US 11,992,468 B2Granted

Abuse-deterrent dosage forms containing esketamine

AssigneeClexio Biosciences Ltd.

InventorsDerek Moe, Randal Seburg, Sagar Rane

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Abstract

Disclosed herein are immediate release oral dosage forms that contain abuse-deterrent and abuse-resistant features. In particular, the disclosed dosage forms can provide deterrence of abuse by ingestion of multiple individual doses. The disclosed dosage forms can likewise provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses. The dosage forms may also exhibit abuse resistant properties when physically manipulated, and also when physically manipulated and then administered in a manner not consistent with oral dosing. The dosage forms may also exhibit abuse resistant properties when administered in a manner intended to result in administration of the esketamine in a higher than therapeutic dose.

Claims8

Dependent claims

A method of manufacturing an immediate release tablet determined to have no more than about 5 wt. % of 2-(2-chlorophenyl)-2-(methylamino)-6-methylidenecyclohexan-1-one comprising

preparing an immediate release tablet comprising between 20 mg and 100 mg of esketamine;
exposing the tablet to a storage period of six months;
after the storage period, measuring by HPLC for the area under a peak corresponding to 2-(2-chlorophenyl)-2-(methylamino)-6-methylidenecyclohexan-1-one present in the tablet;
and,
determining by HPLC that the total amount of 2-(2-chlorophenyl)-2-(methylamino)-6-methylidenecyclohexan-1-one present in the tablet is no more than about 5 wt %;
wherein the peak corresponding to 2-(2-chlorophenyl)-2-(methylamino)-6-methylidenecyclohexan-1-one appears at a relative retention time of about 1.3 minutes when using a C18, 100×3.0 mm, 3.51 μm HPLC column at a temperature of 45° C. and a sample temperature of 4° C., with a mobile phase comprising 0.050% TFA in water and 0.0025% TFA in acetonitrile and UV detection rate of 215 nm.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 18/184,270Filed 15 Mar 2023 · continuation
Priority: 7 May 2019
Published: US 2023/0301941 A128 Sep 2023
Granted: 28 May 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification15 codes

A61K 31/135
Amines: having aromatic rings , e.g. ketamine, nortriptyline
A61K 9/2009
Excipients; Inactive ingredients: inorganic compounds
A61K 9/2013
Excipients; Inactive ingredients: organic compounds, e.g. phospholipids, fats
A61K 9/2018
Organic compounds, e.g. phospholipids, fats: sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates

Family

Application62/844,286Us provisional application · filed 7 May 2019
Application16/869,309Parent of this continuation-in-part · filed 7 May 2020
Application17/523,193Parent of this continuation · filed 10 Nov 2021
US 11,324,707 B2Parent of this continuation-in-part · filed 10 May 2022
US 2023/0301941 A1Pre-grant publication · published 28 Sep 2023
Application17/523,193Parent of this continuation-in-part
US 12,589,083 B2Related patent
US 2020/0352881 A1Published application
US 2022/0062200 A1Published application
US 11,992,468 B2This patent

From the US filing history. Foreign family members aren’t listed.

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