CPC A61K 9/146 (2013.01) [A61K 9/0019 (2013.01); A61K 9/1647 (2013.01); A61K 31/551 (2013.01); A61K 31/5513 (2013.01); A61K 47/34 (2013.01); A61P 25/18 (2018.01)] | 18 Claims |
1. A sustained-release pharmaceutical dosage form comprising between 150 mg and 900 mg of olanzapine, or a pharmaceutically acceptable salt thereof; and at least one biodegradable polymer that is a copolymer of a poly(lactide) and a polyethylene glycol, a copolymer of a poly-1-lactic acid and a polyethylene glycol, or a copolymer of a poly-d-lactic acid and a polyethylene glycol, wherein said dosage form provides a therapeutically effective dose of olanzapine for a period of at least 21 days, wherein the upper limit of a 95% Confidence Interval for the Cmax,avg is ≤100 ng/ml; for use in treating schizophrenia or bipolar disorder in a patient, wherein said treatment comprises subcutaneously administering said dosage form to the patient, with a frequency of no more than once per 21 days, and wherein said treatment is performed without monitoring for post-injection delirium/sedation syndrome (PDSS).
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