Hydrodynamically balanced controlled release compositions containing L-dopa and a decarboxylase inhibitor

Claim 1

A hydrodynamically balanced controlled release composition comprising (a) as the active ingredient, an amount of L-Dopa which is effective in achieving desired levels of L-Dopa in the blood and an amount of a decarboxylase inhibitor selected from the group consisting of N 1 -dl-seryl-N 2 -(2,3,4-trihydroxybenzyl) hydrazine hydrochloride, β-(3,4-dihydroxyphenyl)-α-hydrazino-αmethyl propionic acid, m-hydroxybenzylhydrazine and β-methyldopa, which is effective for the amount of L-Dopa in the composition and wherein the ratio of L-Dopa to decarboxylase inhibitor ranges from about 4:1 to about 10:1 and, (b) in percents by weight based on the total weight of the composition, from about 5% to about 80% of a hydrocolloid or mixture of hydrocolloids selected from the group consisting of acacia, gum tragacanth, locust bean gum, guar gum, karaya gum, agar, pectin, carrageen, soluble and insoluble alginates, methylcellulose, hydroxy-propyl methylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, carboxypolymethylene, gelatin, casein, zein and bentonite; up to about 60% of a fatty material or mixture of fatty materials selected from the group consisting of beeswax, cetyl alcohol, stearyl alcohol, glycerylmonosteareate, hydrogenated caster oil and hydrogenated cottonseed oil and up to about 80% of edible inert pharmaceutical adjunct materials whereby said composition, when used in capsule or tablet form, is hydrodynamically balanced so that, upon contact with gastric fluid, said capsule or tablet acquires and maintains a bulk density of less than one thereby being buoyant in the gastric fluid and remaining buoyant in the gastric fluid of the stomach until substantially all of the active ingredients contained therein have been released.