Abbott Laboratories Corporation

Bgp Products Operations Gmbh

Susan J Semla

Pramod K Gupta

Richard C Hom

Robert N Palmer

Jie Zhang

Gerard F Notario

Karen J Devcich

Ho-Wah Hui

Laman A Al-Razzak

Francisco J Alvarez

Jacqueline E Briskin

Claud Loyd

Robert W Kohler

Linda E Gustavson

Sheri L Crampton

Nelly Milman

Sheri Crampton

Disclosed is a pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment. The composition comprises an erythromycin derivative and a pharmaceutically acceptable polymer so that, when ingested orally, the composition induces statistically significantly lower Cin the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability and minimum concentration substantially equivalent to that of the immediate release composition of the erythromycin derivative upon multiple dosing. The compositions of the invention have an improved taste profile and reduced gastrointestinal side effects as compared to those for the immediate release composition.

Extended release formulations of erythromycin derivatives

Disclosed is a pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment. The composition comprises an erythromycin derivative and a pharmaceutically acceptable polymer so that, when ingested orally, the composition induces statistically significantly lower C in the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability and minimum concentration substantially equivalent to that of the immediate release composition of the erythromycin derivative upon multiple dosing. The compositions of the invention have an improved taste profile and reduced gastrointestinal side effects as compared to those for the immediate release composition.

A process for preparing fine particle pharmaceutical formulations having improved throughput and producing greater uniformity of particle size. The process relates to adding to the dry components of the formulation prior to the steps of wetting, extrusion and spheronization, an extrusion aid material selected from pharmaceutically acceptable oils and waxes having a drop point between about 15.degree. C. and 115.degree. C.

Process for the preparation of fine particle pharmaceutical formulations

Disclosed is a pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment. The composition comprises an erythromycin derivative and a pharmaceutically acceptable polymer so that, when ingested orally, the composition induces statistically significantly lower C.sub.max in the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability and minimum concentration substantially equivalent to that of the immediate release composition of the erythromycin derivative upon multiple dosing. The compositions of the invention have an improved taste profile and reduced gastrointestinal side effects as compared to those for the immediate release composition.

A pharmaceutical tablet containing a therapeutically active compound and between 5% and about 20% by weight of an oil, preferably selected from vegetable, mineral, animal and edible oils, as well as a method for preparing such tablets. Such tablets provide for the controlled release of the therapeutically active compound from the tablet and also enhance the stability of some therapeutically active compounds.

Oil-based tableting method

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Evanston, IL, United States of America

Susan J Semla