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Systematic development of design of experiments (DoE) optimised self-microemulsifying drug delivery system of Zotepine
Authors:Hitesh Dalvadi  Nikita Patel  Komal Parmar
Institution:Department of Pharmaceutics, ROFEL, Shri G M Bilakhia College of Pharmacy, Gujarat, India
Abstract:The aim of present investigation is to improve dissolution rate of poor soluble drug Zotepine by a self-microemulsifying drug delivery system (SMEDDS). Ternary phase diagram with oil (Oleic acid), surfactant (Tween 80) and co-surfactant (PEG 400) at apex were used to identify the efficient self-microemulsifying region. Box–Behnken design was implemented to study the influence of independent variables. Principal Component Analysis was used for scrutinising critical variables. The liquid SMEDDS were characterised for macroscopic evaluation, % Transmission, emulsification time and in vitro drug release studies. Optimised formulation OL1 was converted in to S-SMEDDS by using Aerosil® 200 as an adsorbent in the ratio of 3:1. The S-SMEDDS was characterised by SEM, DSC, globule size (152.1?nm), zeta-potential (?28.1?mV), % transmission study (98.75%), in vitro release (86.57%) at 30?min. The optimised solid SMEDDS formulation showed faster drug release properties as compared to conventional tablet of Zotepine.
Keywords:Zotepine  dissolution rate  self-micro-emulsifying drug delivery system  Box–Behnken design  principal component analysis
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