FORMULATION, CHARACTERIZATION AND EVALUATION OF ISOTRETINOIN GEL FOR TREATMENT OF ACNE VULGARISAbstract
Acne vulgaris is a commonly diagnosed inﬂammatory skin condition that affects pediatric, young and adult patients. The object of the paper is formulation development and evaluation of isotretinoin gel for the treatment of Acne vulgaris. The isotretinoin based anti-acne gel was formulated using different polymers includes carbopol 940, carbopol 934 and carbopol 980. Disodium edetate is used as chelating agents. The anti-acne gel was evaluated for solubility, drug release, pH and drug interaction, in-vitro drug release through Franz diffusion cells, acute skin irritation test and antibacterial test. The evaluation test was also compared with the marketed formulation of isotretinoin gel, that is, sortet gel. The antibacterial and anti-acne activity of different formulations was determined by the modified agar well diffusion method in the culture of Propionibacterium acne. The optimized formulation (F-IB) showed the highest spreadability (48.623 g/cm3), in all formulations and also have a high percentage of drug contents (97.2%). In–vitro diffusion study suggested that F-IA, F-IC, F-IIA and F-IIB showed more diffusion, and drug release from all the formulations, that is, 94.5%, 96.5%, 92.5% and 92.7% as compared to sotret gel (94.2%). The antibacterial activity was studied on anaerobic microorganism P. acne, compared with marketed sortet gel. Formulation batches have shown maximum zone of inhibition to P. acne below marketed formulations and standard benzyl peroxide gel. The anti-acne gel of isotretinoin was successfully formulated and evaluated by different parameters. The results indicate that the active component, that is, isotretinoin is more effective when subjected to gel formulations and produces effective anti-acne activity in the management of Acne vulgaris.