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Stability of Aqueous and Oily Ophthalmic Solutions of Moxifloxacin
Objective. The purpose of this study was to investigate the stability of aqueous and oily ophthalmic solution of moxifloxacin fourth generation of fluoroquinolone. Method. The stability studies on the aqueous and oily ophthalmic formulations of moxifloxacin were carried out by exposing the formulations to accelerated (40° C and 75% RH) and room temperature storage conditions. During storage period, the formulations were periodically examined for pH and the remaining drug concentrations. Results. The accelerated and long term stability studies conducted on aqueous isotonic ophthalmic solutions of moxifloxacin indicate that moxifloxacin (0.5%, w/v) formulation of pH 7.2; containing, BAK (0.01%) and EDTA (0.01%) could provide a shelf life (t90) of 2 years, and the formulation appears promising from corneal permeation point of view. Among all the oily formulations, moxifloxacin (0.05%, w/v) ophthalmic solution in castor oil, with adequate overage, containing benzyl alcohol (0.5%, v/v) appears ideal from stability point of view. Conclusions. Presence of benzyl alcohol, however, appears necessary to maintain sterility of the formulation during use, as eye drops are normally dispensed in multi dose containers. The degradation of moxifloxacin was found to follow first order kinetics..
Moxifloxacin, Ophthalmic Solutions, First Order Kinetics, Benzyl Alcohol.
- Yoshioka T., Sternberg B., Florence A.T.: "Preparation and properties of vesicles (niosomes) of sorbitan monoesters (Span 20, 40, 60 and 80) and a sorbitan triester (Span 85)", International Journal of Pharmaceutics 1994,105. (1), 1-6.
- Pestova E., Millichap J.J., Noskin G.A, Peterson L. R., "Intracellular targets of moxacifloxacin: a comparison with other fluoroquinolones", Journal of Antimicrobial Chemotherpy2000, 45( 5), 583–590.
- Neil MJ, editor. The Merck Index: An encyclopedia of chemicals, drugs, and biologicals. Whitehouse Station (NJ): Merck and Co. Inc; 2006.
- Biedenbach D.J., Jones R.N: "The comparative antimicrobial activity of levofloxacin tested against 350 clinical isolates of Streptococci", Diagnostic Microbiology and Infectious Disease 1996, 25(1), 47-51.
- Dalhoff A. Petersen U.,. Endermann R: "In vitro activity of Bay 12-8039, a new 8-methoxyquinolone", Chemotherapy 1996, 42(6),410-425.
- Davis R., Bryson H.M., "Levofloxacin: a review of its antibacterial activity, pharmacokinetics and therapeutic efficacy", Drugs 1994, 47(4), 677-700.
- Araki T., Kawai Y. Ohta I., Kitaoka H., "Photochemical behavior of sitafloxacin, fluoroquinolone antibiotic, in an aqueous solution", Chemical and Pharmaceutical Bulletin2002, 50(2), 229-234.
- Cruz L. A., Hall R., "Enantiomeric purity assay of moxifloxacin hydrochloride by capillary electrophoresis", Journal of Pharmaceutical and Biomedical Analysis 2005, 38(3), 8-13.
- ICH-Q1A (R2), "Stability testing of new drug substances and products", in Proceedings of the International Conference on Harmonization, Geneva, Switzerland, February 2003.
- Hutchinson D.J, Johnson C.E., Klein K.C., "Stability of extemporaneously prepared moxifloxacin oral suspensions", American Journal of Health-System Pharmacy 2009, 66(7),665667.
- Pawar P.K. and Majumdar D K,: Effect of formulation factors on In vitro permeation of moxifloxacin from aqueous drops through excised goat, sheep, and buffalo corneas", AAPS Pharm. Sci. Tech 2006, 7(1), E13.
- Pawar P K and Majumdar D K, "In vitro permeation characteristics of moxifloxacin from oil drops through excised goat, sheep, buffalo and rabbit corneas", Pharmazie 2007, 62(11), 853-857.
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