Formulation and Evaluation of Extended- Release Tablet of Zolpidem Tartrate by Wet Granulation Technique

Document Type : Original Article

Authors

• Fatemeh Pourhashem ¹
• Mohammad Reza Avadi ²

¹ Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAUPS), Tehran, Iran

² Department of Nanotechnology, Pharmaceutical Sciences Branch, Islamic Azad University (IAUPS), Tehran, Iran

Abstract

The goal of this study was to design and evaluate extended - release system of the hypnotic agent, Zolpidem
tartrate usefulness for the treatment of insomnia. The half-life of this drug is about 1.9 - 3 hours that indicating
it a candidate for the extended release formulation. Our investigation relates to development of extended
drug delivery system based on Hydroxy propyl methyl cellulose (HPMCK4M) as release retardant, polyvinyl
pyrrolidone (PVP k30) as binder and Magnesium Stearate using Factorial design. In vitro release study of
matrix tablets was carried out in 0.01N HCl for 2 hours. All prepared matrix tablets were evaluated for
physicochemical evaluation and drug content. The formulation that had release profile according to United
State Pharmacopoeia selected for stability study according to ICH guidelines

Keywords

• Zolpidem tartrate
• Wet granulation
• Hydroxy propyl methyl cellulose (K4M)
• ؛ Factorial design
• ICH guideline

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