Design augmentation and appraisement of emulgels containing antimicrobial agent

Abstract

quotBackground: Intravenous preparations have good action but have unwanted side effects and oral preparations have less bioavailability. Also, in conjunctivitis, acne vulgaris, and fungal infections, patients have preferred topical preparations only. Cream and gel have bigger globule size and ointment has less patient compliance. Therefore, available topical preparations have issues of less penetration. newlineAim: To formulate and evaluate emulgels of Salicylic acid, Ciprofloxacin, and Chloramphenicol. newlineMaterials and Methods: Saturated solubility studies and simplex-centroid design were used for selection of oil mixtures. Pseudo-ternary phase diagrams were prepared for selection of emulsifier(s). Simplex centroid design was applied in the preparation of the emulsions. Physicochemical and in vitro release studies of emulsions were performed and were optimized by Design-Expert. Gelling agents were screen out based on the basis of gelling property. Antimicrobial agent-excipients compatibility study was performed. The formulas of emulgels were optimized using 23-factorial design. Skin/eye irritation tests and animal models were performed for optimized batches of emulgel. The optimized batches were subjected to 18-months of stability study. One way ANOVA/ Dunnett multiple comparison tests were performed for skin/ eye irritation tests and animal models at 95 % of confidence level. newlineResults: Oil mixture, emulsifier(s), and gelling agent, for Salicylic acid (10 % w/w) were Neem oil (61.4 % w/w) + Isopropyl Myristate (38.6 % w/w) mixture, PEG-20 Sorbitan monolaurate, and SepineoTM P 600, for Ciprofloxacin (0.3 % w/w), Neem oil (63.3 % w/w) + Olive oil (26.2 % w/w) + Mogra oil (10.2 % w/w) mixture, AcrysolTM K-150: PEG-400 (1:2 ratio), and Carbomer 934, and for Chloramphenicol (1 % w/w), Neem oil (59 % w/w) + Olive oil (20 % w/w) + Peppermint oil (20 % w/w) mixture, PEG-400, and Xanthan gum were selected respectively. Fourier Transform Infra-Red peaks obtained for optimized batches of emulgel were correlated with those of the pur