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

Autor: Chalikwar SS; Department of Pharmaceutical Quality Assurance, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India., Surana SJ; Department of Pharmacognosy, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India., Goyal SN; Department of Pharmacology, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India.; Shri Vile Parle Kelavani Mandal's Institute of Pharmacy, Dhule, India., Chaturvedi KK; Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY, USA., Dangre PV; Department of Pharmaceutical Quality Assurance, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India.
Jazyk: angličtina
Zdroj: Journal of microencapsulation [J Microencapsul] 2021 Jan; Vol. 38 (1), pp. 61-79. Date of Electronic Publication: 2020 Nov 30.
DOI: 10.1080/02652048.2020.1851788
Abstrakt: 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 3 2 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 ( Y 1 ) = 102.5 ± 2.52 s, globule size ( Y 2 ) = 225.2 ± 3.40 nm, polydispersity index ( Y 3 ) = 0.294 ± 0.62, and zeta potential ( Y 4 ) = -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.
Databáze: MEDLINE