Vitamin D3 Stability in Acidic HMB Formulations

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Solution Overview

Problem

Vitamin D3 is not stable when combined with acidic compositions, such as HMB in its free acid form, leading to significant degradation over time, which limits the effectiveness of vitamin D supplementation when used together.

Innovation Solution

Incorporating stabilizing excipients like EDTA, butylated hydroxytoluene (BHT), carnitine, rosemary extract, or carnosolic acid into formulations with HMB and vitamin D3 to maintain the stability of vitamin D3 in acidic environments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If vitamin D3 is combined with acidic compositions (HMB free acid form), then the effectiveness of vitamin D supplementation is improved, but the stability of vitamin D3 deteriorates due to significant degradation over time

Engineering Contradiction:
Improveeffectiveness of vitamin D supplementationVSAvoidstability of vitamin D3
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces stabilizing excipients (EDTA, BHT, carnitine, rosemary extract, or carnosolic acid) as intermediary substances that mediate between the acidic HMB environment and vitamin D3. These excipients act as protective intermediaries that prevent direct harmful interactions between the acidic composition and vitamin D3, thereby maintaining vitamin D3 stability while preserving the effectiveness of the supplementation combination.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the chemical environment parameters by adding stabilizing excipients that alter the pH buffering capacity, oxidation resistance, and chelation properties of the formulation. These parameter changes create a more favorable chemical environment for vitamin D3 stability without compromising the acidic nature needed for HMB effectiveness, thus resolving the contradiction between stability and effectiveness.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If stabilizing excipients are added to maintain vitamin D3 stability, then the degradation of vitamin D3 is reduced, but the formulation complexity increases

Engineering Contradiction:
Improvestability of vitamin D3VSAvoidformulation complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent employs relatively simple, well-established stabilizing excipients that are commonly used in the supplement industry (EDTA, BHT, rosemary extract). These are inexpensive, readily available substances that provide effective stabilization without requiring complex formulation strategies. The use of such simple, proven ingredients minimizes formulation complexity while achieving the desired stability outcome.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The stabilizing excipients selected serve multiple functions: they stabilize vitamin D3 against degradation, maintain compatibility with acidic HMB environments, and are generally recognized as safe for supplementation. This multi-functionality reduces the need for additional specialized ingredients or complex stabilization systems, thereby keeping the formulation relatively simple while achieving comprehensive stability protection.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 inclusion of these excipients results in minimal loss of vitamin D3, ensuring its stability and effectiveness over time, even in low pH conditions, thereby enhancing the efficacy of HMB when administered with vitamin D3.

Implementation Method 1

Incorporating stabilizing excipients like EDTA

Methodology Applied
Scientific EffectChelation:

Implementation Method 2

oxidation of Vitamin D can be the predominant route for decomposition at the conjugated double bond system at 5,6 and 7,8 position of the secosteroid structure

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Data Source

PatentUS10925845B2Stability of vitamin D in β-hydroxy-β-methylbutyrate (HMB)
Publication Date: 2021.02.23 METABOLIC TECHNOLOGIES INC
  • US10925845B2 patent drawing
  • US10925845B2 patent drawing

AI summary

The present invention provides a composition comprising an acidic formulation containing β-hydroxy-β-methylbutyrate (HMB), preferably in the free acid form, Vitamin D and a stabilizing excipient, wherein the Vitamin D is stabilized against degradation.