FIELD: medicine.
SUBSTANCE: invention relates to medicine, namely to a taste-masking pharmaceutical composition and a process for its preparation. Taste masking pharmaceutical composition for oral administration contains a plurality of coated particles containing a core and a coating, wherein the core is composed of N-acetylcysteine and the coating contains a triglyceride. NAC particles are characterized in that at least 90 % by weight have a size of 250 mcm or more and an average particle size is from 350 mcm to 500 mcm, wherein the core and / or coated particles have an average aspect ratio of 0.5 to 0.8. Invention allows to obtain particles with a fast release of the drug and a stable release curve and at the same time with sufficient taste masking even for NAC nuclei of irregular shape. In addition, the present invention provides a hot melt coating process for the preparation of such particles and pharmaceutical compositions containing said particles.
EFFECT: method allows to coat the core particles at moderate temperatures, thereby preventing the degradation of the thermolabile active ingredient.
15 cl, 1 dwg, 1 ex
