На сегодняшний день очевидна актуальность проблемы рационального использования теста «Растворение» при изучении фармацевтической эквивалентности лекарственных средств на
разных этапах их регистрации и перерегистрации. В статье изложена методика проведения теста
«Растворение» с целью оценки фармацевтической эквивалентности таблетированных форм
воспроизведенного препарата «АЛКОДЕЗ® ІС» (ОДО «ИНТЕРХИМ», Украина) и референтного
препарата «Метадоксил» (“Laboratori Baldacci S.p.A”, Италия). Результаты проведенного исследования демонстрируют подобие профилей растворения изучаемого генерического и референтного препаратов, что доказывает их фармацевтическую эквивалентность.
Today relevance of the problem of rational use of test “Dissolution” in the study of pharmaceutical
equivalence of drugs in different stages of registration and re-registration is obvious.
The purpose of this work is to develop the methodology of the test “Dissolution” to assess the
pharmaceutical equivalence of the generic drug “ALKODES® ІC” 0.5 g tablets (SLC “INTERHIM”,
Ukraine), and the reference product “Metadoxil” 0.5 g tablets (“Laboratori Baldacci S.p.A”, Italy). The test was performed on 12 tablets of each series of drugs. For determining the dissolution of tablets
the paddle apparatus was used. As dissolution media it was used 0.1 M hydrochloric acid; acetate
buffer pH 4.5; 0.05 M phosphate buffer pH 6.8. The samples were collected at 5, 10, 15, 25, 35, 45,
60 min after starting the test. Amount of metadoxine (active ingredient) was released from the tablet
in standard media and was determined spectrophotometrically by method of standart. The equivalence
of dissolution profiles were evaluated by calculating the similarity factor (f2). Values of coefficient of
similarity (50<f2<100) demonstrate the similarity of dissolution profiles studied generic and reference
products, which proves their pharmaceutical equivalence.
