JP5144513B2 - 医薬物質の粒子の製造法、医薬物質の粒子及びその使用 - Google Patents
医薬物質の粒子の製造法、医薬物質の粒子及びその使用 Download PDFInfo
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- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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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
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Description
(a)医薬物質の溶融物を提供する段階と、
(b)処理チャンバ内に噴霧することによって溶融物の液滴を製造する段階と、
(c)決められた経路で案内され、溶融物の凝固点に応じて温度が決められたプロセスガスの噴流を用いて、処理チャンバ内で固体粒子を噴霧された液滴を通り越して繰り返し案内し、その結果、液滴の少なくとも一部が粒子と接触してその上で凝固する段階と、
(d)粒子を粒径に応じて処理チャンバから取り出す段階と
を含む方法を提供する。
説明及び特許請求の範囲に用いられる技術用語の一部を以下に説明する。
温度110℃のイブプロフェンの溶融物を、前述の構成を特徴とする装置の中に噴霧した。処理チャンバは長方形の断面を特徴とし、0.15×0.2=0.03m2の断面積、及び傾斜した側壁より上に約1mの高さを有している。あらかじめ約40℃に加熱したプロセス空気の流れを、長手方向に装置を通って延びる2つのガス供給スリットを介して約150m3/時で供給する。鉛直方向上方に噴霧する二流体ノズルによって溶融物を噴霧し、圧縮空気を用いて約30g/分の質量流量を有するプロセス空気の噴流の中に供給した。噴霧する空気は90℃まで加熱した。処理チャンバ内には約500gのイブプロフェンの顆粒が存在していた。微粉末を装置の下流でサイクロンによって流出空気から除去し、堆積した固体は核の材料としてスリットの近くで重力測定によって処理チャンバ内に供給した。ジグザグ形の選別器を用いて、処理チャンバの前面から顆粒を連続的に取り出した。選別器で選別された微粒子は選別用の空気によって吹き飛ばし、処理チャンバに戻した。取り出された顆粒は、通常の充填されていない見掛け密度及び通常の粒径分布を有し、したがって次の処理に適している。すなわち、以下の粒径分布が得られた(篩分析)。
>400μm:0.8重量%
315・・・400μm:6.8重量%
250・・・315μm:15.3重量%
160・・・250μm:42.3重量%
100・・160μm:24.9重量%
0・・・100μm:9.9重量%
温度110℃のイブプロフェンの溶融物を、前述の構成を特徴とする装置の中に噴霧した。処理チャンバは長方形の断面を特徴とし、0.2×1.0=0.2m2の断面積、及び傾斜した側壁より上に約1mの高さを有している。あらかじめ約45℃に加熱したプロセス空気の流れを、長手方向に装置を通って延びる2つのガス供給スリットを介して約780m3/時で供給した。プロセス空気の流れ全体を、同じ大きさの4つの吸気チャンバに対して均一に分散させた。前述の処理チャンバは、上側部分で吸気チャンバに沿って広がり、細分されていない。圧縮空気の供給を受け、鉛直方向上方に、総質量流量が約22kg/時のプロセス空気の噴流内への噴霧を行う二流体ノズルによって溶融物を噴霧した。処理チャンバ内には約6kgのイブプロフェンの顆粒が存在していた。装置に組み込まれ、圧縮空気のパルスによって周期的に清浄化されるカートリッジフィルタによって、微粉末を流出空気から除去した。スターホイール放出装置を用いて、処理チャンバからの顆粒を分類せずに前面で取り出した。次いで、放出された顆粒の流れをすべて選別システム内に案内し、そこで標準より大きい部分(>400μm)及び標準より小さい部分(<200μm)を選別して除いた。選別で除去された標準より小さい部分は空気圧によって吹き飛ばし、処理チャンバ内に戻した。標準より大きい材料は、固定されたディスクミルで連続的に粉砕され、同様に顆粒化の核として処理チャンバ内に戻した。この場合も、取り出された顆粒(>200μm且つ<400μm)は、次の処理に適した適当な充填されていない嵩密度、及び以下に列挙する適当な粒径分布を有する。
>400μm:0.8重量%
315・・・400μm:6.8重量%
250・・・315μm:15.3重量%
160・・・250μm:42.3重量%
100・・160μm:24.9重量%
0・・・100μm:9.9重量%
2 (1つ又は複数の)ガスの噴流
3 偏向部
4 放出要素
5 側壁
6 任意の方向に噴霧する(1つ又は複数の)噴霧ノズル
7 上方に噴霧する(1つ又は複数の)噴霧ノズル
8 処理チャンバ
9 処理ステージの断面
10 プロセスガス
11 流出ガス
12 冷却システム又は加熱システムを有する断熱物
13 入力システム
14 膨張区域
15 固体の循環
16 (1つ又は複数の)案内プレート
17 吸気チャンバ
18 圧縮空気のパルス
19 空気流出部
20 固体を伴う流出空気
21 除去され戻される固体
22 ノズル噴霧区域
23 ガスの噴流からの粒子の脱出
24 戻り区域
25 微粉末除去システム
26 供給装置
27 機械的粉砕ユニット
28 熱伝達ユニット
29 側壁
Claims (18)
- 医薬物質から約1.4未満の長さ−幅の比を有する粒子を製造する方法であって、
(a)医薬物質の溶融物を提供する段階と、
(b)処理チャンバ内に噴霧することによって溶融物の液滴を製造する段階と、
(c)決められた経路で案内され、溶融物の凝固点より10〜40℃低い温度のプロセスガスの噴流を用いて、処理チャンバ内で固体粒子を噴霧された液滴を通り越して繰り返し案内し、その結果、液滴の少なくとも一部が粒子と接触してその上で凝固する段階と、
(d)粒子を粒径に応じて処理チャンバから取り出す段階と
を含む上記方法。 - 製造された粒子の平均粒径が0.1〜3mmの範囲である請求項1に記載の方法。
- 粒子の長さ−幅の比が約1.3未満、好ましくは約1.2未満、より好ましくは約1.1未満、特に約1.05未満である請求項1又は2に記載の方法。
- 処理チャンバ内に流動化された固体粒子の噴流層が形成される請求項1から3までのいずれかに記載の方法。
- 溶融物の液滴を噴流層の中に噴霧することによって、固体粒子が噴霧された液滴を通り越して案内される請求項1から4までのいずれかに記載の方法。
- 溶融物の液滴が、放出区域の領域において噴流層の中に噴霧される請求項5に記載の方法。
- 液滴がプロセスガスの噴流と同じ方向に噴霧される請求項6に記載の方法。
- 液滴が、戻り区域に隣接する領域において放出区域の領域内に噴霧される請求項6又は7に記載の方法。
- 溶融物が均質な液相である請求項1から8までのいずれかに記載の方法。
- 溶融物が内部に分散した固体物質を含む請求項1から8までのいずれかに記載の方法。
- 固体粒子が外部から処理チャンバに導入される請求項1から10までのいずれかに記載の方法。
- 医薬物質が活性な医薬成分である請求項1から11までのいずれかに記載の方法。
- 活性な医薬成分がイブプロフェンである請求項12に記載の方法。
- 請求項1から13までのいずれかに記載の方法によって製造される粒子。
- 医薬物質の粒子の集合体であって、粒子が0.1〜3mmの平均粒径を有し、粒子の少なくとも90%が約1.4未満の長さ−幅の比を有し、医薬物質の溶融物から製造される粒子の集合体。
- 医薬物質がイブプロフェンである請求項15に記載の粒子の集合体。
- 請求項1から13までのいずれかに記載の方法によって製造される請求項15に記載の粒子の集合体。
- 医薬剤形を製造するための、請求項14に記載の粒子、或いは請求項15から17までのいずれかに記載の集合体の使用。
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DE102005037630.4 | 2005-08-09 | ||
DE102005037630A DE102005037630A1 (de) | 2005-08-09 | 2005-08-09 | Verfahren zur Herstellung von Teilchen aus pharmazeutischen Substanzen, Teilchen aus pharmazeutischen Substanzen sowie deren Verwendung |
PCT/EP2006/007848 WO2007017254A2 (de) | 2005-08-09 | 2006-08-08 | Verfahren zur herstellung von teilchen aus pharmazeutischen substanzen, kollektiven von diesen teilchen sowie deren verwendung |
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JP2008525472A Active JP5144513B2 (ja) | 2005-08-09 | 2006-08-08 | 医薬物質の粒子の製造法、医薬物質の粒子及びその使用 |
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US (3) | US8597685B2 (ja) |
EP (1) | EP1915135B1 (ja) |
JP (1) | JP5144513B2 (ja) |
DE (1) | DE102005037630A1 (ja) |
DK (1) | DK1915135T3 (ja) |
ES (1) | ES2422433T3 (ja) |
PL (1) | PL1915135T3 (ja) |
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WO (1) | WO2007017254A2 (ja) |
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CN101491483B (zh) * | 2008-12-24 | 2011-12-28 | 烟台开发区博森制药机械有限公司 | 步进增压气冲微滴丸滴头 |
CN101518495B (zh) * | 2009-03-26 | 2011-12-28 | 天津大学 | 一种振动破碎式滴丸机 |
EP2621892B1 (de) | 2010-09-27 | 2015-07-29 | Basf Se | Verfahren zur herstellung eines granulates enthaltend eines oder mehrere komplexbildnersalze |
US8754026B2 (en) | 2010-09-27 | 2014-06-17 | Basf Se | Process for producing granules comprising one or more complexing agent salts |
CN102078259A (zh) * | 2010-12-29 | 2011-06-01 | 天津大学 | 一种制备均匀滴丸的设备及方法 |
EP2704696A1 (en) | 2012-03-26 | 2014-03-12 | Glatt AG | Taste-masked ibuprofen granules |
FR2996454B1 (fr) * | 2012-10-05 | 2015-01-09 | Roquette Freres | Procede de granulation de 1,4-3,6 dianhydrohexitols, granules obtenus et leurs utilisations |
WO2017085295A1 (en) | 2015-11-18 | 2017-05-26 | Hermes Arzneimittel Gmbh | Ibuprofen compositions for direct oral administration |
CN111918920A (zh) | 2018-04-10 | 2020-11-10 | 埃克森美孚化学专利公司 | 热塑性硫化橡胶组合物 |
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WO2024025868A1 (en) * | 2022-07-25 | 2024-02-01 | Spraying Systems Co. | Fluidized bed coating apparatus |
CN117398913B (zh) * | 2023-12-12 | 2024-02-06 | 博德生物技术(德州)有限公司 | 一种牛蒡黄精鹿宝肽片生产用造粒装置 |
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WO2007017254A2 (de) | 2007-02-15 |
EP1915135A2 (de) | 2008-04-30 |
US9119788B2 (en) | 2015-09-01 |
US20140056985A1 (en) | 2014-02-27 |
DE102005037630A1 (de) | 2007-02-15 |
PL1915135T3 (pl) | 2013-09-30 |
ES2422433T3 (es) | 2013-09-11 |
DK1915135T3 (da) | 2013-07-29 |
SI1915135T1 (sl) | 2013-08-30 |
US8597685B2 (en) | 2013-12-03 |
US20100152486A1 (en) | 2010-06-17 |
JP2009504212A (ja) | 2009-02-05 |
US9050254B2 (en) | 2015-06-09 |
US20140054808A1 (en) | 2014-02-27 |
EP1915135B1 (de) | 2013-04-24 |
WO2007017254A3 (de) | 2008-05-15 |
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