Mannitol Carrier Particles for Dry Powder Inhalation
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Solution Overview
Problem
Existing dry powder inhalation formulations face challenges in maintaining good flow properties and achieving high doses of active ingredients without forming uneven agglomerates, which affects the uniformity and aerosol performance of the drug delivery.
Innovation Solution
The use of melt-spray solidified mannitol carrier particles with a specific size range and shape factor, produced through a spray congealing process, which improves flowability and allows for high doses of active ingredients without the need for fine excipient particles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fine excipient particles are added to promote drug particle release from carrier, then respirable fraction increases, but flowability deteriorates
Solution Approach 1:
The invention extracts and eliminates the need for fine excipient particles by redesigning the carrier particle properties. The carrier particles are engineered with optimized size (30-300 micrometers) and surface characteristics that enable effective drug release without requiring additional fine particles, thus resolving the contradiction between respirable fraction and flowability
Solution Approach 2:
The invention changes the physical parameters of the carrier particles, specifically size distribution (30-300 micrometers) and shape factors, to optimize both drug release and flow properties. This parameter optimization allows the system to achieve good respirable fraction without the negative flowability effects caused by fine excipients
2Quantity of substance
If high doses of active ingredient are formulated, then therapeutic effectiveness increases, but formation of uneven agglomerates increases
Solution Approach 1:
The invention applies local quality by creating heterogeneous carrier particle populations with different size ranges (30-300 micrometers) that can accommodate varying drug loads. Larger carriers handle higher drug quantities while maintaining proper distribution, preventing agglomerate formation even at high doses
Solution Approach 2:
The invention uses composite structures where micronized drug particles are associated with carrier particles of specific size and shape characteristics. This composite approach allows high drug doses to be distributed uniformly across the carrier matrix, maintaining manufacturing precision while achieving therapeutic effectiveness
3Ease of operation
If carrier particles are used to improve flowability of micronized powder, then handling ease improves, but adhesion strength between drug and carrier must be optimized
Solution Approach 1:
The invention optimizes carrier particle parameters including size (30-300 micrometers) and shape factors to achieve the right balance between flowability and drug detachment. The enlarged carrier size improves flow properties while controlled surface characteristics ensure adequate adhesion for handling and efficient detachment during inhalation
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 solution provides improved flow characteristics and high homogeneity of active ingredients, enabling effective delivery of high doses with enhanced aerosol performance and stability, as evidenced by high respirable fractions and physical stability of the formulations.
Implementation Method 1
spray congealing process
Implementation Method 2
heating mannitol until complete melting; spraying the molten mannitol... into the spray congealing chamber to obtain droplets; cooling the droplets to induce solidification and particle formation
Data Source
Figure 1
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Figure 4
AI summary
The present invention concerns carrier particles suitable for use in dry powder formulations for inhalation. The invention also relates to processes for their preparation by spray-congealing.