Claims for Patent: 12,138,264

Summary for Patent: 12,138,264

Title:	Pharmaceutical compositions
Abstract:	The present Invention relates to pharmaceutical compositions of (3S, 11aR)-N-[(2,4-difluorophenyl)methyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.
Inventor(s):	Deepak B. Mundhra, Rennan Pan
Assignee:	ViiV Healthcare Co
Application Number:	US18/679,621
Patent Claims:	1. A parenteral pharmaceutical suspension comprising 0.1-50% by weight a compound of formula (I) or a pharmaceutically acceptable salt thereof, 0.1-10% by weight polysorbate, 0.1-10% by weight polyethylene glycol 3350, 4000 or 8000, mannitol, and water, wherein the suspension has mean particle size of 0.1-1 μm, and wherein the suspension has been sterilized by gamma irradiation. 2. The pharmaceutical suspension according to claim 1 for intramuscular administration. 3. The pharmaceutical suspension according to claim 1 for once per month administration. 4. The pharmaceutical suspension according to claim 1 for administration once every two months. 5. The pharmaceutical suspension according to claim 1 for administration at any interval between 30 and 365 days. 6. The pharmaceutical suspension according to claim 2 for once per month administration. 7. The pharmaceutical suspension according to claim 2 for administration once every two months. 8. The pharmaceutical suspension according to claim 2 for administration at any interval between 30 and 365 days. 9. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 1. 10. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 2. 11. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 6. 12. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 7. 13. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 8. 14. The pharmaceutical suspension according to claim 1, wherein the polysorbate is Polysorbate 20 at a quantity of about 20 mg/mL, and the polyethylene glycol is PEG 3350 at a quantity of 20 mg/mL. 15. The pharmaceutical suspension according to claim 2, wherein the polysorbate is Polysorbate 20 at a quantity of about 20 mg/mL, and the polyethylene glycol is PEG 3350 at a quantity of 20 mg/mL. 16. The pharmaceutical suspension according to claim 6, wherein the polysorbate is Polysorbate 20 at a quantity of about 20 mg/mL, and the polyethylene glycol is PEG 3350 at a quantity of 20 mg/mL. 17. The pharmaceutical suspension according to claim 7, wherein the polysorbate is Polysorbate 20 at a quantity of about 20 mg/mL, and the polyethylene glycol is PEG 3350 at a quantity of 20 mg/mL. 18. The pharmaceutical suspension according to claim 8, wherein the polysorbate is Polysorbate 20 at a quantity of about 20 mg/mL, and the polyethylene glycol is PEG 3350 at a quantity of 20 mg/mL. 19. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 15. 20. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 16. 21. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 17. 22. The pharmaceutical suspension according to claim 1, wherein the pharmaceutical suspension comprises 200 mg/mL compound of formula (I), 20 mg/mL polysorbate 20, and 20 mg/mL PEG 3350. 23. The pharmaceutical suspension according to claim 2, wherein the pharmaceutical suspension comprises 200 mg/mL compound of formula (I), 20 mg/mL polysorbate 20, and 20 mg/mL PEG 3350. 24. The pharmaceutical suspension according to claim 6, wherein the pharmaceutical suspension comprises 200 mg/mL compound of formula (I), 20 mg/mL polysorbate 20, and 20 mg/mL PEG 3350. 25. The pharmaceutical suspension according to claim 7, wherein the pharmaceutical suspension comprises 200 mg/mL compound of formula (I), 20 mg/mL polysorbate 20, and 20 mg/mL PEG 3350. 26. The pharmaceutical suspension according to claim 8, wherein the pharmaceutical suspension comprises 200 mg/mL compound of formula (I), 20 mg/mL polysorbate 20, and 20 mg/mL PEG 3350. 27. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 23. 28. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 24. 29. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 25. 30. A method for the treatment of an HIV infection in a human comprising administering the pharmaceutical suspension according to claim 26.