Methods for treating early morning pathologies

Abstract

The present invention provides methods of treating early morning pathologies using a time-specific controlled release dosage formulation which is administered prior to sleep, and which permits or achieves delivery of a pharmaceutically active agent effective for the treatment of the specific early morning pathology to be treated, at about the time of awakening. The time-specific controlled release dosage formulation comprises (1) a core including the pharmaceutically active agent(s) effective for the treatment of the early morning pathology, and (2) a swellable polymeric coating layer substantially surrounding the core. The swellable polymeric coating layer delays the release of the pharmaceutically active agent from the core for a predetermined period of time dependent upon the thickness of the swellable polymeric coating layer, to effect delivery of the pharmaceutically active agent at about the time of awakening.

Description

FIELD OF THE INVENTION[0001]The present invention relates to methods for medical treatment. More particularly, the present invention relates to methods for treating conditions or pathologies, the symptoms of which are more pronounced in early morning.BACKGROUND OF THE INVENTION[0002]It is increasingly recognized that several chronic diseases display rhythmic patterns in the manifestation of symptoms. In this field there is particular interest in those conditions for which symptoms are generally aggravated in the morning. These early morning pathologies are typically treated by either night-time administration of conventional medicines or relatively constant administration of therapeutic agents with the goal of maintaining constant levels of drug in the system of the afflicted subject. By this protocol, the therapeutic benefit of the drag is assured at the time of awakening when the symptoms are generally more pronounced. Unfortunately, the low compliance of patients or the continual...

AI Technical Summary

Benefits of technology

[0005]The methods of the present invention comprise administering to a subject in need of treatment, a time-specific controlled release dosage formulation which is administered prior to sleep, and which permits or achieves delivery of a pharmaceutically active agent effective for the treatment of the specific morning pathology to be treated, at about the time of awakening or a few hours in advance of awakening. The time-specific controlled release dosage formulation comprises (1) a core including the pharmaceutically active agent(s) effective for the treatment of the early morning pathology, and (2) a swellable polymeric coating layer substantially surrounding the core. The swellable polymeric coating layer delays the release of the pharmaceutically active agent from the core for a predetermined period of time dependent upon the thickness of the swellable polymeric coating layer, to effect delivery of the pharmaceutically active agent at the more appropriate time (e.g., at about the time of awakening).

[0006]As a second aspect, the present invention provides a pharmaceutical formulation for the time-specific delivery of a pharmaceutically active agent to a subject in need of the therapeutic effects thereof. The formulation comprises: (1) a core comprising the pharmaceutically active agent and a disintegration enhancing agent; and (2) a swellable polymeric coating layer substantially surrounding the core. The swellable polymeric coating layer delays the release of said pharmaceutically active agent from the core for a predetermined period of time dependent upon the thickness of said swellable polymeric coating layer. The disintegration enhancing agent accelerates the disintegration of the core upon disintegration of the swellable polymeric coating layer to improve the rate of release of the pharmaceutically active agent from the core when the desired time for release is reached.

[0007]As a third aspect, the present invention provides a pharmaceutical formulation for the time-specific delivery of a pharmaceutically active agent to a subject in need thereof. The formulation comprises: (1) a first time-specific dosage unit comprising (a) a core containing the pharmaceutically active agent and a disintegration enhancing agent; and (b) a swellable polymeric coating layer substantially surrounding the core; and (2) a second time-specific dosage unit comprising (a) a core containing the pharmaceutically active agent; and (b) a swellable polymeric coating layer substantially surrounding the core. The swellable polymeric coating layer delays the release of the pharmaceutically active agent from the core for a predetermined period of time dependent upon the thickness of the swellable polymeric coating layer. The disintegration enhancing agent accelerates the disintegration of the core upon dissolution of the swellable polymeric coating layer to improve the rate of release of the pharmaceutically active agent from the core. In this embodiment, the core containing the active ingredient may be differently formulated so as to allow the prompt release of the active component or a further controlled or sustained release, after the desired lag-time. For this purpose, either conventional core excipients or excipients which are capable of forming a matrix system may be used.

Problems solved by technology

Unfortunately, the low compliance of patients or the continual exposure of the system to therapeutic agents may be undesirable in some subjects or some situations.