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Last Updated: December 25, 2024

Claims for Patent: 11,224,597

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Summary for Patent: 11,224,597

Title:	Pharmaceutical compositions
Abstract:	The present Invention relates to pharmaceutical compositions of (3S,11aR)--N-[(2,4-difluorophenyhmethyl]-2,3,5,7,11,11a-hexahydro-6-hydro- xy-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):	Mundhra; Deepak B. (Collegeville, PA), Pan; Rennan (King of Prussia, PA)
Assignee:	ViiV Healthcare Company (Research Triangle Park, NC)
Application Number:	15/292,394
Patent Claims:	1. A parenteral pharmaceutical suspension comprising 0.1-50% by weight a compound of formula (I) ##STR00002## 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 0.1-0.5 pin, and wherein the suspension has been sterilized by gamma irradiation. 2. A pharmaceutical suspension according to claim 1 for subcutaneous administration. 3. A pharmaceutical suspension according to claim 1 for intramuscular administration. 4. A pharmaceutical suspension according to claim 1 for once per month administration. 5. A pharmaceutical suspension according to claim 1 for administration once every two months. 6. A pharmaceutical suspension according to claim 1 for administration once every three months. 7. A pharmaceutical suspension according to claim 1 for administration at any interval between 30 and 365 days. 8. A method for the treatment of an HIV infection in a human comprising administering a pharmaceutical suspension according to claim 1. 9. A 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. 10. A pharmaceutical suspension according to claim 1, wherein the suspension has mean particle size of 200 nm to 0.5 .mu.m. 11. A pharmaceutical suspension according to claim 1 wherein polyethylene glycol is polyethylene glycol 3350. 12. A pharmaceutical suspension according to claim 1, wherein the composition comprises 200 mg/mL compound of formula (I), 45 mg/mL mannitol, 20 mg/mL polysorbate 20, 20 mg/mL PEG 3350, and QS to 1 mL water.

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