Golf-Ball Microparticle Structure for Stable Dry Powder Inhalation
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Solution Overview
Problem
Existing dry powder inhaler systems face challenges in achieving uniform and homogeneous deposition of active pharmaceutical ingredients (APIs) throughout the lungs, with issues related to flight stability, Fine Particle Fraction, and increased stickiness, particularly in formulations using deflated-ball like microparticles.
Innovation Solution
The development of golf-ball like microparticles with a core-shell structure, featuring a carrier shell and API core, and characterized by symmetrical golf-ball like surface depressions, enhances aerodynamic stability and reduces stickiness, resulting in improved Fine Particle Fraction and uniform lung deposition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If deflated-ball like microparticles are used in dry powder inhaler systems, then the particle morphology is simplified, but flight stability deteriorates and Fine Particle Fraction decreases
Solution Approach 1:
The patent applies spheroidality by designing microparticles with a spherical core structure rather than deflated-ball morphology. This spherical geometry provides superior aerodynamic properties and flight stability during inhalation delivery, directly resolving the contradiction between morphological simplicity and flight reliability.
2Ease of manufacture
If deflated-ball like microparticles are used, then manufacturing is simpler, but Fine Particle Fraction is reduced
Solution Approach 1:
The patent employs nested doll principle by creating a core-shell structure where a spherical core containing the API is nested within a carrier shell. This nested architecture enables precise control over particle size distribution and generates the required Fine Particle Fraction while maintaining manufacturability through controlled aggregation of spherical units.
3Quantity of substance
If conventional dry powder systems with lactose carriers are used, then API delivery is achieved, but uniform deposition throughout the lungs is limited to around 30%
Solution Approach 1:
The patent applies local quality principle by engineering the carrier shell with specific local characteristics including surface charge distribution, porosity gradients, and functional group placement. These localized variations in carrier properties enhance API release patterns and promote uniform deposition throughout different lung regions, overcoming the limitation of conventional lactose carriers.
4Adaptability or versatility
If rough particle surfaces with projections and pores are created, then cell and tissue interactions are enhanced, but particle stickiness increases
Solution Approach 1:
The patent employs flexible shells and thin films principle by creating a thin, controlled-carrier shell that encapsulates the spherical API core. This shell provides a balanced surface that enables adequate cell and tissue interactions while maintaining low stickiness through controlled surface properties and preventing excessive aggregation 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 golf-ball like microparticles demonstrate enhanced flight stability and increased Fine Particle Fraction, leading to more effective and uniform delivery of APIs to the lungs, particularly for treating respiratory diseases such as asthma, COPD, pulmonary fibrosis, pneumonia, and lung cancer.
Implementation Method 1
spray-drying of a liquid formulation
Implementation Method 2
obtained by atomization of nanosuspensions of nanoparticles or solutions
Data Source
Figure 1A~2
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Figure 6~7
AI summary
The present invention relates to a method to prepare golf ball like microparticles by spray drying of nanosuspensions of nanoparticles or solutions for dry powder inhalers for use in the treatment and prevention of pulmonary diseases.