Chronotherapeutic dosage forms and methods of treatment using chronotherapy

Abstract

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

Description

[0001] This application claims priority from U.S. Provisional Application No. 60 / 275,382, filed Mar. 31, 2001, the disclosure of which is hereby incorporated by reference in its entirety.[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.[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 conditions such as hypertension, elevated cholesterol, angina, st...

AI Technical Summary

Benefits of technology

[0008] It is a further object of the present invention to provide an oral pharmaceutical dosage form that provides a delayed release of a drug(s) into the gastrointestinal tract of a patient at a predetermined time after oral ingestion of the dosage form.

[0168] In certain preferred embodiments of the invention where the manifestations of the disease state to be treated (e.g., asthmatic attack, pain from arthritis) are greatest upon awakening, the chronotherapeutic formulations are preferably orally administered to the patient at bedtime (e.g., at about 9 or 10 p.m.) and have a lag time of about 5 or 6 hours, so that, e.g., a substantial portion of the drug in the compression coated delayed release oral dosage form is released, e.g., between 2-3 a.m., or between 3-4 a.m., and the drug is absorbed from the gastrointestinal tract and provides therapeutic efficacy at a time which correlates with the peak of the manifestations of the disease state.

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.