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Delayed, sustained-release diltiazem pharmaceutical preparation
| Details |
Inventors: Eichel, deceased, Herman J.; Massmann, Brent D.; Cobb, Jr., Joseph E.;
Assignee: Kinaform Technology, Inc. (Dayton, OH)
Primary Examiner: Page; Thurman K.
Assistant Examiner: Benston, Jr.; William E.
Attorney, Agent or Firm: Killworth, Gottman, Hagan & Schaeff
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, esterified acrylic resin, or ethyl cellulose or mixtures thereof and an additive which controls the rate of hydration and permeability of the hydratable diffusion barrier selected from the group consisting of 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 when the drug core is the preferred diltiazem hydrochloride, different coating thicknesses of the diffusion barrier are used to provide a long delay component and a short delay component. |
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred delayed, sustained-release pharmaceutical preparation of the present invention is a water soluble core drug surrounded by a hydratable diffusion barrier comprising an insoluble film-forming polymer such as Eudragit NE30D (Rohm Pharma), Eudragit RS30D (Rohm Pharma), Aquacoat (FMC Corp.
) ethyl cellulose, or mixtures thereof and an additive which controls the rate of hydration and permeability of the diffusion barrier, together in microparticle form.
The core drug is preferably a soluble orally administered drug.
The solubility of the drug in the intestines should be greater than 10 grams per liter as drugs with lower solubility will not dissolve and diffuse through the hydrated diffusion barrier at adequate rates.
Examples of suitable drugs include propranolol hydrochloride, quinidine gluconate, dextromethorphan hydrobromide, diphenhydramine hydrochloride, disopyramide phosphate, and verapamil hydrochloride.
Most preferred is diltiazem hydrochloride.
The hydratable diffusion barrier is formed by combining the film-forming polymer dispersion and an additive dispersion, and then spray coating the core drug.
In one embodiment, the additive dispersion comprises from about 5 to 20% magnesium stearate, from about 75 to 95% water, and from about 0 to 5% citric acid.
In another embodiment, the additive dispersion comprises from about 5 to 20% magnesium stearate, from about 80 to 95% water, and 0 to 1% simethicone emulsion.
In yet another embodiment, the additive dispersion comprises 3-10% acetyltributyl citrate (ATBC), 7-20% talc and 70-90% water.
The preferred process for applying the hydratable diffusion barrier to the core drug is a fluid bed spray coating process such as the Wurster process or the tangential spray rotor process.
Other spray coating processes such as pan coating or the immersion tube process may be used.
The additive comprises 5-40% (solids basis) of the combined aqueous dispersions of additive dispersion and film-forming polymer dispersion
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