Treatment of migraine headache
AssigneePozen Inc.
InventorsJohn R. Plachetka, Zakauddin T. Chowhan
Life of this patent
Estimating the term…
Abstract
The invention is directed to pharmaceutical compositions useful in the treatment of migraine. The compositions contain metoclopramide and one or more NSAIDs in unit dosage form. By selecting NSAIDs that are non-acidic or segregating the metoclopramide and NSAID, the storage life of the compositions has been increased. Also disclosed are coordinated dosage forms for the sequential release of drugs. The invention encompasses methods of treating migraine using any of these dosage forms.
Claims23
A pharmaceutical composition in unit dosage form suitable for oral administration to a human for the treatment of migraine headache, wherein said unit dosage form is a tablet or capsule, comprising:
- metoclopramide and an acidic NSAID having a pKa below 7 when dissolved in water, present in an amount such that the combination is effective in reducing or eliminating pain associated with said migraine headache and wherein said dosage form is acid-base storage stabilized due to:
- a) a barrier coating separating said metoclopramide from said acidic NSAID;
- or
- b) said acidic NSAID and said metoclopramide being segregated into separate layers of a multilayer tablet in a way that prevents said metoclopramide and said acidic NSAID from contacting one another.
A pharmaceutical composition in unit dosage form suitable for oral administration to a human for the treatment of migraine headache, wherein said unit dosage form is a tablet or capsule, comprising:
- metoclopramide and an acidic NSAID, present in an amount such that the combination is effective in reducing or eliminating pain associated with said migraine headache and wherein said dosage form is acid-base storage stabilized as a result of:
- a) a barrier coating separating said metoclopramide from said acidic NSAID;
- or
- b) said acidic NSALD and said metoclopramide being segregated into separate layers of a multilayer tablet in a way that prevents said metoclopramide and said acidic NSAID from contacting one another;
- and wherein said acidic NSAID is selected from the group consisting of:
- ibuprofen;
- flurbiprofen;
- ketoprofen;
- naproxen;
- oxaprozin;
- etodolac;
- indomethacin;
- ketorolac;
- piroxicam;
- meloxicam;
- and a pharmaceutically acceptable salt thereof.
Dependencies are inferred from the claim text.