Solid self-microemulsifying nutraceutical delivery system for hesperidin using quality by design: assessment of biopharmaceutical attributes and shelf-life

Abstract

Aim

The present study endeavours to develop a solid self-microemulsifying nutraceutical drug delivery system for hesperidin (HES) using quality by design (QbD) to improve its biopharmaceutical attributes.

Methods

A 3² full factorial design was employed to study the influence of factors on selected responses. Risk assessment was performed by portraying Ishikawa fishbone diagram and failure mode effect analysis (FMEA). The in vivo antidiabetic study was carried on induced diabetic rats.

Results

The optimised liquid SMEDDS-HES (OF) formulation showed emulsification time (Y₁) = 102.5 ± 2.52 s, globule size (Y₂) = 225.2 ± 3.40 nm, polydispersity index (Y₃) = 0.294 ± 0.62, and zeta potential (Y₄) = –25.4 ± 1.74 mV, respectively. The solid SMEDDS-HES (SOF-7) formulation was characterised by FTIR, PXRD, DSC, and SEM. The shelf life of SOF-7 was found to be 32.88 months. The heamatological and histopathological data of diabetic rats showed prominent antidiabetic activity.

Conclusions

The optimised formulation showed improved dissolution, desired stability, and promising antidiabetic activity.

Keywords:

• Hesperidin
• self-microemulsifying drug delivery system
• quality by design
• risk assessment
• failure mode effect analysis
• shelf life

Acknowledgement

The authors sincerely thank the Gangwal Chemical Pvt. Ltd (Fuji Chemical Industries Co., Ltd.) for providing gratis sample of Neusilin US 2 and Gattefosse Pvt. Ltd (Mumbai, India) for providing different oils and surfactants for the said study. We also thankful to STIC (Sophisticated Test and Instrumentation Center), Cochin, India, for analysis of samples.

Disclosure statement

The authors declare there is no competing interest in publishing this article.