The Development and Characterization of a New Easily Swallowed Valsartan Oral Jelly

Abstract

For many years oral solid dosage forms were the most preferred dosage form for a wide range of populations due to their safety, efficacy, stability cheapness, and ease of administration. Although, they possess certain drawbacks mainly swallowing difficulties and bioavailability problems. Therefore, oral jellies were developed in an attempt to overcome these restrictions. In this study, six valsartan oral jellies were prepared using three different gelling agents (xanthan gum, sodium alginate, and gelatin) in different concentrations that are designed especially for pediatric patients with swallowing problems. These oral jellies were optimized by the evaluation of the physical appearance, pH, viscosity, and syneresis. In addition to the study of taste masking, content uniformity, and in vitro release profile. Furthermore, FT-IR and stability analyses were performed on the optimum formula. As a result oral jelly (F6) containing 6% gelatin was selected as the optimum formula possessing an acceptable physical property with a pH value of (7.25±0.47) and viscosity of (91200±1.95, 42170 ±2.7) cps at 5 and 10 rpm respectively which showing no syneresis. Moreover, F6 had an acceptable content uniformity of (96.30±1.38) and higher percent drug released in 30 minutes (98.40 ± 1.04) with good taste masking (1.22%±1.18, 4.37%±1.06) after 1 and 2 minutes respectively. Furthermore, the absence of any interactions or instability was assured by the result of the FT-IR and stability analysis. In a conclusion, this study was succeeded to formulate a valsartan oral jelly that can be used as a new easily swallowed form of the antihypertensive drug for the dysphagic population with improved bioavailability.