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.
Highlights
Sevelamer Carbonate is the active ingredient in Renvela tablets
Sevelamer Carbonate, a cross-linked poly, is a novel phosphate binder used for the reduction of serum phosphate levels in patients with end-stage renal disease (ESRD) [1,2,3,4,5,6]
This paper describes the methodology and procedures for the determination the binding constants at two different pH levels utilizing the Langmuir approximation
Summary
Sevelamer Carbonate is the active ingredient in Renvela tablets. Sevelamer Carbonate, a cross-linked poly (allylamine Carbonate), is a novel phosphate binder used for the reduction of serum phosphate levels in patients with end-stage renal disease (ESRD) [1,2,3,4,5,6]. The advantage of Sevelamer Carbonate for ESRD over existing therapies, such as calcium or aluminum supplementation, is that it is a non-absorbed, leading to an improved safety profile. There is evidence that treatment with Sevelamer Carbonate leads to the attenuation of the progression of coronary artery and aortic calcification as well as improved control of parathyroid hormone levels relative to calcium salts [7]. Aluminum is widely recognized as the cost effective phosphate-binding drug but its use is generally re-
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