Spray-Dried Particle Compositions for Room-Temperature Payload Stability
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Solution Overview
Problem
Current methods for manufacturing particle-based vehicles (PBVs) are limited to laboratory scales, require large amounts of chilled non-solvents, result in batch-to-batch variability, and produce aggregated particles, making it difficult to achieve thermostable vaccines that maintain efficacy at room temperature.
Innovation Solution
A method involving reducing lyophilized payloads to a specific size, mixing with a solvent suitable for spray drying, and forming particle-based compositions through spray drying to create particles with controlled sizes and encapsulated payloads, using solvents like alcohols and halogenated hydrocarbons.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If flash nanoprecipitation (FNP) method is used to synthesize PBVs, then particle formation is achieved, but batch size is limited to laboratory scales of approximately 100 mg
Solution Approach 1:
The invention changes the physical-chemical parameters of the synthesis process by using organic solvents suitable for spray drying instead of aqueous systems, and by controlling solvent evaporation rates and particle formation conditions to enable scalable production while maintaining particle quality
Solution Approach 2:
The invention replaces the mechanical mixing and precipitation approach of FNP with a spray drying process that uses controlled atomization and evaporation to form particles, enabling better scalability and batch-to-batch consistency
2Ease of manufacture
If FNP method is used, then particle precipitation is achieved, but vast amounts of chilled non-solvents are required which is neither economical nor environmentally friendly
Solution Approach 1:
The invention utilizes phase transition of solvents from liquid to vapor during spray drying to form particles, eliminating the need for large volumes of chilled non-solvents while maintaining effective particle precipitation and formation
Solution Approach 2:
The invention extracts and eliminates the requirement for vast amounts of chilled non-solvents from the process by using spray drying with volatile organic solvents that evaporate during the atomization process, reducing both quantity and cooling requirements
3Manufacturing precision
If FNP synthesis is used, then particle formation is achieved, but aggregated particles and large variability in yields between batches occur
Solution Approach 1:
The spray drying process is self-regulating through controlled atomization and evaporation rates, automatically producing consistent particle sizes and distributions without requiring extensive technician intervention or skill for batch-to-batch consistency
Solution Approach 2:
The process incorporates controlled feedback mechanisms through monitoring and regulation of spray parameters, drying conditions, and particle formation rates to maintain consistent yields and prevent aggregation across batches
4Stability of the object's composition
If vaccines are stored at refrigeration temperature, then vaccine stability is maintained, but cold chain infrastructure is required which is costly and difficult to achieve in certain parts of the world
Solution Approach 1:
The invention changes the formulation parameters by using organic solvent-based polyanhydride particles that inherently provide enhanced shelf stability at room temperature, eliminating the requirement for refrigeration while maintaining vaccine composition stability
Solution Approach 2:
The particle formulation provides preliminary protection against degradation through the stabilizing matrix and controlled release properties, preemptively preventing the need for cold chain infrastructure before storage and distribution issues arise
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 method enables the production of thermostable vaccines that maintain antigenic and non-antigenic payload stability and efficacy at room temperature for extended periods, overcoming batch-to-batch variability and scalability issues.
Implementation Method 1
spray drying the mixture to form the particle-based composition
Data Source
AI summary
Compositions and methods of using the same wherein the compositions include particles comprising one or more materials soluble in a solvent that is suitable for spray drying and one or more antigenic and/or non-antigenic payloads entrapped within the particles, wherein the composition is stable at room temperature for at least six months.