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02629_2 DEVELOPMENT OF RAPIDLY DISINTEGRATING BIOADHESIVE VAGINAL TABLETS OF CELLULOSE SULFATE (CS) Garg, Sanjay* CS gel is currently being developed as a microbicide. Considering the region specific needs, climatic and socio-economic conditions of India and other tropical countries, novel vaginal tablets of CS were developed. Tablets containing 200 mg of CS per unit and GRAS listed excipients were formulated, which disintegrated in less than 30 seconds in 10 ml of fluids and formed smooth, homogenous, viscous and bioadhesive dispersion that is likely to be retained in vaginal cavity for prolonged intervals. Developing a rapidly disintegrating bioadhesive tablet was highly challenging, since these two properties normally act against each other. At accelerated stability conditions (40&Mac176; C/75% RH) recommended by ICH for Zone IV countries, tablets were found to be stable for a period of three months and the process of preparation of tablets was amenable for large scale production. Formulation of CS into tablets did not have any adverse effect on its activities and safety profile. Inhibition of sperm enzyme and sexually transmitted pathogens (HIV, HSV, Chlamydia) caused by tablets was comparable to that of CS. Further, the absence of cytotoxicity and Lactobacillus inhibition demonstrated the potential of CS tablets as safe and effective vaginal microbicide. These can be taken up for clinical studies after necessary toxicololgical studies and regulatory approvals. Dr. Sanjay Garg |
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