JP2005518411A - 中枢神経系の障害を治療する製薬組成物及び方法 - Google Patents
中枢神経系の障害を治療する製薬組成物及び方法 Download PDFInfo
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Abstract
【解決手段】CNS障害の治療の必要のある哺乳動物に、CNS障害治療量の(a)少なくとも1つのGABAアナログ及び(b)NMDA受容体に対する少なくとも1つの非毒性の拮抗剤を含む製薬組成物を投与することからなり、組成物中の(a)及び(b)の組み合わせた量は、CNS障害治療の量であり、そして組成物中の(b)の量は(a)のCNS障害治療の有効性を相乗的に増強するのに充分であるCNS障害を治療する方法。
Description
アルツハイマー病における痴呆
F02 他に分類された他の疾患の痴呆
F05 アルコール及び他の精神興奮物質により誘導されないせん妄
F06 脳の損傷及び機能不全、及び身体疾患による他の精神障害
F06.0 器質性幻覚
F06.2 器質性妄想(精神分裂性)障害
F06.3 器質性気分(情動)障害
F06.4 器質性不安障害
F06.7 軽度認知障害
F07.1 脳炎後症候群
F07.2 脳震盪後症候群
F11 オピオイドの使用による精神及び行動の障害
F12 大麻の使用による精神及び行動の障害
F13 鎮静薬または催眠薬の使用による精神及び行動の障害
F14 コカインの使用による精神及び行動の障害
F16 幻覚剤の使用による精神及び行動の障害
F17 タバコの使用による精神及び行動の障害
精神分裂症
躁病の再現
F30.0 軽躁病
F30.1 精神病性の徴候のない躁病
F30.2 精神病性の徴候のある躁病
F30.8 他の躁病の再現
F30.9 特定されない躁病の再現
F31 双極情動障害
F31.0 最近の軽躁病の双極情動障害
F31.1 精神病性の徴候のない最近の軽躁病の双極情動障害
F31.2 精神病性の徴候のある最近の軽躁病の双極情動障害
F31.3 軽度または中程度のうつ病の最近の再現の双極情動障害
F31.4 精神病性の徴候のない強度のうつ病の最近の再現の双極情動障害
F31.5 精神病性の徴候のある強度のうつ病の最近の再現の双極情動障害
F32 うつ病の再現
F34 遺残気分[精神病性]障害
F34.0 循環気質
F34.1 胸腺障害
F41 他の不安障害
F41.0 パニック症候群[再現性の発作性不安]
F41.1 一般化不安障害
F41.2 不安及びうつ病の混合障害
F41.3 他の混合した不安障害
F41.8 他の特定の不安障害
F41.9 不特定の不安障害
F42 強迫障害
F43.1 外傷後ストレス障害
F43.2 調整障害
F51 非器質性睡眠障害
F55 非依存性生成物質の乱用
F55.0 抗うつ薬
F55.2 鎮痛薬
F61 混合及び他の人格障害
F63 習慣及び欲求障害
神経系の疾患(G00−G99)
季節性の情動障害
AIDS−神経学的発現
後天性てんかん性失語
筋萎縮性側索硬化
無酸素症または低酸素症
失行
注意欠陥多動症
自閉
脳障害
脳性麻痺
舞踏病
レヴィ小体による痴呆
脳炎及び髄膜炎
脳ヘルニア
てんかん
頭部の損傷
帯状ヘルペス
低酸素症
免疫媒介脳脊髄炎
クール
レノックス・ガストー症候群
白質萎縮
レヴィ小体痴呆
滑脳症
とじこめ症候群
ルーゲーリック症候群
ループス−神経学的後遺症
ライム病−神経学的後遺症
髄膜炎
運動ニューロン疾患
もやもや病
起立性低血圧による複合全身萎縮
発作睡眠
神経線維腫症
AIDSの神経学的発現
ループスの神経学的後遺症
ライム病の神経学的後遺症
ニーマン・ピック病
パーキンソン病
ピック病
ポリオ後遺症
感染後脳脊髄炎
進行性核上麻痺
偽性脳腫瘍
下肢静止不能症候群
シルダー病
シデナム舞踏病
失神
全身性エリテマトーデス
遅発性ジスキネジー
ふるえ
ウィルソン病
のGABAアナログ及びこの製薬上許容できる塩を利用する。
本発明の治療組成物の他の好ましい態様は、式II
本明細書では、「徐放」は、「コントロール放出」及び「抑制された放出」を含み、そして長期間にわたって限定されたレベルで薬剤を放出することに関する。
アミトリプチリン(Elevil(商標))、デシプラミン(Norpramin(商標))、ドキセピン(Sinequan(商標)またはAdapin(商標))、イミプラミン(Tofranil(商標))、ノルトリプチリン(Aventyl(商標)またはPamelor(商標))、クロミプリミン(商標)を含む三環系。
ベンラファキシン(Effexor(商標))、ミルタザピン(Remeron(商標))、ネファゾドン(Serzone(商標))、ミルナシプラン及びデュロキセチン(Cymbalta(商標))を含むノルエピネフリンセロトニン再取り込み阻害剤(「NSRIs」)。
ブプロピオン塩酸塩(Wellbutrin(商標))。
レボドーパ、及びカルビドーパと組み合わされたレボドーパを含むドーパミン作動薬。
タクリン及びドネゼピル;セレギリンを含むアセチルコリンエステラーゼ(AChE)阻害剤。
*抗嗜癖薬
オピオイド拮抗剤。
ドーパミン作動薬。
ニコチン及びニコチン化合物を含むニコチン作動薬。
*メチルフェニデート(Ritalin)
*パーキンソン病薬
メチルドーパ。
抗コリン作動薬。
ブロモクリプチンを含むドーパミン作動薬。
*クロニジンを含むアドレナリン作動薬
*ベンゾジアゼピン及びクロナゼパムを含む抗不安薬
(a)親水性ポリマー例えばガム、セルローズエーテル、アクリル樹脂及び蛋白由来物質。これらのポリマーのなかで、セルローズエーテル特にヒドロキシルアルキルセルローズ及びカルボキシアルキルセルローズが好ましい。鎮痛組成物は、1−80重量%の少なくとも1つの親水性または疎水性のポリマーを含む。
1つの特に好適な担体は、少なくとも1つの水溶性のヒドロキシアルキルセルローズ、少なくとも1つのC12−C36好ましくはC14−C22の脂肪族アルコールそして所望により少なくとも1つのポリアルキレングリコールからなる。
本発明の処方物の徐放のプロフィルは、例えば、疎水性コーティングの厚さの変化、使用される特定の疎水性物質の変更、または例えば異なるアクリル樹脂ラッカーの相対的量の変更、可塑剤が添加される方法の変更(例えば徐放コーティングが疎水性ポリマーの水性分散物から由来するとき)、疎水性ポリマーに関連する可塑剤の量の変化、追加の成分または助剤の含有、製造方法の変更などにより、変更される。上述のように、非毒性NMDA受容体拮抗剤は、GABAアナログを含む担体の任意のコーティングの外側に適用されるかまたはその内に含まれて、非毒性NMDA受容体拮抗剤の即時放出を行い、一方同時にGABAアナログの徐放をもたらす。
以下の例は、本発明によるCNS障害の治療のための製薬組成物の例である。
Claims (54)
- CNS障害の治療を要する哺乳動物に、CNS障害治療量の
(a)少なくとも1つのGABAアナログ及び
(b)NMDA受容体に対する少なくとも1つの非毒性の拮抗剤
を含む製薬組成物を投与することからなり、組成物中の(a)及び(b)の合計量は、CNS障害治療の量であり、そして組成物中の(b)の量は(a)のCNS障害治療の有効性を相乗的に増強するのに充分であることを特徴とするCNS障害を治療する方法。 - GABAアナログがガバペンチンである請求項1の方法。
- GABAアナログがプレガバリンである請求項1の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項1の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項2の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項3の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項4の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項5の方法。
- 製薬組成物の(a)及び(b)が、組み合わされた徐放担体中に存在する請求項1の方法。
- 製薬組成物の(a)及び(b)が、別々の徐放担体中に存在する請求項1の方法。
- 製薬組成物が、治療上有効量の少なくとも1つの他の薬理学的に活性な物質(c)を含む請求項1の方法。
- 製薬組成物が、CNS障害を治療する医薬である他の薬理学的に活性な物質(c)の少なくとも1つを治療上有効量で含む請求項1の方法。
- 製薬組成物が、ニコチン、ニコチン化合物、タクリン、ドンゼピル、レボドーパと組み合わされたカルビドーパ、セレギリン、ブロモクリプチン、ハロペリドール、クロニジン、ピモジド、フルフェナジン、ベンゾジアゼピン、クロロプロマジン、フルオキセチン、クロロニプラミン、アミトリプチリン、ノルトリプチリン、イミプラミン、ブスピロン、ブプロピオン塩酸塩、ベンラファキシン、ミルナシプラン、デュロキセチン、ミルタザピン、ネファゾドン、パロキセチン、セルトラリン、リルゾール、トラゾドン、ドキセピン及びメチルフェニデートからなる群から選ばれるCNS障害の治療用の医薬または医薬の組み合わせである他の薬理学的に活性な物質(c)の少なくとも1つを治療有効量で含む請求項1の方法。
- CNS障害が、世界保健機関の疾患の国際分類(International Classification of Diseases of the World Health Organization)に分類されている請求項1の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項1の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項2の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項3の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項4の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項5の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項6の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項7の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項8の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項9の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項10の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項11の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項12の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項13の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項14の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項15の方法。
- CNS障害の治療を要する哺乳動物に、(b)即時放出形のNMDA受容体に対する少なくとも1つの非毒性拮抗剤と組み合わされた(a)徐放形の少なくとも1つのGABAアナログを含む製薬組成物をCNS障害治療量で投与し、組成物中の(a)及び(b)の合計量はCNS治療量であり、そして組成物中の(b)の量は(a)のCNS障害治療の有効性を相乗的に増強するのに充分であることを特徴とするCNS障害を治療する方法。
- GABAアナログがガバペンチンである請求項32の方法。
- GABAアナログがプレガバリンである請求項32の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項32の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項33の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項34の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項35の方法。
- 非毒性NMDA受容体拮抗剤が、デキストロメトルファン、デキストロファン、アマンタジン、メマンチン、d−メタドン及びその製薬上許容できる塩からなる群から選ばれる少なくとも1員である請求項36の方法。
- 少なくとも1つの非毒性NMDA受容体拮抗剤が、即時放出担体中に存在する請求項32の方法。
- 徐放形が、親水性ポリマー、疎水性ポリマー、長鎖炭化水素、ポリアルキレングリコール、高級脂肪族アルコール、アクリル系樹脂及びこれらの混合物からなる群から選ばれる基礎材料からなる徐放性担体である請求項32の方法。
- 少なくとも1つの非毒性NMDA受容体拮抗剤が、徐放性担体の外側の表面に適用される請求項43の方法。
- 徐放形が、GABAアナログの放出をコントロールするコーティングを有する基礎材料からなる請求項32の方法。
- コーティングが少なくとも1つの非毒性NMDA受容体拮抗剤を含む請求項45の方法。
- 製薬組成物が、治療上有効量の(c)少なくとも1つの他の薬理学的に活性な物質を含む請求項32の方法。
- 薬理学的に活性な物質(c)が徐放形に含まれる請求項47の方法。
- 薬理学的に活性な物質(c)が即時放出形に含まれる請求項47の方法。
- 薬理学的に活性な物質(c)が、徐放形と即時放出形との両者に含まれる請求項47の方法。
- 製薬組成物が、治療上有効量のCNS障害を治療する医薬である少なくとも1つの他の薬理学的に活性な物質(c)を含む請求項32の方法。
- 製薬組成物が、ニコチン、ニコチン化合物、タクリン、ドンゼピル、レボドーパと組み合わされたカルビドーパ、セレギリン、ブロモクリプチン、ハロペリドール、クロニジン、ピモジド、フルフェナジン、ベンゾジアゼピン、クロロプロマジン、フルオキセチン、クロロニプラミン、アミトリプチリン、ノルトリプチリン、イミプラミン、ブスピロン、ブプロピオン塩酸塩、ベンラファキシン、ミルナシプラン、デュロキセチン、ミルタザピン、ネファゾドン、パロキセチン、セルトラリン、リルゾール、トラゾドン、ドキセピン及びメチルフェニデートからなる群から選ばれるCNS障害の治療用の医薬または医薬の組み合わせである他の薬理学的に活性な物質(c)の少なくとも1つをCNS障害治療量で含む請求項32の方法。
- CNS障害が、世界保健機関の疾患の国際分類(International Classification of Diseases of the World Health Organization)に分類されている請求項32の方法。
- CNS障害が、初老性痴呆、老人性痴呆、運動障害、多動、躁病、注意欠陥障害、うつ病、不安、強迫障害、失読症、精神分裂病、頭痛障害、てんかん、トウレット症候群またはアスペルガー症候群である請求項32の方法。
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US20060167032A1 (en) | 2006-07-27 |
WO2003061656A1 (en) | 2003-07-31 |
EP1471909A4 (en) | 2007-07-25 |
AU2003210486B2 (en) | 2007-06-28 |
CN1642547A (zh) | 2005-07-20 |
EP1471909A1 (en) | 2004-11-03 |
CA2473536A1 (en) | 2003-07-31 |
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