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中国药学(英文版) ›› 2015, Vol. 24 ›› Issue (7): 433-441.DOI: 10.5246/jcps.2015.07.056

• 【研究论文】 • 上一篇    下一篇

Formulation development and evaluation of pioglitazone hydrochloride self-emulsifying drug delivery systems

Gannu Praveen Kumar1*, D. Bikshapathi2, P. Madhukar3   

  1. 1. Department of Pharmaceutics, Sahasra Instituite of Pharmaceutical Sciences, Near Ayyappa Swamy Temple, Warangal–506007, India
    2. Department of Pharmaceutics, Vijaya college of Pharmacy, Hyderabad, India
    3. Vijaya College of Pharmacy, Hyderabad, India
  • 收稿日期:2015-02-10 修回日期:2015-03-31 出版日期:2015-07-28 发布日期:2015-04-03
  • 通讯作者: Tel.: +91-9397398024

Formulation development and evaluation of pioglitazone hydrochloride self-emulsifying drug delivery systems

Gannu Praveen Kumar1*, D. Bikshapathi2, P. Madhukar3   

  1. 1. Department of Pharmaceutics, Sahasra Instituite of Pharmaceutical Sciences, Near Ayyappa Swamy Temple, Warangal–506007, India
    2. Department of Pharmaceutics, Vijaya college of Pharmacy, Hyderabad, India
    3. Vijaya College of Pharmacy, Hyderabad, India
  • Received:2015-02-10 Revised:2015-03-31 Online:2015-07-28 Published:2015-04-03
  • Contact: Tel.: +91-9397398024

摘要:

As a widely prescribed anti diabetic drug, pioglitazone belongs to class IΙ under BCS and exhibits low and variable oral bioavailability due to its poor aqueous solubility. Its oral absorption is dissolution rate limited, and its solubility and dissolutionrate need to be enhanced in order to increase its oral bioavailability. In the present study, we aimed to screen various oils, surfactantsand cosolvents. The highest solubility was observed in Labrafac, Tween-80 and propylene glycol. Then the feasibility of formulatingpioglitazone SEDDS was evaluated, and the effect of dilution on the dissolution rate and dissolution efficiency of pioglitazone was also analyzed. A comparative evaluation of pioglitazone from SEDDS was made in SGF and 1% SLS. Dissolution of pioglitazone from SEDDS was rapid and higher compared with pure drug. The rate and extent of release of pioglitazone hydrochloride from stable SEDDS (F1) were higher in 1% SLS compared with SGF. The FTIR spectra proved that there was on chemical interaction between excipients and drug. SEM studies confirmed that the size was small and spherical.

关键词: Pioglitazone, SEDDS, Solubility, Size, Zeta Potential

Abstract:

As a widely prescribed anti diabetic drug, pioglitazone belongs to class IΙ under BCS and exhibits low and variable oral bioavailability due to its poor aqueous solubility. Its oral absorption is dissolution rate limited, and its solubility and dissolutionrate need to be enhanced in order to increase its oral bioavailability. In the present study, we aimed to screen various oils, surfactantsand cosolvents. The highest solubility was observed in Labrafac, Tween-80 and propylene glycol. Then the feasibility of formulatingpioglitazone SEDDS was evaluated, and the effect of dilution on the dissolution rate and dissolution efficiency of pioglitazone was also analyzed. A comparative evaluation of pioglitazone from SEDDS was made in SGF and 1% SLS. Dissolution of pioglitazone from SEDDS was rapid and higher compared with pure drug. The rate and extent of release of pioglitazone hydrochloride from stable SEDDS (F1) were higher in 1% SLS compared with SGF. The FTIR spectra proved that there was on chemical interaction between excipients and drug. SEM studies confirmed that the size was small and spherical.

Key words: Pioglitazone, SEDDS, Solubility, Size, Zeta Potential

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