Details for Patent: 9,907,780

Title:	Low-dose doxepin formulations and methods of making and using the same
Abstract:	The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Inventor(s):	Schioppi; Luigi (Escondido, CA), Dorsey; Brian Talmadge (Encinitas, CA), Skinner; Michael (San Diego, CA), Carter; John (Keswick, CA), Mansbach; Robert (San Diego, CA), Jochelson; Philip (San Diego, CA), Rogowski; Roberta L. (Rancho Santa Fe, CA), Casseday; Cara Baron (San Diego, CA), Perry; Meredith (El Cajon, CA), Knox; Bryan (San Diego, CA)
Assignee:	Pernix Sleep, Inc. (Morristown, NJ)
Filing Date:	Dec 30, 2016
Application Number:	15/394,912
Claims:	1. A pharmaceutical composition comprising about 0.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and about 92% to about 99.8% w/w silicified microcrystalline cellulose. 2. The composition of claim 1, wherein the pharmaceutical composition has dissolution and bioavailability characteristics such that after administration to a 70 kg human, the composition provides a plasma concentration of at least 0.05 ng/mL doxepin within a time frame of not more than about 90 minutes. 3. The composition of claim 1, further comprising about 0.1 to about 1.5% w/w colloidal silicon dioxide. 4. The composition of claim 1, further comprising about 0.25 to about 1.5% w/w magnesium stearate. 5. The composition of claim 1, wherein the composition comprises about 0.8 to about 2 mg of doxepin or a pharmaceutically acceptable salt thereof. 6. The composition of claim 1, wherein the composition comprises about 2.5 to about 4 mg of doxepin or a pharmaceutically acceptable salt thereof. 7. The composition of claim 1, wherein the composition comprises about 3 mg of doxepin or a pharmaceutically acceptable salt thereof. 8. The composition of claim 1, wherein the composition comprises about 5.5 to about 7 mg of doxepin or a pharmaceutically acceptable salt thereof. 9. The composition of claim 1, wherein the composition comprises about 6 mg of doxepin or a pharmaceutically acceptable salt thereof. 10. The composition of claim 1, wherein the composition comprises about 94% to about 98.5% w/w silicified microcrystalline cellulose. 11. A pharmaceutical composition comprising about 0.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and about 92% to about 99.8% w/w silicified microcrystalline cellulose, wherein the pharmaceutical composition has dissolution and bioavailability characteristics such that after administration to a 70 kg human, the composition provides a plasma concentration of at least 0.1 ng/mL doxepin within a time frame of not more than about 60 minutes. 12. The composition of claim 11, wherein the time frame to provide a plasma concentration of at least 0.1 ng/mL is not more than about 50 minutes. 13. The composition of claim 11, further comprising about 0.1 to about 1.5% w/w colloidal silicon dioxide. 14. The composition of claim 11, further comprising about 0.25 to about 1.5% w/w magnesium stearate. 15. The composition of claim 11, wherein the composition comprises about 2.5 to about 4 mg of doxepin or a pharmaceutically acceptable salt thereof. 16. The composition of claim 11, wherein the composition comprises about 3 mg of doxepin or a pharmaceutically acceptable salt thereof. 17. The composition of claim 11, wherein the composition comprises about 5.5 to about 7 mg of doxepin or a pharmaceutically acceptable salt thereof. 18. The composition of claim 11, wherein the composition comprises about 6 mg of doxepin or a pharmaceutically acceptable salt thereof. 19. The composition of claim 11, wherein the composition comprises about 94% to about 98.5% w/w silicified microcrystalline cellulose. 20. A pharmaceutical composition comprising about 2.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and about 94% to about 98.5% w/w silicified microcrystalline cellulose, wherein the pharmaceutical composition has dissolution and bioavailability characteristics such that after administration to a 70 kg human, the composition provides a plasma concentration of at least 0.1 ng/mL doxepin within a time frame of not more than about 60 minutes.