# US 11,897,858 B2 · Salt and solid state forms of escatalopram

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- Number: US 11,897,858 B2
- Document ID: US11897858B2
- Status: Granted
- Kind: B2
- Application number: 17/866,513
- Filed: 2022-07-17
- Published: 2022-11-17
- Granted: 2024-02-13
- Earliest claimed: 2017-10-09
- Assignees: Mark Hasleton
- Applicants: Mark Hasleton
- Inventors: Anton Frenkel; Raeann Ruiyun
- Web page: https://patentgrep.com/patent/US11897858B2

## CPC

- C07D 307/87: Benzo [c] furans; Hydrogenated benzo [c] furans
- A61P 25/24: Antidepressants
- C07B 2200/13: Crystalline forms, e.g. polymorphs
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07B: GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR (preparation of carboxylic acid esters by telomerisation C07C67/47; telomerisation C08F)

## Abstract

The present disclosure relates to a new salt of escitalopram and its solid state forms, processes for the preparation thereof, pharmaceutical compositions thereof, and methods of use thereof.

## Claims

### Claim 1

A method of treating a neuropsychiatric disorder comprising parenterally administering to a subject in need thereof a therapeutically effective amount of escitalopram gentisate.

### Claim 2 (depends on 1)

The method of claim 1, wherein the neuropsychiatric disorder comprises Major Depressive Disorder (MDD).

### Claim 3 (depends on 1)

The method of claim 1, wherein the neuropsychiatric disorder comprises Generalized Anxiety Disorder (GAD).

### Claim 4 (depends on 1)

The method of claim 1, wherein the parenteral administration is by injection.

### Claim 5 (depends on 4)

The method of claim 4, wherein the parenteral administration is by cutaneous, subcutaneous, intramuscular or intravenous injection.

### Claim 6 (depends on 5)

The method of claim 5, wherein the parenteral administration is by subcutaneous injection.

### Claim 7 (depends on 1)

The method of claim 1, wherein the escitalopram gentisate is crystalline.

### Claim 8 (depends on 7)

The method of claim 7, wherein the escitalopram gentisate is characterized by data selected from one or more of the following: an XRPD pattern having peaks at 12.9; 16.8; 18.3; 19.9; and 21.1 degrees 2-theta±0.2 degrees 2-theta; an XRPD pattern substantially as depicted in FIG. 1 and/or FIG. 3; or combinations of thereof.

### Claim 9 (depends on 8)

The method of claim 8, wherein the escitalopram gentisate is further characterized by an XRPD pattern having at least one of the following peaks: 9.2, 10.9, 15.9, 21.6, and 21.9 degrees two theta±0.2 degrees two theta.

### Claim 10 (depends on 7)

The method of claim 7, wherein the escitalopram gentisate is characterized by data selected from one or more of the following: an XRPD pattern having peaks at 10.0; 12.4, 17.3, 20.0, and 21.3 degrees two theta±0.2 degrees two theta; an XRPD pattern substantially as depicted in FIG. 2 and/or FIG. 4; or combinations thereof.

### Claim 11 (depends on 8)

The method of claim 8, wherein the escitalopram gentisate is further characterized by an XRPD pattern having at least one of the following peaks: 8.0, 9.5, 15.0, 16.4, and 22.2 degrees two theta±0.2 degrees two theta.

### Claim 12

A method of treating a neuropsychiatric disorder comprising parenterally administering to a subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of the escitalopram gentisate and a pharmaceutically acceptable excipient.

### Claim 13 (depends on 12)

The method of claim 12, wherein the neuropsychiatric disorder comprises Major Depressive Disorder (MDD).

### Claim 14 (depends on 12)

The method of claim 12, wherein the neuropsychiatric disorder comprises Generalized Anxiety Disorder (GAD).

### Claim 15 (depends on 12)

The method of claim 12, wherein the pharmaceutical composition is formulated for injection into a subject in need thereof.

### Claim 16 (depends on 15)

The method of claim 15, wherein the pharmaceutical composition is formulated for cutaneous, subcutaneous, intramuscular or intravenous injection into a subject in need thereof.

### Claim 17 (depends on 16)

The method of claim 16, wherein the pharmaceutical composition is formulated for subcutaneous injection into a subject in need thereof.

### Claim 18

A method of treating a neuropsychiatric disorder comprising subcutaneously administering to a subject in need thereof a therapeutically effective amount of escitalopram gentisate.

### Claim 19 (depends on 18)

The method of claim 18, wherein the neuropsychiatric disorder comprises Major Depressive Disorder (MDD).

### Claim 20 (depends on 18)

The method of claim 18, wherein the neuropsychiatric disorder comprises Generalized Anxiety Disorder (GAD).