JP5265201B2 - 乱用に対して保護された投薬形の製造方法 - Google Patents
乱用に対して保護された投薬形の製造方法 Download PDFInfo
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Description
a) 前記ポリマー(C)のための溶剤を、少なくとも調合混合物が均一に湿る量で添加し、
b) 場合により少なくとも湿った組成物をいくつかの部分に分け、
c) 1個以上の部分を乾燥させ、ついで
d) 投薬形に成形する
ことを特徴とする、上記固体投薬形の製造方法に関する。
a) 乱用可能性を有する少なくとも1種の有効物質(A)及び少なくとも500Nの耐破壊性を有する少なくとも1種の合成又は天然のポリマー(C)を含有する調合混合物に前記ポリマー(C)のための溶剤を、少なくとも前記調合混合物が均一に湿る量で添加し、
b) 場合により少なくとも湿った組成物をいくつかの部分に分け、
c) 1個以上の部分を乾燥させ、ついで
d) 投薬形に成形する
ことを特徴とする、本発明の上記固体投薬形の製造方法を提供することによって達成される。
N−{1−[2−(4−エチル−5−オキソ−2−テトラゾリン−1−イル)エチル]−4−メトキシメチル−4−ピペリジル}プロピオンアニリド(アルフェンタニル)、5,5−ジアリルバルビツル酸(アロバルビタール)、アリルプロジン、アルファプロジン、8−クロロ−1−メチル−6−フェニル−4H−[1,2,4]トリアゾロ[4,3−a][1,4]−ベンゾジアゼピン(アルプラゾラム)、2−ジエチルアミノプロピオフェノン(アンフェプラモン)、(±)−α−メチルフェネチルアミン(アンフェタミン)、2−(α−メチルフェネチルアミノ)−2−フェニルアセトニトリル(アンフェタミニル)、5−エチル−5−イソペンチルバルビツル酸(アモバルビタール)、アニレリジン、アポコデイン、
5,5−ジエチルバルビツル酸(バルビタール)、ベンジルモルフィン、ベジトラミド、7−ブロモ−5−(2−ピリジル)−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ブロマゼパム)、2−ブロモ−4−(2−クロロフェニル)−9−メチル−6H−チエノ[3,2−f][1,2,4]トリアゾロ[4,3−a][1,4]ジアゼピン(ブロチゾラム)、17−シクロプロピルメチル−4,5α−エポキシ−7α[(S)−1−ヒドロキシ−1,2,2−トリメチル−プロピル]−6−メトキシ−6,14−エンド−エタノモルフィナン−3−オール(ブプレノルフィン)、5−ブチル−5−エチルバルビツル酸(ブトバルビタール)、ブトルファノール、
(7−クロロ−1,3−ジヒドロ−1−メチル−2−オキソ−5−フェニル−2H−1,4−ベンゾジアゼピン−3−イル)−ジメチル−カルバマート(カマゼパム)、(1S,2S)−2−アミノ−1−フェニル−1−プロパノール(カチン/D−ノルプソイドエフェドリン)、7−クロロ−N−メチル−5−フェニル−3H−1,4−ベンゾジアゼピン−2−イルアミン−4−オキシド(クロロジアゼポキシド)、7−クロロ−1−メチル−5−フェニル−1H−1,5−ベンゾジアゼピン−2,4(3H,5H)−ジオン(クロバザム)、5−(2−クロロフェニル)−7−ニトロ−1H−1,4−ベンゾジアゼピン−2(3H)−オン(クロナゼパム)、クロニタゼン、7−クロロ−2,3−ジヒドロ−2−オキソ−5−フェニル−1H−1,4−ベンゾジアゼピン−3−カルボン酸(クロラゼペート)、5−(2−クロロフェニル)−7−エチル−1−メチル−1H−チエノ[2,3−e][1,4]ジアゼピン−2(3H)−オン(クロチアゼパム)、10−クロロ−11b−(2−クロロフェニル)−2,3,7,11b−テトラヒドロオキサゾロ[3,2−d][1,4]ベンゾジアゼピン−6(5H)−オン(クロキサゾラム)、(−)−メチル−[3β−ベンゾイルオキシ−2β(1αH,5αH)−トロパンカルボキシラート](コカイン)、4,5α−エポキシ−3−メトキシ−17−メチル−7−モルフィネン−6α−オール(コデイン)、5−(1−シクロヘキセニル)−5−エチルバルビツル酸(シクロバルビタール)、シクロルファン(Cyclorphan)、シプレノルフィン(Cyprenorphin)、
7−クロロ−5−(2−クロロフェニル)−1H−1,4−ベンゾジアゼピン−2(3H)−オン(デロラゼパム)、デソモルフィン、デキストロモラミド、(+)−(1−ベンジル−3−ジメチルアミノ−2−メチル−1−フェニルプロピル)プロピオナート(デキストロプロポキシフェン)、デゾシン、ジアンプロミド、ジアモルホン(Diamorphon)、7−クロロ−1−メチル−5−フェニル−1H−1,4−ベンゾジアテピン−2(3H)−オン(ジアゼパム)、4,5α−エポキシ−3−メトキシ−17−メチル−6α−モルフィナノール(ジヒドロコデイン)、4,5α−エポキシ−17−メチル−3,6α−モルフィナンジオール(ジヒドロモルフィン)、ジメノキサドール、ジメフェタモール(Dimephetamol)、ジメチルチアンブテン、ジオキサフェチルブチレート、ジピパノン、(6aR,10aR)−6,6,9−トリメチル−3−ペンチル−6a,7,8,10a−テトラヒドロ−6H−ベンゾ[c]クロメン−1−オール(ドロナビノール)、
エプタゾシン、8−クロロ−6−フェニル−4H−[1,2,4]トリアゾロ[4,3−a][1,4]ベンゾジアゼピン(エスタゾラム)、エトヘプタジン、エチルメチルチアンブテン、エチル−[7−クロロ−5−(2−フルオロフェニル)−2,3−ジヒドロ−2−オキソ−1H−1,4−ベンゾジアゼピン−3−カルボキシラート](エチルロフラゼペート)、4,5α−エポキシ−3−エトキシ−17−メチル−7−モルフィネン−6α−オール(エチルモルフィン)、エトニタゼン、4,5α−エポキシ−7α−(1−ヒドロキシ−1−メチルブチル)−6−メトキシ−17−メチル−6,14−エンド−エテノモルフィナン−3−オール(エトルフィン)、
N−エチル−3−フェニル−8,9,10−トリノルボルナン−2−イルアミン(フェンカンファミン)、7−[2−(α−メチルフェネチルアミノ)−エチル]−テオフィリン)(フェネチリン)、3−(α−メチルフェネチルアミノ)プロピオニトリル(フェンプロポレックス)、N−(1−フェネチル−4−ピペリジル)プロピオンアニリド(フェンタニル)、7−クロロ−5−(2−フルオロフェニル)−1−メチル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(フルジアゼパム)、5−(2−フルオロフェニル)−1−メチル−7−ニトロ−1H−1,4−ベンゾジアゼピン−2(3H)−オン(フルニトラゼパム)、7−クロロ−1−(2−ジエチルアミノエチル)−5−(2−フルオロフェニル)−1H−1,4−ジベンゾジアゼピン−2(3H)−オン(フルラゼパム)、
7−クロロ−5−フェニル−1−(2,2,2−トリフルオロエチル)−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ハラゼパム)、10−ブロム−11b−(2−フルオロフェニル)−2,3,7,11b−テトラヒドロ[1,3]オキサゾロ[3,2−d][1,4]ベンゾジアゼピン−6(5H)−オン(ハロキサゾラム)、ヘロイン、4,5α−エポキシ−3−メトキシ−17−メチル−6−モルフィナノン(ヒドロコドン)、4,5α−エポキシ−3−ヒドロキシ−17−メチル−6−モルフィナノン(ヒドロモルホン)、ヒドロキシペチジン、イソメタドン、ヒドロキシメチルモルフィナン、
11−クロロ−8,12b−ジヒドロ−2,8−ジメチル−12b−フェニル−4H−[1,3]オキサジノ[3,2−d][1,4]ベンゾジアゼピン−4,7(6H)−ジオン(ケタゾラム)、1−[4−(3−ヒドロキシフェニル)−1−メチル−4−ピペリジル]−1−プロパノン(ケトベミドン)、
(3S,6S)−6−ジメチルアミノ−4,4−ジフェニルヘプタン−3−イルアセタート(レバセチルメサドール(LAAM))、(−)−6−ジメチルアミノ−4,4−ジフェニル−3−ヘプタノン(レボメサドン)、(−)−17−メチル−3−モルフィナノール(レボルファノール)、レボフェナシルモルファン、ロフェンタニル、6−(2−クロロフェニル)−2−(4−メチル−1−ピペラジニルメチレン)−8−ニトロ−2H−イミダゾ[1,2−a][1,4]ベンゾジアゼピン−1(4H)−オン(ロプラゾラム)、7−クロロ−5−(2−クロロフェニル)−3−ヒドロキシ−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ロラゼパム)、7−クロロ−5−(2−クロロフェニル)−3−ヒドロキシ−1−メチル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ロルメタゼパム)、
5−(4−クロロフェニル)−2,5−ジヒドロ−3H−イミダゾ[2,1−a]イソインドール−5−オール(マジンドール)、7−クロロ−2,3−ジヒドロ−1−メチル−5−フェニル−1H−1,4−ベンゾジアゼパム(メダゼパム)、N−(3−クロロプロピル)−α−メチルフェネチルアミン(メフェノレックス)、メペリジン、2−メチル−2−プロピルトリメチレンジカルバマート(メプロバメート)、メプタジノール、メタゾシン、メチルモルフィン、N,α−ジメチルフェネチルアミン(メタンフェタミン)、(±)−6−ジメチルアミノ−4,4−ジフェニル−3−ヘプタノン(メタドン)、2−メチル−3−o−トリル−4(3H)−キナゾリノン(メタクアロン)、メチル−[2−フェニル−2−(2−ピペリジル)アセタート](メチルフェニダート)、5−エチル−1−メチル−5−フェニルバルビツル酸(メチルフェノバルビタール)、3,3−ジエチル−5−メチル−2,4−ピペリジンジオン(メチプリロン)、メトポン、8−クロロ−6−(2−フルオロフェニル)−1−メチル−4H−イミダゾ[1,5−a][1,4]ベンゾジアゼピン(ミダゾラム)、2−(ベンズヒドリルスルフィニル)アセトアミド(モダフィニル)、4,5α−エポキシ−17−メチル−7−モルフィネン−3,6α−ジオール(モルフィン)、ミロフィン、
(±)−トランス−3−(1,1−ジメチルヘプチル)−7,8,10,10α−テトラヒドロ−1−ヒドロキシ−6,6−ジメチル−6H−ジベンゾ[b,d]ピラン−9(6αH)−オン(ナビロン)、ナルブフェン、ナロルフィン、ナルセイン、ニコモルフィン、1−メチル−7−ニトロ−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ニメタゼパム)、7−ニトロ−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ニトラゼパム)、7−クロロ−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ノルダゼパム)、ノルレボルファノール、6−ジメチルアミノ−4,4−ジフェニル−3−ヘキサノン(ノルメタドン)、ノルモルフィン、ノルピパノン、
ケシ科(Papaver somniferum)に属する植物のいわゆる樹液(アヘン)、7−クロロ−3−ヒドロキシ−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(オキサゼパム)、(シス−トランス)−10−クロロ−2,3,7,11b−テトラヒドロ−2−メチル−11b−フェニルオキサゾロ[3,2−d][1,4]ベンゾジアゼピン−6−(5H)−オン(オキサゾラム)、4,5α−エポキシ−14−ヒドロキシ−3−メトキシ−17−メチル−6−モルフィナノン(オキシコドン)、オキシモルフォン、
ケシ科(Papaver somniferum)に属する植物(亜種のsetigerumを含める)及び植物部分、パパベレタム、2−イミノ−5−フェニル−4−オキサゾリジノン(ペルノリン(Pernolin))、1,2,3,4,5,6−ヘキサヒドロ−6,11−ジメチル−3−(3−メチル−2−ブテニル)−2,6−メタノ−3−ベンズアゾシン−8−オール(ペンタゾシン)、5−エチル−5−(1−メチルブチル)−バルビツル酸(ペントバルビタール)、エチル−(1−メチル−4−フェニル−4−ピペリジンカルボキシラート)(ペチジン)、フェナドキソン、フェノモルファン、フェナゾシン、フェノペリジン、ピミノジン、ホルコデイン、3−メチル−2−フェニルモルホリン(フェンメトラジン)、5−エチル−5−フェニルバルビツル酸(フェノバルビタール)、α,α−ジメチルフェネチルアミン(フェンテルミン)、7−クロロ−5−フェニル−1−(2−プロピニル)−1H−1,4−ベンゾジアゼピン−2(3H)−オン(ピナゼパム)、α−(2−ピペリジル)ベンゾヒドリルアルコール(ピプラドロール)、1′−(3−シアン−3,3−ジフェニルプロピル)[1,4′−ビピペリジン]−4′−カルボキサミド(ピリトラミド)、7−クロロ−1−(シクロプロピルメチル)−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(プラゼパム)、プロファドール、プロヘプタジン、プロメドール、プロペリジン、プロポキシフェン、
N−(1−メチル−2−ピペリジノエチル)−N−(2−ピリジル)プロピオンアミド、メチル{3−[4−メトキシカルボニル−4−(N−フェニルプロパンアミド)ピペリジノ]プロファノアート}(レミフェンタニル)、5−sec−ブチル−5−エチルバルビツル酸(セクブタバルビタール)、5−アリル−5−(1−メチルブチル)−バルビツル酸(セコバルビタール)、N−{4−メトキシメチル−1−[2−(2−チエニル)エチル]−4−ピペリジル}プロピオンアニリド(スフェンタニル)、
7−クロロ−2−ヒドロキシ−メチル−5−フェニル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(テマゼパム)、7−クロロ−5−(1−シクロヘキセニル)−1−メチル−1H−1,4−ベンゾジアゼピン−2(3H)−オン(テトラゼパム)、エチル−(2−ジメチルアミノ−1−フェニル−3−シクロヘキセン−1−カルボキシラート)(チリジン(シス及びトランス))、トラマドール、8−クロロ−6−(2−クロロフェニル)−1−メチル−4H−[1,2,4]トリアゾロ[4,3−a][1,4]ベンゾジアゼピン(トリアゾラム)、
5−(1−メチルブチル)−5−ビニルバルビツル酸(ビニルビタール)、
(1R,2R)−3−(3−ジメチルアミノ−1−エチル−2−メチル−プロピル)−フェノール、
(1R,2R,4S)−2−(ジメチルアミノ)メチル−4−(p−フルオロベンジルオキシ)−1−(m−メトキシフェニル)シクロヘキサノール、
(1R,2R)−3−(2−ジメチルアミノメチル−シクロヘキシル)−フェノール、
(1S,2S)−3(3−ジメチルアミノ−1−エチル−2−メチル−プロピル)−フェノール、
(2R,3R)−1−ジメチルアミノ−3(3−メトキシフェニル)−2−メチル−ペンタン−3−オール、
(1RS,3RS,6RS)−6−ジメチルアミノメチル−1−(3−メトキシ−フェニル)−シクロヘキサン−1,3−ジオール、好ましくはラセミ体として、
3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)−フェニル 2−(4−イソブチル−フェニル)−プロピオネート、
3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル 2−(6−メトキシ−ナフタレン−2−イル)−プロピオネート、
3−(2−ジメチルアミノメチル−シクロヘキセ−1−エニル)−フェニル 2−(4−イソブチル−フェニル)−プロピオネート、
3−(2−ジメチルアミノメチル−シクロヘキセ−1−エニル)フェニル 2−(6−メトキシ−ナフタレン−2−イル)−プロピオネート、
(RR−SS)−2−アセトキシ−4−トリフルオロメチル−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル
(RR−SS)−2−ヒドロキシ−4−トリフルオロメチル−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル
(RR−SS)−4−クロロ−2−ヒドロキシ−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル
(RR−SS)−2−ヒドロキシ−4−メチル−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル
(RR−SS)−2−ヒドロキシ−4−メトキシ−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル
(RR−SS)−2−ヒドロキシ−5−ニトロ−安息香酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステル、
(RR−SS)−2′,4′−ジフルオロ−3−ヒドロキシ−ビフェニル−4−カルボン酸 3−(2−ジメチルアミノメチル−1−ヒドロキシ−シクロヘキシル)フェニル エステルを有するグループから選択されるオピオイド、トランキライザー又は他の麻酔剤の乱用を抑制するために特に適している。
(a) 少なくとも1種の鼻腔及び咽頭腔を刺激する物質、
(b) 必要な最少量の水性の液体を用いて前記投薬形から得られる抽出液中でゲルを形成し、上記ゲルは好ましくは更なる量の水性の液体中に導入した場合に視覚的に区別できるままである、少なくとも1種の粘度上昇する薬剤、
(c) 乱用可能性を有するそれぞれの有効物質に対しする少なくとも1種のアンタゴニスト、
(d) 少なくとも1種の催吐剤、
(e) 嫌忌剤としての少なくとも1種の着色剤、
(f) 少なくとも1種の苦味物質。
組成物を成分(C)又は(D)として使用できるかどうかを試験するために、錠剤型中の前記組成物を、成分(C)又は(D)のための溶剤を用いて溶解させ、かつ溶剤を除去した後に、前記組成物の軟化温度を下回る温度で、直径10mm及び高さ5mmの錠剤に、150Nの力で圧縮成形した。
実施例1
2:締め付け装置。
3:下側加圧プレート。
4:錠剤。
5:間隔。
Claims (25)
- 少なくとも低減された乱用可能性を有する固体投薬形の製造方法において、
a)オピオイド類より成る群から選ばれる、少なくとも1種の有効物質(A)及びポリマー(C)として少なくとも0.5百万g/molの分子量を有するポリエチレンオキシドを含有する調合混合物に、ポリマー(C)に対する、水及び水と脂肪族アルコールとの混合物から選ばれる溶剤を、少なくとも調合混合物が均一に湿る量で添加し、
b)場合により、少なくとも湿った組成物をいくつかの部分(Teilmasse)に分け、
c)1個以上の部分を乾燥させ、ついで
d)投薬形に成形し、
この際、ポリマー(C)を投薬形の全重量に対して、少なくとも30重量%の量で使用し、そして上記投薬形が少なくとも500Nの最小耐破壊性(欧州薬局方に記載された方法にしたがって測定)を有する、上記固体投薬形の製造方法。 - 乾燥された部分それぞれが、投薬形単位の量に相当する、請求項1記載の方法。
- 溶剤の添加の前、ポリマー成分(C)が不溶性の液状分散剤中に、調合混合物がすでに分散されている、請求項1又は2記載の方法。
- 調合混合物を分散する前又はその後に、その調合混合物が投薬形単位の量に相当する部分それぞれに、すでに分けられている、請求項3記載の方法。
- 溶剤と分散剤が相互に混合可能である、請求項3又は4記載の方法。
- 泡の形にある溶剤を調合混合物中に混入する、請求項1記載の方法。
- 前記泡を泡安定剤を用いて安定化する、請求項6記載の方法。
- 溶剤泡を用いて粒状化された組成物を乾燥する、請求項6又は7記載の方法。
- 乾燥され、粒状化された組成物を、それぞれが投薬形単位の量に相当する部分に分け、これらを投薬形に成形する、請求項8記載の方法。
- 成形可能なペーストが得られる量の溶剤を調合混合物に添加する、請求項1記載の方法。
- ペーストを乾燥する前又は乾燥の後に、そのペーストをいくつかの部分に分け、乾燥されたそれらの部分を、場合により投薬形単位の量に相当する部分にそれぞれ更に分けた後、投薬形に成形又は変換(umgeformt)する、請求項10記載の方法。
- 部分がストランドの形を有する、請求項11記載の方法。
- ストランドをスクリーン又はストランド成形装置を用いて製造する、請求項12記載の方法。
- 乾燥されたストランドを個別化し、投薬形に成形する、請求項12記載の方法。
- 錠剤圧縮機を用いて成形を行う、請求項14記載の方法。
- 乾燥されたストランドを成形ローラを用いて又はローラを備えた成形ベルトを用いて投薬形に成形する、請求項12記載の方法。
- ペーストを平面状構造体に加工し、乾燥し、ついでこの構造体から投薬形を打ち抜き加工する、請求項11記載の方法。
- 処理を、押出機を用いて実施する、請求項10〜12のいずれか1つに記載の方法。
- 少なくともポリマー成分(C)が溶解される量の溶剤を調合混合物に添加する、請求項1記載の方法。
- 溶液を平面状の構造体に加工する、請求項19記載の方法。
- 平面状構造体が、フラットダイ(flat die)を備えた押出機を用いて又は溶液を平面状の水平な基材上にキャスティングすることによって得られる、請求項20記載の方法。
- 乾燥された平面状構造体から投薬形を、打ち抜き加工により成形するか又はカレンダー処理により得る、請求項19〜21のいずれか1つに記載の方法。
- 乾燥後に、溶液が投薬形単位の量にそれぞれ相当するような部分量に、その溶液を分ける、請求項19記載の方法。
- 部分量を投薬形単位の形に相当する型に充填する、請求項23記載の方法。
- 溶液を任意の部分量に分け、その部分量を乾燥後に場合により再び一緒にして、投薬形に成形する、請求項19記載の方法。
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- 2006-02-06 EP EP06706680.3A patent/EP1845955B1/de not_active Not-in-force
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TWI449540B (en) | 2014-08-21 |
PE20061204A1 (es) | 2006-12-15 |
IL185017A0 (en) | 2007-12-03 |
US20080311197A1 (en) | 2008-12-18 |
US20150091201A1 (en) | 2015-04-02 |
TW200640500A (en) | 2006-12-01 |
HK1108370A1 (zh) | 2008-05-09 |
DE102005005449A1 (de) | 2006-08-10 |
CN101111232A (zh) | 2008-01-23 |
EP1845955B1 (de) | 2015-05-27 |
CN101111232B (zh) | 2012-03-21 |
US10729658B2 (en) | 2020-08-04 |
AR054222A1 (es) | 2007-06-13 |
IL185017A (en) | 2016-05-31 |
EP1845955A1 (de) | 2007-10-24 |
US20160367486A1 (en) | 2016-12-22 |
US20060188447A1 (en) | 2006-08-24 |
US20160367485A1 (en) | 2016-12-22 |
JP2008528653A (ja) | 2008-07-31 |
US20150283086A1 (en) | 2015-10-08 |
WO2006082097A1 (de) | 2006-08-10 |
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