Patent ID: 9511015
Filing Date: 2016-12-06
CPC Classification: A61K,A61P

Claim Text:
1. An extended release pharmaceutical formulation in solid oral unit dosage form comprising about 40% to about 45% w/w of N-acetylneuraminic acid (NeuAc), or a pharmaceutically acceptable salt thereof; about 20% to about 30% w/w of one or more hydrophilic polymers, wherein the one or more hydrophilic polymers comprise one or more water-swellable, pH independent polymers or hydrogel, and the water-swellable, pH independent polymer is selected from the group consisting of hypromellose, hydroxypropyl ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, and methyl cellulose; and the hydrogel is selected from the group consisting of polyhydroxyethyl methylacrylate (PHEMA), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene oxide (PEO), and polyacrylamide (PA); about 20% to about 25% w/w of one or more anionic, pH-dependent, gel-forming polymers, wherein the one or more anionic, pH-dependent, gel-forming copolymers comprise one or more alginate or salts thereof, or carboxymethyl cellulose or salts thereof; and about 1% to about 5% w/w of one or more hydrocolloid polymers or one or more cationic polymers, wherein the one or more hydrocolloid polymers comprise one or more carrageenans; and the one or more cationic polymers comprise chitosan, trimethylchitosan, quarternized chitosan, glycated chitosan, or galacto-chitosan wherein each unit dosage form contains about 325 mg or about 500 mg of NeuAc; and upon oral administration to a human patient three or four times per day, the formulation provides a therapeutically effective amount and a steady plasma concentration of NeuAc over a period of greater than 6 hours.