JP2013525338A - 医薬品有効成分の粒子加工のための方法 - Google Patents
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Abstract
【選択図】図1
Description
1)フランカルボン酸モメタゾン一水和物(130g)を、水(867g)に懸濁し、30分間撹拌して均一な懸濁液を形成し、実験室規模の高圧キャビテーション(HPC)装置に送り込み、再循環モード(すなわちHPCの排出液を撹拌容器入口に戻すモード)で10kPsi(689バール)の圧力で作動させた。このキャビテーションステップの後、懸濁液を、次のステップで使用するために保持容器に移した。HPC装置を水ですすぎ、この洗浄水を懸濁液の主部分に加えた。
2)懸濁液を、5ml/分の供給速度で、撹拌しながら、実験室規模の噴霧乾燥機に送り込み、66℃の温度で乾燥させた。生成物を、ガラスフラスコ内に収集し、72gを得た。
3)単離した生成物は、US6180781B1に主張されているのと実質的に同じXRPD図1.1を示した。動的水蒸気吸着(dynamic vapour sorption)(DVS)によって測定された非晶質含有率は、1.1%未満であり、無水形は、近赤外分光法によって検出されなかった。TGA値は、3.0%であった。生成された粉末の粒径分布は、Dv10=1.91μm;Dv50=3.97μm;Dv90=7.47μm;スパン=1.4であった。図1を参照のこと。
1)プロピオン酸フルチカゾン(30g)を、水(100g)に懸濁し、均一な懸濁液が得られるまで撹拌し、実験室規模のHPCに送り込み、40kPsi(2758バール)の圧力で、20サイクル作動させた。このキャビテーションステップの後、懸濁液を、次のステップで使用するために保持容器に移した。HPC装置を水ですすぎ、このすすぎ水を懸濁液の主部分に加えた。
2)懸濁液を、5ml/分の供給速度で、撹拌しながら、実験室規模の噴霧乾燥機に送り込み、70℃の温度で乾燥させた。生成物を、ガラスフラスコ内に収集し、21gを得た。
3)単離した生成物は、Dv10=1.20μm;Dv50=2.45μm;Dv90=4.68μm;スパン=1.4という粒径分布と共に、出発材料と実質的に同じXRPDを示した。図2を参照のこと。
1)フランカルボン酸フルチカゾン(9g)を、水(100g)に懸濁し、均一な懸濁液が得られるまで撹拌し、実験室規模のHPCに送り込み、30kPsi(2068バール)の圧力で、20サイクル作動させた。このキャビテーションステップの後、懸濁液を、次のステップで使用するために保持容器に移した。HPC装置を水ですすぎ、このすすぎ水を懸濁液の主部分に加えた。
2)懸濁液を、5ml/分の供給速度で、撹拌しながら、実験室規模の噴霧乾燥機に送り込み、50℃の温度で乾燥させた。生成物を、ガラスフラスコ内に収集し、6.7gを得た。
3)単離した生成物は、Dv10=0.89μm;Dv50=1.95μm;Dv90=3.78μm;スパン=1.5という粒径分布と共に、出発材料と実質的に同じXRPDを示した。図3を参照のこと。
1)キシナホ酸サルメテロール(140g)を、ヘプタン(1400g)に懸濁し、均一な懸濁液が得られるまで撹拌した。次いで、これを実験室規模のHPCに送り込み、15kPsi(1034バール)の圧力で、7サイクル作動させた。このキャビテーションステップの後、懸濁液を、ヘプタンと共に使用するために保持容器に移し、すすぎ水を懸濁液の主部分に加えた。
2)懸濁液を、12ml/分と17ml/分の間の供給速度で、撹拌しながら、実験室規模の噴霧乾燥機に送り込み、40℃の温度で乾燥させた。生成物を、ガラスフラスコ内に収集し、104gを得た。
3)単離した生成物は、Dv10=0.33μm;Dv50=1.37μm;Dv90=3.09μm;スパン=2.0という粒径分布と共に、出発材料と実質的に同じXRPDを示した。図4を参照のこと。
1)チオトロピウム臭化物(20g)を、アセトン(200g)に懸濁し、均一な懸濁液が得られるまで撹拌した。次いで、これを実験室規模のHPCに送り込み、20kPsi(1379バール)の圧力で、21サイクル作動させた。このキャビテーションステップの後、懸濁液を、保持容器に移した。
2)懸濁液を、6ml/分の供給速度で、撹拌しながら、実験室規模の噴霧乾燥機に送り込み、45℃の温度で乾燥させた。生成物を、ガラスフラスコ内に収集し、13gを得た。
3)単離した生成物は、Dv10=0.74μm;Dv50=2.90μm;Dv90=5.58μm;スパン=1.7の粒径分布を示した。
Claims (19)
- 医薬品有効成分(API)の粒径を、該医薬品有効成分の多形を維持しながら縮小させるための方法であって、高圧でのキャビテーションによって該医薬品有効成分を加工するステップを含む、前記方法。
- 前記有効成分が、該有効成分が可溶でない溶媒に懸濁される、請求項1記載の方法。
- 前記溶媒が、水、ヘプタン、アルコール、ケトン、若しくはアルカン、又は2種以上の前述のものの混合物である、請求項1又は2記載の方法。
- 300から3500バールであるキャビテーション圧力を特徴とする、請求項1、2、又は3記載の方法。
- 粉末の形態の加工された有効成分を単離するステップをさらに含む、請求項1〜4のいずれか1項記載の方法。
- 前記単離ステップが、濾過又は噴霧乾燥を含む、請求項5記載の方法。
- 前記単離ステップが、噴霧乾燥を含む、請求項6記載の方法。
- 前記噴霧乾燥ステップが、前記キャビテーションステップの後すぐに行われる、請求項7記載の方法。
- 前記医薬品有効成分が、肺又は鼻への局所送達に適している、請求項1〜8のいずれか1項記載の方法。
- 前記有効成分が、モメタゾン、フルチカゾン、チオトロピウム、シクレソニド、ブデソニド、フォルモテロール、サルメテロール、サルブタモール、ベクロメタゾン、ベタメタゾン、イプラトロピウム、テルブタリン、若しくはヒドロコルチゾン、又は前述のものの1種の医薬として許容し得る塩若しくはエステル、或いは前述の医薬品有効成分又はその医薬として許容し得る塩若しくはエステルの2種以上のものの組み合わせである、請求項1〜9のいずれか1項記載の方法。
- 前記有効成分が、フランカルボン酸モメタゾン若しくはフランカルボン酸モメタゾン一水和物;プロピオン酸フルチカゾン若しくはフランカルボン酸フルチカゾン;チオトロピウム臭化物若しくはチオトロピウム臭化物一水和物;シクレソニド;ブデソニド;フォルモテロール;サルメテロール;サルブタモール;ジプロピオン酸ベクロメタゾン;酢酸ベタメタゾン;イプラトロピウム;テルブタリン;若しくはヒドロコルチゾン17-プロピオナート21-アセタート、又はこれらの医薬品有効成分の2種以上のものの組み合わせである、請求項10記載の方法。
- 前記有効成分が、フランカルボン酸モメタゾン一水和物、プロピオン酸フルチカゾン、フランカルボン酸フルチカゾン、キシナホ酸サルメテロール、又はチオトロピウム臭化物である、請求項1〜11のいずれか1項記載の方法。
- 前記医薬品有効成分の粒径分布が、2.5未満のスパンを含む、請求項1〜12のいずれか1項記載の方法。
- 前記スパンが、2.0未満である、請求項13記載の方法。
- 前記スパンが、1.8.未満である、請求項13又は14記載の方法。
- 医薬組成物を製造する方法であって、請求項1〜15のいずれか1項記載の方法を実施することと、次いで、該医薬品有効成分を1種以上の医薬として許容し得る賦形剤と合わせることとを含む、前記方法。
- 前記医薬組成物が、鼻又は肺への局所送達のための粉末である、請求項16記載の方法。
- 請求項1〜15のいずれか1項記載の方法によって得ることができる、医薬品有効成分(API)。
- 請求項18記載の医薬品有効成分(API)を含む、医薬組成物。
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PT105058A PT105058B (pt) | 2010-04-21 | 2010-04-21 | Processo para processamento de partículas de ingredientes activos farmacêuticos |
PCT/GB2011/000631 WO2011131947A2 (en) | 2010-04-21 | 2011-04-21 | A process for particle processing of active pharmaceutical ingredients |
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JP2017504637A (ja) * | 2014-01-28 | 2017-02-09 | ホビオネ インターナショナル エルティーディー | 支援された粒子径低減方法 |
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JP2019502697A (ja) * | 2015-12-15 | 2019-01-31 | ホビオネ サイエンティア リミテッド | 呼吸域ザフィルルカスト粒子の調製方法 |
US10987305B2 (en) | 2015-12-15 | 2021-04-27 | Cipla Limited | Preparation of respirable zafirlukast particles |
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US20130203717A1 (en) | 2013-08-08 |
MX2012012215A (es) | 2013-05-09 |
PT105058B (pt) | 2013-04-17 |
SG185003A1 (en) | 2012-11-29 |
IL222596A0 (en) | 2012-12-31 |
JP6347608B2 (ja) | 2018-06-27 |
US9956144B2 (en) | 2018-05-01 |
CN102970978A (zh) | 2013-03-13 |
EP2560620B1 (en) | 2020-09-16 |
CA2796978A1 (en) | 2011-10-27 |
MX338594B (es) | 2016-04-25 |
RU2597790C2 (ru) | 2016-09-20 |
BR112012026941A2 (pt) | 2016-07-12 |
RU2012149459A (ru) | 2014-05-27 |
JP6857467B2 (ja) | 2021-04-14 |
CA2796978C (en) | 2019-07-02 |
EP2560620A2 (en) | 2013-02-27 |
PT105058A (pt) | 2011-10-21 |
IL222596B (en) | 2019-03-31 |
WO2011131947A2 (en) | 2011-10-27 |
JP2017019845A (ja) | 2017-01-26 |
PL2560620T3 (pl) | 2021-04-06 |
CN102970978B (zh) | 2017-05-10 |
WO2011131947A3 (en) | 2012-01-05 |
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