DESIGN, DEVELOPMENT AND EVALUATION OF MICONAZOLE NITRATE TOPICAL GEL FOR FUNGAL INFECTIONSAbstract
In this investigation, Miconazole Nitrate topical gels were designed by employing various bioadhesive polymers like polyacrylates (carbopol 940), cellulose derivatives (hydroxyl propyl methyl cellulose and sodium carboxy methyl cellulose) and natural polymers (sodium alginate) alone and in combination. The prepared gels were also characterized for different parameters like visual appearance, pH, consistency, rheological studies, drug content, in vitro release studies, stability studies and antifungal activity. From the results it was found that all the formulations were free of gritty particles and were found to be uniform in consistency. The values of pH were within the range of the skin pH that is in between 5.9 and 6.8, which indicates these gels cannot cause any local irritation to the skin surface. The consistencies of the gels were found to be excellent. The viscosity values of the gel increased in the following manner: carbopol and HPMC >carbopol>carbopol and SCMC >carbopol and sodium alginate > Sodium alginate >SCMC: indicating that carbopol in combination with HPMC was found to be the most viscous gel when compared to the others. The drug content was found to be uniform among various batches prepared and were in the range from 98.78±0.14 to 99.88±0.1%. The release of drug from all the formulations at the end of 8 hours study ranged from 68.78±0.42 to 99.88±0.05%. Gels containing carbopol 940 and HPMC and carbopol 940 alone released the drug at a sustained manner when compared to the gels containing SCMC and sodium alginate alone which released at a faster rate within 8 hours. The antifungal assay revealed that the gels containing carbopol 940 and HPMC in combination and carbopol 940 alone showed the maximum zone of inhibition values of about 15mm and 14mm respectively upto 72 hours. They possessed the maximum antifungal activity. The stability studies revealed good physical stability for all formulated preparations.
S. Nagalakshmi,* Radhika Ramaswamy, Renuga, Sowjanya, Premalatha, Vijayanjani and S. Shanmuganathan
Department of Pharmaceutics, Faculty of Pharmacy, Sri Ramachandra University, Porur, Chennai-600116, Tamil Nadu, India.
29 July, 2014
29 September, 2014
01 December, 2014
01 March, 2015