent/WO2005072704A2/en active Application Filing
- 2005-01-19 ES ES10003076T patent/ES2426957T3/es active Active
- 2005-01-19 PT PT05711867T patent/PT1711164E/pt unknown
- 2005-01-19 CA CA002554064A patent/CA2554064A1/en not_active Abandoned
- 2005-01-19 JP JP2006551345A patent/JP4976139B2/ja not_active Expired - Fee Related
- 2005-01-19 ES ES05711867T patent/ES2340777T3/es active Active
- 2005-01-19 EP EP05711867A patent/EP1711164B1/en active Active
- 2005-01-19 DK DK05711867.1T patent/DK1711164T3/da active
- 2005-01-19 US US11/038,343 patent/US20050186144A1/en not_active Abandoned
- 2005-01-19 MX MXPA06008240A patent/MXPA06008240A/es active IP Right Grant
- 2005-01-19 AT AT05711867T patent/ATE461693T1/de active
- 2005-01-19 RS RSP-2010/0236A patent/RS51335B/en unknown
-
2008
- 2008-01-28 JP JP2008016970A patent/JP2008110991A/ja active Pending
- 2008-07-11 US US12/171,989 patent/US20090022671A1/en not_active Abandoned
-
2010
- 2010-04-13 HR HR20100208T patent/HRP20100208T8/xx unknown
- 2010-04-28 CY CY20101100378T patent/CY1110620T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
EP1711164B1 (en) | 2010-03-24 |
JP2007518817A (ja) | 2007-07-12 |
HRP20100208T8 (en) | 2010-06-30 |
SI1711164T1 (sl) | 2010-06-30 |
EP1711164A2 (en) | 2006-10-18 |
EP2201936B1 (en) | 2013-06-19 |
DK1711164T3 (da) | 2010-07-19 |
JP2008110991A (ja) | 2008-05-15 |
MXPA06008240A (es) | 2006-08-31 |
CY1110620T1 (el) | 2015-04-29 |
US20090022671A1 (en) | 2009-01-22 |
ES2426957T3 (es) | 2013-10-28 |
EP2201936A1 (en) | 2010-06-30 |
WO2005072704A3 (en) | 2006-07-20 |
PL1711164T3 (pl) | 2010-09-30 |
ATE461693T1 (de) | 2010-04-15 |
US20050186144A1 (en) | 2005-08-25 |
HRP20100208T1 (hr) | 2010-05-31 |
CA2554064A1 (en) | 2005-08-11 |
WO2005072704A2 (en) | 2005-08-11 |
DE602005020113D1 (de) | 2010-05-06 |
RS51335B (en) | 2011-02-28 |
ES2340777T3 (es) | 2010-06-09 |
PT1711164E (pt) | 2010-06-28 |
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