JP2014501781A - バンコマイシンの噴霧乾燥 - Google Patents
バンコマイシンの噴霧乾燥 Download PDFInfo
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- JP2014501781A JP2014501781A JP2013548475A JP2013548475A JP2014501781A JP 2014501781 A JP2014501781 A JP 2014501781A JP 2013548475 A JP2013548475 A JP 2013548475A JP 2013548475 A JP2013548475 A JP 2013548475A JP 2014501781 A JP2014501781 A JP 2014501781A
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- powder
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- solution
- peg
- vancomycin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
-
- 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
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Abstract
Description
塩酸バンコマイシン(15重量%)、PEG−400(3重量%)およびマンニトール(3重量%)をWFIに含む5つのバッチを作製し、次いで上記の方法に従って噴霧乾燥した。得られた噴霧乾燥粉末を表3に示されるように試験した。
塩酸バンコマイシン、PEG−400およびマンニトールを様々な濃度でエタノールおよびWFIに溶解させた。様々な製剤を上記のように噴霧乾燥した。得られた粉末を表4に示されるように試験した。
塩酸バンコマイシンの様々な製剤の噴霧乾燥を、ガス温度、ノズル規格などの異なる噴霧乾燥処理の条件を用い、量産規模の噴霧乾燥装置を利用して実施した。実験の結果を以下の表5および6に示す。
WFI中塩酸バンコマイシン(15重量%)、PEG−400(3重量%)およびマンニトール(3重量%)の噴霧乾燥製剤を使用して、安定性試験用のバッチを作製し、Abbott Laboratories(イリノイ州North Chicago)からAPIを調達した。噴霧乾燥バッチを25℃/60%相対湿度(RH)、30℃/60%RHおよび40℃/75%RHで3ヶ月間保管した。カールフィッシャによる水分、(還元溶液の)pH、還元時間およびクロマトグラフィー純度に関する安定性データを表7に示す。バンコマイシンについての現行のUSP(米国薬局方)論文に記載されている分析HPLC法を用いてクロマトグラフィー純度を調べた。噴霧乾燥品を作製するのに使用したAPIロットについての試験結果も比較のために示した。
3つのバンコマイシン製剤をWFIまたはクエン酸緩衝液で調製した。溶液を上記のように噴霧乾燥した。得られた粉末を塩酸バンコマイシン APIとともに、表8に示されるように純度、還元時間および水分について試験した。
Claims (13)
- 注射用の粉末状バンコマイシン医薬製剤を調製するための方法であって、
塩酸バンコマイシンと、ポリエチレングリコール(PEG)とを含む溶液を準備すること、および
溶液を噴霧乾燥して、還元し、静脈内注射により投与することができる粉末を形成することを含む、方法。 - 溶液がマンニトールをさらに含む、請求項1に記載の方法。
- 溶液が、約10〜20重量%の塩酸バンコマイシン、約2〜4重量%のPEGおよび約2〜4重量%のマンニトールを含む、請求項2に記載の方法。
- 溶液が、約2.5重量%のPEGおよび約2.5重量%のマンニトールを含む、請求項3に記載の方法。
- 溶液が、約15%の塩酸バンコマイシンを含む、請求項3に記載の方法。
- 溶液が、約3重量%のPEGおよび約3重量%のマンニトールを含む、請求項3に記載の方法。
- PEGがPEG−400である、請求項1に記載の方法。
- 溶液が、約3.0〜3.7のpHを有する、請求項1に記載の方法。
- 溶液がクエン酸緩衝液をさらに含む、請求項1に記載の方法。
- 溶液がエタノールをさらに含む、請求項1に記載の方法。
- 噴霧乾燥が無菌環境で実施される、請求項1に記載の方法。
- 噴霧乾燥が、1.5〜7.5psigの圧力で実施される、請求項1に記載の方法。
- 前記方法が、粉末を正圧下で加圧容器に移送することをさらに含む、請求項12に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161429844P | 2011-01-05 | 2011-01-05 | |
US61/429,844 | 2011-01-05 | ||
PCT/US2012/020160 WO2012094381A2 (en) | 2011-01-05 | 2012-01-04 | Spray drying vancomycin |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2014501781A true JP2014501781A (ja) | 2014-01-23 |
JP2014501781A5 JP2014501781A5 (ja) | 2015-09-24 |
JP5913367B2 JP5913367B2 (ja) | 2016-04-27 |
Family
ID=46457949
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013548475A Expired - Fee Related JP5913367B2 (ja) | 2011-01-05 | 2012-01-04 | バンコマイシンの噴霧乾燥 |
Country Status (10)
Country | Link |
---|---|
US (3) | US8709310B2 (ja) |
EP (1) | EP2661254B1 (ja) |
JP (1) | JP5913367B2 (ja) |
CN (1) | CN103429228B (ja) |
AU (1) | AU2012204462A1 (ja) |
CA (1) | CA2823628A1 (ja) |
DK (1) | DK2661254T3 (ja) |
ES (1) | ES2645769T3 (ja) |
TW (1) | TW201309346A (ja) |
WO (1) | WO2012094381A2 (ja) |
Families Citing this family (8)
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ITLO20110001A1 (it) * | 2011-05-03 | 2012-11-04 | Fisiopharma Srl | Flaconi di vancomicina cloroidrata con stabilità migliorata |
US8952105B2 (en) | 2012-05-23 | 2015-02-10 | Baker Hughes Incorporated | Variable TG article, method of making, and use of same |
CN104043104B (zh) | 2013-03-15 | 2018-07-10 | 浙江创新生物有限公司 | 含盐酸万古霉素的喷雾干粉及其工业化制备方法 |
JP6480866B2 (ja) * | 2013-09-30 | 2019-03-13 | 第一三共株式会社 | スプレードライ法を用いたD−マンニトールα型結晶の選択的製造方法 |
AU2015229069A1 (en) | 2014-03-14 | 2016-11-03 | CutisPharma,Inc. | Composition and method for vancomycin oral liquid |
PT107568B (pt) | 2014-03-31 | 2018-11-05 | Hovione Farm S A | Processo de secagem por atomização para a produção de pós com propriedades melhoradas. |
US20220184173A1 (en) * | 2019-03-08 | 2022-06-16 | Emphascience, Inc. | Stable pharmaceutical formulations of peptide and protein drugs |
CN114432339B (zh) * | 2022-02-18 | 2023-05-26 | 重庆希尔安药业有限公司 | 一种聚乙二醇钠钾散及其制备方法 |
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DK2661254T3 (da) | 2017-11-06 |
US20150231197A1 (en) | 2015-08-20 |
JP5913367B2 (ja) | 2016-04-27 |
AU2012204462A1 (en) | 2013-07-11 |
US9023258B2 (en) | 2015-05-05 |
EP2661254A4 (en) | 2015-01-28 |
ES2645769T3 (es) | 2017-12-07 |
CN103429228A (zh) | 2013-12-04 |
CA2823628A1 (en) | 2012-07-12 |
TW201309346A (zh) | 2013-03-01 |
EP2661254A2 (en) | 2013-11-13 |
US8709310B2 (en) | 2014-04-29 |
US9763997B2 (en) | 2017-09-19 |
WO2012094381A2 (en) | 2012-07-12 |
US20130009330A1 (en) | 2013-01-10 |
US20140235530A1 (en) | 2014-08-21 |
CN103429228B (zh) | 2016-10-26 |
WO2012094381A3 (en) | 2013-06-20 |
EP2661254B1 (en) | 2017-08-02 |
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