JP5116469B2 - 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
- Publication number
- JP5116469B2 JP5116469B2 JP2007527389A JP2007527389A JP5116469B2 JP 5116469 B2 JP5116469 B2 JP 5116469B2 JP 2007527389 A JP2007527389 A JP 2007527389A JP 2007527389 A JP2007527389 A JP 2007527389A JP 5116469 B2 JP5116469 B2 JP 5116469B2
- Authority
- JP
- Japan
- Prior art keywords
- glucocorticosteroid
- budesonide
- sterilization
- suspension
- glucocorticosteroids
- 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.)
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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
- A61K9/1682—Processes
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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
-
- 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
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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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Otolaryngology (AREA)
- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Steroid Compounds (AREA)
- Dairy Products (AREA)
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 (8)
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 JP2007538089A (ja) | 2007-12-27 |
JP2007538089A5 JP2007538089A5 (ja) | 2008-12-11 |
JP5116469B2 true JP5116469B2 (ja) | 2013-01-09 |
Family
ID=32607464
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 |
---|---|---|---|
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) | ES2670706T5 (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) | PL1755554T3 (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 |
---|---|---|---|---|
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 |
RU2611665C2 (ru) * | 2011-05-03 | 2017-02-28 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Улучшенный состав суспензии кортикостероида для ингаляционного введения |
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 |
AU2016288582B2 (en) * | 2015-06-30 | 2020-05-21 | 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 |
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 |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
GB9410222D0 (en) * | 1994-05-21 | 1994-07-06 | Glaxo Wellcome Australia Ltd | Medicaments |
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 |
US6066292A (en) † | 1997-12-19 | 2000-05-23 | Bayer Corporation | Sterilization process for pharmaceutical suspensions |
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 |
IT1303692B1 (it) * | 1998-11-03 | 2001-02-23 | Chiesi Farma Spa | Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione. |
US6267989B1 (en) | 1999-03-08 | 2001-07-31 | Klan Pharma International Ltd. | Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions |
GB2374013C (en) | 2000-11-24 | 2009-07-01 | Breath Ltd | Sterilisation of pharmaceuticals |
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 |
US7112340B2 (en) * | 2001-10-19 | 2006-09-26 | Baxter International Inc. | Compositions of and method for preparing stable particles in a frozen aqueous matrix |
KR101020687B1 (ko) | 2002-07-02 | 2011-03-11 | 니코메드 게엠베하 | 사이클레소나이드 함유 멸균 수성 현탁액 |
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 ES ES14001800T patent/ES2670706T5/es active Active
- 2005-05-17 PL PL05752889T patent/PL1755554T3/pl unknown
- 2005-05-17 WO PCT/US2005/017292 patent/WO2005115332A2/en active Application Filing
- 2005-05-17 DK DK14001800.3T patent/DK2805712T4/da active
- 2005-05-17 FI FIEP14001800.3T patent/FI2805712T4/fi active
- 2005-05-17 JP JP2007527389A patent/JP5116469B2/ja active Active
- 2005-05-17 MX MXPA06012874A patent/MXPA06012874A/es active IP Right Grant
- 2005-05-17 US US10/594,861 patent/US8791096B2/en active Active
- 2005-05-17 AU AU2005247422A patent/AU2005247422B8/en active Active
- 2005-05-17 EP EP17195406.8A patent/EP3299013A1/en active Pending
- 2005-05-17 DK DK05752889.5T patent/DK1755554T3/en active
- 2005-05-17 ES ES05752889.5T patent/ES2525877T3/es active Active
- 2005-05-17 PT PT140018003T patent/PT2805712T/pt unknown
- 2005-05-17 PL PL14001800.3T patent/PL2805712T5/pl unknown
- 2005-05-17 SI SI200531916T patent/SI1755554T1/sl unknown
- 2005-05-17 EP EP05752889.5A patent/EP1755554B1/en not_active Revoked
- 2005-05-17 SI SI200532207T patent/SI2805712T1/en unknown
- 2005-05-17 PT PT57528895T patent/PT1755554E/pt unknown
- 2005-05-17 CN CN201210068425.7A patent/CN102600491B/zh active Active
- 2005-05-17 EP EP14001800.3A patent/EP2805712B2/en active Active
- 2005-05-17 KR KR1020067023275A patent/KR101148446B1/ko active IP Right Grant
- 2005-05-17 HU HUE14001800A patent/HUE037567T2/hu unknown
- 2005-05-17 LT LTEP14001800.3T patent/LT2805712T/lt unknown
- 2005-05-17 CA CA2569549A patent/CA2569549C/en active Active
- 2005-05-17 CN CN2005800159892A patent/CN1988886B/zh active Active
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2006
- 2006-11-06 IL IL179066A patent/IL179066A/en active IP Right Grant
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2012
- 2012-08-31 JP JP2012191294A patent/JP5473029B2/ja active Active
- 2012-12-10 HK HK12112692.2A patent/HK1171971A1/zh unknown
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2014
- 2014-06-20 US US14/310,825 patent/US10314785B2/en active Active
- 2014-12-08 CY CY20141101076T patent/CY1115948T1/el unknown
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2018
- 2018-09-14 HK HK18111870.2A patent/HK1252557A1/zh unknown
Also Published As
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JP5116478B2 (ja) | 医薬製造法 | |
CA2310222C (en) | New composition of matter | |
MX2007005681A (en) | Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions | |
AU2012200155A1 (en) | Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions |
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