Development and evaluation of hard candy lozenges containing roxithromycin for treatment of oral infection
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The objective of the present study was to developed and evaluate of the hard candy lozenges containing roxithromycin for the treatment of oral bacterial infection. The mouth of human body provides non-shedding surfaces (teeth) for natural microbial colonization. These can the accumulation of large masses of bacteria and their products at stagnant sites. Dental plaque and gingivitis are some of this type of conditions, which can develop due to microbial accumulation on teeth and mouth ulcers are small, painful sores on the inside lining of the mouth. In this current study, Roxithromycin macrolide category wide spectrum antibacterial drug was selected as a drug because the existing market product of Roxithromycin is not available in the form of lozenges that can deliver the drug from the oral cavity. In the present investigation, taste is one of the most important parameters of oral formulations so β-Cyclodextrin is used as a good taste masking agent for bitter drug and also enhances the solubility of the drug. Hard candy lozenges were formulated by heating and Congealing technique with exicipients like sucrose, Isomalt, Glycerin, citric acid, flavor and color and evaluated for organoleptic properties the test like diameter, thickness, weight variation, hardness, friability, mouth dissolving time, and % drug content. The Optimized formulation of Roxithromycin Hard candy lozenges (H6) were sweet in taste, smooth in texture and having a diameter 13.708±0.00 mm, thickness 7.704±0.00 mm, hardness is 11±1kg/cm2 and drug content uniformity is 97±0.02%. The weight variation and friability of lozenges (H6) was passed as per IP and mouth dissolving time is found at 25±2 min. In vitro dissolution study for roxithromycin hard candy lozenges lozenge was performed in pH 6.8 phosphate buffers wherein 95% of the drug was released within 30 min.
Roxithromycin, Lozenges, Hard Candy Lozenges, Beta-Cyclodextrin agent, Oral infections.