A dosage formulation for once daily administration prior to sleeping is described
that provides an initial delay in pharmaceutical release followed by controlled
release of the pharmaceutical. There is also provided a method for preparing a
time specific delayed, controlled release formulation of dosage, which method includes
coating a single pellet with at least one dosage layer, which is coated by at least
one seal coat and at least one outer rate controlling layer of a water soluble
polymer coat. The dosage formulation of this invention provides substantially a
drug free interval of about 0 to 5 hours followed by a drug delivery interval at
a rate permitting bioavailability thereof for up to about 24 hours following oral
administration. A method of using the formulations of the present invention for
the treatment of early morning pathologies is also described.
