AN OIL-IN-WATER NANOEMULSION COMPOSITION OF CLOBETASOL

It relates to an oil-in-water nanoemulsion composition having a continuous aqueous phase and dispersed oil droplets, wherein the nanoemulsion comprises: (a) clobetasol; (b) one or more oil components; and (c) one or more surfactants; together with one or more pharmaceutically acceptable excipients o...

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Hauptverfasser: DELGADO GAÑÁN, Maria Isabel, SANAGUSTIN AQUILUE, Javier, LENDÍNEZ GRIS, María del Carmen
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:It relates to an oil-in-water nanoemulsion composition having a continuous aqueous phase and dispersed oil droplets, wherein the nanoemulsion comprises: (a) clobetasol; (b) one or more oil components; and (c) one or more surfactants; together with one or more pharmaceutically acceptable excipients or carriers wherein: the osmolality of the nanoemulsion is comprised from 100 mOsm/Kg to 500 mOsm/Kg; the droplet average size measured by Dynamic light scattering is comprised from 1 nm to 500 nm; the weight ratio between the oil components and the sum of the oil components and one or more surfactants is comprised from 0.001 to 0.5; the weight ratio between the oil component and clobetasol is comprised from 1:1 to 200:1; and the weight ratio between the surfactant and clobetasol is comprised from 2:1 to 200:1. It also relates to processes for its preparation, its use as a medicament, and in the prophylaxis and/or treatment of inflammatory diseases or conditions.