Statistically 2 Level Factorial by Design Expert: In-vitro Design and Formulation of Levitiracetam Extended Release Tablets

Abstract:

Background: Levitiracetam is an antiepileptic medication that falls into the BCS Class I drug classification. It is used to treat specific types of seizures in adults and children with epilepsy because of its high solubility and permeability. Aim: The objective of the present study is to evaluate the extended release tablets of levitiracetam by direct compression using HPMCK100, HPMCK15and Xanthan gum/Ethyl cellulose effect of the dissolution rate by 2 level factorial designs by Design expert software. Materials and Methods: The Design Expert software used to 2 level factorial designs, the three independent components of X1: drug: HPMCK 100, X2: HPMC K15 and X3: Ethyl cellulose/Xanthan gum was used to do analysis of variance (ANOVA), 3D surface plots, counter plots, optimization, and desirability. Fourier-transform infrared spectroscopy was used to investigate drug-excipient compatibility. Results and Conclusion: The drug release from all the tablets was diffusion control as indicated by the linear Higuchi plots. The release data was analyzed Peppas equation the release exponent (n) was found to be in the range 0.76-0.93. Amount all the levetiracetam tablets prepared formulation F2 formulated employing HPMC K100 60 mg, HMPCK15 25 mg, Xanthane gum 25 mg. In the all cases formulations F1, F3, F4, F5,F8 Indicates nonfickain diffusion and F2, F6, F7 Indicates super case II transport as release mechanism. The formulation F2 was released 100% drug release in a 8 hr. It is fulfill specifications for extended release tablets. The results of ANOVA of dependent variables indicated that the individual and combined effect of the 3 factors is significant (p< 0.05). The design expert software used to find 2 level factorial design, surface, counter plots, optimization and desirability. The optimized formula did better on the desirability level (1.0), indicating that it was a good fit. The FTIR spectra of pure drug and mixture with various excipients, indicates no chemical interaction between drug and excipients.

Keywords: Extended release, Design expert software, Levitiracetam, Direct compression, Drug release 8hr.