Ambient-Stable Liquid Probiotic Syrup via Spore Formulation
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Solution Overview
Problem
Current probiotic formulations, particularly liquid forms, face challenges in maintaining cellular viability and stability at ambient storage conditions due to bacterial growth, fermentation, and offensive odors, leading to short shelf life and inadequate dosing consistency.
Innovation Solution
Development of stable liquid compositions comprising probiotic bacteria of the genera Bacillus/Lactobacillus with at least 60% sweeteners, combined with hydrophilic vehicles, solubilizers, pH modifiers, preservatives, stabilizers, and sweeteners, which retain cellular viability for extended periods at ambient temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If probiotic bacteria are formulated in liquid form at ambient temperature, then ease of administration and palatability are improved, but bacterial growth and fermentation occur leading to short shelf life and loss of probiotic activity
Solution Approach 1:
The patent changes the physical state of probiotic bacteria from vegetative cells to spores, which are metabolically dormant and resistant to environmental stress. This parameter change allows the bacteria to remain stable in liquid formulation at ambient temperature without active growth or fermentation, thereby extending shelf life while maintaining ease of administration in liquid form
Solution Approach 2:
The patent uses a specific vehicle composition containing polyethylene glycol 400, glycerol, and citric acid that creates a protective environment for spores. This vehicle formulation acts as a stabilizing matrix that prevents spore degradation over time, enabling long-term ambient storage without requiring refrigeration or complex preservative systems
2Ease of manufacture
If probiotic bacteria are stored in liquid formulation at ambient temperature, then storage and distribution are simplified, but bacterial metabolism produces gas and offensive odors
Solution Approach 1:
The patent transforms bacteria into spores which are metabolically inactive and do not ferment carbohydrates. This parameter change eliminates gas production and offensive odors that would otherwise occur from bacterial metabolism in liquid formulation, while still allowing ambient temperature storage and simplified distribution
Solution Approach 2:
The patent introduces a specific vehicle composition containing polyethylene glycol 400, glycerol, and citric acid as an intermediary medium. This vehicle protects the spores from environmental stress and prevents any residual metabolic activity, thereby preventing gas and odor formation while maintaining spore viability during storage
3Duration of action of stationary object
If probiotic bacteria are formulated as solid dosage forms, then stability and shelf life are improved, but palatability and compliance in pediatric and geriatric populations deteriorate
Solution Approach 1:
The patent changes the bacterial state to spores and formulates them in a liquid vehicle containing polyethylene glycol 400, glycerol, and citric acid. This parameter change enables the bacteria to remain stable and viable in liquid form at ambient temperature, providing both the palatability of liquid formulations and the shelf life stability previously only achievable with solid dosage forms
Solution Approach 2:
The patent creates a liquid formulation that simultaneously achieves multiple functions: it provides the palatability and ease of administration associated with liquids, while also delivering the stability and shelf life previously only achievable with solid dosage forms. The spore-based liquid formulation serves both sensory and stability requirements
4Ease of operation
If sugars are added to probiotic formulations to improve palatability, then compliance is improved, but bacterial growth is enhanced leading to increased metabolite production at ambient temperatures
Solution Approach 1:
The patent transforms bacteria into spores which are metabolically dormant and cannot actively ferment sugars. This parameter change allows sugars to be added to the formulation for palatability without triggering bacterial growth or metabolite production, as spores remain inactive regardless of substrate availability
Solution Approach 2:
The patent converts the potential harm of sugars (which would normally fuel bacterial growth and metabolite production) into a benefit by using spores that cannot metabolize the sugars. The sugars provide palatability and compliance benefits without the harmful effect of increased metabolic activity, since the spores remain dormant despite the presence of fermentable substrates
Data Source
AI summary
The present invention provides a stable liquid syrup composition compositions comprising probiotic bacteria, retaining their cellular viability at ambient storage conditions for at least two years.