DEVELOPMENT AND EVALUATION OF SUBLINGUAL TABLET OF ZOLPIDEM TARTRATE AN ANTIPSYCHOTIC DRUG
Objective: The present work aims to develop and evaluate sublingual tablets of Zolpidem Tartrate used for the short-term treatment of insomnia.
Methods: The tablet of Zolpidem Tartrate was prepared by direct compression technique using two classes of super disintegrates represented by Crospovidone and Sodium Starch Glycolate (SSG) and the efficiency of these super disintegrants in the tablets was compared with various tests like disintegration time, waiting time, water absorption ratio, in-vitro dissolution profile and stability study.
Results: The disintegration efficiency of Crospovidone is better than SSG. Fourier Transform Infrared (FT-IR) spectrum of pure drug and the mixture of drug polymers revealed no chemical interaction. The pre-compression study indicated good flow properties of the bulk powder. In-vitro drug release from the formulations was studied using buffer pH 6.8. From the entire formulations, F5 and F6 containing 4 % and 5 % of Crospovidone conceded as an optimized formulation which is showing the drug release of 102.00Â±0.21 % and 103.10Â±0.42 % in 30 min considerably.
Conclusion: The results indicated that delivery of Zolpidem Tartrate into the systemic circulation via the sublingual route to improving its bio-availability and circumvent the first-pass effect. The optimized formulations were also found to be stable during stability studies conducted for 3 mg as per ICH guidelines.Keywords: Insomnia, Zolpidem Tartrate, Crospovidone, Sodium Starch Glycolate, In-vitro disintegration, In-vitrodrug release, Sublingual tablet
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