Bacteriophage Stabilization via Cyclodextrin Complexes in Spray Drying
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Solution Overview
Problem
Existing methods for producing bacteriophage compositions are hindered by the sensitivity of bacteriophages to pH, proteolytic degradation, and drying, which limits their stability and the development of effective solid dosage forms.
Innovation Solution
The use of α-linked polymeric glucose and polyols, such as sucrose, in combination with bacteriophages, stabilizes the compositions during spray drying, allowing for the production of stable dry bacteriophage compositions suitable for solid dosage forms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If spray drying is used to produce dry bacteriophage compositions, then production cost and speed are improved, but bacteriophage stability deteriorates due to elevated temperatures and shear stress
Solution Approach 1:
The patent applies preliminary action by pre-forming bacteriophage inclusion complexes with cyclodextrins before the spray drying process. This pre-complexation protects the bacteriophages from the subsequent thermal and mechanical stress of spray drying, allowing fast production while maintaining stability.
Solution Approach 2:
The patent uses cyclodextrins as intermediary substances that form inclusion complexes with bacteriophages. These cyclodextrin-bacteriophage complexes act as protective intermediaries during spray drying, shielding the bacteriophages from elevated temperatures and shear stress while enabling efficient production.
2Reliability
If lyophilisation is used to stabilize bacteriophages during drying, then bacteriophage stability is improved, but production cost and time increase
Solution Approach 1:
The patent changes the physical-chemical parameters of the drying process by using spray drying instead of lyophilisation. Through parameter optimization (temperature, atomization, drying rate), the patent achieves rapid drying (minutes vs. days) while maintaining bacteriophage stability via cyclodextrin protection.
Solution Approach 2:
The patent replaces the mechanical freeze-drying system with a thermal spray drying system. This substitution uses atomization and rapid evaporation instead of freezing and sublimation, dramatically reducing processing time while cyclodextrin complexes protect the bacteriophages from thermal damage.
3Ease of operation
If bacteriophages are produced in liquid formulation, then ease of administration is improved, but storage stability at room temperature deteriorates
Solution Approach 1:
The patent utilizes phase transition by converting the bacteriophage formulation from liquid to dry powder form through spray drying. The cyclodextrin inclusion complexes enable this phase transition while preserving bacteriophage activity, allowing stable room temperature storage with reconstitution to liquid form before administration.
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
This approach significantly enhances the stability of bacteriophages during the spray drying process, maintaining high activity levels in the dry compositions and enabling their use in solid oral dosage forms.
Implementation Method 1
The use of α-linked polymeric glucose and polyols, such as sucrose, in combination with bacteriophages, stabilizes the compositions during spray drying
Implementation Method 2
In spray drying a liquid feed is atomized into very small droplets that are dried in a hot air stream
Implementation Method 3
a liquid feed is atomized into very small droplets
Data Source
AI summary
The present invention relates to a bacteriophage composition comprising at least one bacteriophage species, at least one α-linked polymeric glucose and at least one polyol. In certain embodiments, the α-linked polymeric glucose has a mean molecular weight of greater than 10 kDa.