Abstract

FORMULATION DEVELOPMENT AND ANTIMICROBIAL ACTIVITY EVALUATION OF MEDICATED LOZENGES

Dhumal P. B., Nagoba S. N.*, Ladde S. S. and Rao K. P.

ABSTRACT

The present work is aimed at formulation of medicated lozenges of Ketoconazole as a to provide slow release medicament for the treatment of oral thrush in pediatric patients. There are dosage forms like syrups, tablets in the market but still there is a need for new dosage forms which acts effectively and locally. So the present investigation aims to design, prepare and evaluate medicated lozenge of Ketoconazole. The benefits of these prepared lozenges are increased bioavailability, reduction in gastric irritation by passing first pass metabolism. The lozenges were prepared by heating and congealing method in a candy based industry on request using sucrose as base. All the formulations prepared were subjected to various physico-chemical parameters like hardness, content uniformity, friability, weight variation etc. The prepared formulations have a hardness of 11-13 Kg/cm², free from gritty particles, and good taste. Stability studies of selected formulations were also carried out at 35ºC for a period of six months. Selected formulations were tested for drug excipient interactions subjecting to FTIR Spectral analysis. In-vitro drug dissolution studies showed 96.16% for F1 and 92.41% for F2 release of drug in 30 minutes, 95.31% in 15 minutes from F0 formulation. The prepared medicated lozenges were subjected for antimicrobial activity on causative organisms collected from a diseased patient under the supervision of ethical committee. Ketoconazole showed the zone of inhibition 22 mm and pure Ketoconazole showed 24 mm of zone inhibition. The medicated lozenges can provide an attractive alternative formulation in the treatment of oral thrush in pediatric patients.

Keywords: Ketoconazole, Medicated Lozenges, Oral Thrush.