Development and optimization of mouth-dissolving strips of L-methyl folate: A modern approach for patient compliance

Abstract

The goal of this study is to create a mouth-melting strip of L-methyl folate calcium, which will dissolve and disintegrate more quickly when given orally for the onset of action. : Solvent casting was used to create a calcium L-methyl folate film that dissolves in the mouth. Polymer, plasticizer, and flavouring agents were chosen after early experiments. Once the excipients were chosen, 3 complete factorial designs were used to improve the formulation. Folding endurance (Y1), tensile strength (Y2), and disintegration time (Y3) were chosen as dependent variables, whereas HPMC E5 concentration (X1) and glycerine concentration (X2) were chosen as independent variables. The film's physicochemical parameters, including SEM, thickness, percent elongation, percent cumulative drug release, and palatability, were measured for the optimized batch and compared to those of the commercial product. The formulation of the mouth-dissolving strip took into account outcomes from the trial batch, including transparency, stickiness, and brittleness. The optimal batch has 55% HPMC E5 and 14.9% glycerine, with a folding endurance of 59±0.23, a tensile strength of 4.18±0.07 N/m, and a disintegration time of 40±0.12 seconds. The optimized film has dimensions of 0.08±0.01 mm in thickness, 60±1.58 mg in mass, 15.33±0.25% in elongation, and 98.33±0.27% in content uniformity. The SEM results validate the uniform film with uniform drug distribution. After 3 minutes, the L-methyl folate calcium mouth-dissolving strip had a %CDR of 99.42%. Findings of f2=52.85 and f1=12.5 for the similarity factor suggest that the medication release is clinically and commercially equivalent. One month of stability at 30°C and 65%RH was observed for the improved batch. The results of the created mouth-dissolving strip test are satisfactory, indicating the intended medication release. When compared to pills that dissolve in the mouth, it is clear that it is more patient-friendly.