Spherically Agglomerated Lactose for DPI Lung Deposition
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Solution Overview
Problem
Current dry powder inhalers (DPIs) face challenges in achieving homogeneous distribution and optimal lung deposition of active pharmaceutical ingredients (APIs) due to high cohesion forces between small API particles and carrier materials, leading to inadequate dosing accuracy and lung deposition efficiency.
Innovation Solution
A powder composition comprising spherically agglomerated lactose particles with radially arranged prism-like lactose particles, which adsorb APIs homogeneously, even at high concentrations, allowing for excellent lung deposition without the need for complex mixtures of carrier materials, and are prepared through a process involving lactose solutions, non-solvents, and optional additives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If small API particles are used to reach deeper lung regions, then lung deposition is improved, but cohesion forces increase leading to poor workability and dosing accuracy
Solution Approach 1:
Lactose carrier particles serve as an intermediary between API particles and the environment. The carrier particles with controlled surface properties mediate the interaction between API particles and airflow, enabling small API particles to be handled effectively while maintaining their lung-deposition capability. The carrier reduces cohesive forces between API particles through proper surface characterization.
Solution Approach 2:
The invention changes physical parameters of the carrier particles, specifically surface area and surface energy, to optimize API interaction. By controlling these parameters, the system achieves both good workability (reduced cohesion) and effective lung deposition (sufficient adhesion).
2Ease of operation
If carrier particles are used to reduce cohesive forces, then workability and dosing accuracy are improved, but adhesion strength between carrier and API must be precisely balanced
Solution Approach 1:
The invention systematically adjusts carrier particle parameters (surface area, surface energy) to achieve the optimal adhesion balance. This transforms a complex balancing act into a controlled parameter optimization process, simplifying the formulation development.
3Reliability
If complex mixtures of carrier materials are used to saturate active sites, then adhesion control is improved, but preparation effort and system complexity increase
Solution Approach 1:
The invention extracts and addresses the root cause of adhesion problems by focusing on carrier surface characterization rather than using complex mixtures. By taking out the surface properties as the key control parameter, the system achieves adhesion control with simpler, single-component carriers.
Solution Approach 2:
Instead of changing the chemical composition to complex mixtures, the invention changes physical parameters (surface area, surface energy) of simple carriers to achieve the desired adhesion control, thereby simplifying manufacturing.
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 composition ensures homogeneous API distribution and high lung deposition efficiency, with improved dosing accuracy and flexibility in API loading, achieving optimal deposition in deeper lung regions.
Implementation Method 1
spherically agglomerated lactose particles comprising radially arranged prism-like lactose particles adsorb APIs homogeneously
Data Source
AI summary
The invention relates to a powder composition comprising spherically agglomerated lactose particles comprising radially arranged prism-like lactose particles, at least one active pharmaceutical ingredient (API) and optionally at least one additive, its manufacture and its use for inhalation applications.