Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF NOVEL ORAL JELLIES CONTAINING MONTELUKAST SODIUM AND LEVOCETIRIZINE DIHYDROCHLORIDE

Vasuki R.*, Ramesh Kumar K., Elango K., Mohan Dass S.

ABSTRACT

Convenience of administration and patient compliance are gaining significant importance in the design of dosage forms. Montelukast sodium and levocetirizine dihydrochloride are orally administered anti-asthmatic agent, used in the management of asthma and allergic rhinitis. Difficulty in swallowing (dysphagia) is common among all age groups especially in elderly and pediatrics. Unfortunately, a high percentage of patients suffering from asthma are elderly people showing dysphagia. Persons suffering from dysphagia may get choked when they consume liquid formulation, thus to alleviate such problem liquid formulation of high viscosity was prepared. Formulation of oral soft jellies was carried out using different gelling agent such as Sodium alginate, Gelatin, Gellan gum and combination of Gellan gum & Gelatin. Two different concentrations of sodium alginate 5% & 10%, three different concentrations of gelatin 10%, 15%,20%, two 2 different concentrations of gellan gum 0.5% and 2% and combination of two different concentrations gellan gum 1% with gelatin 0.6 % and gellan gum 0.6% with gelatin 1 % were used respectively. The prepared batches were evaluated for physical appearance, viscosity, pH, weight variation, drug content, syneresis, in vitro drug release. The batch with 0.5% w/v gellan gum drug release (Montelukast sodium 103.98% and Levocetirizine dihydrochloride 102.01%) at 30 min, but all the desired organoleptic properties.

Keywords: Montelukast Sodium, Levocetirizine Dihydrochloride, Gelling agents, Anti-asthmatic agent.