BR0215853A - Testes de bioequivalência para formulações contendo ferro - Google Patents

Testes de bioequivalência para formulações contendo ferro

Info

Publication number
BR0215853A
BR0215853A BR0215853-1A BR0215853A BR0215853A BR 0215853 A BR0215853 A BR 0215853A BR 0215853 A BR0215853 A BR 0215853A BR 0215853 A BR0215853 A BR 0215853A
Authority
BR
Brazil
Prior art keywords
iron
containing formulations
bioequivalence
bioequivalence tests
formulations
Prior art date
Application number
BR0215853-1A
Other languages
English (en)
Inventor
Mary Jane Helenek
Ralf A Lange
Richard P Lawrence
Original Assignee
Luitpold Pharm Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32684391&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR0215853(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Luitpold Pharm Inc filed Critical Luitpold Pharm Inc
Publication of BR0215853A publication Critical patent/BR0215853A/pt

Links

Classifications

    • 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
    • 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
    • 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)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (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)

Abstract

"TESTES DE BIOEQuIVALêNCIA PARA FORMULAçõES CONTENDO FERRO". A presente invenção refere-se a um processo rápido para avaliar a bioeq³ivalência de ferro em formulações de suplemento de ferro, particularmente formulações de complexo ferro-sacarose , que é baseado na cinética de redução de ferro (III) a ferro (II) numa amostra da formulação. Também são descritos processos de controle de qualidade e kits associados.
BR0215853-1A 2002-08-26 2002-08-26 Testes de bioequivalência para formulações contendo ferro BR0215853A (pt)

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
BR0215853A true BR0215853A (pt) 2005-06-21

Family

ID=32684391

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0215853-1A BR0215853A (pt) 2002-08-26 2002-08-26 Testes de bioequivalência para formulações contendo ferro

Country Status (17)

Country Link
US (1) US6911342B2 (pt)
EP (1) EP1540338B1 (pt)
JP (1) JP4408807B2 (pt)
KR (1) KR100908447B1 (pt)
CN (1) CN1685227B (pt)
AT (1) ATE410677T1 (pt)
AU (1) AU2002331712A1 (pt)
BR (1) BR0215853A (pt)
CA (1) CA2494199C (pt)
CY (1) CY1108630T1 (pt)
DE (1) DE60229303D1 (pt)
DK (1) DK1540338T3 (pt)
ES (1) ES2315401T3 (pt)
IL (1) IL167085A (pt)
MX (1) MXPA05002159A (pt)
PT (1) PT1540338E (pt)
WO (1) WO2004019032A1 (pt)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
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
EP1733058B8 (en) 2004-03-16 2012-10-24 Navinta LLC Iron sucrose complexes and method of manufacture thereof
EP1819720B1 (en) 2004-12-06 2013-05-15 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
US8140303B2 (en) * 2008-01-15 2012-03-20 Masato Terashita Bioequivalence evaluation method of evaluating bioequivalence of a generic drug to the corresponding original drug
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.
HUE063182T2 (hu) 2019-02-28 2024-01-28 Renibus Therapeutics Inc Újszerû vaskészítmények és elõállítási és felhasználási eljárásaik
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
EP4392045A1 (en) 2021-08-27 2024-07-03 American Regent, Inc. 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)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
US20040038416A1 (en) 2004-02-26
EP1540338A1 (en) 2005-06-15
DE60229303D1 (de) 2008-11-20
JP2005536738A (ja) 2005-12-02
PT1540338E (pt) 2008-12-04
KR100908447B1 (ko) 2009-07-21
CA2494199A1 (en) 2004-03-04
CY1108630T1 (el) 2014-04-09
MXPA05002159A (es) 2005-12-05
DK1540338T3 (da) 2009-02-09
EP1540338A4 (en) 2006-06-07
IL167085A (en) 2010-06-16
US6911342B2 (en) 2005-06-28
CN1685227A (zh) 2005-10-19
ATE410677T1 (de) 2008-10-15
JP4408807B2 (ja) 2010-02-03
KR20050083658A (ko) 2005-08-26
AU2002331712A1 (en) 2004-03-11
ES2315401T3 (es) 2009-04-01
CA2494199C (en) 2007-02-06
EP1540338B1 (en) 2008-10-08
CN1685227B (zh) 2013-09-04
WO2004019032A1 (en) 2004-03-04

Similar Documents

Publication Publication Date Title
CY1108630T1 (el) Εξεταση βιοισοδυναμιας δια συνθεσεις οι οποιες περιεχουν σιδηρο
WO2004055519A3 (en) Specific markers for pancreatic cancer
BRPI0608376A8 (pt) composição de ligação, método de uso de uma composição de ligação, e, kit de detecção
EP1546162A4 (en) METHODS BASED ON LUMINESCENCE AND PROBES FOR MEASURING CYTOCHROME P450 ACTIVITY
ATE483825T1 (de) Zusammensetzungen für die identifizierung von adenoviren
WO2004088309A3 (en) Methods for diagnosing urinary tract and prostatic disorders
DE60137331D1 (de) Verfahren zur abschätzung des ortes eines gerätes
IL179441A (en) Method of measuring the activity of egln enzyme and of identifying an agent that modulates activity of said enzyme
WO2006069023A3 (en) Assay method and apparatus with reduced sample matrix effects
DE60206923D1 (de) Kardiovaskulares sicherheitstestverfahren
EP1774043A4 (en) COMPOSITIONS, KITS AND METHODS OF IDENTIFICATION, ASSESSMENT, PREVENTION AND THERAPY OF CANCER
DE60325107D1 (de) Verfahren und kit zum quantitativen und/oder qualitativen nachweis von komponenten in einer probe
EP1643894A4 (en) METHOD, KITS AND ANTIBODIES FOR THE DETECTION OF PARATHYROID
WO2005012901A3 (en) Method for measuring aromatase activity
AU2001263771A1 (en) An assay method and kit for testing biological material for exposure to stress using biomarkers
DE602005019156D1 (de) Verfahren zur auswertung von ribonukleotidsequenzen
ATE408832T1 (de) Verfahren zum nachweis von blutzell-antigenen und gegen diese gerichtete antikörper
WO2007076339A3 (en) Isotopically labelled crosslinking agents for the analysis of protein interactions
DK1381696T3 (da) Methods
WO2005093411A3 (en) Assays for identifying modulators of the hydroxylation of ankyrin repeat proteins by 2-oxoglutarate dependent oxigenase and methods of using the same
EP1943359A4 (en) COMPOSITIONS AND METHODS FOR IL13 BIOMARKERS
ATE444493T1 (de) Verfahren zur identifikation von salzempfindlichen personen
UA37538A (uk) Спосіб кількісного визначення формальдегіду
UA6457U (en) Method for predicting seasonal and all-the-year-round allergic rhinitis in urban adolescents of both sexes
TW200722984A (en) Auto testing method and system

Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: VIFOR (INTERNATIONAL) AG (CH)

Free format text: TRANSFERIDO DE: LUITPOLD PHARMACEUTICALS, INC.

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 14A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2385 DE 20-09-2016 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.