FIELD: pharmaceutics.
SUBSTANCE: invention relates to a composition in the form of a sachet for oral administration, containing a multilayer high-dose composition of tranexamic acid containing: i] an inert nucleus; ii] a drug coating layer which contains tranexamic acid and povidone; and iii] the taste-masking layer. Taste-masking layer comprises (a) a poly(meth)acrylate copolymer; (b) povidone; (c) sucralose; and (d) anhydrous colloidal silicon dioxide; where tranexamic acid is present in weight ratio from 50 % to 60 % wt/wt compositions. Invention also relates to a method of producing said composition.
EFFECT: dosage form of a sachet containing a high dose of tranexamic acid can contain a high dose and can be consumed by a subject in need thereof without any difficulties when swallowing.
14 cl, 6 dwg, 4 tbl, 2 ex
