The aim of the present study was to design, develop and evaluate 0.5% w/w oral mucoadhesive gel of antimicrobial tinidazole (TZ) for buccal administration in periodontal disease. 12 gel formulas were developed from carbopol 934P (CB 934P) in combination with/ without poloxamer 407 or cellulose derivative gelling agent (sodium carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose and hydroxypropylmethylcellulose) in different concentrations. CB 934P concentration was constant as 0.5% at 6 formulas and 1% in the others 6 formulas. The developed formulas were evaluated for various parameters like composition compatibility, gelation temperature, viscosity, spreadability, gel strength, mucoadhesion strength, drug content, dose uniformity and in-vitro release study. All formulas were subjected to freeze thaw cycling and 90 days stability studies. Higher poloxamer concentration was associated with lower gelation temperature. Polymer type and concentration were in a direct proportionality with formulas viscosity, mucoadhesion and gel strength. Some formulas gave burst drug release in which more than 50% of tinidazole released after 15 minutes and 100% released after 45 to 60 minutes. Other formulas were able to provide a prolonged drug release lasted for 8 hours. Gel formulas with 0.5% w/w CB 934P alone or combined with 15% w/w poloxamer 407 or 7.5% w/w hydroxypropylcellulose were not able to pass through freeze thaw cycling or/and 90 days stability studies. Finally, mucoadhesive properties and prolonged release behavior of some formulas overcame the main obstacles of buccal application. Hence, both G5 and G2 formulas were recommended for periodontitis treatment by placement in the periodontal pockets.
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