GHB Dosing Regimen Transition to Once Daily

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Solution Overview

Problem

There is a need to develop new methods of administration for gamma-hydroxybutyrate (GHB) forms to improve treatment efficacy and patient compliance for sleep-related disorders and other conditions.

Innovation Solution

The method involves transitioning a GHB dose regimen from a divided, twice daily (DTD) administration to a once daily (OD) dosing regimen, with specific dose adjustments during a transition period and a maintenance period, to optimize treatment outcomes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If GHB is administered as a divided, twice daily (DTD) dose, then treatment efficacy is maintained, but patient compliance and convenience deteriorate due to multiple daily administrations

Engineering Contradiction:

Improvetreatment efficacyVSAvoidpatient compliance

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent combines two separate daily doses of GHB into a single once-daily (OD) administration. This merging of dosing events maintains therapeutic efficacy while significantly improving patient compliance by reducing the burden of multiple daily administrations to a single convenient dose

Inventive Principle:

Principle #5Merging (Combining)

2Object-affected harmful factors

If GHB dose is reduced during transition period, then patient tolerance improves, but treatment efficacy temporarily deteriorates

Engineering Contradiction:

Improvepatient toleranceVSAvoidtreatment efficacy

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent implements a structured transition period with predetermined dose reduction steps before switching to once-daily administration. This preliminary action allows the patient's body to adapt gradually to lower doses, improving tolerance while minimizing the impact on treatment efficacy through controlled, staged adjustments

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If GHB is administered as once daily (OD) dose from the beginning, then patient compliance improves, but treatment efficacy deteriorates due to insufficient dosing

Engineering Contradiction:

Improvepatient complianceVSAvoidtreatment efficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent employs a dynamic dosing strategy where the administration frequency and dose amount are adjusted over time based on patient response and tolerance. The regimen transitions from twice-daily to once-daily administration with intermediate dose adjustments, allowing the system to adapt to patient needs while maintaining optimal efficacy throughout the treatment course

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20250073191A1Method of administering oxybate

Publication Date: 2025.03.06 JAZZ PHARMA IRELAND LTD

AI summary

Provided herein are methods of administering different GHB forms on different days for the treatment of narcolepsy, IH, EDS and other conditions.