FIELD: medicine; pharmaceuticals.
SUBSTANCE: group of inventions relates to the pharmaceutical industry, specifically to a complex of an active ingredient and an active ingredient-sustained-release resin, which is coated, as well as a process for its preparation and a pharmaceutical composition comprising said complex together with a pharmaceutically acceptable carrier. In the disclosed coated complex, the active ingredient is phenylephrine, the resin is a cation exchange resin derived from a sulphonated styrene-divinylbenzene copolymer, at least 90 % of which, prior to combination with phenylephrine, is in the form of particle with size of 74–177 mcm and the coating comprises cellulose acetate and hydroxypropyl cellulose in a weight ratio of 2:1, 3:1, 4:1 or 5:1, respectively, the amount of coating being 20, 25, 30, 35, 40, 45 or 50 wt. % of the weight of the coated complex.
EFFECT: said complex provides bioavailability of the active ingredient for 8 hours or more after administration to a subject and exhibits a secondary peak of Cmax 12 hours after administration to the subject.
6 cl, 11 dwg, 16 tbl, 5 ex
