ATE410677T1 - Bioäquivalenztest für eisenhaltige formulierungen - Google Patents
Bioäquivalenztest für eisenhaltige formulierungenInfo
- Publication number
- ATE410677T1 ATE410677T1 AT02768694T AT02768694T ATE410677T1 AT E410677 T1 ATE410677 T1 AT E410677T1 AT 02768694 T AT02768694 T AT 02768694T AT 02768694 T AT02768694 T AT 02768694T AT E410677 T1 ATE410677 T1 AT E410677T1
- Authority
- AT
- Austria
- Prior art keywords
- iron
- containing formulations
- bioequivalence test
- bioequivalence
- formulations
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 238000009472 formulation Methods 0.000 abstract 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 abstract 2
- CWYNVVGOOAEACU-UHFFFAOYSA-N Fe2+ Chemical compound [Fe+2] CWYNVVGOOAEACU-UHFFFAOYSA-N 0.000 abstract 1
- VTLYFUHAOXGGBS-UHFFFAOYSA-N Fe3+ Chemical compound [Fe+3] VTLYFUHAOXGGBS-UHFFFAOYSA-N 0.000 abstract 1
- FWZTTZUKDVJDCM-CEJAUHOTSA-M disodium;(2r,3r,4s,5s,6r)-2-[(2s,3s,4s,5r)-3,4-dihydroxy-2,5-bis(hydroxymethyl)oxolan-2-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol;iron(3+);oxygen(2-);hydroxide;trihydrate Chemical compound O.O.O.[OH-].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[Na+].[Na+].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 FWZTTZUKDVJDCM-CEJAUHOTSA-M 0.000 abstract 1
- 229910052742 iron Inorganic materials 0.000 abstract 1
- 229940032961 iron sucrose Drugs 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000003908 quality control method Methods 0.000 abstract 1
- 239000013589 supplement Substances 0.000 abstract 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
-
- 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
- A61K31/28—Compounds containing heavy metals
- A61K31/295—Iron group metal compounds
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
- Y10T436/143333—Saccharide [e.g., DNA, etc.]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Physics & Mathematics (AREA)
- Biotechnology (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2002/026989 WO2004019032A1 (en) | 2002-08-26 | 2002-08-26 | Bioequivalence test for iron-containing formulations |
| US10/227,445 US6911342B2 (en) | 2002-08-26 | 2002-08-26 | Bioequivalence test for iron-containing formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ATE410677T1 true ATE410677T1 (de) | 2008-10-15 |
Family
ID=32684391
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT02768694T ATE410677T1 (de) | 2002-08-26 | 2002-08-26 | Bioäquivalenztest für eisenhaltige formulierungen |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US6911342B2 (de) |
| EP (1) | EP1540338B1 (de) |
| JP (1) | JP4408807B2 (de) |
| KR (1) | KR100908447B1 (de) |
| CN (1) | CN1685227B (de) |
| AT (1) | ATE410677T1 (de) |
| AU (1) | AU2002331712A1 (de) |
| BR (1) | BR0215853A (de) |
| CA (1) | CA2494199C (de) |
| CY (1) | CY1108630T1 (de) |
| DE (1) | DE60229303D1 (de) |
| DK (1) | DK1540338T3 (de) |
| ES (1) | ES2315401T3 (de) |
| IL (1) | IL167085A (de) |
| MX (1) | MXPA05002159A (de) |
| PT (1) | PT1540338E (de) |
| WO (1) | WO2004019032A1 (de) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7169359B2 (en) * | 2002-08-26 | 2007-01-30 | Luitpold Pharmaceuticals, Inc. | Bioequivalence test for iron-containing formulations |
| DE10249552A1 (de) | 2002-10-23 | 2004-05-13 | Vifor (International) Ag | Wasserlösliche Eisen-Kohlenhydrat-Komplexe, deren Herstellung und diese enthaltende Arzneimittel |
| US7674780B2 (en) | 2004-03-16 | 2010-03-09 | Navinta Llc | Iron sucrose complexes and method of manufacture thereof |
| WO2006061685A1 (en) * | 2004-12-06 | 2006-06-15 | Emcure Pharmaceuticals Limited | A cost-effective process for preparation of manufacture of iron sucrose |
| JP4797900B2 (ja) * | 2006-09-12 | 2011-10-19 | 三浦工業株式会社 | 鉄の定量方法 |
| JP4797902B2 (ja) * | 2006-09-13 | 2011-10-19 | 三浦工業株式会社 | 鉄の定量方法 |
| US20080132465A1 (en) * | 2006-12-05 | 2008-06-05 | Vincent Windisch | Apparatus and method for isolating iron components from serum |
| EP2237032B1 (de) * | 2008-01-15 | 2015-12-23 | Masato Terashita | Verfahren zur bewertung biologischer äquivalenzen |
| US8058076B2 (en) | 2009-03-31 | 2011-11-15 | Astron Research Limited | In-vitro method for testing bioequivalence of iron-sucrose formulation |
| CN101710113B (zh) * | 2009-12-09 | 2013-04-03 | 南京生命能科技开发有限公司 | 一种测定铁-碳水化合物络合物浊点和游离糖缓冲系数的方法 |
| IT1405688B1 (it) | 2010-06-09 | 2014-01-24 | Biofer Spa | Nuovi complessi a basso peso molecolare tra ferro ed acido maltobionico, uso di questi per la somministrazione intramuscolare o sottocutanea nella terapia di stati anemici, e nuove composizioni farmaceutiche adatte a questi usi. |
| EP3930686B1 (de) | 2019-02-28 | 2023-05-31 | Renibus Therapeutics, Inc. | Neuartige eisenzusammensetzungen und verfahren zur herstellung und verwendung davon |
| CN110551019A (zh) * | 2019-09-12 | 2019-12-10 | 天津医科大学 | 一种亚铁糖(ⅱ)复合物、制备方法及其应用 |
| US12239657B2 (en) | 2021-08-27 | 2025-03-04 | Vifor (International) Ag | Iron compositions and methods of making and using them |
| CN114652844B (zh) * | 2022-04-13 | 2023-10-20 | 南京大学 | 一种基于仿生学设计的纳米组装材料的制备方法及应用 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4389706A (en) * | 1972-05-03 | 1983-06-21 | Westinghouse Electric Corp. | Digital computer monitored and/or operated system or process which is structured for operation with an improved automatic programming process and system |
| US5624668A (en) * | 1995-09-29 | 1997-04-29 | Luitpold Pharmaceuticals, Inc. | Iron dextran formulations |
| US6624668B1 (en) * | 2000-11-08 | 2003-09-23 | Xilinx, Inc. | Digitally programmable phase-lock loop for high-speed data communications |
| US7169359B2 (en) * | 2002-08-26 | 2007-01-30 | Luitpold Pharmaceuticals, Inc. | Bioequivalence test for iron-containing formulations |
-
2002
- 2002-08-26 WO PCT/US2002/026989 patent/WO2004019032A1/en not_active Ceased
- 2002-08-26 CA CA002494199A patent/CA2494199C/en not_active Expired - Lifetime
- 2002-08-26 US US10/227,445 patent/US6911342B2/en not_active Expired - Lifetime
- 2002-08-26 ES ES02768694T patent/ES2315401T3/es not_active Expired - Lifetime
- 2002-08-26 DK DK02768694T patent/DK1540338T3/da active
- 2002-08-26 DE DE60229303T patent/DE60229303D1/de not_active Expired - Lifetime
- 2002-08-26 AU AU2002331712A patent/AU2002331712A1/en not_active Abandoned
- 2002-08-26 CN CN028296664A patent/CN1685227B/zh not_active Expired - Fee Related
- 2002-08-26 EP EP02768694A patent/EP1540338B1/de not_active Revoked
- 2002-08-26 PT PT02768694T patent/PT1540338E/pt unknown
- 2002-08-26 MX MXPA05002159A patent/MXPA05002159A/es active IP Right Grant
- 2002-08-26 AT AT02768694T patent/ATE410677T1/de active
- 2002-08-26 JP JP2004530748A patent/JP4408807B2/ja not_active Expired - Fee Related
- 2002-08-26 BR BR0215853-1A patent/BR0215853A/pt not_active IP Right Cessation
- 2002-08-26 KR KR1020057003274A patent/KR100908447B1/ko not_active Expired - Fee Related
-
2005
- 2005-02-24 IL IL167085A patent/IL167085A/en not_active IP Right Cessation
-
2008
- 2008-12-08 CY CY20081101418T patent/CY1108630T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP1540338B1 (de) | 2008-10-08 |
| WO2004019032A1 (en) | 2004-03-04 |
| DE60229303D1 (de) | 2008-11-20 |
| CN1685227A (zh) | 2005-10-19 |
| AU2002331712A1 (en) | 2004-03-11 |
| BR0215853A (pt) | 2005-06-21 |
| MXPA05002159A (es) | 2005-12-05 |
| EP1540338A1 (de) | 2005-06-15 |
| PT1540338E (pt) | 2008-12-04 |
| JP4408807B2 (ja) | 2010-02-03 |
| IL167085A (en) | 2010-06-16 |
| KR20050083658A (ko) | 2005-08-26 |
| US20040038416A1 (en) | 2004-02-26 |
| CY1108630T1 (el) | 2014-04-09 |
| CA2494199C (en) | 2007-02-06 |
| EP1540338A4 (de) | 2006-06-07 |
| KR100908447B1 (ko) | 2009-07-21 |
| ES2315401T3 (es) | 2009-04-01 |
| US6911342B2 (en) | 2005-06-28 |
| CA2494199A1 (en) | 2004-03-04 |
| DK1540338T3 (da) | 2009-02-09 |
| JP2005536738A (ja) | 2005-12-02 |
| CN1685227B (zh) | 2013-09-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| UEP | Publication of translation of european patent specification |
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