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Priority to ARP130104520ApriorityCriticalpatent/AR093819A1/en
Publication of AR093819A1publicationCriticalpatent/AR093819A1/en
Se divulga un método para determinar la actividad biológica de la defibrotida, que comprende los pasos de: a) poner en contacto defibrotida, euglobulina de mamífero y un sustrato específico para la plasmina que, por reacción con la plasmina, proporciona un producto medible; y b) medir la cantidad de producto formado en tiempos sucesivos, para determinar así la actividad biológica de la defibrotida. También se divulgan formulaciones de defibrotida, preferentemente soluciones de agua, que poseen una actividad biológica definida y, en particular, que posee una actividad de 25 a 35 IU/mg de defibrotida, preferentemente desde 27.5 a 32.5 IU/mg y, más preferentemente, desde 28 a 32 IU/mg.A method for determining the biological activity of defibrotide is disclosed, comprising the steps of: a) contacting defibrotide, mammalian euglobulin and a specific substrate for plasmin which, by reaction with plasmin, provides a measurable product; and b) measure the amount of product formed in successive times, in order to determine the biological activity of defibrotide. Also disclosed are defibrotide formulations, preferably water solutions, which have a defined biological activity and, in particular, which have an activity of 25 to 35 IU / mg of defibrotide, preferably from 27.5 to 32.5 IU / mg and, more preferably, from 28 to 32 IU / mg.
ARP130104520A2013-12-052013-12-05
EUGLOBULIN-BASED METHOD TO DETERMINE THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE
AR093819A1
(en)
Process for preparing a pharmaceutical composition comprising i) providing a first combination comprising a peptide proteasome inhibitor compound, one or more cyclodextrins and water, and ii) contacting the first combination with an acid to form a second combination; pharmaceutical composition
Process for preparing a pharmaceutical composition comprising i) providing a first combination comprising a) a compound b) one or more cyclodextrins and c) water, ii) contacting the first combination with an acid to form a second combination; pharmaceutical composition