FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to a composition in the form of a plurality of particles containing tamsulosin and dutasteride, and to a method for producing such a composition. A multiparticulate composition wherein each particle contains the following: a) an inner core of tamsulosin or a hydrochloride salt thereof, wherein the inner core is coated with a modified release coating, wherein the modified release coating is coated with a first seal coating; and b) an outer cover layer of dutasteride, wherein the outer cover layer is covered with a second seal coat. A method for preparing a multiparticulate composition, the method for preparing each particle comprising the following steps: a) preparing the inner core of tamsulosin or its hydrochloride salt; b) applying a coating dispersion of a modified release polymer to the said inner core to obtain a modified release inner core; c) coating of the said inner core with a modified release solution of a first seal coating to obtain a core with a first seal coating; d) applying to the inner core with the first seal coating an outer coating dispersion of dutasteride to obtain an inner core coated with dutasteride; e) applying to the said dutasteride-coated inner core a dispersion of a second seal coat.
EFFECT: above group of inventions makes it possible to obtain a composition comprising tamsulosin and dutasteride in one dosage unit in the form of a plurality of particles, namely separate granules, in which tamsulosin and dutasteride are physically separated.
15 cl, 2 dwg, 2 ex
