Formulation of Econazole Nitrate as an Ophthalmic Ointment
DOI:
https://doi.org/10.15218/zjms.2009.023Keywords:
Keratomycosis, Econazole nitrate, shelf life.Abstract
Background and objective: Keratomycosis is an important cause of ocular morbidity and can lead to blindness due to lack of ocular antifungal agents. The goal of this study is to formulate a stable effective formula of econazole nitrate ophthalmic ointment.Econazole nitrate has an advantage over other antifungal agents in treatment of mixed infection since it is active against both dermatophytes and candida, and also it is effective in the treatment offilamentous fungi.
Methods: Econazole nitrate ophthalmic ointment of different strength were formulated and compared for their in vitro activity.The effect of different factors (light and type of container) and calculating the expiration date of the selected formula were studied.
Results: Formula A (1gm Econazole nitrate in 100 gm ophthalmic ointment base) and formula B (2gm Econazole nitrate in 100gm ophthalmic ointment base) had good in vitro antifungal activity because both formula A and B inhibit the growth of the fungi used, but formula A was selected because it has the lowest concentration and the same activity. Also the results indicated that the selected formula A was affected by light and its % remaining was (96.7%), while there was no effect of the type of container used to store Econazole nitrate ophthalmic ointment.The expiration date of formula A was calculated to be (2.19) years.
Conclusion: 1% Econazole nitrate ophthalmic ointment appears to be effective in vitro and should be stored in dark container .
Metrics
References
Thomas P.A., Mycotic keratitis-an underestimated mycosis, Journal of medical and veterinary mycology:bi-monthly publication of the international society for human and animal mycology, 1994; 32; 4 : 235-256.
Prajna N.V., John R.K., Nirmalon P.K., Lalitha P. and Srinivasan M., A randomized clinical trial comparing 2% econazole and 5% natamycin for the treatment of fungal keratitis, British journal of ophthalmology, 2003; 87(10) : 1235-1237.
Arora I., Kulshrestha O.P. and Upadhaya S., Treatment of fungal corneal ulcer with econazole, Indian journal of ophthalmology, 1983; 31; 7 : 1019-1021.
Gugnani H.C., Gupta S. and Tawlar R.S., Role of opportunistic fungi in ocular infections in Nigeria, Mycopathologia, 1978; 65; 1-3: 155-166.
Mselle J.,Use of topical clotrimazole in human keratomycosis, Ophthalmologica, 2001;215:357-360.
Dutta L.C., Modern ophthalmology, Butterworth, 1994; chapter 34 (corneal ulcer): 196-214.
B.P, British pharmacopeia C.D, copy right; 2007.
U.S.P xxv, NF 20, compact disk; 2001.
Kucers A., Crowe S., Grayson M.L. and Hoy J., The use of antibiotics a clinical review of antibacterial, antifungal and antiviral drugs, Butterworth-Heinemann, Bath press ,5th ed., part iv, 1997: 1470, 1471.
Sweetman S.C., Martindale, The complete drug reference, London-Chicago pharmaceutical press, 34 ed., 2005 : 397.
Lippincott Williams and Wilkins, Remington's, The science and practice of pharmacy, 21st ed., 2005; chapter 90 (Anti-infectives); chapter 43 (ophthalmic preparations) : 1674, 857.
Ansel H.C., Allen L.V. and Popovich N.G., Ansel's pharmaceutical dosage forms and drug delivery systems, 8th ed., 2005; chapter 17 (special solutions and suspensions), chapter 10 (ointments, creams and gels): 540,287,289.
The pharmaceutical codex, London the pharmaceutical press, 11th ed., 1983: 349, 350.
Samin L.H., Formulation of econazole nitrate as a topical solution, Iraqi journal of pharmaceutical sciences, 2002; 14: 23-34.
Rawlins E.A., Bentley's, Text book of pharmaceutics, Bailliere Tindall London, 8th ed., 1996; chapter 27 (preparations for the eye): 363.
Aulton M.E., Pharmaceutics the science of dosage form design, Churchill Livingstone, 1988; chapter 7 (kinetics and stability testing): 126.
Lachman L., Lieberman A. and Kanig J.L., The theory and practice of industrial pharmacy, 3rd ed., 1986; chapter 26 (kinetic principles and stability testing): 763.
Hui H. and Robinson J.R., Effect of particle dissolution rate on ocular drug bioavailability, Journal of pharmaceutical sciences, 1986; 75; 3: 280-287.
Schoenwald and Stewart P., Effect of particle size on ophthalmic bioavailability of dexamethasone suspension in rabbits, Journal of pharmaceutical sciences, 1980; 69; 4: 391-394.
Robert A., Overview of medically important antifungal azole derivatives, Clinical microbiology reviews, 1988; 1; 2: 187-217.
Sun B., He Y., Wang Y., Comparison of various types of imidazole derivatives for treatment of filamentous fungal keratitis, Chung Hua Yen Ko Tsa Chih, 1996; 32; 4: 260-263.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2009 Heba Antwan Fatohy (Author)
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The copyright on any article published in Zanco J Med Sci is retained by the author(s) in agreement with the Creative Commons Attribution Non-Commercial ShareAlike License (CC BY-NC-SA 4.0).