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IJPER · Lens · Design and Development of Self-Micro Emulsifying Drug Delivery Systems of Rifaximin Using 32 Factorial Design

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Article · Volume 60, Issue 3s (Supplement) · pp. s929-s943

Design and Development of Self-Micro Emulsifying Drug Delivery Systems of Rifaximin Using 32 Factorial Design

Onkar Vilas Jadhav1, Twarita Dilip Deshpande1, Udaykumar Baburao Bolmal1, Anuj Jagannath Shinde1, Shital Vishwas Patil1

  1. 1Department of Pharmaceutics, Rani Chennamma College of Pharmacy, Vaibhav Nagar, Belagavi, Karnataka, INDIA.

Abstract

Aim/Background: This study aimed to enhance the oral bioavailability of Rifaximin by formulating a Self-Micro emulsifying Drug Delivery System, with the goal of improving its aqueous solubility and dissolution performance.Materials and Methods: A 3² full factorial design was applied, wherein the independent variables selected were olive oil and Tween 20, and the chosen responses were emulsification time and drug content. Rifaximin was used as a drug. Various excipients used in the formulation included oils (olive oil, coconut oil, cottonseed oil), surfactants (Tween 20, PEG 400, Span 20), co-surfactants (propylene glycol, Kolliphor RH 40), and solid carriers (microcrystalline cellulose and Aerosil 200). The prepared liquid SMEDDS were characterized by assessing their optical transparency, pH, emulsification time (34.33±1.52 to 57±1.0 sec), zeta potential(-22.7mV), globule size (98.7 to 483.3 nm), robustness to dilution, percent transmittance, viscosity, cloud point, and drug content. Solid SMEDDS were prepared using an adsorption technique.Results: The in vitro release profile showed that rifaximin from S-SMEDDS achieved 92.3624 ± 0.21% drug release, whereas the pure drug exhibited 62.8487 ± 0.24% release, indicating approximately 1.5-fold enhancement in drug release with the solid SMEDDS formulation compared to pure rifaximin. This enhanced release profile suggests improved solubility, which could potentially increase the bioavailability of Rifaximin, a drug known for its poor water solubility.Conclusion: The formulated SMEDDS significantly improved the dissolution behavior of rifaximin, which may potentially enhance its therapeutic performance. This study provides a foundation for future preclinical and clinical investigations of S-SMEDDS systems designed for poorly soluble drugs such as rifaximin.

Keywords: Adsorption Technique; Solubility Enhancement; Factorial Design; Rifaximin; S-SMEDDS; Emulsification Time

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