Abstract

FORMULATION AND EVALUATION OF MEDICATED SOFT CHEW DOSAGE FORM CONTAINING HYDROXYZINE HYDROCHLORIDE

Arati M. Talekar*, Virashri M. Noraje and Vijayanand Pujari

ABSTRACT

Present study aimed to enhance children’s acceptability of medicine by formulating a soft chew dosage form (SCDF) containing hydroxyzine hydrochloride, an antihistaminic agent commonly used to treat various allergic conditions in children. This study involved the development of medicated soft chews using five different gelling agents: sodium alginate, tragacanth, agar, gelatin, and xanthan gum. Compatibility studies were conducted using FTIR and DSC analysis. A total of ten formulations were prepared, incorporating two different concentrations of each gelling agent. Among them, formulations F4B, F11A, and F11B exhibited desirable gel properties and were selected for further evaluation. Physicochemical analysis indicated that all formulations met standard limits, with the percentage of drug content ranging from 97.75% to 101.21%. In-vitro dissolution studies revealed that formulations F4B, F11A, and F11B exhibited drug release between 98.96% and 93.93% within 45 minutes. Based on evaluation results,formulation F4B, which contained 3% agar and 1% gelatin, was identified as the most optimized formulation. A stability study was conducted on F4B, and the results confirmed that the soft chews remained stable when stored at 25°C / 60% RH for up to three months. In conclusion, formulation F4B demonstrated superior drug release characteristics and stability, making it the most promising candidate for improving children’s acceptance of medication.

Keywords: Oral Route, Oral Medicated Jelly, Dysphagia, Patient Compliance, Gelling agents.