Evaluation of the In-Vitro Dissolution Permeation Systems 1 (IDAS1) as a potential tool to monitor for unexpected changes in generic medicaments in poorly regulated markets

Rodriguez, Nelson J.; Grosso, Manuel; Galvez, Blanca; Calderon, Ginna; Lau, Lily; Turner, Vilma A.; Hidalgo, Ismael J.

doi:10.1016/j.ejps.2021.105791

Cited by 1 publication

(1 citation statement)

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“…However, recent studies have reported marked differences in therapeutic efficacy of marketed products containing the same amount of active ingredient, indicating that some generic products are not interchangeable with the innovator and/or each other (31). These differences may be because two-point dissolution analyses are considered sufficient instead of the full profile in batch-release studies, especially for immediate-release tablets, and the commercial lots are not analyzed despite the products being analyzed during the registration process (32,33). Therefore, it is important to obtain a dissolution profile that demonstrates similarity bioseries batch-release studies.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Different Methods for Dissolution Profile Similarity Comparison of Montelukast Tablets in Türkiye

Çoban,

Usta,

Pinar

2024

Dissolution Technol.

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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 modelindependent similarity factor (f 2 ); however, in this study, the bootstrap f 2 confidence interval method was also used due to highly variable dissolution data. The values of f 2 , f ̂2,exp , and f ̂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 (f 2 > 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).

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Section: Discussionmentioning

confidence: 99%