Granted Patent
B2
US 12,440,440 · App. 18/965,257 · Granted Oct 14, 2025
Dry powder esketamine composition for use in the treatment of bipolar depression by pulmonary administration
Inventors:
Maciej Wieczorek (Kielpin, PL); Ewa Tratkiewicz (Warsaw, PL); Przemyslaw Perko (Warsaw, PL)
Assignee:
Novohale Therapeutics, LLC
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Abstract
A dry powder inhalable pharmaceutical composition comprising ketamine or its pharmaceutically acceptable salt for use in a method of treatment of depression by administration via pulmonary route. The composition is especially useful for the treatment of treatment-resistant or treatment-refractory depression.
Claims (21)
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.
2. The oral inhaler of claim 1 , wherein the esketamine, or pharmaceutically acceptable salt thereof, is esketamine hydrochloride.
3. The oral inhaler of claim 1 , wherein the dry powder composition is disposed within a blister cavity.
4. The oral inhaler of claim 1 , wherein the dry powder composition comprises from about 10% to about 35% by weight esketamine or the pharmaceutically acceptable salt thereof.
5. The oral inhaler of claim 1 , wherein the dry powder composition comprises from about 15% to about 30% by weight esketamine or the pharmaceutically acceptable salt thereof.
6. The oral inhaler of claim 5 , wherein the dry powder composition comprises about 17%, about 20%, about 25%, or about 29% by weight esketamine or the pharmaceutically acceptable salt thereof.
7. The oral inhaler of claim 6 , wherein the nominal unit dose of esketamine, or pharmaceutically acceptable salt thereof, is 4.6 mg of esketamine hydrochloride, wherein the dry powder comprises about 20% by weight esketamine hydrochloride.
8. The oral inhaler of claim 1 , wherein the esketamine, or pharmaceutically acceptable salt thereof, is esketamine hydrochloride, wherein the dry powder comprises about 1.6% by weight magnesium stearate.
9. An oral inhaler comprising:
a dry powder composition comprising:
a nominal unit dose of 4.6 mg of esketamine hydrochloride, wherein the dry powder comprises about 20% by weight esketamine hydrochloride;
about 30-79.8% by weight of lactose monohydrate; and
0.2-3% by weight of magnesium stearate; and
wherein the esketamine hydrochloride has a median particle diameter d50 of 1-10 μm, as measured by laser diffraction.
10. The oral inhaler of claim 9 , wherein the dry powder composition is disposed within a blister cavity.
11. The oral inhaler of claim 9 , wherein the dry powder comprises about 1.6% by weight magnesium stearate.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 5, 2025
From: WIECZOREK, MACIEJ; TRATKIEWICZ, EWA; PERKO, PRZEMYSLAW
To: CELON PHARMA S.A.
Reel/Frame 072176/0804 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 5, 2025
From: CELON PHARMA S.A.
To: NOVOHALE THERAPEUTICS, LLC
Reel/Frame 072176/0819 →
Priority Claims (1)
EP 17461651
· Dec 29, 2017
· regional
Continuity (2)
Continuation
16958965
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