Formulation and development of self-microemulsifying drug delivery system of pioglitazone

Jyotsana R. Madan, Bandavane Sudarshan, Vinod S. Kadam, Dua Kama


Self-microemulsifying drug delivery system (SMEDDS) is a promising system for the Biopharmaceutics Classification
System (BCS) class II drugs. The current research aimed to improve the dissolution of poorly water-soluble antidiabetic
drug pioglitazone HCl by formulating it in SMEDDS. Liquid SMEDDS of pioglitazone HCl were formulated with Capmul
MCM C8 and oleic acid as oil phase, Cremophor RH 40 and Tween 80 as surfactant phase, and Transcutol P as cosurfactant
phase after screening various vehicles. The prepared formulations were evaluated for self-emulsifying ability and phase
diagram was constructed to optimize the system. These systems were further characterized for globule size, effect of pH
and robustness, zeta potential, drug content, viscosity, self-emulsification time, polydispersity index, % transmittance,
thermodynamic stability, surface morphology, and drug release. The system was robust to different pH media and dilution
volumes. The optimized system possessed a mean globule size of 122.2 nm, zeta potential around -22.9 mV, drug content
99.66 ± 0.47%, viscosity 0.8874 ± 0.026 cP, emulsification time 38 s, polydispersity index value of 0.5, and transmittance
value of 99.3 ± 0.6%. Drug release in hydrochloric acid buffer pH 2 was found to be 99.35 ± 0.38%. More than three-fold
increase in dissolution characteristics of pioglitazone HCl in SMEDDS was observed as compared to pure and marketed
formulation. Liquid SMEDDS filled in hard gelatin capsule (HGC) shell was found to be compatible. Stability studies show
there was no sign of phase separation or precipitation and no change in drug content was observed.

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