Mixed Salt Oxybate Composition for Narcolepsy Treatment

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Solution Overview

Problem

Patients with narcolepsy treated with sodium oxybate face high sodium intake issues, particularly those with cardiometabolic risks, necessitating a reduction in dietary sodium without compromising therapeutic efficacy.

Innovation Solution

Development of a mixed salt oxybate composition comprising sodium, potassium, magnesium, and calcium oxybate, allowing for a switch from sodium oxybate that maintains equivalent oxybate dosing strength, thereby reducing sodium intake while maintaining therapeutic benefits.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sodium oxybate is used to treat narcolepsy, then therapeutic efficacy is achieved, but sodium intake increases significantly

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidsodium intake

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The invention changes the chemical composition parameter of the oxybate salt from pure sodium oxybate to a mixed salt composition containing potassium, magnesium, and calcium oxybates in addition to sodium oxybate. This parameter change maintains the therapeutic efficacy of oxybate while significantly reducing the sodium content per dose, thereby resolving the contradiction between therapeutic effectiveness and sodium intake.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite salt composition where multiple metal cations (sodium, potassium, magnesium, calcium) are combined with oxybate anions. This composite material approach allows the formulation to maintain the pharmacologically active oxybate component while distributing the ionic composition to reduce sodium burden, thus achieving both therapeutic efficacy and reduced sodium intake.

Inventive Principle:

Principle #40Composite materials

2Reliability

If high dose sodium oxybate is administered chronically, then treatment effectiveness is maintained, but dietary sodium intake becomes excessive

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidexcessive dietary sodium

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention modifies the compositional parameters of the oxybate formulation by incorporating multiple metal cations beyond sodium. This allows chronic administration of effective oxybate doses while the mixed salt composition inherently limits sodium contribution, thereby maintaining treatment effectiveness without causing excessive dietary sodium accumulation over time.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention converts the potential harm of high sodium intake into a benefit by using alternative metal cations (potassium, magnesium, calcium) that are either beneficial or neutral in dietary contexts. The mixed salt composition transforms the limitation of sodium content into an opportunity to provide a more balanced mineral profile suitable for chronic therapy.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Data Source

PatentUS20210361601A1GHB dosing

Publication Date: 2021.11.25 JAZZ PHARMA IRELAND LTD

AI summary

Provided herein are methods of administering GHB formulations for the treatment of narcolepsy and other conditions.