Patent ID: 9554987
Date: 2017-01-31
CPC Classifications: A61K,A61P

Claim:
1. A method for treating a sialic acid deficiency in a human patient in need thereof comprising orally administering a solid dosage form two, three, or four times per day, wherein the solid dosage form is an extended release formulation comprising a blend of about 40% to 45% w/w of N-acetylneuraminic acid (NeuAc), or a pharmaceutically acceptable salt thereof; a hydrophilic polymer or hydrogel; wherein the hydrophilic polymer comprise one or more water-swellable, pH independent polymer selected from hypromellose, hydroxypropyl ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, and methyl cellulose; and the hydrogel is selected from polyhydroxyethyl methylacrylate (PHEMA), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene oxide (PEO), or polyacrylamide (PA); an anionic, pH-dependent, gel-forming copolymer, wherein the anionic, pH-dependent, gel-forming copolymers comprise one or more alginate or salts thereof, or carboxymethyl cellulose or salts thereof; and a hydrocolloid polymer, wherein the hydrocolloid polymer is carrageenan; and wherein about 1950 mg to about 12000 mg of NeuAc or a pharmaceutically acceptable salt thereof, is administered per day; the method provides a therapeutically effective amount of NeuAc over a period of greater than about four hours and a steady plasma level of free NeuAc; and the method provides a mean plasma concentration of free NeuAc at steady state during dosing intervals that is at least about 50% higher than the mean plasma concentration of free NeuAc in the human patient before the administration of the NeuAc or a pharmaceutically acceptable salt thereof, and the mean plasma concentration of free NeuAc at steady state during the dosing intervals is at least about 0.16 mcg/ml.