Formulation and evaluation of mucoadhesive vaginal tablet of clindamycin phosphate

Abstract

Problem statement: The bacterial vaginosis most frequently occur in women of reproductive age group or childbearing age group. In which problems are occur like early or late miscarriage, preterm labour, preterm delivery, preterm labour rapture of membrane, low birth weight and Increase efficiency of HIV. For bacterial vaginosis conventional dosage form are available which have problem like leakage, messiness and short residence time. Purpose: The main purpose of this study was to formulate mucoadhesive intravaginal tablet of clindamycin phosphate. It was developed to achieve good therapeutic effect and patient compliance in the treatment of bacterial vaginosis. The formulation has sustain release effect with good mucoadhesion due to mucoadhesive polymer so that ultimately decrease dose frequency. Method: The mucoadhesive vaginal tablets were prepared by direct compression method. FTIR had employed to study drug excipient incompatibility. Analytical method was developed using HPLC. Optimization of formulation was done by 32 full factorial design using DOE. Result: Mucoadhesive vaginal tablets were evaluated for % swelling index, Mucoadhesin strength, drug content, in-vitro % drug release, ex-vivo mucoadhesion time. The ex-vivo mucoadhesion time of optimized batch F3 upto 9 hr, 99.25 % drug content, 88.34% drug release at 8 hr were obsereved. Stability study shows developed mucoadhesive intravaginal tablet was stable at 30°C ± 2°C at 65 ± 5% RH and 40°C ± 2°C at 75 ± 5% RH condition after three months. Conclusions: From the results it was concluded that the mcoadhesive vaginal tablet had maximum drug release in 8 hr, good mcoadhesion time as well as good stability. This study proves optimized vaginal formulation of clindamycin phosphate is potential against bacterial vaginosis.