SPL Set ID: d8729e42-dbbd-4954-9ce0-298743a15a06

The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine- co -N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is white to off-white hygroscopic powder, practically insoluble in water and in methanol. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are acetylated monoglyceride, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, shellac glaze and talc. Chemical Structure