JPH10508597A - 可融性担体を含有する医薬組成物およびその製造方法 - Google Patents
可融性担体を含有する医薬組成物およびその製造方法Info
- Publication number
- JPH10508597A JPH10508597A JP8515134A JP51513496A JPH10508597A JP H10508597 A JPH10508597 A JP H10508597A JP 8515134 A JP8515134 A JP 8515134A JP 51513496 A JP51513496 A JP 51513496A JP H10508597 A JPH10508597 A JP H10508597A
- Authority
- JP
- Japan
- Prior art keywords
- particles
- diluent
- carrier
- fusible
- drug
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.粒子、好ましくは徐放性粒子を製造するに当り、 (a)高剪断ミキサ内で、薬剤粒子と融点35〜150℃の疎水性および/ま たは親水性の可融性担体または希釈剤の粒子との混合物、または前記薬剤粒子と 前記可融性担体または希釈剤の粒子と水溶性可融性材料または可溶性もしくは不 溶性の有機もしくは無機材料粒子を含有する放出調節成分との混合物を、前記担 体または希釈剤を溶融または軟化させることができる速度およびエネルギー投入 量で機械的に処理して、凝集物を形成し;次いで (b)生成した凝集物を押出す ことを特徴とする粒子の製造方法。 2.工程(b)において、工程(a)から生成した材料を複数個のオリフィスに 通して押出し、次いで小片に形成することを特徴とする請求の範囲1記載の方法 。 3.さらに、 (c)押出物から形成した小片を、所要に応じて低いパーセントの担体または 希釈剤をさらに添加して、引続き機械的に処理し; (d)所要に応じて、工程(c)および場合によっては工程(b)を1回また は2回以上繰り返えす ことを特徴とする請求の範囲2記載の方法。 4.機械的処理中に、マクロ波放射によって熱を供給することを特徴とする請求 の範囲1〜3のいずれか一つの項に記載の方法。 5.マクロ波放射によって熱の一部分のみを供給することを特徴とする請求の範 囲4記載の方法。 6.前記薬剤が、モルヒネ、トラマドーム、ヒドロモルフォン、オキシコドン、 ジアモルフィンまたはこれらのうちの任意の1種の化合物の医薬として許容でき る塩であることを特徴とする請求の範囲1〜5のいずれか一つの項に記載の方法 。 7.疎水性の可融性担体または希釈剤がワックス、例えば、水素化植物油、水素 化ひまし油、蜜蝋、カルナウバ蝋、ミクロクリスタリンワックスおよびグリセ ロールステアレートからなる群から選択したワックスであることを特徴とする請 求の範囲1〜6のいずれか一つの項に記載の方法。 8.前記工程(a)において、前記混合物中に含有させることができる親水性の 可融性材料が、分子量1,000〜20,000のPEGまたはポロキサマーで あることを特徴とする請求の範囲1〜7のいずれか一つの項に記載の方法。 9.前記可融性担体または希釈剤を、前記工程(c)における機械的処理中に、 段階的に添加することを特徴とする請求の範囲3〜8のいずれか一つの項に記載 の方法。 10.請求の範囲1〜9のいずれか一つの項に記載の方法によって得られ、従来の 錠剤形成用賦形剤を含有することのある粒子を圧縮することによって得ることが できる固体の投与形態の医薬組成物。 11.請求の範囲1〜9のいずれか一つの項に記載の方法によって得られ、従来の カプセル剤形成用賦形剤を含有することのある粒子を含有する経口投与用カプセ ル剤の形態の医薬組成物。 12.有効成分が水中で不安定である請求の範囲10または11に記載の固体の投 与形態の医薬組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9422154A GB9422154D0 (en) | 1994-11-03 | 1994-11-03 | Pharmaceutical compositions and method of producing the same |
GB9422154.6 | 1994-11-03 | ||
PCT/GB1995/002579 WO1996014059A1 (en) | 1994-11-03 | 1995-11-03 | Pharmaceutical composition containing a fusible carrier and method for producing the same |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003292426A Division JP2004043485A (ja) | 1994-11-03 | 2003-08-12 | 可融性担体を含有する医薬組成物およびその製造方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH10508597A true JPH10508597A (ja) | 1998-08-25 |
JP3504953B2 JP3504953B2 (ja) | 2004-03-08 |
Family
ID=10763811
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP51513496A Expired - Lifetime JP3504953B2 (ja) | 1994-11-03 | 1995-11-03 | 可融性担体を含有する医薬組成物およびその製造方法 |
JP2003292426A Pending JP2004043485A (ja) | 1994-11-03 | 2003-08-12 | 可融性担体を含有する医薬組成物およびその製造方法 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003292426A Pending JP2004043485A (ja) | 1994-11-03 | 2003-08-12 | 可融性担体を含有する医薬組成物およびその製造方法 |
Country Status (17)
Country | Link |
---|---|
US (1) | US6068855A (ja) |
EP (1) | EP0789559B2 (ja) |
JP (2) | JP3504953B2 (ja) |
KR (1) | KR100413581B1 (ja) |
AT (1) | ATE179886T1 (ja) |
AU (1) | AU3811095A (ja) |
DE (1) | DE69509671T3 (ja) |
DK (1) | DK0789559T4 (ja) |
ES (1) | ES2134501T5 (ja) |
FI (1) | FI114780B (ja) |
GB (1) | GB9422154D0 (ja) |
GR (1) | GR3030938T3 (ja) |
NO (1) | NO320380B1 (ja) |
NZ (1) | NZ294897A (ja) |
TW (1) | TW348062B (ja) |
WO (1) | WO1996014059A1 (ja) |
ZA (1) | ZA959308B (ja) |
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JP2001048778A (ja) * | 1999-08-10 | 2001-02-20 | Dainippon Pharmaceut Co Ltd | 油脂含有徐放性坐剤 |
JP2006502192A (ja) * | 2002-09-23 | 2006-01-19 | ベリオン インコーポレイテッド | 乱用抵抗性の医薬組成物 |
JP2006265258A (ja) * | 1995-07-20 | 2006-10-05 | Smithkline Beecham Plc | パロキセチン制御放出組成物 |
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-
1994
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-
1995
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- 1995-11-03 JP JP51513496A patent/JP3504953B2/ja not_active Expired - Lifetime
- 1995-11-03 AT AT95936019T patent/ATE179886T1/de active
- 1995-11-03 DE DE69509671T patent/DE69509671T3/de not_active Expired - Lifetime
- 1995-11-03 DK DK95936019T patent/DK0789559T4/da active
- 1995-11-03 AU AU38110/95A patent/AU3811095A/en not_active Abandoned
- 1995-11-03 NZ NZ294897A patent/NZ294897A/xx not_active IP Right Cessation
- 1995-11-03 WO PCT/GB1995/002579 patent/WO1996014059A1/en active IP Right Grant
- 1995-11-03 ZA ZA959308A patent/ZA959308B/xx unknown
- 1995-11-03 KR KR1019970702810A patent/KR100413581B1/ko not_active IP Right Cessation
- 1995-11-03 US US08/817,956 patent/US6068855A/en not_active Expired - Lifetime
- 1995-11-03 TW TW084111629A patent/TW348062B/zh not_active IP Right Cessation
- 1995-11-03 ES ES95936019T patent/ES2134501T5/es not_active Expired - Lifetime
-
1997
- 1997-04-28 NO NO19971965A patent/NO320380B1/no not_active IP Right Cessation
- 1997-05-02 FI FI971880A patent/FI114780B/fi not_active IP Right Cessation
-
1999
- 1999-08-10 GR GR990402019T patent/GR3030938T3/el unknown
-
2003
- 2003-08-12 JP JP2003292426A patent/JP2004043485A/ja active Pending
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2006265258A (ja) * | 1995-07-20 | 2006-10-05 | Smithkline Beecham Plc | パロキセチン制御放出組成物 |
JP2001048778A (ja) * | 1999-08-10 | 2001-02-20 | Dainippon Pharmaceut Co Ltd | 油脂含有徐放性坐剤 |
JP2006502192A (ja) * | 2002-09-23 | 2006-01-19 | ベリオン インコーポレイテッド | 乱用抵抗性の医薬組成物 |
JP2012021024A (ja) * | 2002-09-23 | 2012-02-02 | Elan Pharma Internatl Ltd | 乱用抵抗性の医薬組成物 |
JP2015083616A (ja) * | 2002-09-23 | 2015-04-30 | アルケルメス ファーマ アイルランド リミテッドAlkermes Pharma Ireland Limited | 乱用抵抗性の医薬組成物 |
Also Published As
Publication number | Publication date |
---|---|
NO971965D0 (no) | 1997-04-28 |
NO971965L (no) | 1997-04-28 |
DK0789559T3 (da) | 1999-11-15 |
AU3811095A (en) | 1996-05-31 |
DE69509671D1 (de) | 1999-06-17 |
NO320380B1 (no) | 2005-11-28 |
KR970706801A (ko) | 1997-12-01 |
DK0789559T4 (da) | 2002-11-25 |
EP0789559B2 (en) | 2002-10-16 |
FI114780B (fi) | 2004-12-31 |
JP2004043485A (ja) | 2004-02-12 |
ES2134501T3 (es) | 1999-10-01 |
JP3504953B2 (ja) | 2004-03-08 |
TW348062B (en) | 1998-12-21 |
DE69509671T2 (de) | 2000-01-27 |
ES2134501T5 (es) | 2003-05-01 |
WO1996014059A1 (en) | 1996-05-17 |
EP0789559B1 (en) | 1999-05-12 |
NZ294897A (en) | 1998-10-28 |
US6068855A (en) | 2000-05-30 |
ZA959308B (en) | 1996-05-29 |
FI971880A0 (fi) | 1997-05-02 |
GB9422154D0 (en) | 1994-12-21 |
FI971880A (fi) | 1997-06-18 |
DE69509671T3 (de) | 2003-07-31 |
ATE179886T1 (de) | 1999-05-15 |
KR100413581B1 (ko) | 2004-03-31 |
GR3030938T3 (en) | 1999-11-30 |
EP0789559A1 (en) | 1997-08-20 |
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