Pharmaceutical dosage form for pulsatile delivery of methylphenidate
AssigneePharmaquest Limited
InventorsKamal K. Midha, Theodore L. Iorio, Shubha Chungi
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Abstract
Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally 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 or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.
Claims42
A pulsatile release dosage form for oral administration of methylphenidate, comprising:
- (a) a first dosage unit comprising a first methylphenidate dose that is released substantially immediately following oral administration of the dosage form to a patient;
- (b) a second dosage unit comprising a second methylphenidate dose and a means for delaying release of the second dose until approximately 3 to 5 hours following administration of the dosage form to a patient;
- and optionally
- (c) a third dosage unit comprising a third methylphenidate dose and a means for delaying release of the third dose until approximately 7 to 9 hours following oral administration of the dosage form to a patient.
Dependencies are inferred from the claim text.