JP2013255708A - 吸入用パウダーの製造方法 - Google Patents
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Abstract
【解決手段】 本発明は,第1の有効成分と担体を粉砕媒体の存在下に撹拌し,第1の有効成分を解砕しつつ,担体と混合することで担体及び第1の有効成分の混合物を得る第1の混合工程と,第1の混合工程で得られた混合物に,微粒粉体を添加し,粉砕媒体の存在下に撹拌混合する第2の混合工程と,を含む,吸入用パウダーの製造方法に関する。
【選択図】図1
Description
HPLC(液体高速クロマトグラフィー)として,島津製作所製Prominence(登録商標)を用いた。検出波長は,流速228nm,流速は0.8
mL/minとし,移動相としてCH3CN:H2O = 7:1のものを用い,内部標準としてトランス−スチルベン(trans-stilbene) 10 マイクロg/mlを用いた。サンプリング溶液は,メタノール:水:CH3CN:H2O =10:7:3のものを用いた。カラムとして,東ソー社製TSKgel ODS-80Ts直径4.6
mm長さ150 mmのものを用いた。
カスケードインパクターとしてティシュエンヴァイラメンタル(Tisch Environmental)社製シリーズ290 マープルパーソナルカスケードインパクターを用いた。流量は,2l/分であり,サンプル量はブリスター換算で5〜10回分であり,定量分析には,先に説明したHPLCを用いた。
ふるい目開きの異なる3種類のふるい(60,100,200メッシュ)を順に重ね,底部に容器を装着する。粉体(例えば200メッシュ以下)を最上段(60メッシュ)のふるいに2g供給し,一定時間ふるいを振動させる。
振動時間(T)は次式によって決める。
T=20+(1.6−W)/0.016 [sec] (2)
ここで,Wは動的みかけ密度と呼ばれ,次式によって計算する。
W={(P−A)C/100}+A [g/cm3] (3)
振動終了後,上段(60メッシュ)のふるい残量X[g],中段(100メッシュ)のふるい残量Y[g],下段(200メッシュ)のふるい残量Z[g]を測定し,次式により自己凝集度Gを算出する。
G=(X/2+3Y/10+Z/10)×100 (4)
このGが高いほど自己凝集性が高いことを示す。
担体乳糖,β2−刺激剤,細粒乳糖及びコルチゾール誘導体を混合容器内に添加した。その後,混合容器を1分間振盪した。ターブラー混合機を用いて46rpmの回転速度にて1時間混合を行った。
担体乳糖,細粒乳糖を混合・攪拌した後に,β2−刺激剤及びコルチゾール誘導体を混合攪拌した以外は実施例1と同様にして乾燥粉末組成物を得た。
比較例1: 相対標準偏差 10.5%
比較例2: 相対標準偏差 8.3%
実施例2では,有効成分を変えた場合に,本発明が有効であるか否か検討した。実施例1においてキシナホ酸サルメテロール(SX)の替わりにテバAPI社製フマル酸ホルモテロール(FF)(粒径(D50)が5μm以下)を用い,プロピオン酸フルチカゾン(FP)の替わりにテバAPI社製ブデソニド(粒径(D50)が5μm以下)を用いた以外は実施例1と同様にして吸入用パウダーを製造した。そして,実施例1の吸入用パウダー及び実施例2の吸入用パウダーの分散性についてカスケードインパクター用いてFPF(Fine Particle Fraction)を評価した。
実施例3−1.実施例1において,担体乳糖に替えてロケット社製マンニトール(粒径(D50)が60μm)を用い,細粒乳糖に替えてロケット社製マンニトール(粒径(D50)が5μm以下)を用いた以外は実施例1と同様にして吸入用パウダーを製造した。
実施例4−1.実施例1において,細粒乳糖に替えてロケット社製マンニトール(粒径(D50)が5μm以下)を用いた以外は実施例1と同様にして吸入用パウダーを製造した。
Claims (8)
- 第1の有効成分と担体を粉砕媒体の存在下に撹拌し,第1の有効成分を解砕しつつ,担体と混合することで担体及び第1の有効成分の混合物を得る第1の混合工程と,
第1の混合工程で得られた混合物に,微粒粉体を添加し,粉砕媒体の存在下に撹拌混合する第2の混合工程と,
を含む,
吸入用パウダーの製造方法。 - 請求項1に記載の吸入用パウダーの製造方法であって,
前記第1の混合工程は,前記第1の有効成分と異なる第2の有効成分をさらに含む,
吸入用パウダーの製造方法。 - 請求項1に記載の吸入用パウダーの製造方法であって,
前記第2の混合工程は,前記第1の有効成分と異なる第2の有効成分をさらに含む,
吸入用パウダーの製造方法。 - 請求項2又は3に記載の吸入用パウダーの製造方法であって,
前記第1の有効成分は,前記第2の有効成分に比べて自己凝集性が高い,吸入用パウダーの製造方法。 - 請求項2又は3に記載の吸入用パウダーの製造方法であって,
前記第1の有効成分は,キシナホ酸サルメテロールであり,
前記第2の有効成分は,プロピオン酸フルチカゾンである,吸入用パウダーの製造方法。 - 請求項1に記載の吸入用パウダーの製造方法であって,
前記微粒粉体の平均粒径は,前記担体の平均粒径の1/50以上1/5以下である,吸入用パウダーの製造方法。 - 請求項6に記載の吸入用パウダーの製造方法であって,
前記担体及び前記微粒粉体の組成は同一でも異なってもよく,糖類又は糖アルコールである,吸入用パウダーの製造方法。 - 請求項1に記載の吸入用パウダーの製造方法であって,
前記粉砕媒体は,ビーズである,吸入用パウダーの製造方法。
Priority Applications (12)
Application Number | Priority Date | Filing Date | Title |
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JP2012134171A JP5087182B1 (ja) | 2012-06-13 | 2012-06-13 | 吸入用パウダーの製造方法 |
AU2013275641A AU2013275641B2 (en) | 2012-06-13 | 2013-02-25 | Method for producing powder for inhalation |
PCT/JP2013/054710 WO2013187088A1 (ja) | 2012-06-13 | 2013-02-25 | 吸入用パウダーの製造方法 |
EP13803640.5A EP2716281B1 (en) | 2012-06-13 | 2013-02-25 | Method for producing powder for inhalation |
NZ620714A NZ620714A (en) | 2012-06-13 | 2013-02-25 | Method for producing powders for inhalation |
CA2840372A CA2840372C (en) | 2012-06-13 | 2013-02-25 | Method for producing powders for inhalation |
BR112013032841-0A BR112013032841B1 (pt) | 2012-06-13 | 2013-02-25 | Método para a produção de pós para inalação |
US14/128,765 US9532958B2 (en) | 2012-06-13 | 2013-02-25 | Method for producing powders for inhalation |
CN201380001676.6A CN103619326B (zh) | 2012-06-13 | 2013-02-25 | 吸入用粉的制作方法 |
RU2013154972/15A RU2013154972A (ru) | 2012-06-13 | 2013-02-25 | Способ изготовления порошков для ингаляции |
PT138036405T PT2716281T (pt) | 2012-06-13 | 2013-02-25 | Método de produção de pó para inalação |
IL229834A IL229834B (en) | 2012-06-13 | 2013-12-05 | Method for producing powders for inhalation |
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JP2012134171A JP5087182B1 (ja) | 2012-06-13 | 2012-06-13 | 吸入用パウダーの製造方法 |
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JP5087182B1 JP5087182B1 (ja) | 2012-11-28 |
JP2013255708A true JP2013255708A (ja) | 2013-12-26 |
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US (1) | US9532958B2 (ja) |
EP (1) | EP2716281B1 (ja) |
JP (1) | JP5087182B1 (ja) |
CN (1) | CN103619326B (ja) |
AU (1) | AU2013275641B2 (ja) |
BR (1) | BR112013032841B1 (ja) |
CA (1) | CA2840372C (ja) |
IL (1) | IL229834B (ja) |
NZ (1) | NZ620714A (ja) |
PT (1) | PT2716281T (ja) |
RU (1) | RU2013154972A (ja) |
WO (1) | WO2013187088A1 (ja) |
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EP2247629B1 (en) | 2008-01-31 | 2011-09-14 | ExxonMobil Chemical Patents Inc. | Improved utilization of linear alpha olefins in the production of metallocene catalyzed poly-alpha olefins |
JP6116206B2 (ja) * | 2012-11-26 | 2017-04-19 | クリニプロ株式会社 | 吸入用パウダーの製造方法 |
CN108066329B (zh) * | 2016-11-11 | 2021-11-16 | 江苏恒瑞医药股份有限公司 | 一种吸入用氟替卡松或其衍生物的微粒的制备方法 |
IT201900002857A1 (it) | 2019-02-27 | 2020-08-27 | Ntc S R L | Procedimento di riempimento di contenitori con una polvere |
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DE4140689B4 (de) * | 1991-12-10 | 2007-11-22 | Boehringer Ingelheim Kg | Inhalationspulver und Verfahren zu ihrer Herstellung |
JP2001151673A (ja) * | 1999-09-06 | 2001-06-05 | Nikken Chem Co Ltd | 吸入用粉末製剤の製造方法 |
JP4691298B2 (ja) * | 1999-10-12 | 2011-06-01 | 科研製薬株式会社 | 粉末吸入用製剤及びその製造方法 |
GB0010709D0 (en) * | 2000-05-03 | 2000-06-28 | Vectura Ltd | Powders for use a in dry powder inhaler |
CA2420597C (en) | 2000-08-31 | 2011-05-17 | Rtp Pharma Inc. | Milled particles |
ATE420630T1 (de) * | 2000-11-29 | 2009-01-15 | Itoham Foods Inc | Pulverzubereitungen und verfahren zu ihrer herstellung |
EP1337239B2 (en) * | 2000-11-30 | 2015-11-25 | Vectura Limited | Particles for use in a pharmaceutical composition |
US20050158248A1 (en) | 2002-08-21 | 2005-07-21 | Xian-Ming Zeng | Method of preparing dry powder inhalation compositions |
JP4744876B2 (ja) | 2002-08-21 | 2011-08-10 | ノートン・ヘルスケアー リミテッド | 乾燥粉末吸入組成物の製造方法 |
US7230012B2 (en) | 2002-11-14 | 2007-06-12 | Celgene Corporation | Pharmaceutical compositions and dosage forms of thalidomide |
JO3102B1 (ar) * | 2004-03-17 | 2017-09-20 | Chiesi Framaceutici S P A | صيغ صيدلانية لوسائل استنشاق بها مسحوق جاف تشتمل على مكون فعال بقوة منخفضة الجرعة |
GB0525254D0 (en) * | 2005-12-12 | 2006-01-18 | Jagotec Ag | Powder compositions for inhalation |
US20070178166A1 (en) * | 2005-12-15 | 2007-08-02 | Acusphere, Inc. | Processes for making particle-based pharmaceutical formulations for pulmonary or nasal administration |
GB0714134D0 (en) | 2007-07-19 | 2007-08-29 | Norton Healthcare Ltd | Dry-powder medicament |
CN101422436B (zh) * | 2007-10-31 | 2010-12-01 | 江苏正大天晴药业股份有限公司 | 供吸入干粉组合物 |
AU2008325290B2 (en) | 2007-11-07 | 2011-12-08 | Astrazeneca Ab | Dry powder formulations comprising ascorbic acid derivates |
JP2009279558A (ja) | 2008-05-26 | 2009-12-03 | Sumitomo Wiring Syst Ltd | 混合装置 |
WO2011145109A1 (en) * | 2010-05-20 | 2011-11-24 | Sun Pharma Advanced Research Company Ltd., | Dry powder inhalation composition |
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JP5087182B1 (ja) | 2012-11-28 |
CA2840372A1 (en) | 2013-12-19 |
IL229834A0 (en) | 2014-03-31 |
PT2716281T (pt) | 2020-11-19 |
RU2013154972A (ru) | 2015-06-20 |
NZ620714A (en) | 2017-01-27 |
BR112013032841A8 (pt) | 2021-09-08 |
BR112013032841A2 (pt) | 2017-02-21 |
IL229834B (en) | 2019-12-31 |
EP2716281A4 (en) | 2015-08-26 |
EP2716281A1 (en) | 2014-04-09 |
AU2013275641A1 (en) | 2014-02-27 |
BR112013032841B1 (pt) | 2022-04-05 |
US20140134254A1 (en) | 2014-05-15 |
EP2716281B1 (en) | 2020-09-30 |
US9532958B2 (en) | 2017-01-03 |
WO2013187088A1 (ja) | 2013-12-19 |
CN103619326B (zh) | 2018-05-22 |
AU2013275641B2 (en) | 2017-02-02 |
CA2840372C (en) | 2017-12-12 |
CN103619326A (zh) | 2014-03-05 |
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