EFFECT OF STIRRING SPEED AND STIRRING TIME ON CHARACTERIZATION OF CLINDAMYCIN HCL ETHOSOMAL AND ICH Q1A (R2) STABILITY TEST

Abstract

Clindamycin HCl is an antibiotic with limited bioavailability ranging from 0.7% to 12.9% of the applied dose. The ethosomal delivery system can increase the bioavailability of clindamycin HCl. However, in the manufacturing process, the speed and time of stirring are essential factors that affect the characterization of the resulting ethosomes. This study aims to optimize the clindamycin HCl ethosomal formula by varying the stirring speed (7,600 and 15,000 rpm) and stirring time (15 and 30 minutes) using ultra-turrax with a 22 factorial design method. The ethosomal formula was characterized including entrapment efficiency, particle size, polydispersity index and potential zeta. The optimum formula was tested for stability according to the ICH Q1A (R2) standard. The optimum formula was obtained at a stirring speed of 7,600 rpm and a stirring time of 15 minutes with an entrapment efficiency percentage of 72.38 ± 0.36%, a particle size of 270.80 ± 8.69 nm, a polydispersity index of 0.111 ± 0.032 and a potential zeta of-31.21 ± 0.82 mV. The results of the ICH Q1A (R2) stability test showed that the release model of the active substance followed order 0, the activation energy was 4.232 cal/mol, the kinetic constant was 9.897/day with a shelf life of 7.293 days at 25 ± 2°C/60 ± 5% RH and 8.247 days at 5 ± 3°C.