Transdermal Glucose Delivery for Nocturnal Hypoglycemia

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Solution Overview

Problem

Current solutions for nocturnal hypoglycemia, such as GLUCERNA™ shakes or bars, provide glucose level maintenance for only 3 to 4 hours and often include unnecessary nutrients that can cause side effects like obesity and disturbed sleep, as they trigger digestion and deliver long-chain carbohydrates, which are not effectively managed for prolonged periods.

Innovation Solution

A composition and transdermal delivery device for delayed and sustained release of glucose, mannose, lactic acid, and pyruvic acid, designed to release less than 15% of the energy molecule within 2 hours, with sustained release up to 8 hours, avoiding further digestion during sleep and using skin permeation enhancers like propylene glycol and 2-methyl-3-hydroxypyranone for transdermal delivery directly to the central nervous system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If controlled-release technology is applied to deliver carbohydrates for sustained energy release, then the duration of glucose level maintenance is extended, but unnecessary nutrients (vitamins, minerals, lipids) are delivered which cause side effects like obesity and disturbed sleep

Engineering Contradiction:
Improveduration of glucose level maintenanceVSAvoidside effects from unnecessary nutrients
Core Design Contradiction:
Duration of action of moving objectVSObject-generated harmful factors

Solution Approach 1:

The invention segments the nutrient delivery by providing separate formulations: one containing only the necessary carbohydrate energy molecules (glucose, fructose, sucrose, starch) and another containing the unnecessary nutrients (vitamins, minerals, lipids). This allows patients to receive sustained carbohydrate delivery without the harmful side effects of unnecessary nutrients that trigger digestion and cause obesity during sleep.

Inventive Principle:
Principle #1Segmentation

2Duration of action of moving object

If long-chain carbohydrates are delivered for prolonged energy support, then the duration of action is extended, but digestion is triggered during sleep which disturbs enzyme secretion and causes obesity

Engineering Contradiction:
Improveduration of energy supportVSAvoiddigestion triggering during sleep
Core Design Contradiction:
Duration of action of moving objectVSObject-generated harmful factors

Solution Approach 1:

The invention changes the parameter of carbohydrate chain length by providing a mix of short-chain (glucose, fructose, sucrose) and long-chain (starch) carbohydrates in controlled-release formulations. The short-chain carbohydrates provide immediate energy without triggering digestion, while the long-chain carbohydrates provide sustained release. By carefully controlling the ratio and release rate, the formulation extends energy support duration while minimizing digestion triggering during sleep.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If current glucose delivery products are used for nocturnal hypoglycemia, then glucose level is maintained for 3-4 hours, but this is insufficient for nocturnal hypoglycemia management which requires longer duration

Engineering Contradiction:
Improveglucose level maintenance effectivenessVSAvoidduration of glucose level maintenance
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The invention applies preliminary action by administering controlled-release carbohydrate formulations before bedtime to proactively prevent nocturnal hypoglycemia. The formulations are designed to release carbohydrates slowly over 8-12 hours, ensuring glucose levels are maintained throughout the night and early morning without requiring the patient to wake up for additional intake.

Inventive Principle:
Principle #10Preliminary action

4Duration of action of moving object

If controlled-release formulations are used to extend duration of action, then sustained energy release is achieved, but the complexity of the delivery system increases

Engineering Contradiction:
Improveduration of sustained energy releaseVSAvoidcomplexity of controlled-release formulation
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The invention uses parameter changes in the physical and chemical properties of carbohydrates to achieve controlled release without complex delivery systems. By selecting carbohydrates with different molecular weights, chain lengths, and crystallinity (e.g., amylase-resistant starches), and by controlling particle size distribution and moisture content, the formulation achieves sustained release over 8-12 hours using simple tablet or capsule forms that do not require complex mechanical or chemical delivery mechanisms.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Effectively manages nocturnal hypoglycemia by providing up to 8 hours of energy support without disturbing sleep patterns, reducing weight gain in diabetes patients and minimizing side effects, with the transdermal device offering a near zero-order delivery for at least 6-10 hours.

Implementation Method 1

using skin permeation enhancers like propylene glycol and 2-methyl-3-hydroxypyranone for transdermal delivery directly to the central nervous system

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentUS10016370B2Composition, device and method for delayed and sustained release of brain energy molecules
Publication Date: 2018.07.10 ABLE CEREBRAL LLC

AI summary

The present invention relates to compositions, devices and methods of delayed and sustained release of energy molecules for brain function to treat nocturnal hypoglycemia. The composition comprises an energy molecule required for human brain function; wherein the release of the energy molecule is delayed and then sustained over a period of time. The device is a transdermal delivery device comprising a reservoir layer containing the composition and a skin permeation enhancer formulation, an adhesive layer, a backing layer and a release liner. The method comprises administering the composition either orally or through the transdermal delivery device to a subject in need thereof immediately prior to going to sleep.