Formulation and Evaluation of Controlled-Release Tablet of Zolpidem Tartrate by Melt Granulation Technique
Author(s) -
Shailesh Prajapati,
Amit N. Patel,
Chhagan N. Patel
Publication year - 2011
Publication title -
isrn pharmaceutics
Language(s) - English
Resource type - Journals
eISSN - 2090-6153
pISSN - 2090-6145
DOI - 10.5402/2011/208394
Subject(s) - granulation , factorial experiment , chromatography , chemistry , materials science , diffusion , mathematics , composite material , thermodynamics , statistics , physics
The present investigation describes the influence of the concentration of PEG 6000 as a melt binder and ratio of HPMC K4M : PVP on Zolpidem tartrate controlled-release tablet formulations using 3 2 full factorial design. The ratio of HPMC K4M and PVP K30 ( X 1 ) and the concentration of melt binder ( X 2 ) were selected as independent variables, and drug release at 1 hr ( Q 1 ), 4 hr ( Q 4 ), 8 hr ( Q 8 ), diffusion coefficient ( n ), and release rate constant ( K ) were selected as a dependent variable. Tablets were prepared by melt granulation technique and evaluated for various evaluation parameters. It was observed that concentration of melt binder had significant effect on Q 1 , Q 4 , n , and K Binder concentration 25% w/w was found optimum. Optimized formulation ( F 7 ) showed good similarity with theoretical profile of drug. The X 2 variable had a significant effect on dependent variables, and the X 1 variable had no significant effect on dependent variables.
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