CN1942176A - 用于糖皮质激素替代疗法的药物组合物 - Google Patents
用于糖皮质激素替代疗法的药物组合物 Download PDFInfo
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- CN1942176A CN1942176A CNA2005800118623A CN200580011862A CN1942176A CN 1942176 A CN1942176 A CN 1942176A CN A2005800118623 A CNA2005800118623 A CN A2005800118623A CN 200580011862 A CN200580011862 A CN 200580011862A CN 1942176 A CN1942176 A CN 1942176A
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- glucocorticoids
- hydrocortisone
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
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- 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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- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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- A—HUMAN NECESSITIES
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- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
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- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Abstract
Description
糖皮质激素 | 等效量(mg) | 氢化可的松当量(1mg的糖皮质激素对应于以下所列毫克数的氢化可的松) |
乙酸可的松 | 25 | 0.8 |
氢化可的松 | 20 | 1 |
泼尼松龙 | 5 | 4 |
泼尼松 | 5 | 4 |
甲泼松龙 | 4 | 5 |
曲安西龙 | 4 | 5 |
帕拉米松 | 2 | 10 |
倍他米松 | 0.75 | 26.66 |
地塞米松 | 0.75 | 26.66 |
氟氢可的松 | 0.05 | 400 |
溶出试验开始后的时间 | 释放的氢化可的松当量%(基于第一部分中的含量) |
在45分钟内 | 至少约50%,诸如例如,至少约60%,优选至少约70%,至少约80%,或至少约90% |
优选在30分钟内 | 至少约50%,诸如例如,至少约60%,优选至少约70%,至少约80%,或至少约90% |
在20分钟内 | 至少约50%,诸如例如,至少约60%,优选至少约70%,至少约80%,或至少约90% |
在15分钟内 | 至少约50% |
溶出试验开始后的时间 | 释放的氢化可的松当量%(基于组合物中的总含量) |
在24小时内 | 至少约80% |
在22小时内 | 至少约80% |
在20小时内 | 至少约80% |
在10小时内 | 至少约80% |
溶出试验开始后的时间 | 释放的氢化可的松当量%(基于组合物中的总含量) |
在8小时内 | 至少约50% |
在6小时内 | 至少约50% |
在5小时内 | 至少约50% |
溶出试验开始后的时间 | 每小时释放的氢化可的松当量%(基于第二部分中的含量) | 每小时释放的氢化可的松当量%(基于组合物中的总含量) |
从约1到约8小时 | 从约3到约15%,诸如例如,从约3到约10% | 从约1.5到约15%,诸如例如,从约3到约15% |
从约1到约10小时 | 从约3到约15%,诸如例如,从约3到约10% | 从约1.5到约15%,诸如例如,从约3到约15% |
从约1到约12小时 | 从约3到约15%,诸如例如,从约3到约10% | 从约1.5到约15%,诸如例如,从约3到约15% |
商品名 | 化学物质 | 生产商 |
丙酮 | USP/NF | |
倍他米松 | USP/NF | |
磷酸钙 | USP/NF | |
羧甲基纤维素 | USP/NF | |
谷氨酸脱乙酰壳多糖 | USP/NF | |
交聚维酮 | USP/NF | |
乙基纤维素 | USP/NF | |
氢化可的松 | Ph.Eur.,Qual.D | Aventis,Switzerland(byApoteksbolaget) |
乙酸氢化可的松 | USP/NF | |
氢化可的松-21-半琥珀酸酯钠 | Ph.Eur. | Aventis,Switzerland(byApoteksbolaget) |
2-OH-丙基-β-环糊精 | ||
羟丙基甲基纤维素 | USP/NF | |
乳糖 | USP/NF | |
无水乳糖 | USP/NF | |
左薄荷脑 | USP/NF | |
硬脂酸镁 | 硬脂酸镁 | Kissei Japan |
薄荷 | USP/NF |
Methocel E5 | 羟丙基甲基纤维素 | Dow Chemicals,USA(by Colorcon) |
MethocelKV 100LV | USP/NF | Dow Chemicals,USA(by Colorcon) |
微晶纤维素,AvicelPH-102 | USP/NF | FMC Corporation |
石蜡粉末 | USP/NF | |
PEG 300 | USP/NF | |
PEG 6000 | 聚乙二醇 | Svenska Hoechst AB |
PEG 400 | 聚乙二醇 | Fluka,Switzerland |
泼尼松龙 | USP/NF | |
Polyox WSR 301 | 聚氧乙烯 | Dow Chemicals,USA |
胶态二氧化硅 | USP/NF | |
硅酸铝钠 | USP/NF | |
磷酸二氢钠 | NaH2PO4·2H2O | |
硬脂酰富马酸钠 | USP/NF | |
山梨醇 | USP/NF | |
淀粉1500,ColorconUK | 预胶凝淀粉 | Colorcon UK |
糖 | USP/NF | |
糖/淀粉粒 | USP/NF | |
滑石 | USP/NF | |
柠檬酸三乙酯 | USP/NF | |
Xylitab 300Xylisorb 300 | Xyrofin Kotka,Finland(DaniscoSweeteners Ltd,UK) | |
木糖醇 | USP/NF | Roquette,France |
时间 | 1h | 3h | 5h | 7h | 9h | 11h | 13h | 15h |
溶出% | 7 | 24 | 41 | 58 | 70 | 83 | 90 | 95 |
组合物 | 聚合物 | 1分钟,% | 3分钟,% | 5分钟,% | 10分钟,% | 15分钟,% |
A | Na-alg | 15 | 25 | 38 | 65 | 84 |
B | Na-alg | 15 | 25 | 38 | 65 | 84 |
C | HPMC | 18 | 48 | 67 | 88 | 92 |
Claims (111)
Priority Applications (1)
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CN201210499801.8A CN103006592B (zh) | 2004-04-22 | 2005-04-21 | 用于糖皮质激素替代疗法的药物组合物 |
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US56420504P | 2004-04-22 | 2004-04-22 | |
SE04010310 | 2004-04-22 | ||
SE0401031-0 | 2004-04-22 | ||
SE0401031A SE0401031D0 (sv) | 2004-04-22 | 2004-04-22 | A new glucocorticoid replacement therapy |
US60/564,205 | 2004-04-22 | ||
PCT/EP2005/004400 WO2005102271A2 (en) | 2004-04-22 | 2005-04-21 | Pharmaceutical compositions for glucocorticoid replacement therapy |
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Publication Number | Publication Date |
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CN201210499801.8A Active CN103006592B (zh) | 2004-04-22 | 2005-04-21 | 用于糖皮质激素替代疗法的药物组合物 |
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Country Status (26)
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US (3) | US8425937B2 (zh) |
EP (2) | EP3072507B1 (zh) |
JP (2) | JP5149618B2 (zh) |
CN (2) | CN1942176B (zh) |
AU (1) | AU2005235370B2 (zh) |
BR (1) | BRPI0510044B8 (zh) |
CA (1) | CA2564000C (zh) |
CY (2) | CY1118275T1 (zh) |
DK (2) | DK1744730T3 (zh) |
ES (2) | ES2857600T3 (zh) |
HK (1) | HK1179525A1 (zh) |
HR (2) | HRP20161380T1 (zh) |
HU (2) | HUE053248T2 (zh) |
IL (2) | IL178776A (zh) |
LT (2) | LT3072507T (zh) |
ME (1) | ME02584B (zh) |
MX (2) | MX344197B (zh) |
NZ (1) | NZ585340A (zh) |
PL (2) | PL1744730T3 (zh) |
PT (2) | PT3072507T (zh) |
RS (2) | RS55198B1 (zh) |
SE (1) | SE0401031D0 (zh) |
SG (1) | SG188081A1 (zh) |
SI (1) | SI3072507T1 (zh) |
WO (1) | WO2005102271A2 (zh) |
ZA (1) | ZA200609680B (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102448464A (zh) * | 2009-04-07 | 2012-05-09 | 杜奥科特药物公司 | 改进的糖皮质激素疗法 |
CN102933218A (zh) * | 2010-05-20 | 2013-02-13 | 杜奥科特药物公司 | 糖皮质激素基的组合物的剂量学和施用 |
CN104105481A (zh) * | 2012-02-13 | 2014-10-15 | 戴尔诺有限公司 | 氢化可的松控制释放制剂 |
CN107115308A (zh) * | 2016-02-23 | 2017-09-01 | 天津金耀集团有限公司 | 一种氢化可的松双相缓释片剂组合物 |
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Publication number | Priority date | Publication date | Assignee | Title |
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SE0401031D0 (sv) * | 2004-04-22 | 2004-04-22 | Duocort Ab | A new glucocorticoid replacement therapy |
AU2005235369B2 (en) * | 2004-04-22 | 2010-11-11 | Acucort Ab | Pharmaceutical compositions for acute glucocorticoid therapy |
WO2007067494A1 (en) * | 2005-12-06 | 2007-06-14 | Monosol Rx, Llc | Topical film compositions for delivery of actives |
FR2926722B1 (fr) * | 2008-01-25 | 2010-09-03 | Substipharm Dev | Formulation pharmaceutique appropriee pour la preparation de comprimes orodispersibles de prednisolone |
EP2151235B1 (de) * | 2008-07-21 | 2011-02-16 | Dr. Falk Pharma Gmbh | Pharmazeutische Formulierung zur Behandlung des oberen Verdauungstraktes |
GB201119985D0 (en) * | 2011-11-19 | 2012-01-04 | Diurnal Ltd | Treatment of adrenal insufficiency |
JP2014086673A (ja) | 2012-10-26 | 2014-05-12 | Mitsubishi Electric Corp | モノリシック集積回路 |
AU2013337605B2 (en) | 2012-11-02 | 2018-03-01 | Murray & Poole Enterprises, Ltd. | Treatment or prevention of cardiovascular events via the administration of a colchicine derivative |
PL2986280T3 (pl) | 2013-04-16 | 2021-10-25 | Murray & Poole Enterprises, Ltd. | Preparat kolchicyny w postaci o przedłużonym uwalnianiu i metody tworzenia takiego samego |
GB201308933D0 (en) * | 2013-05-17 | 2013-07-03 | Diurnal Ltd | Paediatric composition |
MX348595B (es) * | 2013-08-02 | 2017-06-21 | Laboratorio Raam De Sahuayo S A De C V | Composicion farmaceutica con agentes antiinflamatorios y proceso de produccion. |
ES2716990T5 (es) | 2013-12-23 | 2023-03-24 | Dr Falk Pharma Gmbh | Formulación farmacéutica optimizada para el tratamiento de cambios inflamatorios del esófago |
ES2906778T3 (es) * | 2015-03-30 | 2022-04-20 | Corcept Therapeutics Inc | Uso de antagonistas del receptor de glucocorticoides en combinación con glucocorticoides para tratar la insuficiencia suprarrenal |
RU2748437C2 (ru) * | 2019-10-28 | 2021-05-25 | Федеральное государственное бюджетное учреждение науки Институт цитологии Российской академии наук (ИНЦ РАН) | Производное гидрокортизона в качестве средства для лечения болезни Альцгеймера |
FR3116439B1 (fr) * | 2020-11-26 | 2023-08-04 | Laboratoire Dielen | Comprimé pelliculé contenant au moins un principe actif, adapté à l’administration par voie orale dudit au moins un principe actif chez des sujets humains |
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DE2260384C3 (de) * | 1972-12-09 | 1979-11-29 | Hoechst Ag, 6000 Frankfurt | Oral zu applizierendes Corticosteroid-Präparat |
US5316772A (en) | 1990-12-19 | 1994-05-31 | Solvay & Cie, S.A. (Societe Anonyme) | Bilayered oral pharmaceutical composition with pH dependent release |
US5580578A (en) * | 1992-01-27 | 1996-12-03 | Euro-Celtique, S.A. | Controlled release formulations coated with aqueous dispersions of acrylic polymers |
US5314697A (en) | 1992-10-23 | 1994-05-24 | Schering Corporation | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
PH31467A (en) * | 1994-01-31 | 1998-11-03 | Yamanouchi Pharma Co Ltd | Intrabucally dissolving compressed mouldings and production process thereof. |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102448464A (zh) * | 2009-04-07 | 2012-05-09 | 杜奥科特药物公司 | 改进的糖皮质激素疗法 |
CN102933218A (zh) * | 2010-05-20 | 2013-02-13 | 杜奥科特药物公司 | 糖皮质激素基的组合物的剂量学和施用 |
CN104105481A (zh) * | 2012-02-13 | 2014-10-15 | 戴尔诺有限公司 | 氢化可的松控制释放制剂 |
CN110141557A (zh) * | 2012-02-13 | 2019-08-20 | 戴尔诺有限公司 | 氢化可的松控制释放制剂 |
CN107115308A (zh) * | 2016-02-23 | 2017-09-01 | 天津金耀集团有限公司 | 一种氢化可的松双相缓释片剂组合物 |
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