Claims for Patent: 12,485,111

Summary for Patent: 12,485,111

Title:	Reduced dose metaxalone formulations
Abstract:	Oral dosage forms of metaxalone having improved bioavailability in the fed and fasted states, including dosage forms that employ a reduced dose based on such improved bioavailability.
Inventor(s):	Mukteeshwar Gande, Robert M. Levy
Assignee:	PRIMUS PHARMACEUTICALS Inc
Application Number:	US18/409,208
Patent Claims:	1. An oral dosage form consisting essentially of micronized metaxalone and non-micronized metaxalone and one or more pharmaceutically acceptable excipients. 2. The oral dosage form of claim 1 comprising 640 mg of metaxalone. 3. The oral dosage form of claim 1, wherein the weight ratio of micronized metaxalone to non-micronized metaxalone is 60:40. 4. A compressed tablet consisting essentially of micronized metaxalone and non-micronized metaxalone and one or more pharmaceutically acceptable excipients. 5. The compressed tablet of claim 4, comprising 640 mg of said micronized and non-micronized metaxalone. 6. The compressed tablet of claim 4, wherein the excipients comprise: 10-30 weight parts alginic acid, and 10-30 weight parts propylene glycol alginate. 7. The compressed tablet of claim 6, wherein the excipients further comprise: 20-35 weight parts lactose monohydrate, 40-60 weight parts povidone, and 4-6 weight parts magnesium stearate. 8. The compressed tablet of claim 4, wherein the weight ratio of micronized to non-micronized metaxalone is about 1.5:1. 9. A method of treating musculoskeletal pain comprising administering the compressed tablet of claim 4 to a patient in need thereof. 10. The method of claim 9, comprising administering the compressed tablet in the fasted state.