Devices and methods for facilitating and controlling use of a medication
Inventors
Assignees
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Publication Number
US-9801852-B2
Publication Date
2017-10-31
Expiration Date
Abstract
A method for providing a drug includes providing an inactive form of a drug. The method also includes chemically converting the inactive form of the drug to an active form to provide a drug formulation usable by a patient in need thereof, including using a device configured to remove an abuse-preventing additive from the inactive form of the drug. The method also includes dispensing the drug formulation to the patient in need thereof.
Core Innovation
The document describes abuse-deterring medication use for gamma hydroxybutyrate (GHB), including sodium oxybate (Xyrem). It provides an approach in which an inactive, non-absorbable form of GHB is used in an in-home device, and the inactive form is converted to an active, absorbable form within the device before administration.
In particular, the inactive, non-absorbable form is a n-polyol (C4 or greater) ester of GHB. The conversion is performed by chemically converting the inactive form to an active form of GHB using the device, including passing the inactive form through a filter or packed bed of the device containing a catalyst or reagent to generate the active, absorbable form of GHB formulation.
After conversion, the device dispenses the GHB formulation to a patient. The document further describes in-home device architecture and control aspects, including security features that restrict access, lockout/security features, prescriber-device communication, and logging/indicators to support controlled dispensing of the active, absorbable form.
Claims Coverage
The partial content includes two independent method claims that share a common inventive core: using an in-home device to chemically convert an inactive, non-absorbable n-polyol (C4 or greater) ester of GHB into an active, absorbable form using a filter or packed bed with a catalyst or reagent, and then dispensing that active, absorbable GHB formulation to a patient. Across the independent claims, the main inventive features are complemented by claim dependents that add security/control and prescriber communication for dose-related parameter adjustment, and narrow administration to patient ingestion and/or single-dose dispensing.
Inactive, non-absorbable GHB as an n-polyol (C4 or greater) ester in an in-home device
Adding an inactive, non-absorbable form of gamma hydroxybutyrate (GHB) to an in-home device, wherein the inactive, non-absorbable form of GHB is a n-polyol (C4 or greater) ester of GHB.
Device-based chemical conversion using a catalyst/reagent in a filter or packed bed
Chemically converting, using the device, the inactive, non-absorbable form of GHB in step (a) to an active form of GHB to provide a GHB formulation usable by a patient in need thereof, including passing the inactive, non-absorbable form of GHB through a filter or packed bed of the device containing a catalyst or reagent to generate the active, absorbable form of GHB.
Dispensing the active, absorbable GHB formulation from the in-home device
Dispensing the GHB formulation of step (b) from the device to the patient for use by the patient in need thereof.
Inactive non-absorbable GHB provided to a patient for in-home conversion and dispensing
Providing an inactive, non-absorbable form of gamma hydroxybutyrate (GHB) to a patient in need thereof, wherein the inactive, non-absorbable form of GHB is a n-polyol (C4 or greater) ester of GHB.
Conversion using an in-home filter/packed bed including activated carbon elements
Chemically converting the inactive, non-absorbable form of GHB in step (a) to an active form of GHB, including passing the inactive form of GHB through a filter, or packed bed of an in-home device containing a catalyst or reagent to generate the active, absorbable form of GHB, the filter including activated carbon elements.
Dispensing the active, absorbable GHB to the patient
Dispensing the active, absorbable form of GHB of step (b) to the patient.
Both independent claims center on using an in-home device to convert an inactive, non-absorbable n-polyol (C4 or greater) ester of GHB into an active, absorbable GHB form via a filter or packed bed containing a catalyst or reagent, and then dispensing the active, absorbable GHB formulation to the patient. One independent claim further specifies that the filter includes activated carbon elements. Dependent claims add security/control features, prescriber-device communication to adjust dose-related parameters, and narrows include patient ingestion and single-dose providing/dispensing.
Stated Advantages
Abuse-deterring medication use for GHB, including sodium oxybate (Xyrem).
Generates an active, absorbable GHB formulation usable by a patient in need thereof from an inactive, non-absorbable form within the in-home device.
Restricts access to the in-home device using security and lockout features.
Documented Applications
In-home abuse-deterring medication use for gamma hydroxybutyrate (GHB), including sodium oxybate (Xyrem), involving in-device conversion from an inactive non-absorbable form to an active absorbable form prior to dispensing to a patient.
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