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-11684619-B2
Publication Date
2023-06-27
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 described invention provides methods for treating depression disease in a treatment resistant patient using mucosal administration of a composition comprising an effective amount of ketamine. The composition is administered to a mucosal membrane in an oral cavity, so that transmucosal absorption of ketamine occurs into the patient’s systemic blood stream, and the mucosal administration avoids first pass elimination of ketamine from the patient’s digestive tract and liver, thereby providing a rapid acting antidepressant effect.
The disclosure further extends the approach to mucosal administration of ketamine or dextromethorphan, enabling transmucosal absorption into systemic blood while avoiding first pass elimination from the digestive tract and liver. In addition to oral cavity mucosal membranes, the mucosal membrane is stated to be of a genitourinary tract or rectal tract in the method described, and a pharmaceutically acceptable composition and dosage form are described for administering to mucosa.
The disclosure also describes pharmaceutically acceptable formulations and device-type compositions for mucosal delivery, including mucoadhesive multilayer devices with buffered layers and water-erodible polymers, together with non-adhesive backing layer concepts. Predictive biomarker measures are described, including speech/voice acoustic parameters and corticospinal excitability or resting motor threshold assessed by TMS, together with use of HAM-D in a study concept to evaluate clinical and predictive effects.
The problem addressed is that current antidepressant therapies are described as slow and that IV ketamine has limitations, motivating mucosal transmucosal administration designed to reduce or avoid digestive tract first-pass elimination. The stated goal is rapid-acting antidepressant treatment in treatment resistant depression by delivering ketamine, and optionally dextromethorphan, across mucosal membranes into systemic blood.
Claims Coverage
The provided material contains two independent claims with multiple dependent refinements. Across the independent claims, the inventive features focus on mucosal delivery of ketamine or ketamine/dextromethorphan to enable transmucosal absorption into systemic blood while avoiding first pass elimination from the digestive tract and liver, with specific anatomical and dosage-form limitations.
Oral mucosal ketamine for rapid antidepressant effect while avoiding first-pass elimination
Administering to a mucosal membrane that is in an oral cavity an effective amount of a composition comprising an effective amount of ketamine, wherein the mucosal administration allows for transmucosal absorption of the ketamine into the patient’s systemic blood stream and avoids first pass elimination of ketamine from the patient’s digestive tract and liver, providing a rapid acting antidepressant effect for treating depression in a treatment resistant patient.
Genitourinary or rectal mucosal ketamine or dextromethorphan for rapid antidepressant effect while avoiding first-pass elimination
Administering to a mucosal membrane of a patient an effective amount of a composition comprising an effective amount of ketamine or dextromethorphan, wherein the mucosal administration allows for transmucosal absorption of the ketamine or dextromethorphan into the patient’s systemic blood stream and avoids the first pass elimination of the ketamine or dextromethorphan from the patient’s digestive tract and liver for providing a rapid acting antidepressant effect for treating depression in a treatment resistant patient, wherein the mucosal membrane is of a genitourinary tract or rectal tract, and wherein the dosage form is in the form of a pharmaceutically acceptable troche, film, capsule, tablet, particle, solution, suspension, lollipop, lozenge, emulsion, spray, or aerosol.
The independent claims cover rapid-acting antidepressant treatment in treatment resistant depression by mucosal transmucosal delivery of ketamine (oral mucosal membrane) and by mucosal delivery of ketamine or dextromethorphan (genitourinary or rectal mucosal membrane), with the shared inventive concept of enabling transmucosal absorption into systemic blood while avoiding first pass elimination from the digestive tract and liver.
Stated Advantages
Provides a rapid acting antidepressant effect for treating depression in a treatment resistant patient.
Allows for transmucosal absorption into systemic blood.
Avoids first pass elimination from the patient’s digestive tract and liver.
Documented Applications
Use in a method of treating depression disease in a treatment resistant patient using mucosal membrane administration of ketamine and/or dextromethorphan to provide rapid acting antidepressant effect.
Biomarker and study concept documentation using HAM-D, speech/voice acoustic parameters, and TMS measures (corticospinal excitability/resting motor threshold) to evaluate clinical/predictive outcomes.
Interested in licensing this patent?