MX336930B - Formulaciones de ganaxolona y metodos para la manufactura y el uso de las mismas. - Google Patents

Formulaciones de ganaxolona y metodos para la manufactura y el uso de las mismas.

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Publication number
MX336930B
MX336930B MX2014003925A MX2014003925A MX336930B MX 336930 B MX336930 B MX 336930B MX 2014003925 A MX2014003925 A MX 2014003925A MX 2014003925 A MX2014003925 A MX 2014003925A MX 336930 B MX336930 B MX 336930B
Authority
MX
Mexico
Prior art keywords
making
methods
ganaxolone formulations
ganaxolone
particles
Prior art date
Application number
MX2014003925A
Other languages
English (en)
Inventor
Kenneth Shaw
Mingbao Zhang
Original Assignee
Marinus Pharmaceuticals
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 Marinus Pharmaceuticals filed Critical Marinus Pharmaceuticals
Publication of MX336930B publication Critical patent/MX336930B/es

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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
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    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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  • General Health & Medical Sciences (AREA)
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  • General Chemical & Material Sciences (AREA)
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  • Inorganic Chemistry (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Luminescent Compositions (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención se refiere a una composición farmacéutica comprende partículas estabilizadas sólidas que comprenden ganaxolona, un polímero hidrofílico, un agente humectante y una cantidad efectiva de un agente complejante que es una molécula orgánica pequeña con un peso molecular menor que 550 y que tiene una fracción fenol, una fracción de éster aromático o una fracción de ácido aromático; las partículas estabilizadas tienen un diámetro medio ponderado por volumen (D50) de aproximadamente 50 nm a aproximadamente 500 nm, en donde el agente complejante está presente en una cantidad de aproximadamente 0.05% a 5% peso/peso con base en el peso de las partículas del sólido, o la concentración de ganaxolona en las partículas estabilizadas sólidas es de al menos 50% en peso, o el agente complejante está presente en una cantidad de aproximadamente 0.05% a 5% peso/peso con base en el peso de las partículas del sólido y la concentración de ganaxolona en las partículas estabilizadas sólidas es de al menos 50% en peso y; en donde la composición farmacéutica comprende además uno o más aditivos y excipientes farmacéuticamente aceptables. En una modalidad preferida, las partículas estabilizadas sólidas están en forma de un polvo, y/o son incorporadas en una forma de dosificación seleccionada de una dispersión acuosa, una tableta o una cápsula.
MX2014003925A 2005-11-28 2006-11-28 Formulaciones de ganaxolona y metodos para la manufactura y el uso de las mismas. MX336930B (es)

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