Claims for Patent: 10,849,891

Summary for Patent: 10,849,891

Title:	Formulations of pimavanserin
Abstract:	Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Inventor(s):	Tejwani; Ravi (Monmouth Junction, NJ), Abele; Stephen Edward (White Plains, NY), Vizzotti; Emanuel Joseph (Millburn, NJ)
Assignee:	ACADIA Pharmaceuticals Inc. (San Diego, CA)
Application Number:	16/836,086
Patent Claims:	1. A pharmaceutically acceptable capsule for orally delivering 34 mg of pimavanserin to a patient, wherein the capsule has a size 3 or 4 capsule shell that contains a blended pimavanserin composition comprising: 40 mg granulated pimavanserin tartrate wherein the bulk density of the granulated pimavanserin tartrate is >0.4 g/ml as determined by USP<616>, method 1; and an excipient. 2. The pharmaceutically acceptable capsule of claim 1, wherein the excipient is selected from the group consisting of a cellulose, a polysaccharide, and polyvinylpyrrolidone. 3. The pharmaceutically acceptable capsule of claim 1, wherein the excipient is selected from the group consisting of microcrystalline cellulose, silicified microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxymethyl cellulose, and a lactose cellulose blend. 4. The pharmaceutically acceptable capsule of claim 1, wherein the excipient is selected from the group consisting of sucrose, mannitol, sorbitol, pregelatinized starch, and partially pregelatinized starch. 5. The pharmaceutically acceptable capsule of claim 1, wherein the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide, and talc. 6. The pharmaceutically acceptable capsule of claim 3, wherein the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide, and talc. 7. The pharmaceutically acceptable capsule of claim 1, wherein the blended pimavanserin composition has a D90 particle size distribution of 60-450 .mu.m as measured using laser scattering particle size analysis. 8. A pharmaceutically acceptable capsule for orally delivering 5-34 mg of pimavanserin to a patient, wherein the capsule contains a blended pimavanserin composition comprising: granulated pimavanserin or a pharmaceutically acceptable salt thereof, wherein the bulk density of the granulated pimavanserin or pharmaceutically acceptable salt thereof is 0.4 g/ml to 0.6 g/ml as determined by USP<616>, method 1; a filler and optionally a lubricant. 9. The pharmaceutically acceptable capsule of claim 8, wherein the capsule has a size 3 capsule shell. 10. The pharmaceutically acceptable capsule of claim 8, wherein the capsule has a size 4 capsule shell. 11. The pharmaceutically acceptable capsule of claim 8, wherein the blended pimavanserin composition has a D90 particle size distribution of 60-450 .mu.m as measured using laser scattering particle size analysis. 12. The pharmaceutically acceptable capsule of claim 8, wherein the pharmaceutically acceptable salt is selected from the group consisting of tartrate, hemi-tartrate, citrate, fumarate, maleate, malate, phosphate, succinate, sulphate, and edisylate salt. 13. The pharmaceutically acceptable capsule of claim 8, wherein the granulated pimavanserin is formed by wet granulating native pimavanserin with water, and without the addition of a binder. 14. A method of treating hallucinations and delusions associated with Parkinson's disease psychosis, comprising administering to a patient in need thereof the pharmaceutically acceptable capsule of claim 1. 15. A method of treating a neurogenerative disease, comprising administering to a patient in need thereof the pharmaceutically acceptable capsule of claim 1.