Formulation Development and Evaluation of Solid Self Microemulsifying Drug Delivery System of Azelnidipine

Anuradha P Prajapati; Pratik S Patel; Neha S Vadgama; Sachin Narkhede; Shailesh Luhar; Shivani J Gandhi

doi:10.25004/IJPSDR.2023.150303

Anuradha P Prajapati Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Vapi, Gujarat, India
Pratik S Patel Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Vapi, Gujarat, India
Neha S Vadgama Department of Pharmaceutical Sciences and Drug Research, Punjab University, Patiala, Punjab, India.
Sachin Narkhede Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Vapi, Gujarat, India
Shailesh Luhar Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Vapi, Gujarat, India
Shivani J Gandhi Department of Pharmaceutics, Smt. BNB Swaminarayan Pharmacy College, Vapi, Gujarat, India

DOI: https://doi.org/10.25004/IJPSDR.2023.150303

Keywords: Self-emulsifying drug delivery systems, Azelnidipine poorly soluble, Pseudo-ternary phase diagram.

Abstract

This study aimed to develop a self-micro emulsifying drug delivery system (SMEDDS) for poorly soluble azelnidipine using Capryol 90 as the oil, Tween 80 as the surfactant, and transcutol-HP as the co-surfactant. A factorial design was used to optimize the formulation, and Neusilin UFL2 was used as an adsorbent to convert the liquid SMEDDS to solid SMEDDS. The optimized formulation had a particle size of 80.5nm, a transmittance of 98.2%, a zeta potential of -3.1 mV, and a polydispersibility index of 0.226. The solid SMEDDS tablet exhibited improved drug release (99.4% in 60 minutes) compared to the marketed tablet (67.09.75%) and pure drug (26.17%). This study demonstrates the potential of the SMEDDS approach to enhance the solubility and in-vitro drug release of poorly soluble drugs such as azelnidipine.