JP2000507614A - 偏頭痛の改良治療 - Google Patents
偏頭痛の改良治療Info
- Publication number
- JP2000507614A JP2000507614A JP10521927A JP52192798A JP2000507614A JP 2000507614 A JP2000507614 A JP 2000507614A JP 10521927 A JP10521927 A JP 10521927A JP 52192798 A JP52192798 A JP 52192798A JP 2000507614 A JP2000507614 A JP 2000507614A
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- metoclopramide
- naproxen
- coating
- migraine
- 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.)
- Granted
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Classifications
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/166—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
-
- 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
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Yarns And Mechanical Finishing Of Yarns Or Ropes (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ヒトにおける偏頭痛を治療するための非血管作用性の、超血管作用性症候 群(SVS)を最小にする投与形態であって、 (i)少なくとも局所的胃腸有効量の急速利用可能性メトクロプラミドと、 (ii)治療上有効量の少なくとも1種の長期作用性NSAID を含み、 (iii)その投与形態が共同作用性投与形態であり、 (iv)その投与形態が5HTアゴニスト血管作用剤を含まない、 投与形態。 2.投与形態が酸−塩基貯蔵安定的である請求項1記載の投与形態。 3.メトクロプラミドが少なくとも約5mg含まれる請求項1記載の投与形態 。 4.メトクロプラミドが約1〜約150ng/mlの最高血中濃度が確立され る量で含まれる請求項1記載の投与形態。 5.NSAIDが、フルルビプロフェン、ケトプロフェン、ナプロキセン、オ キサプロジン、エトドラク、インドメタシン、ケトロラク、ナブメタン、メフェ ナム酸、ピロキシカム、またはその医薬上許容される塩からなる群より選択され る請求項1記載の投与形態。 6.NSIADがナプロキセンまたはその医薬上許容される塩である請求項5 記載の投与形態。 7.ナプロキセンまたはその医薬上許容される塩がナプロキセンナトリウムで ある請求項6記載の投与形態。 8.ナプロキセンナトリウムが約100mg〜約1500mgの量で含まれる 請求項7記載の投与形態。 9.ナプロキセンナトリウムが約10〜約150mcg/血液1mlの最高血 中濃度が確立される量で含まれる請求項7記載の投与形態。 10.約200〜約600mgのナプロキセンナトリウムおよび約3〜約30 mgのメトクロプラミドを含む請求項7記載の投与形態。 11.ナプロキセンナトリウムが結晶形態にあり、さらに該結晶が賦形剤で被 覆されている請求項7記載の投与形態。 12.ヒトにおける偏頭痛を治療するための非血管作用性の、超血管作用性症 候群(SVS)を最小にする、酸−塩基貯蔵安定性の均一に被覆された単位投与 形態であって、 (i)少なくとも局所的胃腸有効量の急速利用可能性メトクロプラミドと、 (ii)治療上有効量の少なくとも1種の長期作用性NSAIDを含み、 (iii)その投与形態が共同作用性投与形態であり、 (iv)その投与形態が5HTアゴニスト血管作用剤を含まない、 単位投与形態。 13.(i)医薬上許容される充填剤、賦形剤、結合剤、崩壊剤および滑沢剤 のマトリックス全体に均一に分配させた顆粒形態のNSAIDを含有する第1層 と、それを覆う(ii)内側部分および外側部分を有し、その第2層の外側部分全 体に均一に分配させた結晶形態のメトクロプラミドを有する第2層とからなり、 その内側部分は第2層の外側部分と第1層の間に界面を構成し、(iii)その内 側部分は第2層の錠剤コーティング全体の約1%ないし約15%を構成する、 請求項12記載の投与形態。 14.第2層の外側部分が該外側部分の乾燥成分の少なくとも約20重量%の 量のタルクを含む請求項13記載の投与形態。 15.ヒトにおける、非血管作用性の、超血管作用症候群を最小にする偏頭痛 の治療法であって、少なくとも略有効な局所的な胃腸量のメトクトプラミドを投 与し、 さらには少なくとも1種の長期作用性NSAIDを治療上有効量にて一緒に投 与し、5HTアゴニスト血管作用性剤を投与しない、治療法。 16.メトクロプラミドの投与がNSAIDの投与と共同作用する請求項15 記載の方法。 17.メトロプラミドの投与が、少なくとも約5mgのメトクロプラミドを投 与することを含む請求項15記載の方法。 18.少なくとも略有効な局所的胃腸濃度にてメトクロプラミドを投与するこ とを含む請求項15記載の方法。 19.約1〜約150ng/mlの最高血中濃度が確立される濃度にてメトク ロプラミドを投与することを含む請求項15記載の方法。 20.NSAIDが、フルルビプロフェン、ケトプロフェン、ナプロキセン、 オキサプロジン、エトドラク、インドメタシン、ケトロラク、ナブメタン、メフ ェナム酸、ピロキシカム、またはその医薬上許容される塩からなる群より選択さ れる請求項15記載の方法。 21.NSAID塩がナプロキセンナトリウムである請求項20記載の方法。 22.ナプロキセンナトリウムを、約100mg〜約1500mgの量にて投 与することを含む請求項21記載の方法。 23.ナプロキセンナトリウムを約10〜約150mcg/血液1mlの最高 血中濃度を確立する濃度まで投与することを含む請求項21記載の方法。 24.約200〜約600mgのナプロキセンナトリウム、および約5〜約3 0mgのメトクロプラミドを投与することを含む請求項12記載の方法。 25.投与が経口的であって、メトクロプラミドが迅速に利用可能な形体で投 与される請求項20記載の方法。 26.対象の血中濃度を測定した場合に、投与後少なくとも約60分までに治 療上有効量のナプロキセンナトリウムに到達し、その濃度を投与後少なくとも約 8−12時間維持することを含む請求項21記載の方法。 27.酸−塩基貯蔵安定性の均一に被覆された単位投与形態であり、ヒトにお ける偏頭痛の治療のための、メトクロプラミドおよびNSAIDを含んでなる、 非血管作用性の、超血管作用性症候群を最小にする投与形態の製法であって、 (i)NSAID核上に、内側部分および外側部分を有する被覆層を形成し; (ii)該層の内側部分として、核重量の約1%ないし約8%に等しい重量の被 覆剤を塗布し、ここで、その被覆剤は医薬上許容される被覆材料であり、その被 覆材料にはメトクロプラミドが含まれておらず;つづいて (iii)その内側部分を乾燥し;その後、 (iv)その乾燥した内側部分上に、核重量の約6%ないし約15%に等しい重 量の被覆剤を含む外側部分を塗布する、ここで該被覆剤は、少なくとも約20% のタルク(該外側部分の乾燥重量)を含む医薬上許容される錠剤付着減少被覆材 料であり、さらに該外側部分全体に均一に分配された結晶形態のメトクロプラミ ドを含む、 段階を含む方法。 28.NSAIDがナプロキセンナトリウムである請求項27記載の方法。 29.少なくとも2つの錠剤を、NSAID核を、塗布する内部被覆層と一緒 に錠剤被覆パンにて回転させる工程で被覆層の外側部分をスプレー被覆により塗 布する工程(iv)をさらに含む方法で製造する方法であって、その回転速度は約 10〜約25rpmの回転速度であり、その回転は、核の重量が約4%ないし約 8%増加するまで、約10ないし12インチ離れ、回転式パンの錠剤の4ないし 8インチ上方にて固定する1〜複数のスプレーガンより被覆材料を噴霧すること により行う、請求項29記載の方法。 30.回転が振動回転である請求項29記載の方法。 31.少なくとも2つの錠剤を、NSAID核を、塗布する内部被覆層と一緒 に錠剤被覆パンにて回転させる工程で被覆層の外側部分をスプレー被覆により塗 布する工程(iv)をさらに含む方法で製造する方法であって、その回転速度は約 10〜約25rpmの回転速度であり、その回転は、少なくとも約5mgのメト クロプラミドが各錠剤に塗布されるまで、約10ないし12インチ離れ、回転式 パンの錠剤の4ないし8インチ上方にて固定する1〜複数のスプレーガンより被 覆材料を噴霧することにより行う、請求項30記載の方法。 32.回転が振動回転である請求項31記載の方法。 33.経口投与されたNSAIDを胃内容欝滞の対象の小腸に速やかに導入す る方法であって、NSAIDを含む、同時に折りよく相互に整合的に作用する非 スパイク性酸−塩基単位投与形態の、経口用メトクラプラミドを、有効な局所的 胃腸濃度にて投与することからなる方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US74833296A | 1996-11-12 | 1996-11-12 | |
US08/966,506 US6077539A (en) | 1996-11-12 | 1997-11-10 | Treatment of migraine headache |
US08/748,332 | 1997-11-10 | ||
US08/966,506 | 1997-11-10 | ||
PCT/US1997/020611 WO1998020870A1 (en) | 1996-11-12 | 1997-11-12 | Improved treatment of migraine headache |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2005255155A Division JP2005343906A (ja) | 1996-11-12 | 2005-09-02 | 偏頭痛の改良治療 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2000507614A true JP2000507614A (ja) | 2000-06-20 |
JP3759624B2 JP3759624B2 (ja) | 2006-03-29 |
Family
ID=27114923
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52192798A Expired - Fee Related JP3759624B2 (ja) | 1996-11-12 | 1997-11-12 | 偏頭痛の改良治療 |
JP2005255155A Pending JP2005343906A (ja) | 1996-11-12 | 2005-09-02 | 偏頭痛の改良治療 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2005255155A Pending JP2005343906A (ja) | 1996-11-12 | 2005-09-02 | 偏頭痛の改良治療 |
Country Status (11)
Country | Link |
---|---|
US (3) | US6077539A (ja) |
EP (1) | EP1014961B1 (ja) |
JP (2) | JP3759624B2 (ja) |
AT (1) | ATE269071T1 (ja) |
AU (1) | AU732217C (ja) |
CA (1) | CA2269745C (ja) |
DE (1) | DE69729587T2 (ja) |
DK (1) | DK1014961T3 (ja) |
ES (1) | ES2222522T3 (ja) |
PT (1) | PT1014961E (ja) |
WO (1) | WO1998020870A1 (ja) |
Cited By (5)
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JP2006527195A (ja) * | 2003-06-06 | 2006-11-30 | グラクソ グループ リミテッド | トリプタンおよびnsaidを含む組成物 |
JP2014058540A (ja) * | 2008-01-09 | 2014-04-03 | Charleston Laboratories Inc | 薬学的組成物 |
US10179109B2 (en) | 2016-03-04 | 2019-01-15 | Charleston Laboratories, Inc. | Pharmaceutical compositions comprising 5HT receptor agonist and antiemetic particulates |
WO2019087841A1 (ja) * | 2017-11-01 | 2019-05-09 | ビオフェルミン製薬株式会社 | 特定のNSAIDs及びPPI誘発性小腸障害の予防又は治療剤 |
US10532030B2 (en) | 2009-07-08 | 2020-01-14 | Locl Pharma, Inc. | Pharmaceutical compositions for treating or preventing pain |
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- 1997-11-12 DE DE69729587T patent/DE69729587T2/de not_active Expired - Fee Related
- 1997-11-12 AT AT97946927T patent/ATE269071T1/de not_active IP Right Cessation
- 1997-11-12 DK DK97946927T patent/DK1014961T3/da active
- 1997-11-12 CA CA002269745A patent/CA2269745C/en not_active Expired - Fee Related
- 1997-11-12 WO PCT/US1997/020611 patent/WO1998020870A1/en active IP Right Grant
- 1997-11-12 AU AU52010/98A patent/AU732217C/en not_active Ceased
- 1997-11-12 EP EP97946927A patent/EP1014961B1/en not_active Expired - Lifetime
- 1997-11-12 PT PT97946927T patent/PT1014961E/pt unknown
- 1997-11-12 ES ES97946927T patent/ES2222522T3/es not_active Expired - Lifetime
- 1997-11-12 JP JP52192798A patent/JP3759624B2/ja not_active Expired - Fee Related
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2000
- 2000-03-03 US US09/517,751 patent/US6479551B1/en not_active Expired - Fee Related
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2002
- 2002-09-26 US US10/255,036 patent/US7030162B2/en not_active Expired - Fee Related
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JP2006527195A (ja) * | 2003-06-06 | 2006-11-30 | グラクソ グループ リミテッド | トリプタンおよびnsaidを含む組成物 |
JP2014058540A (ja) * | 2008-01-09 | 2014-04-03 | Charleston Laboratories Inc | 薬学的組成物 |
US9198867B2 (en) | 2008-01-09 | 2015-12-01 | Charleston Laboratories, Inc. | Pharmaceutical compositions |
JP2016155847A (ja) * | 2008-01-09 | 2016-09-01 | チャールストン ラボラトリーズ,インコーポレイテッド | 薬学的組成物 |
JP2017122109A (ja) * | 2008-01-09 | 2017-07-13 | チャールストン ラボラトリーズ,インコーポレイテッド | 薬学的組成物 |
US9775837B2 (en) | 2008-01-09 | 2017-10-03 | Charleston Laboratories, Inc. | Pharmaceutical compositions |
US10532030B2 (en) | 2009-07-08 | 2020-01-14 | Locl Pharma, Inc. | Pharmaceutical compositions for treating or preventing pain |
US10179109B2 (en) | 2016-03-04 | 2019-01-15 | Charleston Laboratories, Inc. | Pharmaceutical compositions comprising 5HT receptor agonist and antiemetic particulates |
US10772840B2 (en) | 2016-03-04 | 2020-09-15 | Charleston Laboratories, Inc. | Sumatriptan promethazine pharmaceutical compositions |
WO2019087841A1 (ja) * | 2017-11-01 | 2019-05-09 | ビオフェルミン製薬株式会社 | 特定のNSAIDs及びPPI誘発性小腸障害の予防又は治療剤 |
US11219650B2 (en) | 2017-11-01 | 2022-01-11 | Biofermin Pharmaceutical Co., Ltd. | Agent for preventing or treating small intestinal injury induced by specific NSAID and PPI |
Also Published As
Publication number | Publication date |
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CA2269745C (en) | 2003-07-29 |
JP2005343906A (ja) | 2005-12-15 |
JP3759624B2 (ja) | 2006-03-29 |
CA2269745A1 (en) | 1998-05-22 |
US20030040537A1 (en) | 2003-02-27 |
DE69729587D1 (de) | 2004-07-22 |
ATE269071T1 (de) | 2004-07-15 |
US6077539A (en) | 2000-06-20 |
PT1014961E (pt) | 2004-10-29 |
EP1014961B1 (en) | 2004-06-16 |
US7030162B2 (en) | 2006-04-18 |
EP1014961A1 (en) | 2000-07-05 |
AU5201098A (en) | 1998-06-03 |
DE69729587T2 (de) | 2005-06-23 |
DK1014961T3 (da) | 2004-10-25 |
US6479551B1 (en) | 2002-11-12 |
WO1998020870A1 (en) | 1998-05-22 |
ES2222522T3 (es) | 2005-02-01 |
EP1014961A4 (en) | 2001-04-11 |
AU732217C (en) | 2005-09-15 |
AU732217B2 (en) | 2001-04-12 |
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