Formulation and in-Vitro Assessment of Doxazosin Mesylate Medicated Gummies as A Patient-Compliant Antihypertensive Dosage Form

Abstract

This study concentrated on the development and in-vitro assessment of Doxazosin Mesylate-loaded medicated gummies as an innovative, patient-friendly oral dosage form for hypertension treatment. Gummies were formulated with gelatin as the gelling ingredient to enhance palatability, facilitate administration, and increase medicinal efficacy. Five formulations (F1–F5) were developed using the direct cook-and-pour method, each comprising 2 mg of Doxazosin Mesylate with a total gummy weight of 3.0 g, while altering gelatin concentration to examine its effect on physic mechanical and release properties. The quantitative analysis was confirmed by a UV–visible spectrophotometric technique in a pH 6.8 phosphate buffer, exhibiting exceptional linearity (R² > 0.999). FTIR analyses validated the compatibility between the medication and excipients, demonstrating the retention of distinct functional groups without notable changes. All formulations had a consistent appearance, appropriate surface pH, regulated moisture content, and adequate water activity. Texture study indicated that increased gelatin content resulted in greater firmness, with F5 exhibiting the highest firmness at 4.32 ± 0.20 N. In-vitro dissolution experiments indicated a gradual improvement in drug release correlated with elevated polymer concentration, culminating in a maximum cumulative release of 98.5% within 60 minutes for F5. The release kinetics exhibited first-order behaviour characterised by non-Fickian diffusion according to the Korsmeyer–Peppas model. Stability experiments verified the physical and chemical stability of the optimised formulation for 90 days under accelerated settings. Medicated gummies of Doxazosin Mesylate offer a viable alternative to traditional pills for enhancing patient adherence in hypertension treatment.