JP2017514884A - 医療用の(r)−ピルリンドールおよびその薬学的に許容可能な塩 - Google Patents
医療用の(r)−ピルリンドールおよびその薬学的に許容可能な塩 Download PDFInfo
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
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- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Abstract
Description
本発明は、疼痛の治療処置および予防での使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩さらにはそれを含む組成物に関する。
疼痛病態の治療は、医療において何よりも重要であることから、その治療および予防のためのさらなる療法が世界的に必要とされている。
本発明は、光学活性化合物(R)−ピルリンドールエナンチオマーが疼痛の治療処置および予防に役立つ有利な鎮痛活性を示すという知見に基づく。
本発明との関連では、次の用語は以下に記載の意味を有する。
・神経に影響を及ぼす機能障害または病理学的変化であるニューロパチー、たとえば、単一の神経幹を含む場合は単ニューロパチー、いくつかの神経幹を逐次的に含む場合は多発性単ニューロパチー、いくつかの神経幹を瀰漫的かつ両側に含む場合は多発性ニューロパチー。
・感覚性、運動性、または自律神経性でありうる末梢性ニューロパチー。最も頻度の高い運動性症状は、筋痙攣、クローヌス、線維束性攣縮、筋萎縮、および筋力または器用さの低下を含む。
・陰性感覚性症状、たとえば、痛覚鈍麻および感覚鈍麻。
・陽性感覚性症状、たとえば、チクチク感、ヒリヒリ感、または耳鳴感のほかに、感覚異常、感覚不全、ヒペルパチー、痛覚過敏、およびアロディニア。
R−ピルリンドール塩酸塩の錠剤
錠剤の製造は、直接圧縮により実施し、すべての成分の混合、シーブ通過、および所要の相対大気湿度での好適な圧縮力によるプレス処理を含んでいた。
錠剤の製造は、好適な溶液を用いた活性成分の顆粒化、乾燥およびシーブ通過、必要な賦形剤の添加、ならびに所要の相対大気湿度での好適な圧縮力によるプレス処理を含む、湿式顆粒化およびそれに続く圧縮により実施した。
(R)−ピルリンドールエナンチオマーのα2Aアドレナリン作動性レセプターアンタゴニスト活性をテストする。
Claims (12)
- 疼痛の治療処置または予防での使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 前記(R)−ピルリンドールがエナンチオマー的に純粋であることを特徴とする、請求項1に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 少なくとも1種の追加の鎮痛剤との組合せ療法での、請求項1および2に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 前記組合せ療法が、活性剤の逐次投与または同時投与から選択される固定用量組合せ療法または個別組合せ療法を含む、請求項3に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 疼痛の治療で少なくとも1種の追加の鎮痛剤の作用を増強するための、請求項3および4に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- (R)−ピルリンドール(S)−マンデル酸塩の形態をとる、請求項1〜5のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- (R)−ピルリンドールメシル酸塩の形態をとる、請求項1〜5のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- (R)−ピルリンドールクエン酸塩の形態をとる、請求項1〜5のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 前記少なくとも1種の追加の鎮痛剤が、ナトリウムチャネルの阻害剤(カルバマゼピン、オクスカルバゼピン、エスリカルバゼピン、フェニトイン、バルプロ酸)、カルシウムチャネルのアンタゴニスト(プレガバリン)、イオンチャネル型および代謝調節型グルタミン酸レセプターのアンタゴニスト、γ−アミノ酪酸活性のエンハンサー(ガバペンチン)、またはμ、κ、およびδオピオイドレセプターのアゴニスト、部分アゴニスト/アンタゴニスト、もしくはアンタゴニストからなる群から選択されるニューロン過興奮性を減少させる化合物であることを特徴とする、請求項3〜8のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 前記少なくとも1種の追加の鎮痛剤が、パラセタモール、非ステロイド系抗炎症薬剤 アセチルサリチル酸、ジクロフェナク、ナブメトン、ニメスリド、ナブメトン、エトドラク、ピロキシカム、クロニキシン酸リシン、ジフルニサル、アセメタシン、グルカメタシン、インドメタシン、プログルメタシン、オキサメタシン、スリンダク、アセクロフェナク、フェンチアザク、ケトロラク、ゾメピラク、メロキシカム、テノキシカム、ロルノキシカム(lornoxican)、フェノプロフェン、フェンブフェン(fenbufeno)、フルルビプロフェン、ベノキサプロフェン、イブプロフェン、ケトプロフェン、デキスケトプロフェン、ピルプロフェン、インドプロフェン、ナプロキセン、オキサプロジン、チアプロフェン、デキシブプロフェン、メクロフェナム酸、メフェナム酸、フルフェナム酸、トルフェナム酸、ニフルム酸、エトフェナメート、アザプロパゾン、オルゴテイン、フェプラゾン、モルニフルメート、テニダップ、グリコサミノグリカン、ポリスルフェート、セレコキシブ、ロフェコキシブ、パレコキシブ、バルデコキシブ、およびエトリコキシブ、グルコサミン、またはジアセレインからなる群から選択される化合物であることを特徴とする、請求項3〜8のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 疼痛が神経因性疼痛である、請求項1〜10のいずれか一項に記載の使用のための(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩。
- 薬学的に許容可能な担体、媒体、または賦形剤と共に請求項1〜11のいずれか一項に記載の(R)−ピルリンドールエナンチオマーまたはその薬学的に許容可能な塩を含む、疼痛の治療のための医薬組成物。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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PCT/PT2014/000028 WO2015171004A1 (en) | 2014-05-09 | 2014-05-09 | (r)-pirlindole and its pharmaceutically acceptable salts for use in medicine |
Publications (1)
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JP2017514884A true JP2017514884A (ja) | 2017-06-08 |
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JP2016567556A Pending JP2017514884A (ja) | 2014-05-09 | 2014-05-09 | 医療用の(r)−ピルリンドールおよびその薬学的に許容可能な塩 |
Country Status (28)
Country | Link |
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US (2) | US20170145015A1 (ja) |
EP (1) | EP3054950B1 (ja) |
JP (1) | JP2017514884A (ja) |
KR (1) | KR102232198B1 (ja) |
CN (1) | CN106413714A (ja) |
AU (1) | AU2014393489B2 (ja) |
CA (1) | CA2948596C (ja) |
CY (1) | CY1119522T1 (ja) |
DK (1) | DK3054950T3 (ja) |
EC (1) | ECSP16086232A (ja) |
ES (1) | ES2649491T3 (ja) |
HR (1) | HRP20171650T1 (ja) |
HU (1) | HUE035030T2 (ja) |
IL (1) | IL248854B (ja) |
LT (1) | LT3054950T (ja) |
MA (1) | MA39448B1 (ja) |
MX (1) | MX368735B (ja) |
NO (1) | NO3054950T3 (ja) |
NZ (1) | NZ726131A (ja) |
PH (1) | PH12016502236A1 (ja) |
PL (1) | PL3054950T3 (ja) |
PT (1) | PT3054950T (ja) |
RS (1) | RS56590B1 (ja) |
RU (1) | RU2695607C2 (ja) |
SI (1) | SI3054950T1 (ja) |
TN (1) | TN2016000497A1 (ja) |
UA (1) | UA116499C2 (ja) |
WO (1) | WO2015171004A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2017514882A (ja) * | 2014-05-09 | 2017-06-08 | テクニメデ ソシエダーデ テクニコ−メディシナル エス.アー. | 医療用のピルリンドールエナンチオマーの薬学的に許容可能な塩 |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RS56590B1 (sr) | 2014-05-09 | 2018-02-28 | Tecnimede Sociedade Tecnico Medicinal S A | (r)-pirlindol i njegove farmaceutski prihvatljive soli za upotrebu u medicini |
KR102421013B1 (ko) * | 2016-05-19 | 2022-07-14 | 에스케이바이오팜 주식회사 | 삼차신경통을 예방 또는 치료하기 위한 카바메이트 화합물의 용도 |
WO2019241564A1 (en) * | 2018-06-13 | 2019-12-19 | Children's Medical Center Corporation | Biomarkers of neuropathic pain |
Citations (1)
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JP2017514882A (ja) * | 2014-05-09 | 2017-06-08 | テクニメデ ソシエダーデ テクニコ−メディシナル エス.アー. | 医療用のピルリンドールエナンチオマーの薬学的に許容可能な塩 |
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CA2500662A1 (en) * | 2002-10-03 | 2004-04-15 | Cypress Bioscience, Inc. | Dosage escalation and divided daily dose of anti-depressants to treat neurological disorders |
US20060135403A1 (en) * | 2002-12-24 | 2006-06-22 | Francine Gervais | Therapeutic formulations for the treatment of beta-amyloid related diseases |
WO2005025550A1 (en) * | 2003-09-15 | 2005-03-24 | Vectura Limited | Pharmaceutical compositions for treating premature ejaculation by pulmonary inhalation |
EP1688161A1 (en) * | 2004-11-02 | 2006-08-09 | Switch Biotech Aktiengesellschaft | Use of pirlindole for the treatment of diseases which are characterized by proliferation of t-lymphocytes and/or hyperproliferation of keratinocytes in particular atopic dermatitis and psoriasis |
RS56590B1 (sr) | 2014-05-09 | 2018-02-28 | Tecnimede Sociedade Tecnico Medicinal S A | (r)-pirlindol i njegove farmaceutski prihvatljive soli za upotrebu u medicini |
MA39447B1 (fr) * | 2014-05-09 | 2018-05-31 | Tecnimede Sociedade Tecnico Medicinal S | Pirlindole ou ses sels pharmaceutiquement acceptables pour une utilisation en médecine |
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2014
- 2014-05-09 RS RS20171093A patent/RS56590B1/sr unknown
- 2014-05-09 LT LTEP14726443.6T patent/LT3054950T/lt unknown
- 2014-05-09 PL PL14726443T patent/PL3054950T3/pl unknown
- 2014-05-09 MA MA39448A patent/MA39448B1/fr unknown
- 2014-05-09 PT PT147264436T patent/PT3054950T/pt unknown
- 2014-05-09 NZ NZ726131A patent/NZ726131A/en unknown
- 2014-05-09 US US15/309,916 patent/US20170145015A1/en not_active Abandoned
- 2014-05-09 CA CA2948596A patent/CA2948596C/en active Active
- 2014-05-09 HU HUE14726443A patent/HUE035030T2/en unknown
- 2014-05-09 DK DK14726443.6T patent/DK3054950T3/da active
- 2014-05-09 UA UAA201611333A patent/UA116499C2/uk unknown
- 2014-05-09 EP EP14726443.6A patent/EP3054950B1/en active Active
- 2014-05-09 ES ES14726443.6T patent/ES2649491T3/es active Active
- 2014-05-09 AU AU2014393489A patent/AU2014393489B2/en active Active
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- 2014-05-09 KR KR1020167031372A patent/KR102232198B1/ko active IP Right Grant
- 2014-05-09 CN CN201480078733.5A patent/CN106413714A/zh active Pending
- 2014-05-09 NO NO14726443A patent/NO3054950T3/no unknown
- 2014-05-09 SI SI201430470T patent/SI3054950T1/sl unknown
- 2014-05-09 RU RU2016148182A patent/RU2695607C2/ru active
- 2014-05-09 WO PCT/PT2014/000028 patent/WO2015171004A1/en active Application Filing
- 2014-05-09 MX MX2016014701A patent/MX368735B/es active IP Right Grant
- 2014-05-09 JP JP2016567556A patent/JP2017514884A/ja active Pending
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Patent Citations (1)
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JP2017514882A (ja) * | 2014-05-09 | 2017-06-08 | テクニメデ ソシエダーデ テクニコ−メディシナル エス.アー. | 医療用のピルリンドールエナンチオマーの薬学的に許容可能な塩 |
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