abstract |
FIELD: antibiotics, pharmacy. n SUBSTANCE: preparative form with sustained release of macrolide compound contains composition as solid dispersion. Macrolide compound in indicated solid dispersion presents in amorphous state on solid base. Preferably, macrolide compound represents tacrolimus or 33-epichloro-33-deoxyascomycin. Solid base is represented by water-soluble polymer, wax, water-insoluble polymer or their combination. In method for test carrying out for evaluation of pattern of dissolving the preparative form with indicated macrolide compound the test solution with concentration 0.001-0.1% of cellulose polymer is used at pH brought about to value 7, not above. After oral intake the novel preparative form releases macrolide compound by sustained pattern and pharmaceutical activity is maintained for a long time. Invention provides reduced frequency of pharmacologically active macrolide compound to 1 time per a day. The novel preparative form has no risk of adverse effects in case of random excessive concentration of macrolide compound. n EFFECT: improved and valuable properties of preparations. n 20 cl, 1 tbl, 34 ex |