JP2006517516A - 置換イミダゾール誘導体を含む改良された製剤 - Google Patents
置換イミダゾール誘導体を含む改良された製剤 Download PDFInfo
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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
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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
- A61K9/0056—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
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
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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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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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
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Chemical Kinetics & Catalysis (AREA)
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- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
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- Neurosurgery (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
R1は、好ましくはハロゲン、より好ましくはフルオロ、最も好ましくは5-フルオロであり、
R2は、好ましくはHであり、
R3は、好ましくはエチルであり、
Yは、好ましくは-CH2-である。
1. ヒトにおける口腔内投与と経口投与の比較
胃前経路によって吸収が改善されることが、フィパメゾールを溶液として経口投与した場合と口腔内スプレーとして投与した場合との比較によって実証された。
健康な志願者(白人男性、年齢18〜35歳、体重60〜90kg)にフィパメゾールを投与量を増加させながら(0.5、1、3、9、18、30、60mg)溶液で経口投与した。各投与後に、薬物動力学的評価のために、間隔を置いて最長で24時間、血液サンプルを採取した。血漿中のフィパメゾールの濃度をHPLC-MS/MSで測定した。標準の安全性臨床検査、ECG(心電図)記録、血圧および心拍数測定ならびに有害事象の問診によって安全性と忍容性を評価した。
使用したプロトコールは、投与方法が口腔内スプレー(0.75、1.5、3、7.5、15、30、60、および90mg、一回投与)である点以外はほぼプロトコールAと同じであった。
この試験では、純粋種のビーグル犬(オス1匹およびメス1匹)にフィパメゾールを急速分散性錠剤(前記実施例3と同じ処方)(20mg/kg)として口腔経由で経口投与した。試験中(8日間、および試験前4日間)を通じて対象の生存能力、行動の変化、処置に対する反応および不健康状態について監視した。加えて、体重および食餌摂取量を記録した。血漿濃度分析(LC/MS/MS法)のために、投与の10、20、30、45分後および1、1.25、1.5、2、2.5、3、4、8時間後に血液を採取した。
2組のヒトの被験者に30mgのフィパメゾールを一回投与することによって、口腔内スプレーと急速溶解性剤形を直接比較した。上記の口腔内スプレーに関する所見とは対照的に、急速溶解性剤形では口腔の紅斑や白化は観察されず、したがって後者は患者の服薬遵守の点で有利である。これらの結果を表4に示す。表4を見れば分るように、急速溶解性錠剤の方が平均最大血漿濃度(Cmax)はより低かったが、標準偏差(SD)および変動係数(CV%)もより低かった。この効果は追試(被験者12人)においても確認され、CmaxのSDは口腔内スプレーおよび急速溶解性剤形でそれぞれ26.2および13.5であった。このより低いSDおよびCV%は、急速溶解性錠剤によって投与すれば目標とするCmaxの制御がより易しいものであり、したがって急速溶解性錠剤が患者の安全性の点で有利であることを示唆している。
Claims (19)
- 有効成分として、一般式(I):
の置換イミダゾール誘導体、または一般式(I)の化合物の薬剤として許容可能な塩、たとえば塩酸塩などの酸付加塩を含み、前記有効成分の胃前吸収を促進する、急速分散性の固形剤形。 - 口腔内に置かれて10秒以内に崩壊するように製剤された、請求項1に記載の急速分散性固形剤形。
- 前記有効成分および前記有効成分に対して不活性な水溶性または水分散性担体の網目構造を含み、前記網目構造は固体状態の組成物から溶媒を昇華させることによって得たものであり、前記組成物は前記有効成分と前記担体の溶媒中溶液とを含む、請求項1または2に記載の急速分散性固形剤形。
- 1種以上のマトリックス形成剤を含む、請求項1から3のいずれか一項に記載の急速分散性固形剤形。
- 前記マトリックス形成剤がゼラチンおよび糖のうち1種以上を含む、請求項4に記載の急速分散性固形剤形。
- 前記マトリックス形成剤がゼラチンおよび少なくとも1種の糖を含む、請求項5に記載の急速分散性固形剤形。
- 前記ゼラチンが魚ゼラチンである、請求項5または6に記載の急速分散性固形剤形。
- 前記糖がマンニトールである、請求項4から7のいずれか一項に記載の急速分散性固形剤形。
- 前記糖が環状糖である、請求項4から7のいずれか一項に記載の急速分散性固形剤形。
- 前記マトリックス形成剤がアミノ酸を含む、請求項4から9のいずれか一項に記載の急速分散性固形剤形。
- 前記アミノ酸がグリシンである、請求項10に記載の急速分散性固形剤形。
- Yが-CH2-である、請求項1から11のいずれか一項に記載の急速分散性固形剤形。
- R1がハロゲンまたはヒドロキシである、請求項1から12のいずれか一項に記載の急速分散性固形剤形。
- R1がハロゲンである、請求項1から13のいずれか一項に記載の急速分散性固形剤形。
- R1が5-ハロゲンである、請求項1から14のいずれか一項に記載の急速分散性固形剤形。
- R1がフルオロである、請求項1から15のいずれか一項に記載の急速分散性固形剤形。
- R2が水素である、請求項1から16のいずれかに記載の急速分散性固形剤形。
- R3がエチルである、請求項1から17のいずれかに記載の急速分散性固形剤形。
- 実質的に上記請求項1から18のいずれか一項に記載した通りである急速分散性固形剤形。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0226076.8A GB0226076D0 (en) | 2002-11-08 | 2002-11-08 | Improved formulations containing substituted imidazole derivatives |
PCT/US2003/034934 WO2004043439A1 (en) | 2002-11-08 | 2003-11-03 | Improved formulations containing substituted imidazole derivatives |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2011264745A Division JP5474033B2 (ja) | 2002-11-08 | 2011-12-02 | 置換イミダゾール誘導体を含む改良された製剤 |
Publications (1)
Publication Number | Publication Date |
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JP2006517516A true JP2006517516A (ja) | 2006-07-27 |
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JP2004551671A Withdrawn JP2006517516A (ja) | 2002-11-08 | 2003-11-03 | 置換イミダゾール誘導体を含む改良された製剤 |
JP2011264745A Expired - Fee Related JP5474033B2 (ja) | 2002-11-08 | 2011-12-02 | 置換イミダゾール誘導体を含む改良された製剤 |
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JP2011264745A Expired - Fee Related JP5474033B2 (ja) | 2002-11-08 | 2011-12-02 | 置換イミダゾール誘導体を含む改良された製剤 |
Country Status (16)
Country | Link |
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US (1) | US9717681B2 (ja) |
EP (1) | EP1581192B1 (ja) |
JP (2) | JP2006517516A (ja) |
KR (1) | KR101170548B1 (ja) |
AU (1) | AU2003287476B2 (ja) |
CA (1) | CA2503630C (ja) |
ES (1) | ES2392967T3 (ja) |
GB (1) | GB0226076D0 (ja) |
HK (1) | HK1080282A1 (ja) |
IL (1) | IL168257A (ja) |
MX (1) | MXPA05004745A (ja) |
NO (1) | NO336460B1 (ja) |
NZ (1) | NZ539731A (ja) |
PL (1) | PL214226B1 (ja) |
RU (1) | RU2349305C2 (ja) |
WO (1) | WO2004043439A1 (ja) |
Families Citing this family (6)
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ATE465491T1 (de) * | 2003-12-01 | 2010-05-15 | Sony Corp | Prozess zur herstellung eines originaldatenträgers für einen optischen datenträger und originaldatenträger für einen optischen datenträger |
US7972621B2 (en) * | 2004-06-03 | 2011-07-05 | R.P. Scherer Technologies, Llc | Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight |
US8268791B2 (en) | 2004-08-25 | 2012-09-18 | Aegis Therapeutics, Llc. | Alkylglycoside compositions for drug administration |
WO2011026080A1 (en) | 2009-08-31 | 2011-03-03 | Wilmington Pharmaceuticals, Llc | Fast disintegrating compositions of meloxicam, processes for preparation, and use to treat arthritis and/or pain |
DK3254676T3 (en) | 2009-10-30 | 2019-03-11 | Ix Biopharma Ltd | QUICK-SOLVING SOLID DOSAGE FORM |
US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
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WO2000061117A1 (en) * | 1999-04-08 | 2000-10-19 | R.P. Scherer Corporation | Fast-dispersing dosage forms containing fish gelatin |
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2002
- 2002-11-08 GB GBGB0226076.8A patent/GB0226076D0/en not_active Ceased
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2003
- 2003-11-03 NZ NZ539731A patent/NZ539731A/en not_active IP Right Cessation
- 2003-11-03 AU AU2003287476A patent/AU2003287476B2/en not_active Ceased
- 2003-11-03 JP JP2004551671A patent/JP2006517516A/ja not_active Withdrawn
- 2003-11-03 US US10/534,117 patent/US9717681B2/en active Active
- 2003-11-03 CA CA2503630A patent/CA2503630C/en not_active Expired - Fee Related
- 2003-11-03 KR KR1020057008248A patent/KR101170548B1/ko active IP Right Grant
- 2003-11-03 MX MXPA05004745A patent/MXPA05004745A/es active IP Right Grant
- 2003-11-03 ES ES03781716T patent/ES2392967T3/es not_active Expired - Lifetime
- 2003-11-03 PL PL375565A patent/PL214226B1/pl unknown
- 2003-11-03 WO PCT/US2003/034934 patent/WO2004043439A1/en active Application Filing
- 2003-11-03 EP EP03781716A patent/EP1581192B1/en not_active Expired - Lifetime
- 2003-11-03 RU RU2005117626/15A patent/RU2349305C2/ru not_active IP Right Cessation
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2005
- 2005-04-27 IL IL168257A patent/IL168257A/en active IP Right Grant
- 2005-05-12 NO NO20052360A patent/NO336460B1/no not_active IP Right Cessation
- 2005-11-11 HK HK05110140.3A patent/HK1080282A1/xx not_active IP Right Cessation
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2011
- 2011-12-02 JP JP2011264745A patent/JP5474033B2/ja not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS5344619A (en) * | 1976-10-06 | 1978-04-21 | Wyeth John & Brother Ltd | Production of molded article carring chemical substance and packaged article containing same |
JPH07506087A (ja) * | 1991-12-20 | 1995-07-06 | オユ ユヴァンチア ファルマ リミテッド | 置換イミダゾール誘導体ならびにそれらの製造法および用途 |
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Also Published As
Publication number | Publication date |
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JP5474033B2 (ja) | 2014-04-16 |
CA2503630C (en) | 2013-07-30 |
CA2503630A1 (en) | 2004-05-27 |
EP1581192B1 (en) | 2012-08-08 |
RU2349305C2 (ru) | 2009-03-20 |
US9717681B2 (en) | 2017-08-01 |
JP2012051941A (ja) | 2012-03-15 |
EP1581192A4 (en) | 2009-12-02 |
ES2392967T3 (es) | 2012-12-17 |
AU2003287476B2 (en) | 2008-11-20 |
KR101170548B1 (ko) | 2012-08-01 |
NO336460B1 (no) | 2015-08-31 |
MXPA05004745A (es) | 2005-08-03 |
WO2004043439A1 (en) | 2004-05-27 |
US20060134194A1 (en) | 2006-06-22 |
NO20052360L (no) | 2005-06-06 |
GB0226076D0 (en) | 2002-12-18 |
RU2005117626A (ru) | 2006-01-20 |
HK1080282A1 (en) | 2006-04-21 |
NZ539731A (en) | 2008-06-30 |
KR20050086458A (ko) | 2005-08-30 |
EP1581192A1 (en) | 2005-10-05 |
PL214226B1 (pl) | 2013-07-31 |
IL168257A (en) | 2014-04-30 |
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