US 12,440,440 B2
Dry powder esketamine composition for use in the treatment of bipolar depression by pulmonary administration
Maciej Wieczorek, Kielpin (PL); Ewa Tratkiewicz, Warsaw (PL); and Przemyslaw Perko, Warsaw (PL)
Assigned to Novohale Therapeutics, LLC, San Diego, CA (US)
Filed by Novohale Therapeutics, LLC, San Diego, CA (US)
Filed on Dec. 2, 2024, as Appl. No. 18/965,257.
Application 18/965,257 is a continuation of application No. 16/958,965, abandoned, previously published as PCT/EP2018/076394, filed on Sep. 28, 2018.
Claims priority of application No. 17461651 (EP), filed on Dec. 29, 2017.
Prior Publication US 2025/0090457 A1, Mar. 20, 2025
Int. Cl. A61K 9/00 (2006.01); A61K 31/135 (2006.01); A61P 25/24 (2006.01)
CPC A61K 9/0075 (2013.01) [A61K 31/135 (2013.01)] 11 Claims
OG exemplary drawing
 
1. An oral inhaler comprising:
a dry powder composition comprising:
a nominal unit dose of esketamine, or a pharmaceutically acceptable salt thereof, wherein the nominal unit dose is 4 mg, calculated as free base;
30-95% by weight of lactose monohydrate; and
0.2-3% by weight of magnesium stearate;
wherein the esketamine, or a pharmaceutically acceptable salt thereof has a median particle diameter d50 of 1-10 μm, as measured by laser diffraction.