Abstract

FORMULATION AND EVALUATION OF ORAL FAST DISSOLVING FILM OF GABAPENTIN BY QbD APPROACH

Manjusha Bhange, Amrapali Jadhav and Sachin Tukaram Thorat*

Abstract

Objective: The objective of the present investigation was to formulate, evaluate and optimize oral film of gabapentin using experimental design (Box Behnken). Methods: Oral films of gabapentin were formulated using HPMC E15 premium polymer as a film forming agent and propylene glycol as plasticizer and Tween 80 as surfactant. The drug & excipients were characterized as per USP 2014. Oral dissolving films were prepared by solvent casting method and were optimized by using box behnken design (A three‑factor, two levels). Formulations were prepared using three independent variables namely polymer quantity(X1), Plasticizer(X2) and surfactant concentration(X3), whereas disintegration time (Y1) and % drug release (Y2) as dependent variables. The formulations were evaluated for in vitro dissolution studies. The stability studies of the films were performed for optimized batch as per ICH guideline. From the results of design batches, best batch was selected and evaluated for In-Vivo pharmacokinetic study in albino rat model. Results: Box Behnken Design using Design Expert Software was used to optimize and evaluate the main effects, interaction effects and quadratic effects of the formulation ingredients on the disintegration time & in vitro drug release. Films were characterized such as thickness, weight variation, appearance content uniformity, folding endurance, surface pH, in-vitro drug release, films were found to be satisfactory when evaluated for all parameters of the films was found to be neutral. The designs establish the role of the derived polynomial equation and contour plots in predicting the values of dependent variables for the preparation and optimization and examined In-Vivo study. The optimized batch is passed the accelerated stability studies. The statistically optimized formulation was characterized with UV, FT-IR (Fourier transformation-infrared spectroscopy) and DSC (differential scanning calorimetry) studies and found no chemical interactions between drug and polymer. Conclusion: In salivary pH the prepared fast dissolving films of Gabapentin could be a better alternative for achieving rapid oral bioavailability in treatment of neuropathic pain.

Keywords: Oral film of gabapentin was optimization, Box Behnken Design and Solvent Casting Technique, In-Vivo study.