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Results.The investigations of the physical-chemical properties of the diclofenac sodium substance (micronisation, solubility) and the basis of the solid fat carrier, which affect the release of the active ingredient from the drug formulation were carried. The «particle size» figure for 2 samples of the active ingredient was from 100 to 400 μm and not more than 15 μm, respectively. The optimal composition of suppositories was developed by the method of 2-factor experiments. The conditions for the «Dissolution» test were determined: the volume of the medium (720 ml), the dissolution temperature (37.0 ± 0.5) oC, the time taken for sampling (15, 30, 45, 60, 90 min), the dissolution medium – buffered solution with a pH of 7.4. The calculated similarity factor f2 was 67, which indicates the similarity of the release profiles and the equivalence of the researched drug.

zaporožskij medicinskij žurnal

Development of the composition and research of the equivalence of suppositories with diclofenac sodium by in vitro method using “Dissolution” test for lipophilic solid dosage forms