JP2008501750A - 慢性閉塞性肺疾患(copd)の治療のためのオピオイド - Google Patents
慢性閉塞性肺疾患(copd)の治療のためのオピオイド Download PDFInfo
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- JP2008501750A JP2008501750A JP2007526290A JP2007526290A JP2008501750A JP 2008501750 A JP2008501750 A JP 2008501750A JP 2007526290 A JP2007526290 A JP 2007526290A JP 2007526290 A JP2007526290 A JP 2007526290A JP 2008501750 A JP2008501750 A JP 2008501750A
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- opioid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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Abstract
Description
有効成分
剤型
持続放出性マトリックス製剤
(a)オピオイドと共に上述した少なくとも1種の疎水性及び/又は親水性物質(例えば水溶性ヒドロキシアルキルセルロース)を含む顆粒を形成すること;
(b)少なくとも1種の疎水性及び/又は親水性物質を含む顆粒を、少なくとも1種のC12−C36脂肪アルコール(及び、該当する場合は、他のマトリックス成分)と混合すること;及び
(c)場合により、顆粒を圧縮し、成形すること
によって実施し得る。
マトリックスビーズを製造するための工程
持続放出性被覆製剤
アルキルセルロースポリマー
アクリルポリマー
可塑剤
被覆ビーズ製剤の製造
持続放出性浸透投与剤型
以下に列挙した成分を以下の量で、本発明におけるオキシコドン/ナロキソン錠剤の生産のために使用した。
以下に列挙した成分を以下の量で、本発明におけるオキシコドン/ナロキソン錠剤の生産のために使用した。
活性化合物の放出を、HPLCを使用してpH1.2で、USPに従ったバスケット法を適用して12時間にわたって測定した。錠剤オキシコドン/ナロキソン−0(Ox/Nal-0)、オキシコドン/ナロキソン−5(Ox/Nal-5)及びオキシコドン/ナロキソン−10(Ox/Nal-10)を試験した。
錠剤からの活性化合物の放出を、pH1.2で12時間又はpH1.2で1時間、及びその後pH6.5で11時間にわたって測定した。放出速度は、HPLCを用いてUSPに従ったバスケット法によって測定した。
Eudragite(登録商標)RS30Dとトリアセチンとを、60メッシュスクリーンを通過させながら組み合わせ、低せん断下で約5分間又は均一な分散が認められるまで混合する。
1.ステアリルアルコールフレークを衝撃式粉砕機に通す。
2.オキシコドンHCl、ステアリン酸、ステアリルアルコール及びEudragit RSPOを適切な混練機/混合機において混合する。
3.混合した材料を高温の二軸押出機に持続的に供給し、生じたストランドをコンベア上に収集する。
4.ストランドをコンベア上で放置冷却する。
5.ペレタイザーを用いてストランドを1mmペレットに切断する。
6.ペレットを、微細なペレットと大き過ぎるペレットに関して約0.8〜1.4mmの大きさの許容範囲にスクリーニングする。
7.400mg/カプセルの充填重量でカプセルに充填する(サイズ00カプセルに充填する)。
擬似胃液(SGF)900ml及び擬似腸液(SIF)900ml中100rpmでUSP装置1(バスケット)を用いて、282nmで観測する、光ファイバーUV溶解。
実施例11は、多施設無作為プラセボ対照二重盲検平行群試験である。試験は、54歳〜76歳までの7名の男性及び女性のやせ型定型II期又はIII期(ATS病期分類)COPD気腫患者に関して実施された。
6分間でカバーされた平均距離(m):
症例報告書式からの呼吸困難評価:
Claims (13)
- 慢性閉塞性肺疾患(COPD)を有する患者を治療する薬剤の製造のための、少なくとも1種のオピオイドを含有するオピオイド制御放出経口投与剤型の使用。
- 定常状態で12時間ごとに投与したとき有効な治療を提供する、慢性閉塞性肺疾患(COPD)を有する患者を治療する薬剤の製造のための、少なくとも1種のオピオイドを含有するオピオイド制御放出経口投与剤型の使用。
- 定常状態で24時間ごとに投与したとき有効な治療を提供する、慢性閉塞性肺疾患(COPD)を有する患者を治療する薬剤の製造のための、少なくとも1種のオピオイドを含有するオピオイド制御放出経口投与剤型の使用。
- 前記経口投与剤型が、遊離塩基又は製薬上許容される塩の形態の、オキシコドン、ヒドロコドン、ヒドロモルフォン、モルフィン、メタドン、オキシモルフォン、フェンタニル及びスフェンタニルを含む群から選択されるオピオイドアゴニストを含有する、前記請求項のいずれかに記載の使用。
- 前記経口投与剤型が、遊離塩基又は製薬上許容される塩の形態の、オピオイドアゴニストと、ナルトレキソン、ナルメフェン及びナロキソンを含む群から選択されるオピオイドアンタゴニストとの混合物を含有する、前記請求項のいずれかに記載の使用。
- 前記経口投与剤型が、オキシコドン又はその製薬上許容される塩を含有する、前記請求項のいずれかに記載の使用。
- 前記経口投与剤型が、モルフィン又はその製薬上許容される塩を含有する、前記請求項のいずれかに記載の使用。
- 前記経口投与剤型が、遊離塩基又は製薬上許容される塩の形態の、オキシコドンとナロキソンとの混合物を含有する、前記請求項のいずれかに記載の使用。
- 前記経口投与剤型は、保存に安定した医薬製剤であり、その活性化合物が持続的に、不変的に且つ独立して前記製剤から放出される、請求項8に記載の使用。
- オキシコドンがナロキソンの単位投与量より多く存在する、請求項8又は9に記載の使用。
- ナロキソンが1〜50mgの範囲の量で存在する、請求項8〜10に記載の使用。
- オキシコドンが10〜150mg、好ましくは10〜80mgの範囲の量で存在する、請求項8〜11に記載の使用。
- オキシコドンとナロキソンとが、最大25:1、好ましくは最大20:1、15:1、特に好ましくは5:1、4:1、3:1、2:1又は1:1の範囲の重量比で存在する、請求項8〜12に記載の使用。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04013468A EP1604666A1 (en) | 2004-06-08 | 2004-06-08 | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
PCT/EP2005/006155 WO2005120507A1 (en) | 2004-06-08 | 2005-06-08 | Opioids for the treatment of the chronic obstructive pulmonary disease (copd) |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008501750A true JP2008501750A (ja) | 2008-01-24 |
JP4669878B2 JP4669878B2 (ja) | 2011-04-13 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007526290A Expired - Fee Related JP4669878B2 (ja) | 2004-06-08 | 2005-06-08 | 慢性閉塞性肺疾患(copd)の治療のためのオピオイド |
Country Status (15)
Country | Link |
---|---|
US (2) | US8518925B2 (ja) |
EP (4) | EP1604666A1 (ja) |
JP (1) | JP4669878B2 (ja) |
CN (1) | CN1984658B (ja) |
AT (1) | ATE495744T1 (ja) |
CA (1) | CA2569743C (ja) |
CY (1) | CY1111500T1 (ja) |
DE (1) | DE602005026007D1 (ja) |
DK (1) | DK1765349T3 (ja) |
ES (1) | ES2360120T3 (ja) |
HK (1) | HK1104471A1 (ja) |
PL (1) | PL1765349T3 (ja) |
PT (1) | PT1765349E (ja) |
SI (1) | SI1765349T1 (ja) |
WO (1) | WO2005120507A1 (ja) |
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JP2012520261A (ja) * | 2009-03-10 | 2012-09-06 | ユーロ−セルティーク エス.エイ. | オキシコドンおよびナロキソンを含む即時放出医薬組成物 |
JP2013533303A (ja) * | 2010-08-13 | 2013-08-22 | ユーロ−セルティーク エス.エイ. | 保存に安定な製剤を製造するための結合剤の使用 |
JP2015193668A (ja) * | 2010-12-21 | 2015-11-05 | マリンクロッド エルエルシー | モルフィナンを含む安定した固体剤形の薬学的組成物を生成する方法 |
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- 2005-06-08 CN CN2005800230727A patent/CN1984658B/zh not_active Expired - Fee Related
- 2005-06-08 JP JP2007526290A patent/JP4669878B2/ja not_active Expired - Fee Related
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WO2002092059A1 (en) * | 2001-05-11 | 2002-11-21 | Endo Pharmaceuticals, Inc. | Abuse-resistant opioid dosage form |
WO2003007802A2 (en) * | 2001-07-18 | 2003-01-30 | Euro-Celtique, S.A. | Pharmaceutical combinations of oxycodone and naloxone |
WO2003013538A1 (en) * | 2001-08-06 | 2003-02-20 | Euro-Celtique, S.A. | Oral dosage form comprising a therapeutic agent and an adverse-effect agent |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2012520261A (ja) * | 2009-03-10 | 2012-09-06 | ユーロ−セルティーク エス.エイ. | オキシコドンおよびナロキソンを含む即時放出医薬組成物 |
JP2013533303A (ja) * | 2010-08-13 | 2013-08-22 | ユーロ−セルティーク エス.エイ. | 保存に安定な製剤を製造するための結合剤の使用 |
JP2015193668A (ja) * | 2010-12-21 | 2015-11-05 | マリンクロッド エルエルシー | モルフィナンを含む安定した固体剤形の薬学的組成物を生成する方法 |
Also Published As
Publication number | Publication date |
---|---|
HK1104471A1 (en) | 2008-01-18 |
CA2569743C (en) | 2013-10-01 |
WO2005120507A1 (en) | 2005-12-22 |
CY1111500T1 (el) | 2015-08-05 |
SI1765349T1 (sl) | 2011-04-29 |
CN1984658A (zh) | 2007-06-20 |
CN1984658B (zh) | 2012-04-18 |
ATE495744T1 (de) | 2011-02-15 |
US8518925B2 (en) | 2013-08-27 |
DE602005026007D1 (de) | 2011-03-03 |
PT1765349E (pt) | 2011-04-08 |
EP1961421A1 (en) | 2008-08-27 |
EP1765349B1 (en) | 2011-01-19 |
EP1765349A1 (en) | 2007-03-28 |
EP2283843A2 (en) | 2011-02-16 |
US20140057933A1 (en) | 2014-02-27 |
ES2360120T3 (es) | 2011-06-01 |
CA2569743A1 (en) | 2005-12-22 |
PL1765349T3 (pl) | 2011-06-30 |
US20070185146A1 (en) | 2007-08-09 |
DK1765349T3 (da) | 2011-05-16 |
JP4669878B2 (ja) | 2011-04-13 |
EP1604666A1 (en) | 2005-12-14 |
EP2283843A3 (en) | 2011-05-18 |
EP1765349B9 (en) | 2011-12-07 |
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