FORMULATION DEVELOPMENT AND CHARACTERIZATION OF NOVEL MICROSPHERES OF TERBINAFINE HYDROCHLORIDE
Authors: Jadhav VV , KASHID PS, YADAV MB, MANDHARE TA AND OTARI K

ABSTRACT
The study was aimed to formulate and evaluate microspheres of terbinafine hydrochloride by using chemical cross-linking method. Terbinafine HCl is BCS class II which has low solubility. To enhance solubility of drug with the help of PVP K30 as a carrier ratio of 1.1 ,1.2 and 1.3 using solvent evaporation technique. To achieve these objective nine formulations of microspheres were prepared. A 3² factorial design was employed in formulating the microspheres with Albumin and HPMC K15M as independent variables. Drug entrapment and Percentages drug release was considered as dependent variable. The prepared microspheres were characterized for their drug content, drug entrapment, percentage yield, in vitro release study. The FTIR results revealed that are is no interactions between the drug and polymers. The DSC analysis revealed that there are no interactions between the drug terbinafine hydrochloride and selected polymers. Surface morphology was studied using scanning electron microscopy (SEM). The examination of the internal structure of M5 microspheres shows that the interior of microspheres structure was solid in appearances with no pores or perforation. The microspheres were found to be spherical, quite smooth surfaces when viewed microscopically. The in vitro release studies showed that drug release was controlled (best with M5 formulation) for more than 12 h. Keyword: Solid dispersion, Terbinafine hydrochloride, Surface morphology, BCS class II.
Publication date: 01/10/2025
    https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9539.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.10.9539