SPL Set ID: 71f61492-8971-424a-8415-dfd2e15d05d9

1 drug(s) with this SPL Set ID

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Sevelamer carbonate SEVELAMER CARBONATE
800 mg Tablet
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

Sevelamer carbonate is 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 hygroscopic, but 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 Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are castor oil, colloidal silicon dioxide, crospovidone, dibutyl sebacate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, purified water and triacetin. The tablet is printed with black pharmaceutical ink which contains ferrosoferric oxide, propylene glycol and shellac. Image

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