Quality by design enabled self-nano emulsifying drug delivery systems development for the oral delivery of telmisartan: Improvement of biopharmaceutical performance

Abstract

Abstract Purpose: To increase the drug's oral bioavailability, a self-nano emulsifying drug delivery system was designed using capmul MCM, labrasol, and tween-20 as the oil, surfactant, and co-surfactant, respectively. Oil and Smix were tested for pre-isotropic compatibility and optimization of the formulations by using DoE software. Dispersibility, self-emulsifying duration, mean globule size, and stability were determined by a heating-cooling cycle and phase separation. Methods: Self-nano emulsifying systems were created into free-flowing granules by adsorbing using the ratios of aerosil 200, sylysia 350, 550, and 730 as porous carriers and neusilin as an adsorbing agent. The FT-IR study assessed the drug's compatibility with various excipients and confirm no interaction. The produced granules were analyzed using differential scanning calorimetry, dissolution profile, and other flow property measures. The SEM examination revealed no evidence of drug precipitation on the carrier's surface. Self-nano emulsifying tablets were prepared through direct compression and changed by adding hydrophilic polymers like Avicel 112 and cross-povidone. Results: The tablets produced had a round form, a pleasing appearance, less friability, and a faster rate of disintegration. The X-RD was used to characterize the physical properties of the pure drug and S-SEDDS, which determined that both the pharmaceutical and formulations were amorphous. Comparative dissolving testing with capsules in SGF pH 1.2 and phosphate buffer pH 6.8 revealed a significant increase in drug dissolution over the pure drug. Conclusion: The study signifies the chosen drug using S-SEDDS improved its biopharmaceutical performance significantly, which may be relevant to other drugs with similar properties.