Claims for Patent: 11,324,751

Summary for Patent: 11,324,751

Title:	Dosing regimens associated with extended release paliperidone injectable formulations
Abstract:	The present invention provides a method of treating patients with long acting injectable paliperidone palmitate formulations.
Inventor(s):	Gopal; Srihari (Belle Mead, NJ), Venkatasubramanian; Raja (Newtown, PA), T'Jollyn; Huybrecht (Ghent, BE)
Assignee:	Janssen Pharmaceutica NV (Beerse, BE)
Application Number:	17/314,281
Patent Claims:	1. A method for administering paliperidone palmitate to a patient in need of treatment for psychosis, schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar disorder who has been administered a first dose of a six-month paliperidone palmitate extended-release injectable suspension (PP6M), comprising administering a second dose of the PP6M to a deltoid or gluteal muscle of the patient within a dosing window of a dosing regimen for the PP6M that is up to two weeks before or three weeks after a time that is six months after administration of the first dose such that the patient has not missed a dose based on the regimen, wherein there is no intervening dose of paliperidone palmitate between the first dose and the second dose; wherein the first dose and the second dose each comprise about 1092 mg paliperidone palmitate; and wherein the PP6M comprises about 280 mg/mL to about 350 mg/mL of the paliperidone palmitate. 2. The method of claim 1, wherein the patient has a steady state paliperidone plasma concentration at the time of the first dose. 3. The method of claim 1, wherein the patient is in need of treatment for schizophrenia. 4. The method of claim 3, wherein the first and second dose of PP6M are administered to a gluteal muscle of the patient. 5. The method of claim 4, wherein the PP6M further comprises: about 8 mg/mL to about 12 mg/mL of a wetting agent; one or more buffering agents; about 65 mg/mL to about 85 mg/mL of a suspending agent; and water q.s. ad 100%. 6. The method of claim 5, wherein the PP6M is from about pH 6.0 to about pH 8.0. 7. The method of claim 5, wherein the one or more buffering agents comprise citric acid monohydrate, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, or sodium hydroxide. 8. The method of claim 5, wherein the PP6M comprises: about 312 mg/mL of paliperidone palmitate; about 10 mg/mL of the wetting agent, wherein the wetting agent is polysorbate 20; and about 75 mg/mL of the suspending agent, wherein the suspending agent is polyethylene glycol 4000. 9. The method of claim 4, wherein the PP6M comprises about 312 mg/mL of paliperidone palmitate. 10. A method for administering paliperidone palmitate to a patient in need of treatment for psychosis, schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar disorder who has been administered a first dose of a six-month paliperidone palmitate extended-release injectable suspension (PP6M), comprising administering a second dose of the PP6M to a deltoid or gluteal muscle of the patient within a dosing window of a dosing regimen for the PP6M that is up to two weeks before or three weeks after a time that is six months after administration of the first dose such that the patient has not missed a dose based on the regimen, wherein there is no intervening dose of paliperidone palmitate between the first dose and the second dose; wherein the first dose and the second dose each comprise about 1560 mg paliperidone palmitate; and wherein the PP6M comprises about 280 mg/mL to about 350 mg/mL of the paliperidone palmitate. 11. The method of claim 10, wherein the patient is in need of treatment for schizophrenia. 12. The method of claim 11, wherein the first and second dose of PP6M are administered to a gluteal muscle of the patient. 13. The method of claim 12, wherein the PP6M comprises about 312 mg/mL of paliperidone palmitate. 14. The method of claim 12, wherein the PP6M further comprises: about 8 mg/mL to about 12 mg/mL of a wetting agent; one or more buffering agents; about 65 mg/mL to about 85 mg/mL of a suspending agent; and water q.s. ad 100%. 15. The method of claim 14, wherein the PP6M is from about pH 6.0 to about pH 8.0. 16. The method of claim 14, wherein the one or more buffering agents comprise citric acid monohydrate, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, or sodium hydroxide. 17. The method of claim 14, wherein the PP6M comprises: about 312 mg/mL of paliperidone palmitate; about 10 mg/mL of the wetting agent, wherein the wetting agent is polysorbate 20; and about 75 mg/mL of the suspending agent, wherein the suspending agent is polyethylene glycol 4000. 18. The method of claim 10, wherein the patient has a steady state paliperidone plasma concentration at the time of the first dose.