BRPI0108041B8 - nova forma galênica oral de liberação prolongada da molsidomina. - Google Patents

nova forma galênica oral de liberação prolongada da molsidomina.

Info

Publication number
BRPI0108041B8
BRPI0108041B8 BRPI0108041A BR0108041A BRPI0108041B8 BR PI0108041 B8 BRPI0108041 B8 BR PI0108041B8 BR PI0108041 A BRPI0108041 A BR PI0108041A BR 0108041 A BR0108041 A BR 0108041A BR PI0108041 B8 BRPI0108041 B8 BR PI0108041B8
Authority
BR
Brazil
Prior art keywords
molsidomine
hours
dosage form
released
angina
Prior art date
Application number
BRPI0108041A
Other languages
English (en)
Other versions
BR0108041A (pt
BR0108041B1 (pt
Inventor
Geczy Jozsef-Michel
Original Assignee
Therabel Pharmaceuticals Ltd
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
Application filed by Therabel Pharmaceuticals Ltd filed Critical Therabel Pharmaceuticals Ltd
Publication of BR0108041A publication Critical patent/BR0108041A/pt
Publication of BR0108041B1 publication Critical patent/BR0108041B1/pt
Publication of BRPI0108041B8 publication Critical patent/BRPI0108041B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Hydrogenated Pyridines (AREA)

Abstract

"nova forma galênica oral de liberação prolongada da molsidomina". a presente invenção se refere a uma nova forma galênica oral de liberação prolongada da molsidomina destinada ao tratamento da crise anginosa sob todas as suas formas (angina de esforço, angina espástica, angina mista). segundo a invenção, esta nova forma galênica contém uma quantidade terapeuticamente eficaz de molsidomina ou de um de seus metabólicos ativos e no que ela apresenta uma taxa de dissolução in vitro [medida espectrofotometricamente a 286 ou 311nm segundo o método descrito na pharmacopée européenne, 3<a> edição (ou u.s.p. xxiv) a 50 t.p.m em 500ml de um meio hc1 0,1 n, a 37 <198>c]de: - 15 a 25% de molsidomina liberada após 1 hora - 20 a 35% de molsidomina liberada após 2 horas - 50 a 65% de molsidomina liberada após 6 horas - 75 a 95% de molsidomina liberada após 12 horas - >85% de molsidomina liberada após 18 horas - >90% de molsidomina liberada após 24 horas o pico plasmático de molsidomina obtido in vivo se apresentando nas 2 horas e meia a 5 horas, de preferência nas 3 a 4 horas, seguindo a administração da citada forma e tendo um valor compreendido entre 25 e 40ng/ml de plasma. aplicação: indústria terapêutica
BRPI0108041A 2000-02-24 2001-02-22 nova forma galênica oral de liberação prolongada da molsidomina. BRPI0108041B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0002307A FR2805462B1 (fr) 2000-02-24 2000-02-24 Nouvelle forme galenique orale a liberation prolongee de la molsidomine
PCT/EP2001/002055 WO2001062256A1 (fr) 2000-02-24 2001-02-22 Nouvelle forme galenique orale a liberation prolongee de la molsidomine

Publications (3)

Publication Number Publication Date
BR0108041A BR0108041A (pt) 2002-10-29
BR0108041B1 BR0108041B1 (pt) 2013-06-18
BRPI0108041B8 true BRPI0108041B8 (pt) 2021-05-25

Family

ID=8847342

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0108041A BRPI0108041B8 (pt) 2000-02-24 2001-02-22 nova forma galênica oral de liberação prolongada da molsidomina.

Country Status (36)

Country Link
US (1) US7767227B2 (pt)
EP (1) EP1265614B1 (pt)
JP (1) JP4945043B2 (pt)
KR (1) KR100814191B1 (pt)
CN (1) CN100396284C (pt)
AT (1) ATE296632T1 (pt)
AU (2) AU2001240653B9 (pt)
BE (1) BE1013487A3 (pt)
BG (1) BG66111B1 (pt)
BR (1) BRPI0108041B8 (pt)
CA (1) CA2400886C (pt)
CZ (1) CZ301993B6 (pt)
DE (1) DE60111196T2 (pt)
DZ (1) DZ3273A1 (pt)
EE (1) EE05098B1 (pt)
ES (1) ES2241803T3 (pt)
FR (1) FR2805462B1 (pt)
HK (1) HK1050138B (pt)
HR (1) HRP20020692B1 (pt)
HU (1) HU229799B1 (pt)
IL (2) IL151205A0 (pt)
IS (1) IS2446B (pt)
MA (1) MA25576A1 (pt)
MD (1) MD3119C2 (pt)
MX (1) MXPA02008262A (pt)
NO (1) NO329495B1 (pt)
NZ (1) NZ520691A (pt)
OA (1) OA12183A (pt)
PL (1) PL201631B1 (pt)
PT (1) PT1265614E (pt)
RS (1) RS50291B (pt)
RU (1) RU2263506C2 (pt)
SK (1) SK286313B6 (pt)
UA (1) UA73972C2 (pt)
WO (1) WO2001062256A1 (pt)
ZA (1) ZA200206042B (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2805462B1 (fr) * 2000-02-24 2003-08-15 Therabel Res Nouvelle forme galenique orale a liberation prolongee de la molsidomine
US7803402B2 (en) * 2002-07-06 2010-09-28 Sanjeev Khandelwal Pharmaceutical preparations
FR2868314B1 (fr) * 2004-04-05 2008-10-24 Therabel Pharmaceuticals Ltd Nouvelle utilisation therapeutique de la molsidomine et de ses sels pharmaceutiquement acceptables
EP2468269A1 (en) 2010-11-26 2012-06-27 Universitätsklinikum Münster Nitric oxide donors in therapy of nitric oxide deficiency-induced disturbances of cerebral microcirculation
BE1028879B1 (fr) 2020-12-11 2022-07-12 Europharmaceuticals Comprimé à libération prolongée de la molsidomine

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3522191A1 (de) * 1985-06-21 1987-01-15 Cassella Ag Photostabilisierung von sydnoniminen
CN1006522B (zh) * 1986-04-30 1990-01-24 田道制药有限公司 缓放性制剂的制备方法
HU210921B (en) * 1990-03-28 1995-09-28 Chinoin Gyogyszer Es Vegyeszet Process for preparing inclusion complexes of n-ethoxycarbonyl-3-morpholino-sydnonimine formed with cyclodextrines and pharmaceutical compositions containing them
HU211648A9 (en) * 1990-03-28 1995-12-28 Chinoin Gyogyszer Es Vegyeszet Inclusion complexes of 3-morpholino-sydnonimine or its salts or its tautomer isomer, process for the preparation thereof, and pharmaceutical compositions containing the same
DE4140192C2 (de) * 1991-12-05 1996-02-29 Alfatec Pharma Gmbh Sol-gesteuerte Thermokolloidmatrix auf Gelatinebasis für perorale Retardformen
DE59408793D1 (de) * 1993-05-11 1999-11-11 Hoechst Ag Galenische Zubereitungen von Molsidomin
WO1995001767A1 (en) * 1993-07-08 1995-01-19 Cygnus Therapeutic Systems Monolithic matrix transdermal delivery system
IT1266565B1 (it) * 1993-07-22 1997-01-09 Ct Lab Farm Srl Composizioni farmaceutiche a rilascio controllato a base di uno o piu' sali farmaceuticamente accettabili dell'acido gamma-idrossi-butirrico.
HU218280B (en) * 1994-04-26 2000-07-28 Cyclodextrin inclusion complexes containing sin-1a which are stable intheir solid state, process for their preparation and pharmaceutical compositions containing the comlexes
DE4443105C2 (de) * 1994-12-03 1997-03-13 Hoechst Ag Verfahren zur Herstellung Molsidomin-haltiger Tabletten
JPH09114680A (ja) * 1995-10-19 1997-05-02 Fuji Xerox Co Ltd シーケンス制御装置
IT1282576B1 (it) * 1996-02-06 1998-03-31 Jagotec Ag Compressa farmaceutica atta a cedere la sostanza attiva in tempi successivi e predeterminabili
PE57198A1 (es) * 1996-03-25 1998-10-10 American Home Prod Formula de liberacion prolongada
JP2002522354A (ja) * 1997-09-19 2002-07-23 シャイア ラボラトリーズ,インコーポレイテッド 固溶体ビードレット
FR2775188B1 (fr) * 1998-02-23 2001-03-09 Lipha Forme galenique a liberation immediate ou liberation prolongee administrable par voie orale comprenant un agent promoteur d'absorption et utilisation de cet agent promoteur d'absorption
FR2805462B1 (fr) * 2000-02-24 2003-08-15 Therabel Res Nouvelle forme galenique orale a liberation prolongee de la molsidomine

Also Published As

Publication number Publication date
JP2003523981A (ja) 2003-08-12
US20030045522A1 (en) 2003-03-06
KR20020081323A (ko) 2002-10-26
FR2805462A1 (fr) 2001-08-31
HRP20020692B1 (en) 2011-10-31
HUP0300607A2 (hu) 2003-08-28
PT1265614E (pt) 2005-10-31
ES2241803T3 (es) 2005-11-01
AU4065301A (en) 2001-09-03
EE200200472A (et) 2003-12-15
HK1050138B (zh) 2005-07-29
MXPA02008262A (es) 2004-04-05
HU229799B1 (en) 2014-07-28
HRP20020692A2 (en) 2004-02-29
EP1265614B1 (fr) 2005-06-01
US7767227B2 (en) 2010-08-03
CA2400886A1 (fr) 2001-08-30
DZ3273A1 (fr) 2001-08-30
SK286313B6 (en) 2008-07-07
CA2400886C (fr) 2011-04-19
MD3119C2 (ro) 2007-04-30
NO20024043D0 (no) 2002-08-23
SK12202002A3 (sk) 2002-12-03
EE05098B1 (et) 2008-12-15
HK1050138A1 (en) 2003-06-13
WO2001062256A1 (fr) 2001-08-30
CN1419451A (zh) 2003-05-21
UA73972C2 (en) 2005-10-17
BG107027A (bg) 2003-04-30
OA12183A (fr) 2006-05-09
RS50291B (sr) 2009-09-08
IS6504A (is) 2002-08-14
ATE296632T1 (de) 2005-06-15
CN100396284C (zh) 2008-06-25
CZ301993B6 (cs) 2010-09-01
PL357550A1 (en) 2004-07-26
DE60111196D1 (de) 2005-07-07
HUP0300607A3 (en) 2006-02-28
BE1013487A3 (fr) 2002-02-05
BG66111B1 (bg) 2011-05-31
NO20024043L (no) 2002-08-23
MA25576A1 (fr) 2002-10-01
JP4945043B2 (ja) 2012-06-06
MD20020212A (en) 2002-12-31
FR2805462B1 (fr) 2003-08-15
KR100814191B1 (ko) 2008-03-17
AU2001240653B9 (en) 2005-10-27
IL151205A0 (en) 2003-04-10
IL151205A (en) 2011-01-31
ZA200206042B (en) 2003-07-29
DE60111196T2 (de) 2006-05-11
MD3119B2 (en) 2006-08-31
BR0108041A (pt) 2002-10-29
IS2446B (is) 2008-11-15
YU62202A (sh) 2006-01-16
EP1265614A1 (fr) 2002-12-18
PL201631B1 (pl) 2009-04-30
BR0108041B1 (pt) 2013-06-18
NZ520691A (en) 2004-07-30
RU2263506C2 (ru) 2005-11-10
RU2002121503A (ru) 2004-03-20
NO329495B1 (no) 2010-11-01
AU2001240653B2 (en) 2005-05-26

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]

Free format text: DE ACORDO COM O ART.34 "II" DA LPI (LEI 9279, DE 14/05/96), O EXAME FICA SUSPENSO PARA QUE O REQUERENTE APRESENTE DOCUMENTOS NECESSARIOS A REGULARIZACAO DO PROCESSO E EXAME DO PEDIDO.

B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 18/06/2013, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/02/2001 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21A Patent or certificate of addition expired [chapter 21.1 patent gazette]

Free format text: PATENTE EXTINTA EM 22/02/2021