Elaboration of beeswax microspheres loaded by pure and complexed niflumic acid with -cyclodextrin as novel lipid- controlled drug release formulations

Abstract

Controlled release systems based on natural lipid beeswax and loaded with Niflumic acid (NA) or inclusion complexes of NA with β-cyclodextrin are developed with the aim of simultaneously increasing the drug solubilisation, reducing the gastric side effects, and controlling the drug release. Simple and Green methods are used; firstly, the inclusion complexes of NA:b-CD (1:1) are prepared by physical grinding, co-evaporation, and co-precipitation. Secondly, the beeswax microspheres are elaborated by the hot-melt technique of microencapsulation using three emulsifying agents: PVA, Tween 20, and Tween 80. The formulations are analysed by FTIR, XRD, DSC, SEM, and optical microscopy.  Depending on the complex type and surfactant agent, microencapsulation efficacy ranged from 50 to 96%. The in-vitro drug dissolution study in acidic fluid at pH = 1.2 and 37 °C showed different release profiles. So, the effect of surfactant is highlighted, and a remarkable efficacy of the combination of inclusion complex and microencapsulation using beeswax is perceived for simultaneously increasing the drug solubility and controlling the drug release.

KEY WORDS: Beeswax, Niflumic acid, b-Cyclodextrin inclusion complex, Microencapsulation, Drug delivery

Bull. Chem. Soc. Ethiop. 2026, 40(10), 2237-2253.                                           

DOI: https://dx.doi.org/10.4314/bcse.v40i10.13