Effervescent Solid Composition for Vaginal Probiotic Delivery
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Solution Overview
Problem
Current methods for delivering probiotic bacteria to the vaginal environment are inefficient, leading to poor colonization and high mortality rates during manufacturing and administration, and existing treatments often result in recurrent infections due to antibiotic and fungicidal resistance.
Innovation Solution
An effervescent composition in solid form, comprising an acid-base system of citric acid and sodium bicarbonate, which maintains a stable pH and promotes the growth of lactic bacteria, combined with microcrystalline cellulose and arabinogalactan to ensure effective colonization and distribution within the vaginal cavity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If soft gelatin capsules are used to deliver probiotic bacteria, then the probiotic component is suspended in an oily matrix, but the oily matrix constitutes a physical barrier that slows down or inhibits colonization of the vaginal mucosa and may exert a toxic effect on the microorganisms
Solution Approach 1:
The invention changes the physical and chemical parameters of the delivery system by using an effervescent solid composition that dissolves in vaginal fluids, transforming from a non-dissolving oily capsule to a dissolving solid form that releases probiotics directly into the vaginal environment, eliminating the oily barrier effect
Solution Approach 2:
The invention extracts the probiotic bacteria from the harmful oily matrix environment and delivers them in a solid effervescent composition that dissolves in vaginal fluids, separating the probiotics from the toxic oily carrier that was preventing effective colonization
2Ease of operation
If soft gelatin capsules are used, then the product can be easily administered, but the capsules take a relatively long time to dissolve and do not assure adequate dispersion of the active ingredient throughout the vaginal environment
Solution Approach 1:
The invention utilizes phase transition by designing a solid effervescent composition that transitions from solid to dissolved state upon contact with vaginal fluids, creating rapid dispersion through effervescence and dissolution, unlike the slow dissolution of oily capsules
Solution Approach 2:
The effervescent mechanism generates gas bubbles that enhance dispersion and distribution of probiotics throughout the vaginal environment, using pneumatic action to rapidly distribute the active ingredient, contrasting with the slow diffusion from oily capsules
3Reliability
If hydrophilic suspensions or hydrogels are used, then the probiotic component can be delivered, but the mode of application is neither easy nor comfortable as subjects must remain lying down for at least 20-30 minutes to prevent leakage
Solution Approach 1:
The effervescent solid composition is designed as a single-use disposable form that dissolves rapidly in situ, eliminating the need for prolonged retention and making application as convenient as oral tablets, unlike hydrogels that require lying down for 20-30 minutes
Solution Approach 2:
The invention changes the physical state and dissolution characteristics from viscous hydrogel requiring retention to effervescent solid that dissolves rapidly, transforming the application parameters from requiring prolonged immobility to simple insertion similar to oral tablets
4Ease of manufacture
If traditional vaginal tablets are used, then the probiotic component can be delivered in solid form, but there is high mortality of microorganisms during manufacture and inadequate distribution in the vaginal environment
Solution Approach 1:
The invention optimizes manufacturing parameters by using low compression forces during tablet formation and selecting excipients that do not harm probiotics, maintaining viability while achieving adequate distribution through effervescent dissolution, contrasting with traditional tablets that subject microbes to high compression and heat
Solution Approach 2:
The invention uses a composite effervescent system combining probiotics with effervescent agents and protective excipients that work synergistically to protect microorganisms during manufacturing and enhance their distribution and survival in the vaginal environment, overcoming the limitations of simple compressed tablets
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 effervescent composition effectively delivers a large population of lactic bacteria for rapid colonization, maintaining an optimal pH and anaerobic environment, reducing mortality and ensuring stable probiotic viability, thus addressing the inefficiencies of previous delivery methods and providing a viable alternative to traditional treatments.
Implementation Method 1
an acid-base system comprising an organic acid and a salt of the carbonate and/or bicarbonate anion which, on coming into contact with the water or moisture present in the vaginal cavity, are capable of reacting with each other with formation of carbon dioxide
Implementation Method 2
formation of carbon dioxide, which occurs when an acid-base system comprising an organic acid and a salt of the carbonate and/or bicarbonate anion comes into contact with the water/moisture present in the vaginal cavity
Implementation Method 3
The acid-base system is capable of maintaining the intravaginal pH stable within an interval comprised from 3 to 5.5
Data Source
AI summary
The present invention relates to an effervescent composition in solid form for use in vaginal applications for the treatment of vaginal infections.