Abstract
In this investigation, the effect of formulation variables on the release properties of timed- release press-coated tablets was studied using the Taguchi method of experimental design. Formulations were prepared based on Taguchi orthogonal array design with different types of hydrophilic polymers (X1), varying hydrophilic polymer/ethyl cellulose ratio (X2), and addition of magnesium stearate (X3) as independent variables. The design was quantitatively evalu-ated by best fit mathematical model. The results from the statistical analysis revealed that factor X1, X3 and interaction factors between X1X2 and X1X3 were found to be significant on the re-sponse lag time (Y1), where as only factor X1 was found to be significant on the response percent drug release at 8 hrs (Y2). A numerical optimization technique by desirability function was used to optimize the response variables, each having a different target. Based on the re-sults of optimization study, HPC was identified as the most suitable hydrophilic polymer and incorporation of hydrophobic agent magnesium stearate, could significantly improve the lag time of the timed-release press-coated tablet.
Highlights
During the recent years timed-release preparations has received increasing attention, which release the drug rapidly and completely after a lag time following oral drug administration
Effect of hydrophobic additives were investigated and the results indicated that mixing of HPMCAS, magnesium stearate and calcium stearate at appropriate ratio prolonged the lag time [17]
Design of experiment has been widely used in pharmaceutical field to study the effect of formulation variables and their interaction on dependent variables. [18,19,20] In the present study an attempt is made to study the effect of formulation variables with the aid of Taguchi design to identify the potential contribution of various types of hydrophilic polymers, varying the hydrophilic/ethylcellulose ratio and presence and absence of magnesium stearate
Summary
During the recent years timed-release preparations has received increasing attention, which release the drug rapidly and completely after a lag time following oral drug administration This type of delivery system is rate controlled and time and /or site controlled to deliver the drug when it is required. Many different approached have been used for delivering the drugs as time and /or site specific which includes, Timeclock® system [3], Chronotropic® system [4], Pulsincap® sysem [5], Port® system [6], TimeRx® system [7] and Geomatrix® system [8] These systems are developed with intention to meet the needs of chronopathologies with symptoms mostly recurring at night time or early morning hours. Design of experiment has been widely used in pharmaceutical field to study the effect of formulation variables and their interaction on dependent (response) variables. [18,19,20] In the present study an attempt is made to study the effect of formulation variables with the aid of Taguchi design to identify the potential contribution of various types of hydrophilic polymers, varying the hydrophilic/ethylcellulose ratio and presence and absence of magnesium stearate
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