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US 8,507,000 B2Granted
Controlled release formulation of erythromycin derivatives
AssigneeNostrum Pharmaceuticals, Inc.
InventorNirmal Mulye
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AssigneeNostrum Pharmaceuticals, Inc.
InventorNirmal Mulye
Estimating the term…
The present invention is directed to a controlled release formulation in tablet form comprising a pharmaceutically effective amount of an erythromycin derivative and a lubricating effective amount of a lubricant in the absence of material selected from the group consisting of alginic acid or salts thereof or hydrophilic sustained release polymers in amounts effective to retard the release of the erythromycin derivatives in the pharmaceutical composition. It is also directed to a method for facilitating the release of erythromycin derivative from a pharmaceutical composition comprising a therapeutically effective amount of a lubricating effective amount of a lubricant said method comprising adding to said composition an release promoter in tablet disintegrating effective amounts to facilitate the release of the erythromycin derivative from the tablet.
A controlled release formulation in tablet form comprising a composition comprising a pharmaceutically effective amount of clarithromycin and a lubricating effective amount of a lubricant and a release promoter in a tablet disintegrating effective amounts to facilitate the release of clarithromycin from the tablet and optionally a hydrophobic sustained release agent in the absence of a material selected from the group consisting of alginic acid or salts thereof and hydrophilic sustained release polymers, the composition, comprised of clarithomycin, lubricant, release promoter and, when present in said formulation, hydrophobic sustained release agent, being present in the core of a coated tablet or in an uncoated tablet.
A method for preparing a sustained release formulation comprised of clarithromycin in tablet form which method comprises milling a composition comprised of a therapeutically effective amount of clarithromycin and a lubricating effective amount of a lubricant, and optionally a release promoter in tablet disintegrating effective amounts to facilitate the release of clarithromycin from the tablet and optionally a hydrophobic sustained release agent, mixing said milled composition and compressing the mixture into a tablet, wherein said composition is present in an uncoated tablet or in the core of a coated tablet, the formulation being free of a material selected from the group consisting of alginic acid or salts thereof and hydrophilic sustained release polymers.
Dependencies are inferred from the claim text.