Formulations of pimavanserin
DCFirst Claim
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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 encapsulates a blended pimavanserin composition comprising:
- 40 mg granulated pimavanserin tartrate wherein the bulk density of the granulated pimavanserin tartrate is 0.4 to 0.6 g/ml as determined by USP<
616>
, method 1;
microcrystalline cellulose having a particle size distribution (D90) of 180 to 340 μ
m;
wherein the particle size distribution is measured using laser light scattering with a Malvern Mastersizer 2000 LLS PS system, a Scirocco 2000 dry dispersion unit and a sample size of 10 g.
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Abstract
Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
130 Citations
20 Claims
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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 encapsulates a blended pimavanserin composition comprising:
-
40 mg granulated pimavanserin tartrate wherein the bulk density of the granulated pimavanserin tartrate is 0.4 to 0.6 g/ml as determined by USP<
616>
, method 1;microcrystalline cellulose having a particle size distribution (D90) of 180 to 340 μ
m;
wherein the particle size distribution is measured using laser light scattering with a Malvern Mastersizer 2000 LLS PS system, a Scirocco 2000 dry dispersion unit and a sample size of 10 g. - View Dependent Claims (2, 3, 4, 10)
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5. 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:
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40 mg granulated pimavanserin tartrate wherein the bulk density of the granulated pimavanserin tartrate is 0.4 to 0.6 g/ml as determined by USP<
616>
, method 1; and57-60% w/w microcrystalline cellulose. - View Dependent Claims (6, 7, 8, 9, 11)
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12. 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 to 0.6 g/ml as determined by USP<
616>
, method 1;
a filler and a lubricant, whereinthe D90 particle size distribution of the blended pimavanserin composition is 100 to 300 μ
m as measured using laser scattering particle size analysis. - View Dependent Claims (13)
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14. 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 of 0.4 g/ml to 0.6 g/ml as determined by USP<
616>
, method 1;
a filler and optionally a lubricant.- View Dependent Claims (15, 16, 17, 18, 19, 20)
Specification