Chronotherapeutic dosage forms

Abstract

A chronotherapeutic pharmaceutical formulation comprising a core containing an active agent (e.g., a drug) and a surfactant and a delayed release compression coating comprising a natural or synthetic gum applied onto the surface of the core.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 60 / 504,037, filed on Sep. 19, 2003, the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION [0002] The present invention relates to a chronotherapeutic dosage form containing a therapeutically effective amount of a drug. The present invention is further related to methods of preparing such formulations, and to methods of treatment utilizing such formulations. BACKGROUND OF THE INVENTION [0003] Coordinating biological rhythms (chronobiology) with medical treatment is called chronotherapy. Chronotherapy takes into consideration a person's biological rhythms in determining the timing—and sometimes the amount—of medication to optimize desired effects of a drug(s) and minimize the undesired effects. The synchronization of medication levels to the biological rhythms of disease activity is playing an increasing role in the management of common cardiovascular cond...

AI Technical Summary

Benefits of technology

[0028] In certain embodiments, the surfactant is in an effective amount to facilitate the release of the drug from the dosage form upon exposure of the dosage form to an aqueous solution. In certain preferred embodiments, the surfactant is included in an amount that facilitates the immediate release of the drug from the core of the dosage form upon exposure of the dosage form to an aqueous solution. For example, in certain embodiments, after the dosage form is exposed to an aqueous solution, the coating of the dosage form delays the release of the drug from the dosage form by delaying the exposure of the core to the aqueous solution, after the aqueous solution is exposed to the core, the inclusion of the surfactant in the core promotes the release of the drug from the core (e.g., by promoting dissolution of the drug the into the aqueous solution).

[0029] In certain preferred embodiments, the inclusion of the surfactant in the core of the dosage form facilitates the complete release of the drug from the dosage form in less than 4 hours after initial release, preferably in less than 3 hours after initial release, more preferably in less 2 hours after initial release, and most preferably in less than 1 hour after initial release.

Problems solved by technology

When one wakes up, hay fever is at its most tormenting, and in the morning hours, as ones blood pressure rises to meet the day, one is most likely to suffer a heart attack or stroke.

Rheumatoid arthritis improves through the day, but osteoarthritis grows worse.

This disintegration would typically have a detrimental effect upon the sustained release of the active agent.

Such coated pharmaceutical formulations, in addition to slowing the release rate of the active agent contained within the core of the tablet, can also effectuate a delay in the release of the active ingredient for a desired period of time such that the dissolution of the active drug core can be delayed.