US 11,813,359 B2
Sustained release olanzapine formulations
Carine Claassen-Punt, Leiden (NL); Mark Alan Smith, Elkton, MD (US); Ling Chen, Exton, PA (US); and Ari Andrew Gershon, Petach Tikva (IL)
Assigned to Teva Pharmaceuticals International GMBH, Jona (CH)
Filed by Teva Pharmaceuticals International GMBH, Jona (CH)
Filed on May 11, 2020, as Appl. No. 16/871,339.
Application 16/871,339 is a continuation of application No. 15/926,076, filed on Mar. 20, 2018, granted, now 10,646,443.
Claims priority of provisional application 62/473,608, filed on Mar. 20, 2017.
Prior Publication US 2021/0046007 A1, Feb. 18, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/16 (2006.01); A61P 25/18 (2006.01); A61K 31/551 (2006.01); A61K 31/5513 (2006.01); A61K 47/34 (2017.01); A61K 9/14 (2006.01); A61K 9/00 (2006.01)
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).