ES2282062T1 - Composicion farmaceutica que contiene irbesartan. - Google Patents

Composicion farmaceutica que contiene irbesartan. Download PDF

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Publication number
ES2282062T1
ES2282062T1 ES05775601T ES05775601T ES2282062T1 ES 2282062 T1 ES2282062 T1 ES 2282062T1 ES 05775601 T ES05775601 T ES 05775601T ES 05775601 T ES05775601 T ES 05775601T ES 2282062 T1 ES2282062 T1 ES 2282062T1
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ES
Spain
Prior art keywords
approximately
composition according
composition
irbesartan
tablet
Prior art date
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Pending
Application number
ES05775601T
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English (en)
Inventor
Gershon Kolatkar
Erela Zisman
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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Filing date
Publication date
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of ES2282062T1 publication Critical patent/ES2282062T1/es
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Abstract

Composición que comprende más del 70% de irbesartán p/p y por lo menos un excipiente farmacéuticamente aceptable.

Claims (40)

1. Composición que comprende más del 70% de irbesartán p/p y por lo menos un excipiente farmacéuticamente aceptable.
2. Composición según la reivindicación 1, que presenta un perfil de disolución según el cual más de aproximadamente el 85% del irbesartán está disuelto en aproximadamente 30 minutos utilizando el aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de 50 rpm.
3. Composición que comprende más del 70% de irbesartán, en la que dicha composición presenta un perfil de disolución según el cual más de aproximadamente el 85% del irbesartán está disuelto en aproximadamente 30 minutos utilizando el aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de 50 rpm.
4. Composición según la reivindicación 3, que comprende más del 75% p/p de irbesartán y por lo menos un excipiente farmacéuticamente
aceptable.
5. Composición según cualquiera de las reivindicaciones 1 a 4, en forma de comprimido.
6. Composición según cualquiera de las reivindicaciones 1 a 5, en la que dicha composición comprende un aglutinante.
7. Composición según la reivindicación 6, en la que el aglutinante es povidona o almidón pregelatinizado.
8. Composición según la reivindicación 7, en la que el aglutinante es povidona.
9. Composición según la reivindicación 8, en la que la povidona está comprendida entre aproximadamente 1,0 y aproximadamente 7,0% p/p de la composición.
10. Composición según cualquiera de las reivindicaciones 6 a 9, en la que un aglutinante es almidón pregelatinizado (almidón 1500).
11. Composición según la reivindicación 10, en la que el almidón pregelatinizado (almidón 1500) está comprendido entre aproximadamente 1,0 y aproximadamente 10,0% p/p de la composición.
12. Composición según cualquiera de las reivindicaciones 1 a 11, en la que dicha composición comprende un disgregador.
13. Composición según la reivindicación 12, en la que un disgregador es la croscarmelosa sódica.
14. Composición según la reivindicación 13, en la que la croscarmelosa sódica es Ac-Di-Sol y está comprendida entre aproximadamente el 1,0% y aproximadamente el 7,0% p/p de la composición.
15. Composición según cualquiera de las reivindicaciones 1 a 14, en la que dicha composición comprende un tensioactivo.
16. Composición según la reivindicación 15, en la que dicho tensioactivo es poloxámero 188.
17. Composición según la reivindicación 16, en la que el poloxámero 188 está comprendido aproximadamente entre el 0,2 y aproximadamente el 6,0% p/p de la composición.
18. Composición según cualquiera de las reivindicaciones 1 a 17, en la que dicha composición comprende un diluyente.
19. Composición según la reivindicación 18, en la que dicho diluyente es celulosa microcristalina.
20. Composición según la reivindicación 19, en la que la celulosa microcristalina es Avicel PH 102 FMC y comprende entre aproximadamente el 2,0 y aproximadamente el 10,0% p/p de la composición.
21. Composición según cualquiera de las reivindicaciones 1 a 20, en la que dicha composición comprende un antiadherente.
22. Composición según la reivindicación 21, en la que el antiadherente es dióxido de silicio.
23. Composición según la reivindicación 22, en la que el dióxido de silicio es syloid 244 y comprende entre aproximadamente 0,4% p/p y aproximadamente el 0,5% p/p de la composición.
24. Composición según cualquiera de las reivindicaciones 1 a 23, en la que dicha composición comprende un lubricante.
25. Composición según la reivindicación 24, en la que dicho lubricante es estearato de magnesio.
26. Composición según la reivindicación 25, en la que el estearato de magnesio comprende entre aproximadamente el 0,2% y aproximadamente el 2,0% p/p de la composición.
27. Composición según cualquiera de las reivindicaciones 1 a 26, en la que además dicha composición comprende por lo menos un agente farmacéutico activo adicional.
28. Composición según la reivindicación 27, en la que el agente farmacéutico activo adicional es un agente diurético.
29. Composición según la reivindicación 27 ó 28, en la que el agente activo adicional es hidroclorotiazida.
30. Composición según la reivindicación 1, en la que la composición comprende, en peso, 75% de irbesartán, y en peso, aproximadamente 10% de aglutinante, aproximadamente 7,5% de diluyente, aproximadamente 4% de disgregador, aproximadamente 2% de tensioactivo, aproximadamente 1% de lubricante y aproximadamente 0,5% de antiadherente; en la que dicho aglutinante consiste en almidón pregelatinizado y povidona; dicho diluyente es microcelulosa cristalina y dicho disgregador es croscarmelosa sódica, dicho tensioactivo es poloxámero 188, dicho lubricante es estearato de magnesio y dicho antiadherente es dióxido de silicio.
31. Composición según la reivindicación 1, en la que la composición comprende, en peso, 79,79% de irbesartán, y los excipientes farmacéuticos comprenden en peso, aproximadamente 8,5% de aglutinante, aproximadamente 5,9% de diluyente, aproximadamente 3,1% de disgregador, aproximadamente 1% de tensioactivo, aproximadamente 1% de lubricante y aproximadamente 0,5% de antiadherente; en la que dicho aglutinante consiste en almidón pregelatinizado y povidona; dicho diluyente es microcelulosa cristalina, dicho disgregador es croscarmelosa sódica, dicho tensioactivo es poloxámero 188, dicho lubricante es estearato de magnesio y dicho antiadherente es dióxido de silicio.
32. Composición según la reivindicación 30 ó 31, en la que dicha composición es un comprimido, de modo que el comprimido tiene un rendimiento de disolución de modo que más del 85% del irbesartán contenido en la misma se disuelve en 30 minutos en las condiciones siguientes: aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de
50 rpm.
33. Composición según la reivindicación 5, en la que el comprimido se prepara mediante un procedimiento de granulación en húmedo.
34. Composición según la reivindicación 1, que presenta un perfil de disolución según el cual más del 80% del irbesartán se disuelve en 10 minutos utilizando el aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de 50 rpm.
35. Composición según la reivindicación 1, que presenta un perfil de disolución según el cual más del 85% del irbesartán se disuelve en aproximadamente 10 minutos utilizando el aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de 50 rpm.
36. Composición según la reivindicación 1, que presenta un perfil de disolución según el cual por lo menos aproximadamente el 75% del irbesartán se disuelve en aproximadamente 5 minutos, por lo menos aproximadamente el 85% del irbesartán se disuelve en aproximadamente 10 minutos y por lo menos aproximadamente el 95% del irbesartán se disuelve en aproximadamente 20 minutos utilizando el aparato 2 de USP, colocando el comprimido en 1000 ml de ácido clorhídrico 0,1 N a 37ºC con una velocidad del agitador de 50 rpm.
37. Composición según la reivindicación 1, en la que la composición comprende, en peso, 79,79% de irbesartán, entre aproximadamente el 3% y aproximadamente el 7% de hidroclorotiazida, entre aproximadamente 5,3% y aproximadamente 7,5% de aglutinante, entre aproximadamente 3,5% y aproximadamente 6% de diluyente, entre aproximadamente 3% y aproximadamente 3,2% de disgregador, entre aproximadamente 1% y aproximadamente 1,1% de lubricante, y entre aproximadamente 0,4% y aproximadamente 0,5% de antiadherente; en la que dicho aglutinante consiste en almidón pregelatinizado y povidona; dicho diluyente es microcelulosa cristalina, dicho disgregador es croscarmelosa sódica, dicho lubricante es estearato de magnesio y dicho antiadherente es dióxido de silicio.
38. Composición según la reivindicación 36, en la que la composición comprende, en peso, 79,79% de irbesartán, 2,13% de povidona, 6,38% de almidón pregelatinizado, 3,15% de croscarmelosa sódica, 1,01% de poloxámero 188, 5,96% de celulosa microcristalina, 1,01% de estearato de magnesio y 0,43% de dióxido de silicio.
39. Composición según la reivindicación 37, en la que la composición comprende 150 mg de irbesartán y 12,5 mg de hidroclorotiazida.
40. Composición según la reivindicación 37 en la que la composición comprende, en peso, 79% de irbesartán, aproximadamente 3,3% de hidroclorotiazida, aproximadamente 3,1% de almidón pregelatinizado, aproximadamente 2,1% de povidona, aproximadamente 5,3% de celulosa microcristalina, aproximadamente 4,7% de croscarmelosa sódica, aproximadamente 0,4% de dióxido de silicio y aproximadamente 1% de estearato de magnesio.
ES05775601T 2004-06-04 2005-06-02 Composicion farmaceutica que contiene irbesartan. Pending ES2282062T1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US57742704P 2004-06-04 2004-06-04
US577427P 2004-06-04

Publications (1)

Publication Number Publication Date
ES2282062T1 true ES2282062T1 (es) 2007-10-16

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ES05775601T Pending ES2282062T1 (es) 2004-06-04 2005-06-02 Composicion farmaceutica que contiene irbesartan.

Country Status (11)

Country Link
US (2) US8226977B2 (es)
EP (1) EP1750862B1 (es)
JP (2) JP4880591B2 (es)
AT (1) ATE493973T1 (es)
AU (1) AU2005249794A1 (es)
CA (1) CA2568640C (es)
DE (1) DE602005025755D1 (es)
ES (1) ES2282062T1 (es)
IL (1) IL179718A0 (es)
PL (1) PL1750862T3 (es)
WO (1) WO2005118166A2 (es)

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JP2008501680A (ja) 2008-01-24
IL179718A0 (en) 2007-05-15
EP1750862A4 (en) 2008-06-11
US20050271720A1 (en) 2005-12-08
PL1750862T3 (pl) 2011-06-30
CA2568640C (en) 2011-08-09
JP2011252022A (ja) 2011-12-15
EP1750862B1 (en) 2011-01-05
WO2005118166A3 (en) 2006-07-27

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