Development And Optimization of An Oral Film Containing Levocetirizine Dihydrochloride to Tackle Allergic Conditions Using Factorial Design

The development and improvement of fast-dissolving oral films with compounds that Levocetirizine Dihydrochloride, applying a factorial design strategy to improve patient adherence and enable a rapid therapeutic response to allergic reactions. Hydroxypropyl methylcellulose (HPMC E15) was selected as the film-forming agent, The plasticizer was polyethylene glycol 400, while croscarmellose sodium was incorporated as a super disintegrant. Utilizing a 3² complete factorial design, methodically examine the impact of different concentrations of HPMC E15 and PEG 400 on key formulation attributes, including duration of breakdown and release of medication characteristics. The films fabricated using the solvent casting method and assessed for various physicochemical properties, such as thickness, folding endurance, surface pH, drug distribution uniformity, timing of disintegration in vitro, and speed of dissolution. Statistical techniques and response surface methodology were used to pinpoint the ideal formulation. The final oral film demonstrated rapid dissolution within seconds, achieving over 95% drug release in under 5 minutes. This study illustrates that factorial design is an effective approach for developing and optimizing oral film formulations, thereby improving treatment effectiveness and enhancing patient convenience. Aim: The aim is to formulate and optimize and evaluate a oral film formulation of Levocetirizine dihydrochloride to increase its permeability, reduce disintegration time, and ensure prolonged folding endurance for the effective treatment of allergic conditions. Method: The oral film was created using HPMC E15 as the polymer, with PEG 400 serving as the plasticizer, respectively, along with croscarmellose sodium as super disintegrant. This solution was then casted on a gel based flat surface glass plate to produce the final oral film. Result: The optimized formulation was subjected to thorough evaluation, which included assessments of disintegration time, folding endurance, thickness, pH, drug content, thermal analysis via DSC, and in vitro dissolution studies. The formulation demonstrated a drug release rate of 99.98% over a duration of 31 seconds. Conclusion: The developed Levocetirizine dihydrochloride oral film exhibited enhanced solubility, favourable physicochemical properties, and a controlled drug release profile, positioning it as a promising candidate for the treatment of allergic conditions.