Non-pulsatile prolonged-release betahistine oral solid compositions

A non-pulsatile 24 hours prolonged-release oral solid composition comprising an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipients or carriers, wherein the composition exhibits a dissolution profile according to which:

• up to 30% by weight of betahistine is dissolved in 1 hour;
• from 35% to 45% by weight of betahistine is dissolved in 2 hours;
• from 46% to 60% by weight of betahistine is dissolved in 4 hours;
• from 61% to 80% by weight of betahistine is dissolved in 8 hours;
• from 81% to 97% by weight of betahistine is dissolved in 16 hours;
• and
• from 98% to 100% by weight of betahistine is dissolved in 24 hours
• wherein the dissolution profile is measured using a USP type I apparatus (basket), placing the composition in 900 mL of phosphate buffer having pH 6.8, at 37° C. and 100 rpm,
• wherein the pharmaceutically acceptable excipients or carriers comprise one or more hydrophilic matrix forming agents, and
• wherein the hydrophilic matrix forming agent is a mixture of hydroxypropylmethylcellulose and carrageenan.