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AssigneePosivisionary Solutions LLP
InventorsJohn Claude Savoir vilboeuf, Maria Teresa de Jesus Francisco Doce, Teresita del Nino Jesus Costales Gonzalez, Miriam V Illa Vargas
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The present invention consists of an extended-release metoclopramide hydrochloride pharmaceutical composition, in 30 mg drug substance 5 tablets, for use in gastrointestinal disorders. The formulation is mainly composed of a hydrophilic polymer, a hydrophobic polymer, a hydrophilic component and metoclopramide hydrochloride. The hydrophilic polymer is swollen by hydration when contacting water, forming a gel coat which controls drug substance release. The water inside the matrix dissolves the drug substance and this is diffused outside through the gel coat. The hydrophobic polymer shows plastic deformation properties under compression, tending to surround the drug substance particles reducing the pore quantity and dimensions in the matrix structure, delaying as a consequence the drug substance release. The hydrophilic component is part of the gel coating structure providing support thereto. Drug substance is the metoclopramide hydrochloride or a pharmaceutically acceptable salt thereof.
An extended release pharmaceutical composition, a tablet of about 200 milligrams, for release into the gastrointestinal environment, comprising metoclopramide hydrochloride from about 21 to 35 milligrams by weight, from hydrophilic and hydrophobic polymers and hydrophilic components and hydrophilic components which promote water penetration within the tablet, all those from about 179 to 165 milligrams by weight, which are pharmaceutically acceptable so that when composition is orally taken, extended release is induced while keeping a bioavailability substantially equivalent to the immediate release composition.
Dependencies are inferred from the claim text.