DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE PALIPERIDONE ESTERS
First Claim
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1. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising(1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
- (2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
(3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 34th to about the 38th day of treatment.
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Abstract
The present invention provides a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations.
58 Citations
34 Claims
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1. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising
(1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and (3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 34th to about the 38th day of treatment. - View Dependent Claims (2, 3)
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4. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising
(a) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 100 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the eighth day of treatment; and (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 36th day of treatment. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 23, 24, 25)
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17. A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment comprising
(a) administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 75 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 34th to about the 38th day of treatment. - View Dependent Claims (18, 19)
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20. A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment comprising
(a) administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the eighth day of treatment; and (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 50 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 36th day of treatment. - View Dependent Claims (21, 22)
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26. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising
(a) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a maintenance dose of from about 25 mg-eq. to about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 100 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 34th to about the 38th day of treatment. - View Dependent Claims (27, 28)
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29. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising
(a) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; -
(b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a maintenance dose of from about 25 mg-eq. to about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the eighth day of treatment; and (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 100 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 36th day of treatment. - View Dependent Claims (30, 31, 32, 33, 34)
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Specification