Evaluation of Different Methods for Dissolution Profile Similarity Comparison of Montelukast Tablets in Türkiye
DISSOLUTION TECHNOLOGIES, cilt.31, sa.1, ss.40-49, 2024 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 31 Sayı: 1
- Basım Tarihi: 2024
- Dergi Adı: DISSOLUTION TECHNOLOGIES
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, International Pharmaceutical Abstracts
- Sayfa Sayıları: ss.40-49
- Açık Arşiv Koleksiyonu: AVESİS Açık Erişim Koleksiyonu
- Süleyman Demirel Üniversitesi Adresli: Evet
Özet
This study aimed to evaluate the highly variable in vitro dissolution profiles of generics and innovator montelukast
products in the Turkish drug market by comparing model-dependent and model-independent analysis methods. Seven
generic montelukast sodium products were tested, labeled G1–G7, and compared with the innovator. Dissolution tests
were carried out with United States Pharmacopeia (USP) apparatus 2 (paddle) in 900 mL of distilled water containing
0.5% 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 used
due to highly variable dissolution data. The values of f2, f̂
2,exp, and f̂
2,bc were calculated with DDSolver, Bootf2BCA, and
PhEq_bootstrap software. DDSolver was also used for model-dependent calculations. Two generic products showed
similarity with the innovator (f2 > 50) in biorelevant media (G4 in FeSSIF and G7 in FaSSIF); however, satisfactory results
were not obtained in 0.5% SDS. The observed differences may be due to the dissolution method or nature of montelukast
sodium (i.e., pH-dependent, poorly water-soluble, first-pass metabolism-exposed drug).