Formulation, Development and Evaluation of Sildenafil Citrate Oral Jelly

Abstract

Background: The site of drug administration, such as oral or intravenous, frequently categorizes the route of administration. Drug delivery through oral jelly reduces product costs and enhances product stability and appearance. Oral jelly is used as a drug carrier for different diseases like erectile dysfunction, arthritis, hypertension, and sore throats. Medicated jelly is easy to administer at any time and place without water. Aim: To formulate, develop, and evaluate sildenafil citrate oral jelly. Methods: Oral jelly formulations (F1–F5) with different amounts of excipients and sildenafil citrate were made and tested for things like pH, appearance, viscosity, and drug release in a test tube. The data were analyzed by SPSS version 25 software. Results: The pre-formulation FTIR study revealed that there was no significant interaction between the drug and the excipients used. The pH of all of the formulations was within the desirable range (6.3-6.8), indicating their suitability for product stability and patient acceptability. The stability study indicated that during one-month storage at 25⁰ C and at 40⁰ C/ 75% RH, no significant changes in the properties of the product were found. The viscosity of the formulations increased with increasing sodium CMC concentrations. The HPLC-based in vitro drug release study indicated that the best drug release was achieved in the F5 formulation. Conclusion: It was concluded that F5 is the formulation of choice, satisfying the ideal characteristics of an oral jelly formulation with an improvement in the drug bioavailability over the existing marketed oral formulations of Sildenafil.