Oral pharmaceutical dosage forms for pulsatile delivery of an antiarrhythmic agent
AssigneePierce Management, LLC
InventorsKamal K. Midha, Mark Hirsh, Whe-Yong Lo
Life of this patent
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Abstract
Novel pharmaceutical dosage forms provide for pulsatile delivery of an antiarrhythmic agent that releases the drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optional third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads, granules, or particles or may comprise a single tablet with the first, second and optional third dosage units incorporated therein, or a “coated core” dosage form. Methods of treatment using the pharmaceutical dosage forms are provided as well.
Claims64
A pulsatile release dosage form for treatment of conditions responsive to the administration of an antiarrhythmic agent, comprising:
- (a) an immediate release dosage unit comprising a first dose of the active agent that is released substantially immediately following oral administration of the dosage form to a patient, said first dose providing an initial burst of active agent followed by a time interval during which little or no active agent is released from the immediate release dosage unit;
- (b) a delayed release dosage unit comprising a second dose of the active agent and a means for delaying release of the second dose until approximately 6 hours to less than 14 hours following oral administration of the dosage form;
- and optionally
- (c) a second delayed release dosage unit comprising a third dose of the active agent and a means for delaying release of the third dose until at least 4 hours to approximately 8 hours following release of the second dose from the dosage form.
Dependencies are inferred from the claim text.