Formulation, Development and Characterization of Multi-Layer Medicated Chewing Gum of Montelukast Sodium and Levocetirizine Dihydro chloride By: Desai, Dhara.

Abstract

The objective of the present work was to formulate a multilayer medicated chewing gum for combination therapy. Montelukast Sodium is a powerful and selective antagonist of leukotriene D4 which is administered by oral route & it is effective on cysteinyl leukotrine receptor in the respiratory tract treatment for the parameter of asthma inflammation significantly. Levocetirizine Dihydrochloride is an antihistamine which works by blocking the effects of histamine and dries secretions in the nose and used for relief of symptoms associated with the common cold. Thus, it was decided to develop a suitable combination formulation for the treatment of asthma. Medicated chewing gum was prepared using direct compression method which avoids the first pass metabolism, better patient compliance and stability. Drug-Drug and Drug-Excipient compatibility study was carried out. Drug-drug incompatibility indicated change in colour, So Multilayer chewing gum approach has been chosen. Thus, addition of barrier layer between both the drugs it solved the issue of drug -drug incompatibility. Montelukast sodium is BCS class II drug this improvement was done using Inclusion complex with Hydroxy propyl- β- cyclodextrin. Taste masking of both drugs were achieved by using sucralose, peppermint powder and menthol used as cooling agent. Gum base, softening agent and magnesium stearate also optimized. 32 full factorial design used to evaluate the in vitro time of chewing and barrier layers strength were as independent variable while %CDR of Montelukast Sodium and %CDR of levocetirizine Dihydrochloride as dependent variable. Optimized formulation batch shown release 95% of Montelukast Sodium and 80% of Levocetirizine Dihydrochloride in 5minute. The study shown that use of combination therapy is boon for the patients suffering from asthma.