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

0163] Chronotherapy is a treatment approach that allows for better control of blood pressure during the day and night by delivering medication in amounts proportional to patients' needs and, therefore, in synchrony with the circadian blood pressure rhythm. More chronotherapeutic antihypertension medication is delivered in the morning and daytime when blood pressure is greatest, and less at night when blood pressure typically declines to the lowest level. The incidence of early morning cardiovascular events could theoretically be decreased if early morning surges in blood pressure and heart rate are blunted by the chronotherapeutic administration of indicated drugs using appropriate delivery systems.

0164] The calcium channel blocker verapamil reduces heart rate as well as blood pressure, which is especially beneficial for patients with both ischemic heart disease and hypertension. These characteristics of verapamil and its appropriate half-life made it a good choice for the formulation of an antihypertensive drug with a chronotherapeutic oral drug absorption system (CODAS). This system was designed to be taken at bedtime, to cause a 4- to 5-hour initial lag in drug delivery and, thereafter, to achieve a controlled release of drug. CODAS-verapamil capsules (Verelan.RTM. PM) were made ...

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 su...