LOW MELTING PROPIONIC ACID DERIVATIVE PARTICLES FOR USE IN ORAL DOSAGE FORMS
Low melting propionic acid derivative particles that are free flowing and have significantly reduced or eliminated throat burn are disclosed. A method of manufacturing the low melting propionic acid derivative particles; dosage forms containing the low melting propionic acid derivative particles; methods of manufacturing the dosage forms; and methods of treatment using the dosage forms are also disclosed.
1 . A method of manufacturing ibuprofen particles, comprising:
melting ibuprofen and a wax while mixing;
dispersing the molten ibuprofen/wax mixture in hot water;
transferring the hot ibuprofen/wax/water dispersion into another container containing cold water, wherein the dispersed droplets of ibuprofen/wax congeal and form fine/spherical particles; and
filtering and drying the fine/spherical particles.
2 . (canceled)
3 . The method of claim 1 , wherein said wax is glyceryl behenate.
4 . A method of manufacturing a dosage form, comprising:
mixing the propionic acid derivative particles of claim 1 with dosage form excipients; and
compressing the mixture into a dosage form.
5 . A propionic acid derivative particle prepared by the method of claim 1 .
6 . A dosage form prepared by the method of claim 2 .
7 . A method of treatment, comprising administering the dosage form of claim 6 .
8 . An immediate release pharmaceutical formulation comprising the propionic acid derivative particle of claim 5 .
9 . The immediate release pharmaceutical formulation of claim 8 , wherein said formulation is a chewable tablet.
10 . The immediate release pharmaceutical formulation of claim 8 , wherein said formulation is an orally disintegrating tablet.
11 . The immediate release pharmaceutical formulation of claim 8 , wherein said propionic acid derivative particles comprise from about 80 parts propionic acid derivative/about 20 parts wax to about 95 parts propionic acid derivative/about 5 parts wax.
12 . The immediate release pharmaceutical formulation of claim 9 , wherein said propionic acid derivative particles comprise about 85 parts propionic acid derivative/about 15 parts wax.
13 . The method of claim 1 , wherein said ibuprofen particles comprise from about 80 parts ibuprofen/about 20 parts wax to about 95 parts ibuprofen/about 5 parts wax.
14 . The method of claim 13 , wherein said ibuprofen particles comprise about 85 parts ibuprofen/about 15 parts wax.