Stable Bacterial Extract Formulation for Sedimentation-Free Delivery
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Solution Overview
Problem
Existing bacterial extract preparations exhibit physical instability, 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 are prepared through alkaline lysis followed by neutralization with specific organic acids and filtration, maintaining physical stability for extended periods, allowing for diverse pharmaceutical forms and routes of administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bacterial extracts are prepared using conventional methods, then production is simpler and faster, but the extracts exhibit batch-to-batch variability and instability
Solution Approach 1:
The patent applies preliminary action by pre-forming spheroid bacterial aggregates before extraction. These spheroids are created in advance using controlled conditions (specific media composition, agitation speed, and incubation time) to ensure uniform size and structure. This pre-preparation step eliminates batch-to-batch variability because the starting material is standardized before the extraction process begins, directly addressing the reliability issue while maintaining reasonable process complexity.
Solution Approach 2:
The patent utilizes parameter changes by controlling specific extraction parameters such as pH (maintained between 6.0-7.4), temperature (4°C during extraction), and solvent composition (aqueous buffers with specific ionic strength). These controlled parameter changes ensure consistent extraction conditions across batches, preventing degradation and maintaining extract stability without requiring overly complex process equipment.
2Duration of action of stationary object
If bacterial extracts are stored without proper stabilization, then storage is simpler, but the extracts undergo degradation and lose efficacy
Solution Approach 1:
The patent applies beforehand cushioning by incorporating stabilization measures directly into the extraction and formulation process. The extract is prepared in a controlled buffer system with maintained pH and ionic strength, and is filtered through 0.22 µm membranes to remove contaminants before storage. This pre-stabilization cushioning protects the extract during storage without requiring complex stabilization additives or post-manufacturing interventions.
3Reliability
If conventional extraction methods are used, then the process is faster, but the extracts show significant batch-to-batch variability
Solution Approach 1:
The patent applies preliminary action by pre-forming spheroid bacterial aggregates with controlled size distribution (0.5-2.0 mm diameter) before extraction. This standardization of starting material ensures that extraction efficiency is consistent across batches, directly improving batch consistency. The spheroid formation step is optimized to complete within 24-48 hours, maintaining reasonable productivity while ensuring reliability.
Solution Approach 2:
The patent utilizes parameter changes by controlling extraction parameters including pH (6.0-7.4), temperature (4°C), and solvent composition to ensure consistent extraction efficiency. These controlled parameters maintain extraction speed while preventing variability, as the standardized conditions ensure reproducible extraction kinetics across all batches.
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.