Systematic development of design of experiments (DoE) optimised self-microemulsifying drug delivery system of Zotepine

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

Acknowledgements

The authors would like to thank Symed laboratories for given gift sample of Zotepine and Tata Institute of Fundamental Research for providing X-ray diffraction facility.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.