Dry Powder Vaccine Formulation for Room Temperature Stability
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Solution Overview
Problem
Current vaccine formulations, particularly for influenza, face challenges in stability, storage requirements, and delivery methods, as they are often unstable at room temperature and require refrigeration, and existing delivery methods may not effectively induce both mucosal and systemic immune responses.
Innovation Solution
A composition comprising an antigen, a first saccharide, a second saccharide, and microcrystalline cellulose, with specific weight and molar ratios, freeze-dried with annealing, to create a dry powder vaccine that is stable at room temperature and can induce both mucosal and systemic immune responses when administered intranasally.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid vaccine formulations are used, then immune response induction is effective, but storage stability at room temperature deteriorates
Solution Approach 1:
The patent changes the physical state parameter of the vaccine formulation from liquid to dry powder form through freeze-drying. This parameter change enables the vaccine to be stored at room temperature without degradation while maintaining antigenic potency and immune response induction capability.
Solution Approach 2:
The patent utilizes freeze-drying technology to transition the liquid vaccine formulation into a solid dry powder state. This phase transition removes water from the formulation, preventing microbial growth and chemical degradation, thereby improving storage stability while preserving biological activity.
2Reliability
If refrigeration is required for storage, then vaccine stability is maintained, but storage and distribution complexity increases
Solution Approach 1:
The patent changes the storage temperature parameter from requiring refrigeration (2-8°C) to compatible with room temperature storage. This parameter change eliminates the need for complex refrigeration systems while maintaining vaccine stability through the dry powder formulation.
3Ease of operation
If traditional delivery methods are used, then system simplicity is maintained, but induction of both mucosal and systemic immune responses deteriorates
Solution Approach 1:
The patent uses intranasal delivery as an intermediary route that simultaneously activates both mucosal and systemic immune responses. The nasal mucosa serves as a gateway that allows the vaccine to induce local immunity while also triggering systemic immune activation, achieving dual immune response without complex delivery systems.
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 dry powder vaccine formulation is stable at room temperature, maintains antigenic potency, and effectively stimulates mucosal and systemic immune responses, including the production of IgG and sIgA antibodies, offering improved delivery and storage advantages over traditional liquid vaccines.
Implementation Method 1
freeze-drying a liquid with annealing
Implementation Method 2
drying comprises a first drying and a second drying
Implementation Method 3
freeze-drying a liquid with annealing
Implementation Method 4
the annealing is conducted at a temperature of from about −20° C. to about −28° C.
Data Source
AI summary
Provided herein are vaccine compositions for example in a dry powder form for intranasal delivery, and their preparation methods. Also provided are methods of using vaccine compositions, for example in stimulating mucosal or systemic immune responses by delivering the vaccine compositions intranasally.