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 AJAC  Vol.4 No.5 , May 2013
Comparison of Binding Parameter Constants between Sevelamer Carbonate Tablets and Renvela Tablets by a Validated Ion Chromatography Method
Abstract: Sevelamer Carbonate is a crossolinked polymeric amine, it is the active ingredient in Renvela Tablets. Sevelamer Carbonate is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Carbonate were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Ion Chromatography. An Ion Chromatogrpahy method has been developed to estimate free phosphate in in-vitro phosphate binding study of Sevelamer Carbonate Tablets. The method is selective and capable of detecting phosphate in the presence of placebo matrix. The method has been validated with a lower limit of quantitation of 0.2 mM for Phosphate. A linear response function was established in the range of concentrations 0.2 - 30.0 mM (r > 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the acceptance as per Food and Drug Administrations guidelines. Phosphate was stable in the set of stability studies viz. bench-top and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer Carbonate Tablets.
Cite this paper: V. Vallapragada, G. Inti, S. Geevanagari, S. Vidiyala and S. Jadi, "Comparison of Binding Parameter Constants between Sevelamer Carbonate Tablets and Renvela Tablets by a Validated Ion Chromatography Method," American Journal of Analytical Chemistry, Vol. 4 No. 5, 2013, pp. 213-220. doi: 10.4236/ajac.2013.45027.
References

[1]   D. P. Rosenbaum, H. S. R. Farley, W. H. Mandeville, M. Pitruzzello and D. I. Goldberg, “Effect of RenaGel, a Non-Abosrbable, Cross-Linked, Polymeric Phosphate Binder, on Urinary Phosphorus Excretion in Rats,” Nephrology Dialysis Transplantation, Vol. 12, No. 5, 1997, pp. 961-964. doi:10.1093/ndt/12.5.961

[2]   G. M. Chertow, S. K. Burke, J. M. Lazarus, K. H. Stenzel, D. Wombolt, D. Goldberg, et al., “Poly Allylamine Chloride (RenaGel): A Noncalcemic Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Renal Failure,” American Journal of Kidney Diseases, Vol. 29, No. 1, 1997, pp. 66-71. doi:10.1016/S0272-6386(97)90009-3

[3]   S. K. Burke, E. A. Slatopolsky and D. Goldberg, “Rena-Gel, a Novel Calcium- and Aluminium-Free Phosphate Binder, Inhibits Phosphate Absorption in Normal Volunteers,” Nephrology Dialysis Transplantation, Vol. 12, No. 8, 1997, pp. 1640-1644. doi:10.1093/ndt/12.8.1640

[4]   R. A. Swearingen, X. Chen, J. S. Petersen, K. S. Riley, D. Wang and E. Zhorov, “Determination of the Binding Parameter Constants of Renagel Capsules and Tablets Utilizing the Langmuir Approximation at Various pH by Ion Chromatography,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 29, No. 1-2, 2002, pp. 195-201. doi:10.1016/S0731-7085(02)00007-9

[5]   J. R. Mazzeo, R. M. Peters, M. R. Hanus, X. Chen and K. A. Norton, “A Phosphate Binding Assay for Sevelamer Hydrochloride by Ion Chromatography,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 19, No. 6, 1999, pp. 911-915. doi:10.1016/S0731-7085(98)00193-9

[6]   S. R. H. Farley, W. H. Manderville, J. Ward and K. L. Miller, “Design and Characterization of Sevelamer Hydrochloride: A Novel Phosphate-Binding Pharmaceutical,” Journal of Macromolecular Science, Part A: Pure and Applied Chemistry, Vol. 36, No. 7-8, 1999, pp. 1085-1091.

[7]   G. M. Chertow, S. K. Burke and P. Raggi, “Sevelamer Attenuates the Progression of Coronary and Aortic Calci- fication in Hemodialysis Patients,” Kidney International, Vol. 62, No. 1, 2002, pp. 245-252. doi:10.1046/j.1523-1755.2002.00434.x

[8]   A. C. Alfrey, G. R. LeGendre and W. D. Kaehny, “The Dialysis Encephalopathy Syndrome, Possible Aluminum Intoxication,” The New England Journal of Medicine, Vol. 294, No. 4, 1976, pp. 184-188. doi:10.1056/NEJM197601222940402

[9]   I. S. Parkinson, M. K. Ward and D. N. S. Kerr, “Dialysis Encephalopathy, Bone Disease and Anaemia: The Alu- minium Intoxication Syndrome during Regular Haemodi- alysis,” Journal of Clinical Pathology, Vol. 34, No. 11, 1981, pp. 1285-1294. doi:10.1136/jcp.34.11.1285

[10]   J. J. Plachot, G. C. Witmer, S. Halpern, V. Mendes, A. Bourdeau, J. Fritsch, et al., “Bone Ultrastructure and X- Ray Microanalysis of Aluminum-Intoxicated Hemodia- lyzed Patients,” Kidney International, Vol. 25, No. 5, 1984, pp. 796-803. doi:10.1038/ki.1984.92

[11]   H. H. Malluche and M. M. Faugere, “Risk of Adynamic Bone Disease in Dialyzed Patients,” Kidney International Supplement, Vol. 38, No. 38, 1992, pp. S62-S67.

[12]   M. Touam, F. Martinez, B. Lacour, R. Bourdon, J. Zingraff, S. Di Giulio, et al., “Aluminium-Induced, Reversible Microcytic Anemia in Chronic Renal Failure: Clinical and Experimental Studies,” Clinical Nephrology,No. 6, Vol. 19, 1983, pp. 295-298.

[13]   M. Wallot, K. E. Bonzel, A. Winter, B. Georger, B. Lettgen and M. Bald, “Calcium Acetate versus Calcium Carbonate as Oral Phosphate Binder in Pediatric and Adolescent Hemodialysis Patients,” Pediatric Nephrology, Vol. 10, No. 5, 1996, pp. 625-630. doi:10.1007/s004670050175

[14]   W. G. Goodman, J. Goldin, B. D. Kuizon, C. Yoon, B. Gales, D. Sider, et al., “Coronary-Artery Calcification in Young Adults with End-Stage Renal Disease Who Are Undergoing Dialysis,” The New England Journal of Medicine, Vol. 342, No. 20,2000, pp. 1478-1483. doi:10.1056/NEJM200005183422003

[15]   J. A. Delmez, C. A. Tindira, D. W. Windus, K. Y. Norwood, K. S. Giles, T. L. Nighswander, et al., “Calcium Acetate as a Phosphorus Binder in Hemodialysis Patients,” Journal of the American Society of Nephrology, Vol. 3,No. 1, 1992, pp. 96-102.

[16]   C. H. Hsu, “Are We Mismanaging Calcium and Phosphate Metabolism in Renal Failure?” American Journal of Kidney Diseases, Vol. 29, No. 4, 1997, pp. 641-649. doi:10.1016/S0272-6386(97)90352-8

[17]   G. Eknoyan, A. Levin and N. W. Levin, “Bone Metabolism and Disease in Chronic Kidney Diseases,” American Journal of Kidney Diseases, Vol. 42, Suppl. 3, 2003, pp. 1-201. doi:10.1016/S0272-6386(03)00905-3

[18]   W. Y. Qunibi, R. E. Hootkins, L. L. McDowell, M. S. Meyer, M. Simon, R. O. Garza, et al., “Treatment of Hyperphosphatemia in Hemodialysis Patients: The Calcium Acetate Renagel Evaluation (CARE Study),” Kidney International, Vol. 65,No. 5, 2004, pp. 1914-1926. doi:10.1111/j.1523-1755.2004.00590.x

[19]   D. J. Block, J. Robertson, T. S. Chasan, A. Blair, M. Dillon and A. J. Bleyer, “A Randomized, Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride and Sevelamer Carbonate in Patients on Hemodialysis,” Clinical Nephrology, Vol. 68, 2007, pp. 386-391.

[20]   M. Hanus, E. Zhorov, D. Brommage, M. Plone and H. S. R. Farley, “Assessment of Phosphate Binding by Sevelamer Carbonate Powder for Oral Suspension Mixed in Foods,” Nephrology Nursing Journal, Vol. 39, No. 9, 2012, pp. 239-243,255.

[21]   M. Ketteler, M. Rix, S. Fan, N. Pritchard, O. Oestergaard, S. C. Taber, et al., “Efficacy and Tolerability of Sevelamer Carbonate in Hyperphosphatemic Patients Who Have Chronic Kidney Disease and Are Not on Dialysis,” Clinical Journal of the American Society of Nephrology, Vol. 3, No. 4, 2008, pp. 1125-1130. doi:10.2215/CJN.05161107

 
 
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