Dry powder ketamine composition for use in the treatment of depression by pulmonary administration

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.

Description

TECHNICAL FIELD[0001]The present invention relates to a composition comprising ketamine, in particular dry powder formulation for use in a method of treatment of depression by pulmonary administration.PRIOR ART[0002]Depression, especially major depressive disorder, bipolar disorder and treatment-resistant depression (TRD) is a serious problem in a modern society. Many treatment options have been developed for treating depression, including monotherapy or combination therapy in a convenient for patients oral administration regimen. However, there is a relatively high percentage of patients that are treatment-refractory or partially or totally treatment-resistant to existing antidepressants. In practice, at present the only real choice in such severe cases can be electroshocks.[0003]Ketamine is a known anesthetic and analgetic, used for anesthesia and in the treatment of chronic pain. Ketamine is a chiral compound and can exist as a racemate and as S-enantiomer (known as esketamine) o...

AI Technical Summary

Benefits of technology

The patent describes a new treatment for depression using a dry powder pharmaceutical formulation of ketamine or its acceptable salt. The medication is administered through the lungs, which allows for faster absorption and reduces the risk of side effects. The patent includes data showing the composition of the ketamine powder and its effectiveness in treating depression. Overall, the invention provides a safer and more effective method for treating depression.

Problems solved by technology

Depression, especially major depressive disorder, bipolar disorder and treatment-resistant depression (TRD) is a serious problem in a modern society.

However, there is a relatively high percentage of patients that are treatment-refractory or partially or totally treatment-resistant to existing antidepressants.

The knowledge of the pharmacology of ketamine is still poor.

Dissociative and psychomimetic effects are among most often observed side-effects and significantly lower the comfort of patients.

The knowledge about norketamine and further metabolites is still not full.

Furthermore, little is known about toxicity of norketamine and other metabolites.

This, in combination with high individual variations of their concentrations dependent on the status of hepatic enzymes, as a rule makes them undesired compounds.

Attempts of oral administration were generally unsuccessful or the effects were observed only after several weeks of administration.

However, after oral administration the drug rapidly undergoes metabolism to norketamine.

16-20%); while intravenous administration results in marked increase in ketamine bioavailability, it has also many disadvantages (e.g. long-time of infusion, patient discomfort, need for surveillance).

However, with intranasal administration ketamine to oropharyngeal area significant amounts of ketamine will be swallowed by a patient by oral route and can undergo systemic metabolism to norketamine to cause undesired side effects.

Because of this the administration via nebulization will be imprecise and non-reliable.

Images