Formulation Development and Evaluation of Orodispersible films of Chlorpheniramine Maleate

This study aimed to formulate Orodispersible films (ODFs) of Chlorpheniramine maleate (CPM) and develop a dosage form with rapid onset of action and ease of administration, circumventing the need to swallow or use water. The solvent casting method was employed to prepare three optimized films (F1, F2, and F3) containing varying proportions of sodium alginate and pectin as polymers, polyethylene glycol (PEG-400) and glycerol as plasticizers, sodium starch glycolate as a super disintegrant, and sodium benzoate as a preservative. The formulated ODFs were evaluated for physical characteristics such as uniformity of weight, thickness, folding endurance, drug content uniformity, surface pH, determination of moisture content, and mouth dissolving time which gave satisfactory results. The formulations were also subjected to disintegration test and in-vitro drug release tests. All three formulations released greater than 65% of the drug within 6 minutes but F3 displayed superior performance by releasing almost half the amount of the drug within 1 minute and 82.27 ± 11% drug within 6 minutes. The films of chlorpheniramine maleate containing natural polymer showed folding endurance (300.00 ± 1.00 No. of folds), in-vitro disintegration time (57 ± 0.57 sec.), surface pH (5.5 ± 0.10 pH), thickness (0.07 ± 0.01 mm) and percentage content uniformity (99.53 ±0.37 %).