IP Library Granted Patent US 12,636,265
Granted Patent B2
US 12,636,265 · App. 17/187,641 · Granted May 26, 2026

Compositions of complexing agents

Inventors: Jeffrey Becker (Santa Barbara, CA); Gregg Peterson (Santa Barbara, CA); Jason Wallach (Philadelphia, CA)
Assignee: Bexson Biomedical, Inc.
A61K31/135A61K9/0019A61K47/40
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Quick Facts
Patent No.
US 12,636,265
App. No.
17/187,641
Granted
May 26, 2026
Kind
B2
Abstract

Provided herein are subcutaneous formulations of ketamine that are useful for treating a variety of disease and disorders. The subcutaneous ketamine formulations provided herein reduce injection site irritation and pain.

Claims (11)

1 . A pharmaceutical composition, comprising:

(i) an active pharmaceutical compound comprising a cationic ionized base; and

(ii) a complexing agent comprising a substituted cyclodextrin comprising a plurality of acidic functional groups, at least one of which acidic functional groups is a counter-anion to the cationic ionized base of the active pharmaceutical compound;

wherein a first solution consisting of (i) at a first concentration, (ii) at a second concentration, and water has a lower osmolality than a second solution consisting of (i) at the first concentration, a sodium salt of the complexing agent at the second concentration, and water, wherein the acidic functional groups of the complexing agent in the second solution are counter-anions to the sodium, thereby increasing the osmolality of the second solution relative to the first solution.

2 . A pharmaceutical composition comprising:

(i) an active pharmaceutical compound having an ionized nitrogen cation; and

(ii) a sodium salt of a substituted cyclodextrin comprising a plurality of acidic functional groups, from which sodium cations have been removed such that at least one of the plurality of acidic functional groups is a counter-anion to the ionized nitrogen cation of the active pharmaceutical compound;

wherein a first solution consisting of (i), (ii), and water has a lower osmolality than a second solution consisting of equivalent amounts of (i), (ii), and water but in which sodium cations have not been removed from (ii).

3 . An aqueous pharmaceutical composition formed by the process comprising:

removing at least one sodium of a sodium salt of a substituted cyclodextrin comprising a plurality of acidic functional groups and replacing the at least one sodium with an active pharmaceutical compound having a cationic nitrogen, the removal of the at least one sodium thereby reducing an osmolality of a first composition formed by combining the active pharmaceutical compound and the sodium salt of the substituted cyclodextrin compared to a second composition formed by combining the active pharmaceutical compound and a sodium salt of the substituted cyclodextrin in concentrations equivalent to the first composition but in which the at least one sodium has not been removed from the salt of the substituted cyclodextrin.

4 . The pharmaceutical composition of claim 3 , further comprising adding a base in a sufficient amount to neutralize the acidic functional groups of the substituted cyclodextrin.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2026
From: BEXSON BIOMEDICAL, INC.
To: PKX BIO, INC.
Reel/Frame 075811/0381 →
RELEASE OF SECURITY INTEREST Recorded Apr 21, 2026
From: STEVANATO GROUP, S.P.A.
To: BEXSON BIOMEDICAL, INC.
Reel/Frame 074432/0480 →
SECURITY INTEREST Recorded Jul 27, 2023
From: BEXSON BIOMEDICAL, INC.
To: STEVANATO GROUP, S.P.A.
Reel/Frame 064406/0164 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2021
From: BECKER, JEFFREY; PETERSON, GREGG; WALLACH, JASON
To: BEXSON BIOMEDICAL, INC.
Reel/Frame 057837/0301 →
Continuity (3)
Continuation 16874485 · May 14, 2020
Provisional Application 62848420 · May 15, 2019
Related Publication 20210186896A1 · Jun 24, 2021
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