COMPARATIVE IN VITRO EVALUATION OF BRANDS OF CLOTRIMAZOLE CREAM FORMULATIONS MARKETED IN ETHIOPIA

  • Dereje Debebe Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Tesfaye Gabriel Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Yonas Brhane Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Abraham Temesgen Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Muluken Nigatu Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Tesfa Marew Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Abstract

The aim of present work was to undertake comparative in vitro quality evaluation of six marketed clotrimazole cream formulations in Ethiopia with respect to physico-chemical properties like viscosity, spreadability, extrudability, pH and drug content. In vitro clotrimazole release from cream formulations was also studied using synthetic cellulose acetate membrane at 37 ºC in a solvent containing methanol and PBS 7.4 in the ratio of 75:25 as receiver medium. The cumulative amounts of the drug released over 12 h (µg mm-2) were analyzed. All clotrimazole cream formulations showed good and smooth homogeneous appearance with white color. The pH of clotrimazole cream formulations ranged from 4-7, which is a physiologically acceptable pH range and in principle devoid of any skin irritation. Clotrimazole content ranged from 90-110%, ensuring the uniformity of the drug content in all formulations. The increase in diameter of clotrimazole cream formulations following the spreadability test was found to range from 4-6 cm. Cream formulation D (Clotri-Denk) exhibited highest viscosity values than other formulations, whereas formulation E (Chinese Clotrimazole BP) showed lowest viscosity value. Cream formulation F (Mycoril) showed better extrudability and spreadability as compared to other formulations. Drug release from all formulations was slow in the first 6 hrs. After the 6th hr, steady drug release continued for formulation D and E. Fast drug release was observed in formulations A (Candid) and B (Candigen), whereas for the formulations C (Canesten), D and E, steady drug release pattern was observed after the 6th hr. It can be concluded that all clotrimazole cream formulations fulfilled the quality criteria of in-house and pharmacopeias specifications.

Keywords: In Vitro Evaluation, Clotrimazole, Cream, Spreadability, Extrudability, Ethiopia

Downloads

Download data is not yet available.

Author Biographies

Dereje Debebe, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
Tesfaye Gabriel, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Yonas Brhane, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Abraham Temesgen, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Muluken Nigatu, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Tesfa Marew, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

References

1. Carbo, M., Schultz, T.W., Wong G.K. and Van, B.G. Development and Validation of In Vitro Release Testing Methods for Semi-solid Formulations. Pharm. Tech. 1993; 112-128.
2. Gelone, S.A. and O’Donnell, J. Anti infectives. In Remington the science and practice of pharmacy, 21st Edition ed, Troy DB, 2006; pp 1626–1684. Baltimore: Lippincott Williams and Wilkins.
3. Lorand, T. and Kocsis, B. Recent advances in antifungal agents. Mini-Rev Med Chem 2007; 7:900–911.
4. Hoogerhaide, J.G. and Wyka, B.E. Clotrimazole. In: Analytical profiles of drug substances. Volume 11. Floret, K. (Editor). Academic Press INC. New York. 1982.
5. Bachhav, Y.G. and Patravale, V.B. Microemulsion-Based Vaginal Gel of Clotrimazole: Formulation, In Vitro Evaluation, and Stability Studies. AAPS Pharm Sci Tech, 2009; 10: 476-482.
6. Czerninski, R., Sivan, S., Steinberg, D., Gati, I., Kagan, L. and Friedman, M. A novel sustained-release clotrimazole varnish for local treatment of oral candidiasis. Clin Oral Invest 2010; 14:71–78.
7. Singh, M.P., Nagori, B.P., Shaw, N.R., Solanki, R. and Tiwari, M. A Comparison Study of QC Parameters of Marketed Topical Gel Formulations. Int J Pharmace Res Bio-Sci 2014; 3: 471-481.
8. Bero, L.A. Review of Application of Clotrimazole for topical or intravaginal use in vulvovaginal candidiasis. Selection and Use of Essential Medicines, WHO. 2005
9. Mohamed, M.I. Optimization of Chlorphenesin Emulgel Formulation. The AAPS 2004; J 6: 1-7.
10. El-Houssieny, B.M. and Hamouda, H.M. Formulation and evaluation of clotrimazole from pluronic F127 gels. Drug Discov Ther, 2010; 4(1), 33-43.
11. Jelvehgari, M., Rashidi, M.R., and Mirza Mohammadi S.H. Adhesive And Spreading Properties of Pharmaceutical Gel Composed of Cellulose Polymer. Jundish J Nat Pharmace Prod 2007; 2: 45-58.
12. Nair, R., Sevukarajan, M., Mohammed, B., and Kumar, J. Formulation of Microemulsion based vaginal gel in-vitro and in-vivo evaluation. Der Pharmacia Lettre, 2010; 2: 99-105.
13. Prajapati, B.G. and Patel, M.M. Crosslinked chitosan gel for local drug delivery of clotrimazole. J Sci Tec 6: 43-52.
14. Das, K., Dang, R. and Machale, M.U. (2009) Formulation and Evaluation of a Novel Herbal Gel of Stevia Extract. Iranian J Derm 2010; 12: 117–122.
15. Najmuddin, M., Mohsin, A.A., Khan, T., Patel, V. and Shelar, S. Formulation and Evaluation of Solid Dispersion Incorporated Gel of Ketoconazole. Res J Pharm Bio and Chem Sci 2010; 1: 406–412.
16. Akhtar, N., and Pathak, K. Cavamax W7 Composite Ethosomal Gel of Clotrimazole for Improved Topical Delivery: Development and Comparison with Ethosomal Gel. AAPS PharmSciTech. 2012; 13(1), 344–355. doi: 10.1208/s12249-012-9754-y.
17. Souto, E., Wissing, S., Barbosa, C. and Muller, R. Development of a controlled release formulation based on SLN and NLC for topical clotrimazole delivery. Int J Pharm 2004; 278:71–7.
18. Sabri, L.A., Sulayman, H.T. and Khalil, Y.I. An Investigation Release and Rheological Properties of Miconazole Nitrate from Emulgel. Iraqi J Pharm Sci, 2009; 18: 26-31.
19. Hashem, F.M., Shaker, D.S., Ghorab, M.K., Nasr, M. and Ismail, A. Formulation, Characterization, and Clinical Evaluation of Microemulsion Containing Clotrimazole for Topical Delivery. AAPS PharmSciTech, 2011; 12(3), pp.879–886. Available at: http://www.springerlink.com/index/10.1208/s12249-011-9653-7.
20. Ueda, C.T., Shah, V.P., Derdzinski, K., Ewing, G., Flynn, G., Maibach, H., Marques, M., Rytting, H., Shaw, S., Thakker, K. and Yacobi, A. Topical and Transdermal Drug Products. Pharmacopeial Forum 2009; 35: 750 – 765.
21. Lopes, L.B., Collett, J.H., Vitória, M.L.B. and Bentley, L.B. Topical Delivery of Cyclosporin A: an In Vitro Study using Monoolein as a Penetration Enhancer. Eur J Pharm Biopharm 2005; 60: 25–30.
22. Gopi, C., Kumar, V.T.M. and Dhanaraju, M.D. Design and Evaluation of Novel Ibuprofen Gel and its Permeability Studies. Int J Biopharm 2010; 1: 82–84.
23. Chen, M., Liu, X. and Fahr, A. Skin Penetration and Deposition of Carboxyfluorescein and Temoporfin from Different Lipid Vesicular Systems: In Vitro study with Finite and Infinite Dosage Application. Inter J Pharm 2011; 408: 223–234.
24. Sanna, V., Peana, A.T. and Moretti, M.D.L. Effect of Vehicle on Clotrimazole Permeation from New Topical Formulations, In Vitro and In Vivo Studies. Current Drug Delivery 2009; 6: 93-100.
25. Nawaz, A., Jan, S.U., Khan, N.R., Hussain, A. and Khan, G.M. Formulation and in vitro evaluation of clotrimazole gel containing almond oil and Tween 80 as penetration enhancer for topical application. Pak J Pharm Sci, 2013; 26(3), pp.617–622.
26. Garg, A., Aggarwal, D., Garg, S. and Singla, A.K. (2002) Spreading of Semisolid Formulations: An Update. Pharmaceutical Technology. Circle/eINFO 74.
27. Chow, K.T., Chan, L.W. and Heng, P. Characterization of Spreadability of Non- aqueous Ethylcellulose Gel Matrices Using Dynamic Contact Angle. J Pharm Sci 2008; 97: 3467–3482.
28. Chaudhary, H., Kohli, K., Amin, S., Rathee, P. and Kumar, V. Optimization and Formulation Design of Gels of Diclofenac and Curcumin for Transdermal Drug Delivery by Box-Behnken Statistical Design. J Pharm Sci 2010. DOI 10.1002/jp 22292.
Statistics
244 Views | 233 Downloads
How to Cite
Debebe, D., Gabriel, T., Brhane, Y., Temesgen, A., Nigatu, M., & Marew, T. (2018). COMPARATIVE IN VITRO EVALUATION OF BRANDS OF CLOTRIMAZOLE CREAM FORMULATIONS MARKETED IN ETHIOPIA. Journal of Drug Delivery and Therapeutics, 8(1), 17-22. https://doi.org/10.22270/jddt.v8i1.1546