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

Main Article Content

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.


Download data is not yet available.

Article Details

How to Cite
R. Madan, J., Sudarshan, B., Kadam, V. S., & Kama, D. (2014). Formulation and development of self-microemulsifying drug delivery system of pioglitazone. Asian Journal of Pharmaceutics (AJP), 8(1).


Scientific Discussion, European Medcines Agency. Available from: www. [Last accessed Dec 2007].

Tang JL, Sun J, He ZG. Self-emulsifying drug delivery systems: Strategy

for improving oral delivery of poorly soluble drugs. Curr Drug Ther


Porter CJ, Pouton CW, Cuine JF, Charman WN. Enhancing intestinal drug

solubilisation using lipid-based delivery systems. Adv Drug Deliv Rev


Kale AA, Patravale VB. Design and evaluation of self-emulsifying

drug delivery systems (SEDDS) of nimodipine. AAPS Pharm Sci Tech


Mahajan HD, Shaikh T, Baviskar D, Wagh RD. Design and development

of solid self-micro-emulsifying drug delivery system (SMEDDS) of

fenofibrate. Int J Pharm Pharm Sci 2011;3:163-6.

Arsen AT, Ogbonna A, Abu-Rmaileh R, Abrahamsson B, Ostergaard J,

Müllertz A. “SNEDDS Containing Poorly Water Soluble Cinnarizine;

Development and in vitro Characterization of Dispersion, Digestion

and Solubilizationâ€. Pharmaceutics 2012;4:641-65.

Date AA, Nagarsenker MS. Design and evaluation of self-nanoemulsifying

drug delivery systems (SNEDDS) for cefpodoxime proxetil. Int J Pharm


Xi J, Chang Q, Chan CK, Meng ZY, Wang GN, Sun JB, et al. Formulation

development and bioavailability evaluation of a self-nanoemulsified

drug delivery system of oleanolic acid. AAPS PharmSciTech


Borhade V, Nair H, Hegde D. Design and evaluation of

self-microemulsifying drug delivery system (SMEDDS) of tacrolimus.

AAPS PharmSciTech 2008;9:13-21.

Patel AR, Vavia PR. Preparation and in vivo evaluation of

SMEDDS (Self-microemulsifying drug delivery system) containing

fenofibrate. AAPS J 2007;9:E344-52.

Kamble M, Borwandkar VG, Mane SS, Omkar R. Formulation and

evaluation of lipid based nanoemulsion of glimepiride using

self-emulsifying technology. Indo Am J Pharm Res 2012;2:1011-25.

Sha X, Wu J, Chen Y, Fang X. Self-microemulsifying drug-delivery

system for improved oral bioavailability of probucol: Preparation and

evaluation. Int J Nanomed 2012;7:705-12.

Atef E, Belmonte AA. Formulation and in vitro and in vivo characterization

of a phenytoin self-emulsifying drug delivery system (SEDDS). Eur J

Pharm Sci 2008;35:257-63.

Villar AM, Naveros BC, Campmany AC, Trenchs MA, Rocabert CB,

Bellowa LH. Design and optimization of self-nanoemulsifying drug

delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil.

Int J Pharm 2012;431:161-75.

Syed M. Liquid filled hard gelatin capsule: A modern day approach

to improve bioavailability of class II drugs, Oral Presentation, IIIrd

National Conference on “Recent challenges in pharmaceutical science

and technologyâ€, UICT, Jalgaon, India; 2013.

Tang B, Cheng G, Gu JC, Xu CH. Development of solid self

microemulsifying drug delivery system: Preparation techniques and

dosage forms. Drug Discov Today 2008;13:606-12.

Zhang P, Liu Y, Feng N, Xu J. Preparation and evaluation of

self-microemulsifying drug delivery system of oridonin. Int J Pharm


Sudhanshu S, Preeti KS. Formulation, In vitro characterization and

stability studies of self microemulsifying drug delivery systems of

domperidone. Int J Innov Pharm Res 2010;1:66-73.

Elnaggar YS, El-Massik MA, Abdallah OY. Self-nanoemulsifying drug

delivery systems of tamoxifen citrate: Design and optimization. Int J

Pharm 2009;380:133-41.

Food and Drug Administration. Guidance for industry: Immediate

release solid oral dosage forms: Scale-up and post-approval changes.

Rockville: US Department of Health and Human Services, FDA, Center

for Drug Evaluation and Research; November; Dec 1995.

Grove M, Müllertz A, Nielsen JL. Development and characterisatio n of

self microemulsifying drug delivery systems (SMEDDS) of seocalcitol.

Eur J Pharm Sci 2006;28:233-42.

Bachhav YG, Patravale VB. SMEDDS of glyburide: Formulation, in vitro

evaluation, and stability studies. AAPS Pharm Sci Tech 2009;10:482-7.

ICH Harmonized Tripartite Guideline stability Testing of New drug

Substances and Product Q1A (R2), current step 4 version; Dec 2003.