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<p>This study aimed to evaluate the highly variable in vitro dissolution profiles of generics and innovator montelukastproducts in the Turkish drug market by comparing model-dependent and model-independent analysis methods. Sevengeneric montelukast sodium products were tested, labeled G1–G7, and compared with the innovator. Dissolution testswere carried out with United States Pharmacopeia (USP) apparatus 2 (paddle) in 900 mL of distilled water containing0.5% sodium dodecyl sulfate (SDS), fasted state simulated intestinal fluid (FaSSIF), or fed state simulated intestinal fluid(FeSSIF). The most accepted and used model for dissolution profile comparison of regulations in the world is the model independent similarity factor (f2); however, in this study, the bootstrap f2 confidence interval method was also useddue to highly variable dissolution data. The values of f2, f̂2,exp, and f̂2,bc were calculated with DDSolver, Bootf2BCA, andPhEq_bootstrap software. DDSolver was also used for model-dependent calculations. Two generic products showedsimilarity with the innovator (f2 > 50) in biorelevant media (G4 in FeSSIF and G7 in FaSSIF); however, satisfactory resultswere not obtained in 0.5% SDS. The observed differences may be due to the dissolution method or nature of montelukastsodium (i.e., pH-dependent, poorly water-soluble, first-pass metabolism-exposed drug). <br></p> |
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