Lyophilized Human Milk Dosage Form With CO2 Sterilization
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Solution Overview
Problem
There is a need for a convenient dosage form of lyophilized mammalian/human milk that can be used as a pharmaceutical or nutraceutical composition without reconstitution or dilution in liquid, while preserving the natural quality and nutritional value, and ensuring complete or nearly complete sterilization without loss of beneficial components.
Innovation Solution
A process involving initial freezing, cold thawing, and lyophilization of mammalian milk at specific temperatures and pressures, followed by flash supercritical CO2 treatment to sterilize and reduce harmful cellular content, resulting in a dosage form such as capsules, tablets, or oral dissolving strips that retain nutritional and health attributes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pasteurization is used to sterilize milk, then sterility is improved, but nutritional and bioactive components are degraded
Solution Approach 1:
The patent employs freeze-drying (lyophilization) which utilizes phase transitions of water from liquid to solid (freezing) and then from solid to gas (sublimation under vacuum) to preserve milk components. This avoids thermal degradation while achieving sterilization, as the process occurs at low temperatures below the melting point of ice.
Solution Approach 2:
The patent creates an inert environment through vacuum conditions during freeze-drying, removing oxygen and other gases that could cause oxidation or microbial growth. This inert atmosphere helps preserve nutritional components while achieving sterilization without heat exposure.
2Loss of substance
If freeze-drying is used to preserve milk, then nutritional content is retained, but convenient dosage form for pharmaceutical use is not achieved
Solution Approach 1:
The patent segments the lyophilized milk into discrete dosage units (tablets, capsules, or single-serving packets) that can be easily administered without requiring reconstitution. This segmentation transforms the continuous lyophilized material into convenient, pre-measured pharmaceutical dosage forms.
Solution Approach 2:
The patent creates single-use disposable dosage units of lyophilized milk that are convenient for administration and disposal. Each unit is self-contained and requires no preparation, making it ideal for pharmaceutical and nutraceutical applications where convenience and sterility are paramount.
3Loss of substance
If conventional lyophilization is used, then milk is preserved in dry form, but harmful cellular components are not eliminated
Solution Approach 1:
The patent applies preliminary freezing before lyophilization to ensure complete ice formation, which traps and inactivates cellular components. This preliminary action of controlled freezing at specific temperatures and rates prepares the matrix to immobilize harmful cells before the drying process begins, enhancing sterilization effectiveness.
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 process produces lyophilized milk that retains its nutritional and health-promoting attributes, effectively sterilizes harmful cellular content, and provides elevated local dosing of active ingredients for improved mammalian health, including wound healing, digestive health, and immune system boosting.
Implementation Method 1
lyophilization at controlled temperatures and pressures
Implementation Method 2
freeze-drying, has become an accepted practice
Implementation Method 3
flash supercritical CO2 treatment to sterilize and preserve the milk
Implementation Method 4
A process involving initial freezing, cold thawing, and cryoshaving of milk
Data Source
AI summary
The present invention provides novel oral dosage comprising lyophilized mammalian (human) milk and optionally a physiologically acceptable excipient or carrier, and their use for improvement of mammalian (human) health. Also provided a novel process for preparing lyophilized mammalian milk with desired nutritional and cellular content, initially freezing raw milk obtained from a mammalian source, forming a layer of a predefined thickness from the frozen milk at a temperature from −4° C. to −80° C., and drying the formed layer at a temperature from −20° C. to +60° C. at a pressure from 5 micron Hg to atmospheric pressure to provide the lyophilized human milk. The process optionally comprises comprising treating said lyophilized milk via flash supercritical CO2 treatment comprising soaking said lyophilized milk with supercritical CO2