Patent ID: 11918559
Assignee: PRIMUS PHARMACEUTICALS, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A solid oral pharmaceutical tablet consisting essentially of 640 mg of metaxalone and one or more pharmaceutically acceptable excipients, wherein the metaxalone consists essentially of from 40 to 80 wt % of a first grade of particles of metaxalone and from 20 to 60 wt % of a second grade of particles of metaxalone and 10 to 30 weight parts propylene glycol alginate, further wherein:
a) 90% of the first grade of particles of metaxalone are smaller than 100 microns when tested according to the Malvern Method;
b) at least 35% of the second grade of particles of metaxalone are retained on a #120 sieve when tested by the Sieve Method;
c) the first and second grades of metaxalone cause the oral dosage form to be bioequivalent to itself under both fed and fasted conditions in terms of AUC0-inf, wherein said bioequivalence is the 90% confidence interval for a geometric mean test-to-reference area, and whereby peak concentration ratios are within a bioequivalence interval of 0.80-1.25.