SPL Set ID: a56c857e-bc39-484c-908d-f5957857efbb

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 hydrophilic, but insoluble in water. 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 400 mg or 800 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are colloidal silicon dioxide, stearic acid and Opadry Clear 84F590009 containing polyethylene glycol, polyvinyl alcohol, and talc. The tablet imprint contains Opacode S-1-17823 Black containing ferrosoferric oxide, propylene glycol and shellac. 01