Substituted amylose (SA) polymers were produced from high-amylose corn starch by etherification of its hydroxyl groups with\nchloroacetate. Amorphous high-amylose sodium carboxymethyl starch (HASCA), the resulting SA polymer, was spray-dried\nto obtain an excipient (SD HASCA) with optimal binding and sustained-release (SR) properties. Tablets containing different\npercentages of SD HASCA and tramadol hydrochloride were produced by direct compression and evaluated for dissolution. Oncedaily\nand twice-daily SD HASCA tablets containing two common dosages of tramadol hydrochloride (100mg and 200mg), a freely\nwater-soluble drug, were successfully developed. These SR formulations presented high crushing forces, which facilitate further\ntablet processing and handling. When exposed to both a pH gradient simulating the pH variations through the gastrointestinal\ntract and a 40% ethanolmedium, a very rigid gel formed progressively at the surface of the tablets providing controlled drug-release\nproperties. These properties indicated that SDHASCA was a promising and robust excipient for oral, sustained drug-release, which\nmay possibly minimize the likelihood of dose dumping and consequent adverse effects, even in the case of coadministration with\nalcohol.\n1. Introduction
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