Buffered Beta-Hydroxybutyrate Foodstuff for Ketone Delivery

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Solution Overview

Problem

Current compositions and methods for achieving nutritional ketosis face limitations due to gastric degradation, bioavailability issues, and excessive sodium intake, making it difficult to maintain therapeutic levels of ketones in the blood.

Innovation Solution

A foodstuff composition that includes a partially buffered free acid of β-hydroxybutyrate with specific molar ratios of (D)-β-hydroxybutyrate, its salts, and 1,3-butanediol, along with Ketone Ester, which are enantiomerically enriched to enhance bioavailability and reduce gastric degradation, allowing for higher doses without excessive salt intake.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If free acid form of (D/L)-β-hydroxybutyrate is used intravenously, then therapeutic levels of ketones can be achieved, but gastrointestinal tolerability is poor due to acidity

Engineering Contradiction:
Improvetherapeutic ketone levelsVSAvoidgastrointestinal distress
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary buffering agent (such as sodium bicarbonate, potassium bicarbonate, or calcium carbonate) that mediates between the acidic free acid form of β-hydroxybutyrate and the gastrointestinal tract. This intermediary substance neutralizes the acid in the stomach, preventing gastrointestinal distress while allowing the β-hydroxybutyrate to be absorbed and converted to therapeutic ketone levels in the blood.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If (D/L)-β-HB(Na+) salt is used, then sodium intake is provided, but limitations on sodium intake restrict therapeutic effectiveness

Engineering Contradiction:
Improvetherapeutic ketone levelsVSAvoidsodium intake
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the chemical parameter of the β-hydroxybutyrate compound from its sodium salt form to its free acid form, which is then buffered by a separate buffering agent. This parameter change allows the formulation to provide therapeutic ketone levels without being constrained by daily sodium intake limits, as the buffering agent can be selected independently of sodium restrictions.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent segments the functional requirements into separate components: the β-hydroxybutyrate free acid provides the ketone precursor, while the buffering agent separately provides acid neutralization and cation supply. This segmentation allows the formulation to achieve therapeutic effects without relying on high sodium intake, as the buffering function is performed by a separate substance.

Inventive Principle:
Principle #1Segmentation

3Reliability

If racemic (D/L)-β-hydroxybutyrate is used, then both enantiomers are provided, but only the (D) isomer is bioactive, reducing efficiency

Engineering Contradiction:
Improvebioactive ketone productionVSAvoidamount of β-hydroxybutyrate required
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies asymmetry by using only the (D)-enantiomer of β-hydroxybutyrate instead of the racemic mixture. Since the (L)-enantiomer is not bioactive, excluding it from the formulation eliminates wasted material and allows for more efficient conversion to therapeutic ketone levels with a lower total amount of β-hydroxybutyrate required.

Inventive Principle:
Principle #4Asymmetry

4Reliability

If 1,3-butanediol is used in excess, then ketone production is enhanced, but inebriation occurs

Engineering Contradiction:
Improveketone productionVSAvoidinebriation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the approach by using buffered free acid form of β-hydroxybutyrate as the primary ketone precursor, which has a higher safety margin and does not cause inebriation. This parameter change allows achieving therapeutic ketone levels without the harmful side effects associated with excessive 1,3-butanediol consumption.

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

The composition effectively increases serum levels of (D)-β-hydroxybutyrate, achieving rapid and sustained ketosis with improved bioavailability and reduced risk of gastrointestinal distress and salt overload, enabling therapeutic levels of ketones to be reached safely.

Implementation Method 1

a partially buffered free acid of β-hydroxybutyrate which is defined as less than a 1:1 molar equivalent with respect to the buffering base

Methodology Applied
Scientific EffectBuffering:

Implementation Method 2

only the (D) isomer is bioactive

Methodology Applied
Scientific EffectEnantiomer conversion:

Implementation Method 3

(D/L) 1,3-butanediol, which is converted in the liver to (D)-β-hydroxybutyrate free acid

Methodology Applied
Scientific EffectLiver conversion:

Implementation Method 4

The composition effectively increases serum levels of (D)-β-hydroxybutyrate, achieving rapid and sustained ketosis with improved bioavailability

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS20240376503A1Exogenous ketone blend compositions for delivery of ketone bodies
Publication Date: 2024.11.14 KETONEAID INC
  • US20240376503A1 patent drawing
  • US20240376503A1 patent drawing
  • US20240376503A1 patent drawing

AI summary

A foodstuff can include a free acid β-hydroxybutyrate, and a base. The β-hydroxybutyrate, and base, are present at a less than 1:1 molar equivalence. Ketone Ester may also be incorporated as a component of the foodstuff.