SPL Set ID: 649e5b7b-aa2f-4975-8c00-01d647d35c01

The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer Carbonate is known chemically as poly(allylamine-co-N, N'-diallyl-1,3- diamino-2-hydroxypropane) carbonate salt. Sevelamer Carbonate is white to off-white powder, practically insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 0.8 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, opadry clear, opacode black, povidone and sodium chloride. Opadry clear contains hypromellose 2910 (15 mPas), hypromellose 2910 (5 mPas), di-acetylated monoglycerides. Opacode black contains shellac, ferrosoferric oxide. description