Ketamine or dextromethorphan formulations and methods of use
Inventors
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Assignees
MemberWest Virginia UniversityWest Virginia UniversityWest Virginia University is a public R1 research institution offering diverse undergraduate and graduate programs across science, engineering, business, creative arts, and media. The university emphasizes experiential learning, research, and innovation, with notable strengths in academic program development, research excellence, community engagement, and a commitment to affordability, career readiness, and student success. WVU supports a vibrant campus environment, industry partnerships, and impactful scholarship, preparing students for careers through hands-on education, research, and applied learning.
West Virginia University is a public R1 research institution offering diverse undergraduate and graduate programs across science, engineering, business, creative arts, and media. The university emphasizes experiential learning, research, and innovation, with notable strengths in academic program development, research excellence, community engagement, and a commitment to affordability, career readiness, and student success. WVU supports a vibrant campus environment, industry partnerships, and impactful scholarship, preparing students for careers through hands-on education, research, and applied learning.
Publication Number
US-11878014-B2
Publication Date
2024-01-23
Expiration Date
Abstract
The present invention provides a method of treating depression disease in a treatment resistant patient comprising administering to a mucosal membrane of a patient an effective amount of a pharmaceutically acceptable composition comprising an effective amount of ketamine or dextromethorphan, wherein the mucosal administration of the ketamine or dextromethorphan containing composition allows for the mucosal absorption of the composition eliminating the digestive tract of the patient for effecting a rapid acting antidepressant treatment of the treatment resistant patient. This method includes administering the composition to a patient's mucosal membrane of a respiratory tract, a genitourinary tract, an oral tract, or rectal tract of the patient. A pharmaceutically acceptable composition comprising ketamine or dextromethorphan and a vehicle is disclosed. A biomarker for identifying a depressive disease is set forth.
Core Innovation
The invention relates to treating treatment-resistant depression using ketamine and/or dextromethorphan administered via a mucosal membrane route, preferably buccal or transbuccal administration. The described approach enables transmucosal absorption and aims to provide rapid antidepressant effects within about 24 hours. A key aspect is that the delivery is positioned to eliminate the digestive tract.
The invention further provides pharmaceutically acceptable compositions in which an effective amount of ketamine or dextromethorphan, or both, is distributed within a pharmaceutically acceptable vehicle capable of being placed in contact with a mucosal membrane of a patient. The vehicle is described as a device having a mucoadhesive layer and a non-adhesive backing layer, with the mucoadhesive layer buffered to a pH of between about 4.0 and 7.0 and the non-adhesive backing layer buffered to a pH of between about 4.0 and 6.0. The pH values of the mucoadhesive layer and the non-adhesive backing layer are different.
The mucoadhesive layer and the non-adhesive backing layer include different combinations of polymers, while each layer comprises at least one water-erodible polymer. The water-erodible polymer is selected from cellulosic polymer, olefinic polymer, polyether, and polyalcohol polymer classes. The invention also includes biomarkers intended to predict antidepressant responsiveness, using changes in speech parameters and corticospinal excitability.
Speech parameters include acoustic vocal parameters such as speech rate and voice frequency measured at baseline and after treatment. Corticospinal excitability is described using resting motor threshold measured at baseline and after treatment, including with transcranial magnetic stimulation.
Claims Coverage
The provided content includes one independent claim (clm-00001). This claim covers a pharmaceutically acceptable device composition for mucosal membrane contact that includes ketamine and/or dextromethorphan distributed in a vehicle with a specifically buffered mucoadhesive layer and a separately buffered non-adhesive backing layer, where both layers include water-erodible polymers selected from defined polymer classes.
Buffered mucoadhesive and non-adhesive layers for mucosal delivery
A device capable of being placed in contact with a mucosal membrane, wherein the device has a mucoadhesive layer containing ketamine buffered to a pH of between about 4.0 and 7.0 and a non-adhesive backing layer buffered to a pH of between 4.0 and 6.0, with the pH of the mucoadhesive layer and the pH of the non-adhesive backing layer being different.
Water-erodible polymer selection across device layers
The mucoadhesive layer and the non-adhesive backing layer comprise different combinations of polymers but each of the mucoadhesive layer and the non-adhesive backing layer comprises at least one water-erodible polymer selected from the group consisting of a cellulosic polymer, an olefinic polymer, a polyether, and a polyalcohol.
Ketamine or dextromethorphan composition distributed within mucosal-contact vehicle
A pharmaceutically acceptable composition comprising an effective amount of ketamine or dextromethorphan, or both, distributed within a pharmaceutically acceptable vehicle capable of being placed in contact with a mucosal membrane of a patient.
Across the independent claim, the inventive coverage is centered on a mucosal-contact device composition that distributes an effective amount of ketamine and/or dextromethorphan in a vehicle with a buffered mucoadhesive layer and a differently buffered non-adhesive backing layer, where both layers include water-erodible polymers selected from defined polymer classes.
Stated Advantages
Rapid antidepressant effects within about 24 hours.
Eliminates the digestive tract.
Documented Applications
Treating treatment-resistant depression using mucosal (preferably buccal/transbuccal) administration of ketamine and/or dextromethorphan with transmucosal absorption.
Predicting antidepressant responsiveness using changes in speech parameters and corticospinal excitability measured at baseline and after treatment, including using transcranial magnetic stimulation and resting motor threshold.
Interested in licensing this patent?