Claims for Patent: 11,090,291

Summary for Patent: 11,090,291

Title:	Opioid receptor modulator dosage formulations
Abstract:	Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.
Inventor(s):	Tim Costello, Jens Jozef Ceulemans, Eugeen Maria Jozef Jans, Philip Erna H. Heyns
Assignee:	Allergan Holdings ULC
Application Number:	US17/175,082
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,090,291
Patent Claims:	1. An abuse-deterrent, mono-phasic pharmaceutical tablet comprising: about 75 mg of 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, about 60-80% by weight filler; about 2-8% by weight disintegrant; about 10% by weight mannitol; and optionally, a glidant and/or lubricant. 2. The tablet of claim 1, comprising about 65-75% by weight filler, and about 10% by weight mannitol. 3. The tablet of claim 2, further comprising a glidant. 4. The tablet of claim 3, wherein the glidant is colloidal silica. 5. The tablet of claim 4, wherein the colloidal silica is present in an amount of about 0.55-0.95% by weight. 6. The tablet of claim 2, further comprising a lubricant, wherein the lubricant is magnesium stearate. 7. The tablet of claim 6, wherein the magnesium stearate is present in an amount of about 0.45-1.0% by weight. 8. The tablet of claim 3, further comprising a lubricant, wherein the lubricant is magnesium stearate. 9. The tablet of claim 8, wherein the magnesium stearate is present in an amount of about 0.45-1.0% by weight. 10. The tablet of claim 1, wherein the disintegrant is crospovidone. 11. An abuse-deterrent, mono-phasic pharmaceutical tablet comprising: about 75 mg of 5-({[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid; about 390 mg 450 mg filler; about 12 mg 48 mg disintegrant; about 60 mg of mannitol; colloidal silica; and magnesium stearate. 12. The tablet of claim 11, wherein the filler is silicified microcrystalline cellulose, and the disintegrant is crospovidone. 13. An abuse-deterrent, mono-phasic pharmaceutical tablet comprising: about 100 mg of 5-({[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, about 60-80% by weight filler; about 2-8% by weight disintegrant; about 10% by weight mannitol; and optionally, a glidant and/or lubricant. 14. The tablet of claim 13, comprising about 65-75% by weight filler, and about 10% by weight mannitol. 15. The tablet of claim 14, further comprising a glidant. 16. The tablet of claim 15, wherein the glidant is colloidal silica. 17. The tablet of claim 16, wherein the colloidal silica is present in an amount of about 0.55-0.95% by weight. 18. The tablet of claim 14, further comprising a lubricant, wherein the lubricant is magnesium stearate. 19. The tablet of claim 18, wherein the magnesium stearate is present in an amount of about 0.45-1.0% by weight. 20. The tablet of claim 15, further comprising a lubricant, wherein the lubricant is magnesium stearate. 21. The tablet of claim 20, wherein the magnesium stearate is present in an amount of about 0.45-1.0% by weight. 22. The tablet of claim 13, wherein the disintegrant is crospovidone. 23. An abuse-deterrent, mono-phasic pharmaceutical tablet comprising: about 100 mg of 5-({[(2s)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid; about 520 mg-600 mg of filler; about 16 mg-64 mg of disintegrant; about 80 mg of mannitol; colloidal silica; and magnesium stearate. 24. The tablet of claim 23, wherein the filler is silicified microcrystalline cellulose, and the disintegrant is crospovidone.