Stabilized Bacterial Extract Formulations for Clear Liquid Dosing
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Solution Overview
Problem
Existing bacterial extract formulations are physically unstable, leading to sedimentation and precipitation, which limits their use in alternative pharmaceutical forms and administration routes such as intranasal, pulmonary, and intratracheal, and poses challenges in manufacturing and storage, affecting regulatory approval and patient convenience.
Innovation Solution
Stabilized bacterial extract formulations prepared by alkaline lysis and neutralization with specific organic acids, followed by filtration and pH adjustment, ensuring improved physical stability under various conditions, allowing for diverse pharmaceutical forms and routes of administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If bacterial extracts are formulated in liquid or alternative forms, then ease of administration and patient convenience are improved, but physical stability deteriorates due to sedimentation and precipitation
Solution Approach 1:
The patent applies parameter changes by modifying the chemical composition parameters of the bacterial extract formulation. Specifically, it adjusts the concentration of excipients, pH levels, and buffer compositions to optimize physical stability while maintaining the extract's bioactivity in liquid and alternative formulations suitable for various administration routes.
Solution Approach 2:
The patent employs composite materials by creating a multi-component formulation system that combines bacterial extract with carefully selected excipients, stabilizers, and buffer systems. This composite approach prevents sedimentation and precipitation while enabling the development of liquid formulations, inhalable powders, and other alternative dosage forms that improve ease of administration.
2Adaptability or versatility
If bacterial extracts are used in alternative pharmaceutical forms and administration routes, then adaptability and versatility are improved, but manufacturing complexity increases due to stability challenges
Solution Approach 1:
The patent applies universality by developing a standardized stable formulation platform that can be adapted across multiple administration routes and pharmaceutical forms. The core stabilized bacterial extract composition serves as a universal base that can be processed into liquid formulations for injection, inhalable powders for respiratory delivery, and other alternative dosage forms, reducing manufacturing complexity through platform technology.
Solution Approach 2:
The patent implements preliminary action by pre-stabilizing the bacterial extract through optimized formulation development and stability testing before scaling to manufacturing. This preliminary stabilization work establishes robust formulation parameters and processing protocols that simplify subsequent manufacturing operations across different pharmaceutical forms and administration routes.
3Duration of action of stationary object
If bacterial extracts are stored for extended periods, then duration of action is improved, but stability deteriorates due to aggregation and precipitation
Solution Approach 1:
The patent applies continuity of useful action by implementing a continuous stabilization strategy that maintains formulation integrity throughout the entire storage duration. This involves selecting excipients and buffer systems that continuously prevent aggregation and precipitation, along with establishing appropriate storage conditions that maintain compositional stability over extended periods, thereby enabling long-term storage while preserving bioactivity.
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 stabilized bacterial extracts maintain clarity and prevent aggregation for extended periods, facilitating broader administration routes, enhancing manufacturing processes, and ensuring precise dosing with user-friendly delivery devices, improving treatment adherence and patient convenience.
Implementation Method 1
The present invention relates to a stable purified bacterial extract obtainable by alkaline lysis of one or more bacterial species
Implementation Method 2
followed purification by filtration of the neutralized bacterial extract
Data Source
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AI summary
The present invention relates to novel stable bacterial extract preparations having substantial increased stability overtime, novel methods of preparation thereof, pharmaceutical formulations based on these novel stabilized bacterial extracts, as well as novel routes of administration and delivery devices for treating and/or preventing acute and chronic immunological disorders resulting from infections and/or inflammation and/or neoplasms and/or dysbiosis.