Formulations of pimavanserin

Abstract

Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.

1 .- 72 . (canceled) 
     
     
         73 . 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 pimavanserin tartrate; and   and excipient;   
       wherein the bulk density of the blended pimavanserin composition is >0.4 g/ml as determined by USP<616>, method 1. 
     
     
         74 . The pharmaceutically acceptable capsule of  claim 73 , wherein the excipient is selected from the group consisting of a cellulose, a polysaccharide, and polyvinylpyrrolidone. 
     
     
         75 . The pharmaceutically acceptable capsule of  claim 73 , 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. 
     
     
         76 . The pharmaceutically acceptable capsule of  claim 73 , wherein the excipient is selected from the group consisting of sucrose, mannitol, sorbitol, pregelatinized starch, and partially pregelatinized starch. 
     
     
         77 . The pharmaceutically acceptable capsule of  claim 73 , wherein the excipient is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide, and talc. 
     
     
         78 . The pharmaceutically acceptable capsule of  claim 73 , wherein the excipient is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide, and talc. 
     
     
         79 . The pharmaceutically acceptable capsule of  claim 73 , wherein the blended pimavanserin composition has a D90 particle size distribution of 60-450 μm as measured using laser scattering particle size analysis. 
     
     
         80 . A pharmaceutically acceptable capsule for orally delivering 5-34 mg of pimavanserin to a patient, wherein the capsule contains a blended pimavanserin composition comprising:
 pimavanserin or a pharmaceutically acceptable salt thereof;   a filler; and   optionally a lubricant;   wherein the bulk density of the blended pimavanserin composition is 0.4 g/ml to 0.6 g/ml as determined by USP<616>, method 1.   
     
     
         81 . The pharmaceutically acceptable capsule of  claim 80 , wherein the capsule has a size 3 capsule shell. 
     
     
         82 . The pharmaceutically acceptable capsule of  claim 80 , wherein the capsule has a size 4 capsule shell. 
     
     
         83 . The pharmaceutically acceptable capsule of  claim 80 , wherein the blended pimavanserin composition has a D90 particle size distribution of 60-450 μm as measured using laser scattering particle size analysis. 
     
     
         84 . The pharmaceutically acceptable capsule of  claim 80 , 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. 
     
     
         85 . The pharmaceutically acceptable capsule of  claim 80 , wherein the pimavanserin is granulated pimavanserin formed by wet granulating native pimavanserin with water, and without the addition of a binder. 
     
     
         86 . A pharmaceutically acceptable capsule for orally delivering 34 mg of pimavanserin to a patient, wherein the capsule has a capsule shell with a capsule shell size 3 or 4, that encapsulates a blended pimavanserin composition comprising:
 40 mg pimavanserin tartrate;   
       wherein the bulk density of the blended composition is >0.4 g/ml as determined by USP<616>, method 1. 
     
     
         87 . The pharmaceutically acceptable capsule of  claim 86 , wherein the capsule shell is a hard shell size 4 capsule. 
     
     
         88 . 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 73 . 
     
     
         89 . A method of treating a neurogenerative disease, comprising administering to a patient in need thereof the pharmaceutically acceptable capsule of  claim 73 .