Purushotham Rao.K, Anand Ambekar, Ajay kartik, Vinay B. Shinde and Pratima. S
Objective: Convenience of administration and patient compliance are gaining significant importance in the design of dosage forms. Difficulty in swallowing (dysphasia) is common among all age groups, especially in elderly and pediatrics. Ketoconazole was formulated as ororetentive jelly for the treatment of oral candidiasis. There are dosage forms like syrups, tablets in the market but still there is a need for new dosage form which acts effectively and locally. The jellies can provide an attractive alternative formulation in the treatment of oral candidiasis. So the present investigation aims to design, prepare and evaluate ketoconazole jellies using polymers such as xanthan gum, sodium carboxy methyl cellulose with different concentrations. The benefits of these prepared jellies are increased bioavailability, reduction in gastric irritation by-passing first pass metabolism.
Methods: The sucrose based jellies were prepared by heating and congealing method. Preformulation studies, organoleptic, physical characteristics, drug content, pH, spreadability, syneresis, in vitro dissolution testing, drug release kinetics and stability studies were conducted.
Results: The prepared formulations are free from gritty particles. All the formulations were tested for drug excipient interactions subjecting to IR Spectral analysis. In vitro drug dissolution studies showed 95.12% for K1, 90.66% for K2 and 95.22% for K3 in 30 minutes. Among the 7 formulations, formulation K3 containing 5% Sodium carboxy methyl cellulose was found to be promising. Short-term stability studies on the promising and other formulations indicated that there were no significant changes in the drug content and in vitro dissolution characteristics. IR spectroscopic studies indicated that there were no drug-excipient interactions. Anti-fungal studies revealed that there is no change in the molecular activity of the drug. Results of in vivo studies indicated compatible drug delivery.
Conclusions: The prepared jellies of ketoconazole could stay in the mouth for a longer period of time, which indicates a potential use of jellies of ketoconazole for treating oral candidiasis.
