JP2007516998A - 乱用防止製剤の製造方法 - Google Patents
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- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
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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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- B30B11/16—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using pocketed rollers, e.g. two co-operating pocketed rollers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
- B30B11/34—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets
Abstract
Description
(a)乱用の可能性がある少なくとも1つの活性成分と、少なくとも500Nの破壊強度を示す少なくとも1つの合成または天然ポリマー(C)とを含む配合混合物を、力の作用により複数の成形品に成形する。
(b)任意でこれら成形品を1つ1つ取り、任意でいずれについても大きさによって選別する。
(c)少なくとも前記ポリマー(C)の軟化点にまで加熱した後またはその加熱中に、前記成形品が少なくとも500Nの破壊強度を有するまで前記成形品に力を加え、任意で前記成形品を被覆し、任意で全ての成形品を再び混ぜる。
(a)乱用の可能性がある少なくとも1つの活性成分と、少なくとも500Nの破壊強度を示す少なくとも1つの合成または天然ポリマー(C)と、任意の補助物質(B)とを含む配合混合物を、力の作用により複数の成形品に成形する。
(b)任意でこれら成形品を1つ1つ取り、任意でいずれについても大きさによって選別する。
(c)少なくとも前記ポリマー(C)の軟化点にまで加熱した後またはその加熱中に、前記成形品が少なくとも500Nの破壊強度を有するまで前記成形品に力を加え、任意で前記成形品を被覆し、任意で全ての成形品を再び混ぜる。
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−カルボキシレート)(チリジン(シスおよびトランス))、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、(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(好ましくはラセミ化合物として)、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−イソブトキシ−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−シクロヘキサ−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−シクロヘキサ−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、ならびに対応する立体異性化合物、各場合に、対応するその誘導体、特に、アミド、エステルまたはエーテル、および各場合に、生理学的に許容されるその化合物、特に、その塩および溶媒和物、特に好ましくは塩酸塩。
本発明の方法において、剥離剤を、付形輪郭(その中で、力が成形品に作用される)および成形品に適用するのが好都合であり、それによって、キャリヤーベルトまたは圧力ローラーから成形品を再び剥離しやすくし得る。好適な剥離剤は、薬学的に一般的な剥離剤、例えば、タルカム、ステアリン酸マグネシウムである。好ましい剥離剤は、工程温度においてそれらの凝集状態を変化させない剥離剤である。
(a)鼻腔および/または咽頭を刺激する少なくとも1つの物質。
(b)少なくとも1つの粘度上昇剤(該粘度上昇剤は、好ましくは製剤から得られる水性抽出物としての、必要とされる最少量の水性液の補助によって、ゲルを形成し、該ゲルは、好ましくは、付加的量の水性液に導入された場合に視覚的に識別可能に維持される)。
(c)乱用可能性を有する各活性成分の少なくとも1つの拮抗物質。
(d)少なくとも1つの催吐薬。
(e)嫌悪物質としての少なくとも1つの染料。
(f)少なくとも1つの苦味物質。
A) 成分(C)または(D)としてポリマーを使用し得るかを調査するために、150Nの力を使用して、少なくともポリマーの軟化点に対応する温度で、ポリマーをプレスして、直径10mm、高さ5mmのタブレットを形成し、ポリマーのDSCダイヤグラムによって測定する。このように製造したタブレットを使用して、European Pharmacopoeia 1997,p.143,144,method no.2.9.8に記載されているタブレット破壊強度測定法に従って、下記の装置を使用して破壊強度を測定する。測定に使用される装置は、Zwick GmbH & Co.KG,Ulm,Germanyからの、名称「TMTC−FR2.5 TH.D09」、Fmax = 2.5kN、最大牽引(maximum draw)1150mmのシングルコラムベンチモデルマティリアルテスターであり、該装置は、1コラムおよび1スピンドル、クリアランスビハインド(clearance behind)100mm、および調節可能試験速度0.1〜800mm/分で、testControlソフトウエアと共に設定すべきである。測定は下記を使用して行う。ねじ込みインサート付き圧力ピストンおよびシリンダー(口径10mm)、力変換機、Fmax.1kN、直径=8mm、ISO 7500−1により10Nからクラス0.5、2Nからクラス1、DIN 55350−18により製造会社試験証明M(Zwick総力Fmax=1.45kN)(全ての装置は、Zwick GmbH & Co.KG,Ulm,Germanyより)、テスターの注文番号BTC−FR 2.5TH.D09、力変換機の注文番号BTC−LC 0050N.P01、センタリング装置の注文番号BO 70000 S06。
Claims (10)
- (a)乱用の可能性がある少なくとも1つの活性成分と、少なくとも500Nの破壊強度を示す少なくとも1つの合成または天然ポリマー(C)と、任意の補助物質(B)とを含む配合混合物を、力の作用により複数の成形品に成形するステップと、
(b)前記成形品を1つ1つ取り、いずれについても大きさによって選別する任意のステップと、
(c)少なくとも前記ポリマー(C)の軟化点までに加熱した後又はその加熱中に、前記成形品が少なくとも500Nの破壊強度を有するまで前記成形品に力を加え、任意で前記成形品を被覆し、任意で全ての成形品を再び混ぜるステップと
を特徴とする、乱用の可能性を少なくとも減少した固体状の医薬製剤を製造する方法。 - 連続的または不連続的に行うことを特徴とする請求項1に記載の方法。
- 前記配合混合物が、前記成分(C)を少なくとも30wt%含有することを特徴とする請求項1または2に記載の方法。
- 前記配合混合物が、前記成分(C)を少なくとも50wt%含有することを特徴とする請求項1〜3のいずれか一項に記載の方法。
- 前記配合混合物の成形ステップ(a)を、少なくとも0.5kNの力の作用と、任意の60℃未満の加熱により行うことを特徴とする請求項1〜4のいずれか一項に記載の方法。
- 前記ステップ(c)において、少なくとも0.1kN、好ましくは1kN〜120kNの力を加える前に又はその間に、前記成形品を少なくとも60℃に加熱することを特徴とする請求項1〜5のいずれか一項に記載の方法。
- 前記ステップ(a)又は(c)において、プレス、好ましくはタブレットプレス、成形ローラー、またはローラーを備えた成形ベルトを使用して前記力を加えることを特徴とする請求項1〜6のいずれか一項に記載の方法。
- 前記ステップ(a)での成形により、タブレットを製造することを特徴とする請求項1〜7のいずれか一項に記載の方法。
- 前記ステップ(a)での成形により、最小寸法が0.5mm、好ましくは1〜3.5mmの多粒子状の製剤を製造することを特徴とする請求項1〜7のいずれか一項に記載の方法。
- 前記活性成分としてオピオイド活性を有する成分を使用することを特徴とする請求項1〜9のいずれか一項に記載の方法。
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Application Number | Priority Date | Filing Date | Title |
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DE10361596.2 | 2003-12-24 | ||
DE10361596A DE10361596A1 (de) | 2003-12-24 | 2003-12-24 | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
PCT/EP2004/014679 WO2005063214A1 (de) | 2003-12-24 | 2004-12-23 | Verfahren zur herstellung einer gegen missbrauch gesicherten darreichungsform |
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JP2007516998A true JP2007516998A (ja) | 2007-06-28 |
JP4895821B2 JP4895821B2 (ja) | 2012-03-14 |
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US (6) | US20070003616A1 (ja) |
EP (1) | EP1699440B1 (ja) |
JP (1) | JP4895821B2 (ja) |
CN (1) | CN1917862B (ja) |
AR (1) | AR046994A1 (ja) |
AT (1) | ATE447942T1 (ja) |
AU (1) | AU2004308653B2 (ja) |
CA (1) | CA2551231A1 (ja) |
CY (1) | CY1110609T1 (ja) |
DE (2) | DE10361596A1 (ja) |
DK (1) | DK1699440T3 (ja) |
ES (1) | ES2336571T3 (ja) |
HK (1) | HK1099511A1 (ja) |
IL (1) | IL176296A0 (ja) |
PE (1) | PE20050814A1 (ja) |
PL (1) | PL1699440T3 (ja) |
PT (1) | PT1699440E (ja) |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2008504327A (ja) * | 2004-07-01 | 2008-02-14 | グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 乱用に対して保護された経口剤形 |
JP2008528654A (ja) * | 2005-02-04 | 2008-07-31 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 遅延放出性を有する耐破壊性の投薬形 |
KR101951249B1 (ko) * | 2018-05-08 | 2019-02-22 | 주식회사 지티앤티 | 펠릿 성형 장치 |
Families Citing this family (87)
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US20030068375A1 (en) | 2001-08-06 | 2003-04-10 | Curtis Wright | Pharmaceutical formulation containing gelling agent |
US20040253310A1 (en) | 2001-09-21 | 2004-12-16 | Gina Fischer | Morphine polymer release system |
US20040234602A1 (en) | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
EP2301526B1 (en) | 2003-03-26 | 2016-03-23 | Egalet Ltd. | Morphine controlled release system |
DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
US8075872B2 (en) | 2003-08-06 | 2011-12-13 | Gruenenthal Gmbh | Abuse-proofed dosage form |
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- 2003-12-24 DE DE10361596A patent/DE10361596A1/de not_active Withdrawn
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Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US20020187192A1 (en) * | 2001-04-30 | 2002-12-12 | Yatindra Joshi | Pharmaceutical composition which reduces or eliminates drug abuse potential |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008504327A (ja) * | 2004-07-01 | 2008-02-14 | グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 乱用に対して保護された経口剤形 |
JP2008528654A (ja) * | 2005-02-04 | 2008-07-31 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 遅延放出性を有する耐破壊性の投薬形 |
KR101951249B1 (ko) * | 2018-05-08 | 2019-02-22 | 주식회사 지티앤티 | 펠릿 성형 장치 |
Also Published As
Publication number | Publication date |
---|---|
PT1699440E (pt) | 2010-02-17 |
US20070003616A1 (en) | 2007-01-04 |
US20160367487A1 (en) | 2016-12-22 |
CN1917862B (zh) | 2011-08-03 |
EP1699440A1 (de) | 2006-09-13 |
WO2005063214A1 (de) | 2005-07-14 |
US20150164811A1 (en) | 2015-06-18 |
IL176296A0 (en) | 2006-10-05 |
AR046994A1 (es) | 2006-01-04 |
ES2336571T3 (es) | 2010-04-14 |
US20130320592A1 (en) | 2013-12-05 |
US20090005408A1 (en) | 2009-01-01 |
US20170049706A1 (en) | 2017-02-23 |
CA2551231A1 (en) | 2005-07-14 |
DE502004010368D1 (de) | 2009-12-24 |
EP1699440B1 (de) | 2009-11-11 |
AU2004308653A1 (en) | 2005-07-14 |
ATE447942T1 (de) | 2009-11-15 |
AU2004308653B2 (en) | 2009-09-03 |
DK1699440T3 (da) | 2010-03-29 |
SI1699440T1 (sl) | 2010-03-31 |
DE10361596A1 (de) | 2005-09-29 |
PL1699440T3 (pl) | 2010-04-30 |
US11224576B2 (en) | 2022-01-18 |
JP4895821B2 (ja) | 2012-03-14 |
CY1110609T1 (el) | 2015-04-29 |
CN1917862A (zh) | 2007-02-21 |
HK1099511A1 (en) | 2007-08-17 |
PE20050814A1 (es) | 2005-11-10 |
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