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AR107711A2 - COMPRESSED PHARMACEUTICAL, PHARMACEUTICAL GRANULES AND PROCEDURE FOR PREPARATION, ORAL SOLID PHARMACEUTICAL FORM, CAPSULE - Google Patents

COMPRESSED PHARMACEUTICAL, PHARMACEUTICAL GRANULES AND PROCEDURE FOR PREPARATION, ORAL SOLID PHARMACEUTICAL FORM, CAPSULE

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Publication number
AR107711A2
AR107711A2 ARP170100459A ARP170100459A AR107711A2 AR 107711 A2 AR107711 A2 AR 107711A2 AR P170100459 A ARP170100459 A AR P170100459A AR P170100459 A ARP170100459 A AR P170100459A AR 107711 A2 AR107711 A2 AR 107711A2
Authority
AR
Argentina
Prior art keywords
pharmaceutical
diluent
tablet
free
capsule
Prior art date
Application number
ARP170100459A
Other languages
Spanish (es)
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Publication of AR107711A2 publication Critical patent/AR107711A2/en

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  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Comprimido farmacéutico que comprende la sal de bis-(monoetanolamina) del ácido 3’-[(2Z)-[1-(3,4-dimetilfenil)-1,5-dihidro-3-metil-5-oxo-4H-pirazol-4-ilideno]hidrazino]-2’-hidroxi-[1,1’-bifenil]-3-carboxílico (eltrombopag olamina), donde el comprimido fue realizado por el uso de un diluyente o diluyentes que están libres de metales de coordinación y/o que están libres de azúcares reductores. Dicho comprimido fabricado por medio de un proceso de granulación en húmedo y que tiene el 90% de las partículas de fármaco de un tamaño de partículas mayor de 10 micrómetros pero menor de 90 micrómetros. Cápsula farmacéutica, forma de dosificación y gránulos farmacéuticos correspondientes. Uso para preparar un medicamento útil para tratar la trombocitopenia o para agonizar el receptor de TPO en un ser humano que lo necesita. Proceso para preparar formas de dosificación correspondientes. Reivindicación 8: Un comprimido farmacéutico de acuerdo con ia reivindicación 1 caracterizada porque comprende: a) de 2% a 65% eltrombopag olamina; b) de 25% a 89% de diluyente; c) hasta 8% aglutinante; d) hasta 2% de lubricante; y e) de 4% a 12% de desintegrante. Reivindicación 17: Un comprimido farmacéutico de acuerdo con la reivindicación 8, caracterizado porque el componente diluyente comprende un azúcar no reductor y celulosa microcristalina. Reivindicación 18: Un comprimido farmacéutico de acuerdo con la reivindicación 17, caracterizado porque el azúcar no reductor es manitol, el aglutinante es polivinilpirrolidona, el desintegrante es glicolato de almidón sódico y el lubricante es estearato de magnesio. Reivindicación 25: Una forma farmacéutica oral sólida caracterizada porque Bis (monoetanolamina) del ácido 3’-[(2Z)-[1-(3,4-dimetilfenil)-1,5-dihidro-3-metil-5-oxo-4H-pirazoi-4-ilideno]hidrazino}-2’-hidroxi-[1,1’-bifenil}-3-carboxílico en la que la forma farmacéutica oral sólida se prepara usando un diluyente o diluyentes que están sustancialmente libres de metales de coordinación y/o que están sustancialmente libres de azúcares reductores.Pharmaceutical tablet comprising the bis- (monoethanolamine) salt of 3 '- [(2Z) - [1- (3,4-dimethylphenyl) -1,5-dihydro-3-methyl-5-oxo-4H-pyrazole acid -4-ylidene] hydrazino] -2'-hydroxy- [1,1'-biphenyl] -3-carboxylic acid (eltrombopag olamine), where the tablet was made by using a diluent or diluents that are free of coordination metals and / or that are free of reducing sugars. Said tablet manufactured by means of a wet granulation process and having 90% of the drug particles of a particle size greater than 10 micrometers but less than 90 micrometers. Pharmaceutical capsule, dosage form and corresponding pharmaceutical granules. Use to prepare a useful medication to treat thrombocytopenia or to agonize the TPO receptor in a human being in need. Process to prepare corresponding dosage forms. Claim 8: A pharmaceutical tablet according to claim 1 characterized in that it comprises: a) from 2% to 65% eltrombopag olamine; b) from 25% to 89% diluent; c) up to 8% binder; d) up to 2% lubricant; and e) from 4% to 12% disintegrant. Claim 17: A pharmaceutical tablet according to claim 8, characterized in that the diluent component comprises a non-reducing sugar and microcrystalline cellulose. Claim 18: A pharmaceutical tablet according to claim 17, characterized in that the non-reducing sugar is mannitol, the binder is polyvinyl pyrrolidone, the disintegrant is sodium starch glycolate and the lubricant is magnesium stearate. Claim 25: A solid oral pharmaceutical form characterized in that Bis (monoethanolamine) of 3 '- [(2Z) - [1- (3,4-dimethylphenyl) -1,5-dihydro-3-methyl-5-oxo-4H acid -pyrazoi-4-ylidene] hydrazino} -2'-hydroxy- [1,1'-biphenyl} -3-carboxylic acid in which the solid oral pharmaceutical form is prepared using a diluent or diluents that are substantially free of coordination metals and / or that are substantially free of reducing sugars.

ARP170100459A 2007-05-03 2017-02-23 COMPRESSED PHARMACEUTICAL, PHARMACEUTICAL GRANULES AND PROCEDURE FOR PREPARATION, ORAL SOLID PHARMACEUTICAL FORM, CAPSULE AR107711A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US91576107P 2007-05-03 2007-05-03

Publications (1)

Publication Number Publication Date
AR107711A2 true AR107711A2 (en) 2018-05-23

Family

ID=38777752

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170100459A AR107711A2 (en) 2007-05-03 2017-02-23 COMPRESSED PHARMACEUTICAL, PHARMACEUTICAL GRANULES AND PROCEDURE FOR PREPARATION, ORAL SOLID PHARMACEUTICAL FORM, CAPSULE

Country Status (3)

Country Link
AP (1) AP2007004090A0 (en)
AR (1) AR107711A2 (en)
UA (1) UA96261C2 (en)

Also Published As

Publication number Publication date
UA96261C2 (en) 2011-10-25
AP2007004090A0 (en) 2007-08-31

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