JP2007538089A - グルココルチコステロイドの熱滅菌 - Google Patents
グルココルチコステロイドの熱滅菌 Download PDFInfo
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- JP2007538089A JP2007538089A JP2007527389A JP2007527389A JP2007538089A JP 2007538089 A JP2007538089 A JP 2007538089A JP 2007527389 A JP2007527389 A JP 2007527389A JP 2007527389 A JP2007527389 A JP 2007527389A JP 2007538089 A JP2007538089 A JP 2007538089A
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- A—HUMAN NECESSITIES
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
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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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
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- Animal Behavior & Ethology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
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- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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- Steroid Compounds (AREA)
Abstract
Description
本発明の他の態様では、本明細書中に開示される前記方法により調製される無菌置換活性グルココルチコステロイド懸濁液を含む組成物が開示される。
「滅菌に有効な時間」なる文言は、指定される特定の条件下で滅菌をもたらすのに必要とされる最短時間を意味する。好ましくは、滅菌に有効な時間は約2分〜約180分である。
本発明のこの態様の他の具体的態様は、医薬上許容され得る賦形剤、希釈剤等を用いて医薬上適当な濃度に前記懸濁液を希釈するステップをさらに含む。
ブデソニドの熱滅菌
濃縮されたブデソニドサンプルを、高剪断ミキサーを用いるホモジェナイゼーションにより当該固体材料を分散させ、密封容器に入れることにより調製し、表1に示す時間および温度での加熱に供した。サンプルは記載の時間、記載の温度で加熱された。
続いて、加熱された濃縮サンプルを分析し、ブデソニド含量と不純物レベル(公知のものも未知のものも)をUV/ビス・ディテクターを用いてHPLC分析により測定した。その結果を表2〜5に示す。
濃縮されたブデソニドサンプルをさらに、レーザー・ディフラクションによる粒子サイズ分析に供した。その分布を表6に示す。図1および図2に、熱ストレスをかけられた濃縮物のブデソニド含量と全不純物を各々図示する。
滅菌は、スポア・ストリップ・バイオインジケータを使用して、これをサンプル濃縮物と同時に処理することにより確認した。
ブデソニドの熱滅菌-試験2
実施例1で、変性産物の生成の明らかに濃度依存性の低下が観察されたことをきっかけに、許容可能な変性と粒子サイズを維持して滅菌され得る最低のブデソニド濃度限度を決定するための試験を次に行った。加熱および処理時間を121℃で30分間に限定したことを除き、実施例1に概説した方法に従い、サンプルを調製した。
ベクロメタゾンジプロピオネートの熱滅菌
実施例1の方法を用いて、表10に示すベクロメタゾンジプロピオネート濃縮物および希釈物を調製した。不純物レベルおよび粒子サイズの測定も、先に概説したように測定した。結果は、ベクロメタゾン含量の有意な変化または不純物の増加が、オートクレーブでの加熱の際に生じなかったことを示す(データは示さず)。さらに、オートクレーブにかけることより、粒子サイズの分布に有意な変化は生じなかった。
特許請求の範囲に記載される発明を詳細に、その特定の具体的態様を用いて記載したが、特許請求の範囲に記載される発明の本質および範囲から離れることなく、当該発明に対する種々の変更および加減をなすことができる。つまり、例えば当業者は、通常の実験のみを用いて、本明細書中に記載される特定の物質および方法に対する多くの均等物を認識または確認することができるであろう。そのような均等物は、本発明の範囲内にあるとみなされ、本願の特許請求の範囲によりカバーされる。
Claims (17)
- 置換活性グルココルチコステロイドの懸濁液に湿熱を、滅菌に有効な時間適用するステップを含む、置換活性グルココルチコステロイドの滅菌のための方法。
- グルココルチコステロイドの水性懸濁液を加熱するステップを含み、前記ステップにおいて、前記グルココルチコステロイドが十分に低い水溶度を有し、かつ、少なくとも50%の前記グルココルチコステロイドが加熱中に懸濁液の形態にある十分量で使用される、グルココルチコステロイドの滅菌のための方法。
- 少なくとも60%の前記グルココルチコステロイドが加熱中に懸濁液の形態にある請求項2に記載の方法。
- 加熱を約101℃〜約145℃の温度で行う請求項1〜3のいずれか1項に記載の方法。
- 加熱を、オートクレーブにより行う請求項1〜4のいずれか1項に記載の方法。
- 加熱を約2〜約180分間行う請求項1〜5のいずれか1項に記載の方法。
- 前記懸濁液がさらに界面活性剤を含む請求項1〜6のいずれか1項に記載の方法。
- 前記界面活性剤が約0.75mg/ml〜約60mg/mlの濃度で含まれる請求項7に記載の方法。
- 前記グルココルチコステロイドがブデソニドまたはベクロメタゾンジプロピオネートである請求項1〜8のいずれか1項に記載の方法。
- 前記グルココルチコステロイドがブデソニドであり、前記加熱を121℃で約20〜30分間または110℃で約120分間行う請求項9に記載の方法。
- 前記グルココルチコステロイドがベクロメタゾンジプロピオネートであり、前記加熱を121℃で約20〜30分間または110℃で約120分間行う請求項9に記載の方法。
- 前記グルココルチコステロイドが約15mg/ml〜約150mg/mlの濃度である請求項1〜11のいずれか1項に記載の方法。
- 約15mg/ml〜約150mg/mlの濃度のブデソニドの水性懸濁液を約101℃〜約145℃の温度で約2分〜約180分間加熱するステップを含む、ブデソニドの滅菌のための方法。
- 前記懸濁液を医薬上適当な濃度に希釈するステップをさらに含む請求項1〜13のいずれか1項に記載の方法。
- 請求項1〜14のいずれか1項に記載の方法により得られ得る組成物。
- 請求項1〜14のいずれか1項に記載の方法により得られるグルココルチコステロイドを含み、当該グルココルチコステロイドの粒子サイズが、Dv100が20μm未満であり、Dv90が10μm未満であり、およびDv50が5μm未満である無菌水性懸濁液。
- 前記懸濁液が、ブデソニドの量に基づき0.2重量%未満の1,2-ジヒドロブデソニドを含む、請求項1〜14のいずれか1項に記載の方法により得られる無菌水性ブデソニド懸濁液。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0410995.5A GB0410995D0 (en) | 2004-05-17 | 2004-05-17 | Heat sterilization of glucocorticosteroids |
GB0410995.5 | 2004-05-17 | ||
PCT/US2005/017292 WO2005115332A2 (en) | 2004-05-17 | 2005-05-17 | Heat sterilization of glucocorticosteroids |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012191294A Division JP5473029B2 (ja) | 2004-05-17 | 2012-08-31 | グルココルチコステロイドの熱滅菌 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2007538089A true JP2007538089A (ja) | 2007-12-27 |
JP2007538089A5 JP2007538089A5 (ja) | 2008-12-11 |
JP5116469B2 JP5116469B2 (ja) | 2013-01-09 |
Family
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007527389A Active JP5116469B2 (ja) | 2004-05-17 | 2005-05-17 | グルココルチコステロイドの熱滅菌 |
JP2012191294A Active JP5473029B2 (ja) | 2004-05-17 | 2012-08-31 | グルココルチコステロイドの熱滅菌 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2012191294A Active JP5473029B2 (ja) | 2004-05-17 | 2012-08-31 | グルココルチコステロイドの熱滅菌 |
Country Status (21)
Country | Link |
---|---|
US (2) | US8791096B2 (ja) |
EP (3) | EP3299013A1 (ja) |
JP (2) | JP5116469B2 (ja) |
KR (1) | KR101148446B1 (ja) |
CN (2) | CN102600491B (ja) |
AU (1) | AU2005247422B8 (ja) |
CA (1) | CA2569549C (ja) |
CY (1) | CY1115948T1 (ja) |
DK (2) | DK2805712T4 (ja) |
ES (2) | ES2525877T3 (ja) |
FI (1) | FI2805712T4 (ja) |
GB (1) | GB0410995D0 (ja) |
HK (2) | HK1171971A1 (ja) |
HU (1) | HUE037567T2 (ja) |
IL (1) | IL179066A (ja) |
LT (1) | LT2805712T (ja) |
MX (1) | MXPA06012874A (ja) |
PL (2) | PL2805712T5 (ja) |
PT (2) | PT2805712T (ja) |
SI (2) | SI1755554T1 (ja) |
WO (1) | WO2005115332A2 (ja) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
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PE20050941A1 (es) | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
GB0425266D0 (en) * | 2004-11-16 | 2004-12-15 | Norton Healthcare Ltd | Pharmaceutical manufacturing process |
EP2704724B1 (en) * | 2011-05-03 | 2016-10-26 | Chiesi Farmaceutici S.p.A. | Improved suspension formulation of beclometasone dipropionate for administration by inhalation |
CN111224763B (zh) * | 2013-03-11 | 2022-09-30 | 北京三星通信技术研究有限公司 | 一种下行传输方法和用户终端设备 |
US9867973B2 (en) | 2013-06-17 | 2018-01-16 | Medline Industries, Inc. | Skin antiseptic applicator and methods of making and using the same |
US9511156B2 (en) | 2014-01-08 | 2016-12-06 | Carefusion 2200, Inc. | Systems, methods, and devices for sterilizing antiseptic solutions |
US11027032B2 (en) | 2014-01-08 | 2021-06-08 | Carefusion 2200, Inc. | Systems, methods, and devices for sterilizing antiseptic solutions |
US9895455B2 (en) | 2015-06-30 | 2018-02-20 | Carefusion 2200, Inc | Systems, methods, and devices for sterilizing antiseptic solutions |
WO2017004412A1 (en) * | 2015-06-30 | 2017-01-05 | Carefusion 2200, Inc. | Systems, methods, and devices for sterilizing antiseptic solutions |
WO2022098321A1 (en) * | 2020-11-09 | 2022-05-12 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Process for the preparation of sterilised suspensions for the administration by inhalation |
CN112891328A (zh) * | 2021-04-12 | 2021-06-04 | 上海方予健康医药科技有限公司 | 一种吸入用布地奈德混悬液的制备方法 |
Citations (5)
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JPH10500420A (ja) * | 1994-05-21 | 1998-01-13 | グラクソ、ウェルカム、オーストラリア、リミテッド | フルチカゾンプロピオネート処方物 |
JP2001526089A (ja) * | 1997-12-19 | 2001-12-18 | バイエル・アクチエンゲゼルシヤフト | 製薬懸濁剤の新規な滅菌方法 |
JP2002528484A (ja) * | 1998-11-03 | 2002-09-03 | キエシ・フアルマチエウテイチ・ソチエタ・ペル・アチオニ | 吸入搬送用薬剤粒子の懸濁液を製造する方法 |
WO2003035031A1 (en) * | 2001-10-19 | 2003-05-01 | Baxter International Inc. | Stable composition comprising particles in a frozen aqueous matrix |
JP2004513749A (ja) * | 2000-11-24 | 2004-05-13 | ブレス リミテッド | 薬剤の滅菌 |
Family Cites Families (13)
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US3692430A (en) | 1971-06-18 | 1972-09-19 | John W Timmons | Liquid pumping system |
US3962430A (en) | 1974-08-07 | 1976-06-08 | Merck & Co., Inc. | Sterilization of solid non-electrolyte medicinal agents employing sodium chloride |
US5933781A (en) | 1997-01-31 | 1999-08-03 | Qualcomm Incorporated | Pilot based, reversed channel power control |
SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
US6598603B1 (en) * | 1997-12-31 | 2003-07-29 | Astra Aktiebolag | Method for treating respiratory diseases |
EP0938896A1 (en) | 1998-01-15 | 1999-09-01 | Novartis AG | Autoclavable pharmaceutical compositions containing a chelating agent |
US6241969B1 (en) * | 1998-06-26 | 2001-06-05 | Elan Corporation Plc | Aqueous compositions containing corticosteroids for nasal and pulmonary delivery |
US6267989B1 (en) | 1999-03-08 | 2001-07-31 | Klan Pharma International Ltd. | Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions |
NL1016981C2 (nl) | 2000-12-22 | 2002-06-25 | Nutricia Nv | Pasteuriseren of steriliseren. |
DE10145361A1 (de) † | 2001-09-14 | 2003-04-03 | Pari Gmbh | Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation |
BRPI0312377A8 (pt) | 2002-07-02 | 2015-12-15 | Altana Pharma Ag | Suspensão aquosa estéril contendo ciclesonida |
EP1454636A1 (en) † | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
DE602005026225D1 (de) | 2004-03-12 | 2011-03-24 | Cipla Ltd | Sterilisationsprozess für Steroide |
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2004
- 2004-05-17 GB GBGB0410995.5A patent/GB0410995D0/en not_active Ceased
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2005
- 2005-05-17 HU HUE14001800A patent/HUE037567T2/hu unknown
- 2005-05-17 ES ES05752889.5T patent/ES2525877T3/es active Active
- 2005-05-17 KR KR1020067023275A patent/KR101148446B1/ko active IP Right Grant
- 2005-05-17 ES ES14001800T patent/ES2670706T5/es active Active
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JPH10500420A (ja) * | 1994-05-21 | 1998-01-13 | グラクソ、ウェルカム、オーストラリア、リミテッド | フルチカゾンプロピオネート処方物 |
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