Respirable Dry Powders With Composite Core-Shell Structure
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Solution Overview
Problem
Current dry powder technologies for respiratory drug delivery, such as lactose carrier particle blends and porous particles, face limitations including low therapeutic agent density, poor processability, and non-uniform dosing, while active inhalers suffer from durability issues and patient compliance problems due to their complex design.
Innovation Solution
Development of respirable dry powders with a volume median geometric diameter of 10 micrometers or less, high tap density, and high therapeutic agent content, using metal cation salts like sodium, potassium, or calcium salts, which are highly processable and dispersible, allowing for efficient delivery of therapeutic agents directly to the respiratory tract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If lactose carrier particle blends are used for deagglomeration and aerosolization, then therapeutic agent dispersibility is improved, but therapeutic agent density per unit volume decreases and loss of therapeutic agent increases
Solution Approach 1:
The invention uses composite particles comprising a porous core and a non-porous shell, combining the advantages of both porous structures (high surface area, good dispersibility) and non-porous structures (high density, low loss). The porous core provides deagglomeration and aerosolization capability, while the non-porous shell maintains high therapeutic agent density and prevents loss during inhalation.
Solution Approach 2:
Different regions of the particle have different properties: the core is porous to enable dispersibility, while the shell is non-porous to maintain density and prevent loss. This local differentiation of properties resolves the contradiction between dispersibility and density.
2Stability of the object's composition
If porous particles are used to achieve homogeneous dry powder, then powder homogeneity is improved, but mass density and processability deteriorate
Solution Approach 1:
The composite particle structure with porous core and non-porous shell achieves both homogeneity (through controlled porous structure) and high mass density (through the dense shell), resolving the contradiction between these two properties.
Solution Approach 2:
The particle exhibits local quality differentiation where the core provides homogeneity through porosity while the shell provides high density, thereby resolving the contradiction between powder homogeneity and mass density.
3Manufacturing precision
If active inhalers with energy sources are used to disperse dry powder, then dispersibility of poorly dispersible powders is improved, but device complexity and durability worsen
Solution Approach 1:
The composite particles are designed to self-disperse through their inherent porous core structure when subjected to inhalation flow, eliminating the need for active energy sources in the device. The particle structure itself provides the dispersibility function, reducing device complexity.
Solution Approach 2:
The invention extracts the active energy source from the inhaler device, relying instead on the passive dispersal capability of the composite particle structure driven by patient inhalation, thereby simplifying the device.
4Quantity of substance
If large volume dry powder is used to deliver effective dose with porous particles, then therapeutic agent delivery is improved, but device size and patient compliance worsen
Solution Approach 1:
The composite particles with high mass density enable delivery of effective therapeutic doses in smaller volumes compared to purely porous particles, allowing for more compact device design while maintaining therapeutic efficacy.
Solution Approach 2:
The non-porous shell provides high density to reduce volume requirements, while the porous core maintains dispersibility, thereby enabling effective dose delivery in compact form.
Data Source
AI summary
The invention related to dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutics agents to patients.