Chronotherapeutic compositions and methods of their use
AssigneeCirc Pharma Research & Development Limited
InventorsJohn Devane, Jackie Butler
Life of this patent
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Abstract
Chronotherapeutic formulations of cardiovascular drugs are disclosed. The formulations comprise at least one cardiovascular drug that exhibits an in vivo elimination half-life of less than about 8 hours; wherein the formulation exhibits the following in vivo profile following administration to a subject: a) a delay in release of therapeutic levels of the at least one drug for about 2 to about 8 hours; b) a Tmax at about 8 to about 12 hours; c) a drug plasma level within 50% of the peak for greater than or equal to 12 hours; and d) a peak-to-trough ratio of drug plasma levels greater than or equal to about 4.
Claims26
-13. (canceled)
A method of treating one or more cardiovascular conditions comprising administering, to a subject in need of such a treatment, a pharmaceutical formulation comprising at least one cardiovascular drug that exhibits an in vivo elimination half-life of less than about 8 hours;
- wherein the formulation exhibits the following in vivo profile following administration to a subject:
- a) a delay in release of therapeutic levels of the at least one drug for about 2 to about 8 hours;
- b) a Tmax at about 8 to about 12 hours;
- c) a drug plasma level within 50% of the peak for greater than or equal to 12 hours;
- and
- d) a peak-to-trough ratio of drug plasma levels greater than or equal to about 4.
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A method of reducing the effects of the rebound phenomena in a subject that is to be withdrawn from a cardiovascular drug comprising replacing the cardiovascular drug being administered to the subject with a formulation that contains the cardiovascular drug to be withdrawn wherein the formulation comprises at least one cardiovascular drug that exhibits an in vivo elimination half-life of less than about 8 hours, wherein the formulation exhibits the following in vivo profile following administration to a subject:
- a) a delay in release of therapeutic levels of the at least one drug for about 2 to about 8 hours;
- b) a Tmax at about 8 to about 12 hours;
- c) a drug plasma level within 50% of the peak for greater than or equal to 12 hours;
- and
- d) a peak-to-trough ratio of drug plasma levels greater than or equal to about 4, and administering that formulation for at least about 7 days before ceasing the administration of the cardiovascular drug.
-38. (canceled)
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Dependencies are inferred from the claim text.