CENTRAL COMPOSITE DESIGN WITH BCS CLASS-I ANTI-EPILEPTIC DRUG USING IN VITRO FLOATING DEVELOPMENT AND OPTIMISATION
In Vitro Floating Development and Optimisation
DOI:
https://doi.org/10.55766/sujst5791Keywords:
Extended Release, Floating, In vitro, Levetiracetam, OptimizationAbstract
Levetiracetam (Lev) is a widely used antiepileptic drug known for its excellent solubility and permeability. The present study aimed to statistically optimize the formulation of gastro-retentive floating tablets using Design-Expert software. A central composite design (CCD) was employed to evaluate the effects of three independent variables: Methocel K100M Premium (X1), Methocel K15M Premium (X2), and cetostearyl alcohol (X3). The prepared tablets were assessed for swelling–erosion behavior, buoyancy, dissolution characteristics, and drug release kinetics. Comparisons were made between the optimized formulation, formulation F9, and the marketed tablet (Levipil, manufactured by Sun Pharma). Additional analyses included response surface plots and counter plots. The order of drug dissolution among the tested formulations was as follows: F13 > F1 = F3 = F5 = F6 = F8 = F10 = F11 = F15 > F7 = F12 > F2 = F9 > F4 = F14. The marketed tablet achieved 100% drug release within 10 min, while formulation F13 and the optimized formulation released 100% of the drug in 7.0 h and 9.5 h, respectively. The optimized formulation followed zero-order release kinetics and exhibited non-Fickian diffusion (diffusion exponent = 0.54), indicating a controlled and sustained release mechanism. These findings demonstrate that the optimized gastro-retentive floating tablet is well suited for extended-release delivery of Lev. The optimized formulation was further validated through statistical analysis, confirming that it met all dissolution criteria and theoretical predictions.
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