Ingestible Compositions Shelf-Life Stability Component

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Solution Overview

Problem

Ingestible compositions face challenges in maintaining shelf-life stability due to exposure to humidity, elevated temperatures, microorganisms, and oxidizing agents during manufacturing and storage, leading to degradation of their effectiveness.

Innovation Solution

Incorporating a minimally dimensioned shelf-life stability component that enhances storage stability by two-fold or greater, allowing the compositions to remain effective for extended periods, such as one year or longer, under various environmental conditions, by using protective barriers and electrochemical materials that maintain functionality and active agent potency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If ingestible compositions are stored during manufacturing and distribution, then production efficiency is improved, but quality degradation occurs due to exposure to humidity, elevated temperatures, microorganisms and oxidizing agents

Engineering Contradiction:
Improveproduction efficiencyVSAvoidquality stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

A shelf-life stability component is introduced as an intermediary substance that actively protects the active agent and carrier materials from degradation. This component acts as a mediator between the ingestible composition and environmental stressors (humidity, temperature, microorganisms, oxidizing agents), preventing direct harmful interactions and maintaining composition integrity during storage and transport.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The shelf-life stability component is incorporated into the composition formulation in advance, before storage and distribution begin. This preliminary inclusion ensures protective effects are already in place during manufacturing and storage periods, preventing quality degradation before it can occur rather than attempting to address it after storage exposure.

Inventive Principle:
Principle #10Preliminary action

2Duration of action of stationary object

If storage time is extended to allow distribution and end-user storage, then product availability is improved, but effectiveness degradation occurs

Engineering Contradiction:
Improvestorage durationVSAvoideffectiveness
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The shelf-life stability component serves as a consumable protective element that is depleted over time as it protects the active agent. By incorporating this sacrificial protective component, the composition can maintain effectiveness for extended storage periods (one year or longer) that would otherwise be impossible, enabling long-term storage and distribution while preserving therapeutic effectiveness.

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

3Reliability

If protective measures are added to prevent degradation, then shelf-life stability is improved, but composition complexity increases

Engineering Contradiction:
Improveshelf-life stabilityVSAvoidcomposition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention addresses shelf-life stability by modifying the chemical composition parameters of the ingestible formulation. Rather than adding complex physical protective structures or systems, the solution changes the chemical parameters by incorporating a shelf-life stability component that chemically or physically protects the active agent through molecular interactions, maintaining simplicity while achieving extended stability.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3808257A1Ingestible compositions comprising a shelf-life stability component
Publication Date: 2021.04.21 OTSUKA PHARM CO LTD
  • EP3808257A1 patent drawingFigure 1A~1B
  • EP3808257A1 patent drawingFigure 2
  • EP3808257A1 patent drawingFigure 3

AI summary

Compositions that include a shelf-life stability component are provided. In some instances, the compositions are ingestible compositions which include the shelf-life stability component and an ingestible component. Aspects of the disclosure further include methods of making and using the compositions.