Chronotherapeutic dosage forms containing glucocorticosteroid and methods of treatment

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, s...

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 steroidal drug(s) into the gastrointestinal tract of a patient at a predetermined time after oral ingestion of the dosage form.

[0122] The benefits of chronotherapeutics include safety and more efficient treatment than conventional therapies. This is achieved by delivering more medication when risk of disease is greater, and delivering less medication when potential for disease symptoms are less likely. Other benefits to the patient include an increased quality of life and a once-a-day drug delivery system to increase patient compliance.

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.

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