Solid Dosage Forms for Bacteria Delivery via Lyophilization

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Solution Overview

Problem

The formulation of solid dosage forms for pharmaceutical products often affects the bioavailability of active ingredients, and existing formulations may not effectively utilize bacteria or microbial extracellular vesicles (mEVs) to achieve optimal therapeutic effects.

Innovation Solution

Development of solid dosage forms comprising a pharmaceutical agent with a mass percentage ranging from 5% to 95%, including bacteria such as Prevotella histicola or Veillonella parvula, and microbial extracellular vesicles, combined with diluents, lubricants, and glidants, specifically designed to enhance bioavailability and systemic effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bacteria or microbial extracellular vesicles are incorporated into solid dosage forms, then therapeutic effects and bioavailability are improved, but formulation stability and manufacturing complexity increase

Engineering Contradiction:

Improvetherapeutic effectVSAvoidformulation complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs carrier materials (such as sugars, starches, celluloses, and polymers) as intermediaries to deliver bacteria or mEVs to target sites. These carriers facilitate the incorporation and stable formulation of sensitive biological agents while maintaining therapeutic efficacy and enabling standard manufacturing processes.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Quantity of substance

If high concentrations of bacteria or mEVs are used to improve bioavailability, then therapeutic effectiveness increases, but formulation stability and bacterial viability decrease

Engineering Contradiction:

ImprovebioavailabilityVSAvoidformulation stability

Core Design Contradiction:

Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent utilizes lyophilization (freeze-drying) to change the physical state of bacteria or mEVs from liquid/suspension form to a stable frozen-dried powder. This parameter change enables high concentrations to be maintained in solid dosage forms while preserving viability and stability during storage and manufacturing.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs phase transition through lyophilization, where water is removed from the bacterial or mEV suspension by freezing and vacuum sublimation. This phase change creates a stable amorphous or crystalline matrix that maintains biological activity while enabling long-term storage and formulation stability.

Inventive Principle:

Principle #36Phase transitions

3Ease of manufacture

If conventional solid dosage form formulation methods are used, then manufacturing simplicity is maintained, but bioavailability and therapeutic effectiveness are reduced

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidbioavailability

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent performs preliminary actions by pre-freezing the bacterial or mEV suspension and then applying vacuum sublimation to remove water before final formulation. This preliminary preparation creates a stable, pre-processed material that can be easily incorporated into conventional solid dosage forms while maintaining high bioavailability and therapeutic effectiveness.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20230372409A1Solid dosage forms of bacteria

Publication Date: 2023.11.23 EVELO BIOSCIENCES INC

AI summary

Methods and compositions related to solid dosage forms that facilitate the oral delivery of bacteria and/or agents of bacterial origin are provided herein.