Comparison of Dissolution Profiles of Furosemide Tablets Available in the Argentinian Market
DOI:
https://doi.org/10.6000/1929-5030.2014.03.04.1Keywords:
Furosemide, tablets, dissolution profiles, commercial products, model-dependent, model-independent.Abstract
In this work dissolution profiles of furosemide tablets of nine commercial products marketed in Argentine were evaluated. All brands fulfill the specifications of dissolution test of USP. Comparison of dissolution profiles were carried out by model-dependent and model independent approaches. Results obtained via model-dependent approach show a first order drug release mechanism especially for Brand I (reference) and Brand IV. Results obtained via model-independent approach show that there was not significant difference in Dissolution efficiency between the reference product and Brands II, III and IV and in Mean dissolution time between the reference product and Brands II, III, IV and V. Using fit factors, only Brands I and III were similar.References
[1] Perioli L, D’Alba G, Pagano C. New oral solid dosage form for furosemide oral administration. Eur J Pharm Biopharm 2012; 80: 621-9. http://dx.doi.org/10.1016/j.ejpb.2011.12.011
[2] Khan F, Li M, Schlindwein W. Comparison of in vitro dissolution tests for commercially available aspirin tablets. Diss Technol 2013; 20: 48-58.
[3] Disposición N° 4788 (ANMAT), Buenos Aires, Argentina, 15 de Agosto de 2012.
[4] Granero GE, Longhi MR, Mora MJ, et al. Biowaiver monographs for immediate release solid oral dosage forms: Furosemide. J Pharm Sci 2010; 99: 2544-56. http://dx.doi.org/10.1002/jps.22030
[5] Doherty C, York P. Evidence for solid- and liquid-state interactions in a furosemide-polyvinylpyrrolidone solid dispersion. J Pharm Sci 1987; 76: 731-7. http://dx.doi.org/10.1002/jps.2600760912
[6] Akbuga J, Gürsoy A, Yetimoglu F. Preparation and properties of tablets prepared from furosemide-PVP solid dispersion systems. Drug Dev Ind Pharm 1988; 14: 2091- 108. http://dx.doi.org/10.3109/03639048809152004
[7] Ozdemir N, Ordu S. Improvement of dissolution properties of furosemide by complexation with beta-cyclodextrin. Drug Dev Ind Pharm 1998; 24: 19-25. http://dx.doi.org/10.3109/03639049809082348
[8] Shin SC, Oh IJ, Lee YB, Choi HK, Choi JS. Enhanced dissolution of furosemide by coprecipitating or cogrinding with crospovidone. Int J Pharm 1998; 175: 17-24. http://dx.doi.org/10.1016/S0378-5173(98)00260-9
[9] Shin SC, Kim J. Physicochemical characterization of solid dispersion of furosemide with TPGS. Int J Pharm 2003; 251: 79-84. http://dx.doi.org/10.1016/S0378-5173(02)00586-0
[10] Farcas A, Jarroux N, Farcas AM, Harabagiu V, Guegan P. Synthesis and characterization of furosemid complex in bcyclodextrin. Dig J Nanomater Bios 2006; 1: 55-60.
[11] Kaukonen AM, Laitinen L, Salonen J, et al. Enhanced in vitro permeation of furosemide loaded into thermally carbonized mesoporous silicon (TCPSi) microparticles. Eur J Pharm Biopharm 2007; 66: 348-56. http://dx.doi.org/10.1016/j.ejpb.2006.11.021
[12] Patel RP, Patel DJ, Bhimani DP, Patel JK. Physicochemical characterization and dissolution study of solid dispersions of furosemide with polyethylene glycol 6000 and polyvinyl pyrrolidone K30. Diss Technol 2008; 15: 17-25.
[13] Chaulang G, Patel P, Hardikar S, Kelkar M, Bhosale A, Bhise S. Formulation and evaluation of solid dispersions of furosemide in sodium starch glycolate. Trop J Pharm Res 2009; 8: 43-51. http://dx.doi.org/10.4314/tjpr.v8i1.14711
[14] Zvonar A, Berginc K, Kristl A, Gaperlin M. Microencapsulation of self-microemulsifying system: improving solubility and permeability of furosemide. Int J Pharm 2010; 388: 151-8. http://dx.doi.org/10.1016/j.ijpharm.2009.12.055
[15] Perioli L, Ambrogi V, Nocchetti M, Sisani M, Pagano C. Preformulation studies on host–guest composites for oral administration of BCS class IV drugs: HTlc and furosemide. Appl Clay Sci 2011; 53: 696-703. http://dx.doi.org/10.1016/j.clay.2011.06.006
[16] De Zordi N, Monaghan M, Kikic I, et al. Applications of supercritical fluids to enhance the dissolution behaviors of Furosemide by generation of microparticles and solid dispersions. Eur J Pharm Biopharm 2012; 81: 131-41. http://dx.doi.org/10.1016/j.ejpb.2012.01.002
[17] Yuksel N, Kanik AE, Baykara T. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm 2000; 209: 57-67. http://dx.doi.org/10.1016/S0378-5173(00)00554-8
[18] Polli JE, Rekhi GS, Ausburger LL, Shah VP. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J Pharm Sci 1997; 86: 690-700. http://dx.doi.org/10.1021/js960473x
[19] Costa FO, Sousa JJS, Pais AACC, Formosinho SJ. Comparison of dissolution profiles of Ibuprofen pellets. J Control Release 2003; 89: 199-212. http://dx.doi.org/10.1016/S0168-3659(03)00033-6
[20] Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996; 20: 64-74.
[21] Guidance for the industry: dissolution testing of immediate release solid oral dosage forms, FDA, Center for Drug Evaluation and Research, Rockville, MD, 1997.
[22] Guideline on the investigation of bioequivalence: EMA, Committee for Medicinal Products for Human Use (CHMP), London, UK, 2010.
[23] Disposición N° 5568 (ANMAT), Buenos Aires, Argentina, 5 de Febrero de 2009.
[24] Maggio RM, Castellano PM, Kaufman TS. A new principal component analysis-based approach for testing ""similarity"" of drug dissolution profiles. Eur J Pharm Sci 2008; 34: 66-77. http://dx.doi.org/10.1016/j.ejps.2008.02.009
[25] Ruiz ME, Gregorini A, Talevi A, Volonté MG. Dissolution studies of generic medications: New evidence of deviations from the Transitivity principle. Diss Technol 2012; 19: 13-24.
[26] The United States Pharmacopeia 37th Ed.) U.S. Pharmacopeial Convention, Rockville, MD; 2014, 3104-3105.
[27] Khan KA, Rhodes CT. Effect of compaction pressure on the dissolution efficiency of direct compression systems. Pharm Acta Helv 1972; 47: 594-607.
[28] Aguilar Ros A, Caamaño Somoza M, Martín Martín FR, Montejo Rubio MC. Parámetros amodelísticos: comparación de perfiles. In Biofarmacia y Farmacocinética, ejercicios y problemas resueltos, 1st ed. Elsevier España S. L., Barcelona, España, 2008; pp. 3-4.
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2014-12-17
How to Cite
Han, Y. K., Simionato, L. D., Calvo, R. G., Mattei, M. B., & Segall, A. I. (2014). Comparison of Dissolution Profiles of Furosemide Tablets Available in the Argentinian Market. Journal of Applied Solution Chemistry and Modeling, 3(4), 186–193. https://doi.org/10.6000/1929-5030.2014.03.04.1
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