Delayed, sustained-release pharmaceutical preparation

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

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424489, A61K 914

Patent

active

053763840

ABSTRACT:
A delayed, sustained-release pharmaceutical preparation is provided in which a water-soluble drug core is surrounded by a hydratable diffusion barrier which delays drug release for about 2-10 hours. The hydratable diffusion barrier comprises a film-forming polymer such as an acrylic resin or ethyl cellulose and an additive which controls the rate of hydration and permeability of the hydratable diffusion barrier selected from the group consisting of fully esterified acrylic resins containing quaternary amine side chains, lubricants, anionic surfactants, plasticizers, inert water-soluble materials, and mixtures thereof. In the preferred sustained-release pharmaceutical preparation, the film-forming polymer is combined with the additive and coated onto core drug granules to produce a diffusion barrier surrounding the core drug and form microparticles which may then be admixed with an immediate release drug.

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Ozturk et al, "Mechanism of Release from Pellets Coated with an Ethylcellulose-Based Film," J. of Controlled Release, vol. 14, No. 3, Dec. 1990.

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