Formulation and Evaluation Once Daily Mucoadhesive Vaginal Tablet of Clotrimazole Using Natural and Synthetic Polymers

Abstract

Clotrimazole was formulated in mucoadhesive vaginal tablet by direct compression technique using natural and synthetic polymer. 
Tablets were prepared by directly compression using chitosan as natural polymer and HPMC K15 M as synthetic polymer together 
with or without addition of microcrystalline cellulose (MCC). The drug content in the tablet was kept 20% each. Drug dissolution rate 
studies from tablets were carried out in buffer pH 4.8 and distilled water. The mucoadhesive strength was evaluated by detachment 
force measurement using porcine vaginal mucosal membrane. Chitosan showed maximum bioadhesion and was directly proportional to its total content. The formulations were tested for their swelling behavior using agar - agar plate technique. Swelling study data revealed that swelling index increased with an increase in the content of HPMC K15 M. The formula containing 3:1 % polymer ratio shoed adequate release properties in both media and gave lower values of swelling index compared with the other formulations. The 
biopharmaceutical studies showed that F1, F3, F4 and F5 formulation released the drug up to 20, 26, 27 and 29 hours respectively, while the F2 formulation was able to release the drug for 24 hours so it is best suitable for once a day dosing frequency. Similarly F2 was negligibly affected by aging. Thus F2 formulation may be considered a good candidate for the vaginal mucoadhesive dosage forms