6533b82dfe1ef96bd1290a87

RESEARCH PRODUCT

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

Alfredo García-arietaVirginia MerinoVirginia MerinoMarta SallanMatilde Merino-sanjuánMatilde Merino-sanjuánLluís SolerMaría Pleguezuelos-villaMaría Pleguezuelos-villaMª Jesús HernándezVictor Mangas-sanjuanVictor Mangas-sanjuanDaniel PerisAmparo NácherAmparo NácherIrene Hidalgo

subject

microstructureequivalencelcsh:RS1-441Pharmaceutical Sciencegeneric semisolid formulation02 engineering and technology030226 pharmacology & pharmacyDosage formArticlelcsh:Pharmacy and materia medica03 medical and health sciences0302 clinical medicinetopical drugStatisticsinter-batch variabilityEquivalence (measure theory)Parametric statisticsMathematics021001 nanoscience & nanotechnologyMicrostructureConfidence intervalReference productSample size determinationDrug releaserheology0210 nano-technology

description

Demonstration of similar microstructure is essential for demonstrating the equivalence of generic topical products since the microstructure of semisolids may affect the drug release. The objective of this study was to compare the microstructure-defining physical parameters of different batches of a reference ointment containing calcipotriol and betamethasone (Daivobet 50 &micro

yearjournalcountryeditionlanguage
2019-10-01Pharmaceutics
10.3390/pharmaceutics11100503http://europepmc.org/articles/PMC6835722