Laboratorios Salvat, S.a.

Javier Sanagustín Aquilué

María Isabel Delgado Gañán

María Del Carmen Lendínez Gris

Adolfo Téllez Molina

Maria Mar Terraz Mendoza

Xavier Capdevila Nortes

María Del Carmen LENDÍNEZ Gris

It relates to a single-dose packaging unit which is a blow-fill-seal (BFS) container which comprises a sterile pharmaceutical or veterinary liquid composition which is a solution, wherein a) the composition comprises a therapeutically effective amount of clotrimazole or a pharmaceutically or veterinary acceptable salt thereof, together with one or more pharmaceutically or veterinary acceptable excipients or carriers, and b) the container has a volume from 0.05 to 8 mL, with the condition that the water content of the composition is equal to or lower than 4% by weight with respect to the total composition weight. It also relates to a secondary packaging comprising one or more single-dose packaging units.

Single-dose packaged clotrimazole liquid composition

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.

Oil-in-water nanoemulsion composition of clobetasol

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Esplugues De Llobregat, Spain

Javier Sanagustín Aquilué