JP4939218B2 - 乱用防止剤形 - Google Patents
乱用防止剤形 Download PDFInfo
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- JP4939218B2 JP4939218B2 JP2006522321A JP2006522321A JP4939218B2 JP 4939218 B2 JP4939218 B2 JP 4939218B2 JP 2006522321 A JP2006522321 A JP 2006522321A JP 2006522321 A JP2006522321 A JP 2006522321A JP 4939218 B2 JP4939218 B2 JP 4939218B2
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- 238000007493 shaping process Methods 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 229960003188 temazepam Drugs 0.000 description 1
- ISIJQEHRDSCQIU-UHFFFAOYSA-N tert-butyl 2,7-diazaspiro[4.5]decane-7-carboxylate Chemical class C1N(C(=O)OC(C)(C)C)CCCC11CNCC1 ISIJQEHRDSCQIU-UHFFFAOYSA-N 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- IQWYAQCHYZHJOS-UHFFFAOYSA-N tetrazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CCCCC1 IQWYAQCHYZHJOS-UHFFFAOYSA-N 0.000 description 1
- 229960005214 tetrazepam Drugs 0.000 description 1
- 229960000278 theophylline Drugs 0.000 description 1
- 238000003856 thermoforming Methods 0.000 description 1
- 229960000984 tocofersolan Drugs 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- LLPOLZWFYMWNKH-UHFFFAOYSA-N trans-dihydrocodeinone Natural products C1C(N(CCC234)C)C2CCC(=O)C3OC2=C4C1=CC=C2OC LLPOLZWFYMWNKH-UHFFFAOYSA-N 0.000 description 1
- 229960003386 triazolam Drugs 0.000 description 1
- 208000021331 vascular occlusion disease Diseases 0.000 description 1
- 229960005392 vinylbital Drugs 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Chemical class 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Chemical class 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 235000004835 α-tocopherol Nutrition 0.000 description 1
- 239000002076 α-tocopherol Substances 0.000 description 1
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Description
)ピペリジノ]プロパノエート}(レミフェンタニル)、5−sec−ブチル−5−エチルバルビツール酸(セクブタバルビタール)、5−アリル−5−(1−メチルブチル)−バルビツール酸(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}−プロピオナニリド(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−カルボキシレート)(チリジン(cisおよびtrans))、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−ビニルバルビツール酸(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、(1R,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−1−セニル)−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−1−セニル)−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)−フェニルエステルおよび対応する立体異性体化合物、各場合の対応する誘導体、特にアミド、エステルまたはエーテルおよび各場合に製薬学的に許容されうる化合物、特に塩および溶媒和物、特に好ましくは、塩酸塩を含む群から選択されるオピオイド、トランキライザーまたは別の麻薬の乱用を防止するのに極めて特に好適である。
(a)鼻腔および/または咽頭を刺激する少なくとも1種の物質、
(b)必要最小量の水性液体の助けにより、剤形から得られる抽出物とゲルを形成する少なくとも1種の粘度上昇剤であって、ゲルは、好ましくは、さらなる量の水性液体に導入されるとき、視覚的に識別可能である粘度上昇剤、
(c)乱用の可能性のある作用成分の各々の少なくとも1種のアンタゴニスト、
(d)少なくとも1種の催吐剤、
(e)嫌悪剤としての少なくとも1種の染料、
(f)少なくとも1種の苦味物質。
ポリマーが成分(C)または(D)として使用することができるかどうかを証明するために、少なくともポリマーの軟化点に対応する温度において150Nの力を使用してポリマーを圧縮して、直径10mmおよび高さ5mmの錠剤を形成し、ポリマーのDSCダイアグラムの助けにより測定する。この方法で製造した錠剤を使用して、ヨーロッパ薬局方1997、ページ143〜144、方法番号2.9.8に公開されている錠剤の破壊強度を測定するための装置を用いて破壊強度を測定する。測定に使用する装置は「Zwick Z2.5」物質テスターであり、最大けん引(maximum draw)が1150mmの場合にFmax=2.5kNであり、1カラムおよび1スピンドル、100mmの後部空間(clearance behind)および0.1〜800mm/minの間で調節可能な試験速度、ならびにtestControlソフトウェアを用いて設定されるべきである。測定は、ねじ込み式挿入の圧力ピストンおよびシリンダー(径10mm)、力変換機、Fmax.1kN、径=8mm、クラス0.5から10N,クラス1から2N、ISO7500−1に対応を使用して、製造業者の試験証明書M、DIN55350−18に対応(Zwick gorss force Fmax=1.45kN)(全ての装置はZwick GmbH&Co.KG,Ulm,ドイツ製)を用いて実施され、テスターはオーダー番号BTC−FR2.5TH、力変換機はオーダー番号BTC−LC0050N.P01、センタリング装置はオーダー番号BO70000S06である。
実施例1の300mg部の粉末混合物を80℃に加熱し、錠剤形成ツールのダイに入れた。次いで、圧縮を実施した。錠剤は、実施例1の錠剤と同じ特性を示す。
この乾燥した混合物にさらに別の成分全てを添加し、自由落下ミキサーで15分混合した。
Claims (43)
- 乱用の可能性のある一種または複数の作用成分(A)と、任意の生理学的に許容されうる補助物質(B)と、少なくとも50万の分子量を有する熱可塑性ポリアルキレンオキサイド(C)と、任意の少なくとも1種のワックス(D)とを含有し、少なくとも500Nの破壊強度を示すことを特徴とする、押出せずに熱成形された乱用防止剤形。
- 錠剤形態であることを特徴とする請求項1に記載の剤形。
- 必要に応じて錠剤に圧縮された又はカプセルにパッケージングされた、マルチパーティクルの形態であることを特徴とする請求項1に記載の剤形。
- 必要に応じて錠剤に圧縮された又はカプセルにパッケージングされた、マイクロタブレット、マイクロペレット、顆粒、スフェロイド、ビーズまたはペレットの形態であることを特徴とする請求項3に記載の剤形。
- ポリアルキレンオキサイド(C)として、ポリエチレンオキサイド、ポリメチレンオキサイド、ポリプロピレンオキサイド、それらのコポリマーおよび混合物を含む群から選択される少なくとも1種のポリマーを含有することを特徴とする請求項1〜4のいずれか1項に記載の剤形。
- ポリアルキレンオキサイド(C)として、ポリエチレンオキサイドを含有することを特徴とする請求項5に記載の剤形。
- ポリエチレンオキサイド(C)が少なくとも50万の分子量を有することを特徴とする請求項1〜6のいずれか1項に記載の剤形。
- ポリエチレンオキサイド(C)の分子量が少なくとも100万であることを特徴とする請求項7に記載の剤形。
- ポリエチレンオキサイド(C)の分子量が100〜150万であることを特徴とする請求項8に記載の剤形。
- ワックス(D)として、軟化点が少なくとも60℃の少なくとも1種の天然、半合成または合成ワックスを含有することを特徴とする請求項1〜9のいずれか1項に記載の剤形。
- ワックス(D)がカルナウバワックスまたはミツロウであることを特徴とする請求項10に記載の剤形。
- 成分(C)および任意の(D)は、剤形が少なくとも500Nの破壊強度を有するような量で存在することを特徴とする請求項1〜11のいずれか1項に記載の剤形。
- 作用成分(A)が、オピオイド、トランキライザー、覚醒剤、バルビツール酸塩およびさらに麻薬を含む群から選択される少なくとも1種の作用成分であることを特徴とする請求項1〜12のいずれか1項に記載の剤形。
- (a)鼻腔および/または咽頭を刺激する少なくとも1種の物質、
(b)必要最小量の水性液体の助けにより、剤形から得られる抽出物とゲルを形成する少なくとも1種の粘度上昇剤、
(c)乱用の可能性のある作用成分の少なくとも1種のアンタゴニスト、
(d)少なくとも1種の催吐剤、
(e)嫌悪剤としての少なくとも1種の染料、
(f)少なくとも1種の苦味物質
の少なくとも1つをさらに含むことを特徴とする請求項1〜13のいずれか1項に記載の剤形。 - ゲルは、さらなる量の水性液体に導入されるとき、視覚的に識別可能である請求項14に記載の剤形。
- 成分(a)の刺激物質が灼熱、掻痒、くしゃみの促し、分泌物形成の増加またはこれらの刺激の少なくとも2つの組み合わせを生ずることを特徴とする請求項14又は請求項15に記載の剤形。
- 成分(a)の刺激物質が、少なくとも1種のホットな物質の薬物の1つ以上の成分に基づいていることを特徴とする請求項13〜15のいずれか1項に記載の剤形。
- ホット物質の薬物が、Allii sativi bulbus(ニンニク)、Asari rhizoma cum herba(アサルム(Asarum)根および葉)、ショウブ(Calami)根茎(ショウブ根)、Capsici fructus(トウガラシ)、Capsici fructus acer(カイエンペッパー)、Curcumae longae rhizoma(ウコン根)、Curcumae xanthorrhizae rhizoma(ジャワウコン根)、Galangae rhizoma(ガランガル根)、Myristicae semen(ナツメグ)、Piperis nigri fructus(コショウ)、Sinapis albae semen(白カラシ種)、Sinapis nigri semen(黒カラシ種)、Zeroariae rhizoma(zeodoary根)およびZingiberis rhizoma(ショウガ根)を含む群から選択される少なくとも1種の薬物であることを特徴とする請求項17に記載の剤形。
- ホット物質の薬物が、Capsici fructus(トウガラシ)Capsici fructus acer(カイエンペッパー)およびPiperis nigri fructus(コショウ)を含む群から選択される少なくとも1種の薬物であることを特徴とする請求項18に記載の剤形。
- ホット物質の薬物の成分が、o−メトキシ(メチル)フェノール化合物、酸アミド化合物、からし油もしくはスルフィド化合物であるかまたはこのような化合物由来であることを特徴とする請求項17〜19のいずれか1項に記載の剤形。
- ホット物質の薬物の成分が、ミリスチシン、エレミシン、イソオイゲノール、β−アサロン、サフロール、ジンジェロール、キサントリゾール、カプサイシノイドを含む群から選択される少なくとも1つの成分およびこれらの成分由来の化合物であることを特徴とする請求項17〜20のいずれか1項に記載の剤形。
- ホット物質の薬物の成分が、カプサイシン、ピペリンから選択される少なくとも1つの成分およびこれらの成分由来の化合物であることを特徴とする請求項21に記載の剤形。
- ホット物質の薬物の成分が、トランス−ピペリン、グルコシノレートから選択される少なくとも1つの成分およびこれらの成分由来の化合物であることを特徴とする請求項21又は22に記載の剤形。
- ホット物質の薬物の成分が、非揮発性からし油に基づいた成分およびこの成分由来の化合物であることを特徴とする請求項21〜23のいずれか1項に記載の剤形。
- ホット物質の薬物の成分が、p−ヒドロキシベンジルからし油、メチルメルカプトからし油またはメチルスルホニルからし油に基づいた成分およびこの成分由来の化合物であることを特徴とする請求項21〜24のいずれか1項に記載の剤形。
- 成分(b)が、11重量%のカルボキシメチルセルロースナトリウムを含有する微結晶性セルロース(Avicel(登録商標)RC 591)、カルボキシメチルセルロースナトリウム(Blanose(登録商標)、CMC−Na C300P(登録商標)、Frimulsion BLC−5(登録商標)、Tylose C300P(登録商標))、ポリアクリル酸(Carbopol(登録商標)980 NF、Carbopol(登録商標) 981、イナゴマメ粉末(Cesagum(登録商標) LA−200、Cesagum(登録商標) LID/150、Cesagum(登録商標) LN−1)、柑橘類またはリンゴのペクチン(Cesapectin(登録商標) HM Medium Rapid Set)、ろう状のトウモロコシデンプン(C*Gel 04201(登録商標))、アルギン酸ナトリウム(Frimulsion ALG(E401)(登録商標))、グァー粉末(Frimulsion BM(登録商標)、Polygum 26/1−75(登録商標))、イオタ型カラギーン(Frimulsion D021(登録商標))、カラヤゴム、ゲラン(gellan)ゴム(Kelcogel F(登録商標)、Kekcogel LT100(登録商標)、ガラクトマンナン(Meyprogat 150(登録商標))、タラ(tara)ビーン粉末(Polygum 43/1(登録商標))、プロピレングリコールアルギネート(Protanal−Ester SD−LB(登録商標))、リンゴペクチン、ヒアルロン酸ナトリウム、トラガカント、タラ(tara)ゴム(Vidogum SP 200(登録商標))、発酵多糖ウェラン(welan)ゴム(K1A96)、キサンタンゴム(Xantural 180(登録商標))を含む群から選択される少なくとも1種の粘度上昇剤であることを特徴とする請求項14〜25のいずれか1項に記載の剤形。
- 成分(c)が、ナロキソン、ナルトレキソン、ナルメフェン、ナリド(nalid)、ナルメクソン(nalmexone)、ナロルフィン、ナルフィン(naluphine)および対応する生理学的に許容されうる化合物、特に塩基、塩または溶媒和物を含む群から選択される少なくとも1種のオピオイドアンタゴニストであることを特徴とする請求項14〜26のいずれか1項に記載の剤形。
- 使用される成分(c)が、刺激物質アンタゴニストとしての少なくとも1種の神経遮断剤であることを特徴とする請求項14〜26のいずれか1項に記載の剤形。
- 使用される成分(c)が、ハロペリドール、プロメタジン、フルフェナジン、ペルフェナジン、レボメプロマジン、チオリダジン、ペラジン、クロルプロマジン、クロルプロチキシン(chlorprothixine)、ズクロペンチキソール、フルペンチキソール、プロチペンジル、ゾテピン、ベンペリドール、ピパンペロン、メルペロンおよびブロムペリドールを含む群から選択される神経遮断剤であることを特徴とする請求項28に記載の剤形。
- 成分(d)の催吐剤が、トコンの一種または複数の成分であることを特徴とする請求項14〜29のいずれか1項に記載の剤形。
- 成分(d)の催吐剤が、成分エメチンに基づいているおよび/またはアポモルヒネであることを特徴とする請求項30に記載の剤形。
- 成分(e)が少なくとも1種の生理学的に許容されうる染料であることを特徴とする請求項14〜31のいずれか1項に記載の剤形。
- 成分(f)が、芳香油、果実の芳香物質、安息香酸デナトニウムおよび少なくとも2種の成分を含むその混合物を含む群から選択される少なくとも1種の苦味物質であることを特徴とする請求項14〜32のいずれか1項に記載の剤形。
- 芳香油が、ハッカ油、ユーカリ油、苦扁桃油、メントールおよびそれらの混合物を含む群から選択される少なくとも1種であることを特徴とする請求項33に記載の剤形。
- 果実の芳香物質が、レモン、オレンジ、ライム、グレープフルーツおよび少なくとも2種の成分を含む混合物を含む群から選択される少なくとも1種であることを特徴とする請求項33又は34に記載の剤形。
- 作用成分(A)は、直接接触しないで、成分(c)および/または(d)および/または(f)から空間的に分離されており、剤形が適切に投与されると、サブユニット(Y)の成分(c)および/または(d)および/または(f)は生体内および/または服用時に作用を発揮しないことを特徴とする請求項14〜35のいずれか1項に記載の剤形。
- 作用成分(A)は、少なくとも1つのサブユニット(X)に存在し、成分(c)および/または(d)および/または(f)は少なくとも1つのサブユニット(Y)に存在することを特徴とする請求項36に記載の剤形。
- 少なくとも部分的に放出制御剤形の少なくとも1種の作用成分を含有することを特徴とする請求項1〜37のいずれか1項に記載の剤形。
- 乱用の可能性のある作用成分(A)の各々が放出制御マトリックスに存在することを特徴とする請求項38に記載の剤形。
- 成分(c)および/または任意に存在する成分(D)も放出制御マトリックス材料として作用することを特徴とする請求項39に記載の剤形。
- 成分(A)、(B)、(C)および任意に存在する成分(D)を混合するとともに、任意に存在する(a)〜(f)を同時混合するかまたは必要であれば成分(c)および任意の(D)の添加と共に別個に混合し、
得られた混合物を、必要に応じて顆粒化した後に、前もってまたは同時に熱に暴露しながら、力を加えることによって成形して剤形を製造することを特徴とする、押出成形機を使用しないで、請求項1〜40のいずれか1項に記載の剤形を製造する方法。 - 顆粒化が、溶融造粒法または湿式造粒法によって実施されることを特徴とする請求項41に記載の方法。
- 請求項41または請求項42に記載の方法によって得られる請求項1〜40のいずれか1項に記載の剤形。
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US20160089439A1 (en) | 2014-09-28 | 2016-03-31 | Satara Pharmaceuticals, LLC | Prevention of Illicit Manufacutre of Methamphetamine from Pseudoephedrine Using Food Flavor Excipients |
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