17-OHPC Powder Particle Size Control via High-Pressure Homogenization
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Solution Overview
Problem
Current methods for achieving desirable particle sizes and maintaining crystallinity in pharmaceutical inhalants, such as 17-alpha-hydroxyprogesterone caproate (17-OHPC), face challenges with particle size control, contamination, and structural changes during milling processes, which affect the efficacy and stability of the final product.
Innovation Solution
The use of high-pressure homogenization (HPH) combined with spray drying to reduce the particle size of 17-OHPC to a range of 1-10 microns, maintaining its crystalline structure and minimizing impurities, while achieving a suitable particle size distribution for inhalation delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If milling processes are used to reduce particle size of 17-OHPC, then particle size is reduced, but crystalline structure is altered and impurities are generated
Solution Approach 1:
The patent replaces traditional mechanical milling processes with high-pressure homogenization technology. This substitution uses hydraulic pressure and cavitation effects instead of mechanical grinding forces, thereby achieving particle size reduction while preserving the crystalline structure of 17-OHPC and minimizing impurity generation.
Solution Approach 2:
The patent changes the processing parameters from mechanical force-based milling to pressure-based homogenization. By controlling pressure parameters (high pressure followed by rapid release) and using cavitation effects, the system achieves fine particle size (1-10 microns) while maintaining the original crystalline properties of the pharmaceutical compound.
2Length of moving object
If milling processes are used to reduce particle size of 17-OHPC, then particle size is reduced, but contamination occurs
Solution Approach 1:
The patent replaces mechanical milling with high-pressure homogenization, eliminating contact between the pharmaceutical substance and milling media that cause contamination. The homogenization process uses fluid pressure and cavitation in a closed system, preventing introduction of external contaminants while achieving the desired particle size reduction.
3Productivity
If particle size is reduced for inhalation delivery, then delivery efficacy is improved, but manufacturing precision becomes more difficult
Solution Approach 1:
The patent employs feedback control in the high-pressure homogenization process by monitoring particle size distribution and adjusting pressure parameters accordingly. This allows precise control of the final particle size within the 1-10 micron range required for optimal inhalation delivery, ensuring consistent manufacturing quality.
Solution Approach 2:
The patent optimizes multiple parameters including pressure magnitude, pressure duration, number of homogenization cycles, and cavitation conditions to achieve precise particle size control. By systematically adjusting these parameters, the process reliably produces particles in the 1-10 micron range with narrow size distribution, meeting inhalation delivery requirements.
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
This approach results in a therapeutically effective powder composition with optimal particle size and crystallinity, enhancing the delivery and stability of 17-OHPC for treating glucocorticoid-insensitivity related diseases and IL-17 cytokine-mediated auto-inflammatory conditions.
Implementation Method 1
The manufacture of 17-OHPC powder involves applying cavitational forces on formulations containing 17-OHPC through repeating cycles of high pressure homogenization
Implementation Method 2
followed by spray drying
Data Source
AI summary
The present invention relates to a pharmaceutical formulation powder that contains 17α-hydroxyprogesterone caproate (17-OHPC) powder and the method of producing the formulation produces particles that are suitable as an inhalant. The formulations, methods and kits of powdered 17-OHPC as taught herein may be used to reduce cytokine interleukin-17 (IL-17 or IL-17A) levels in both broncheoalveolar lavage fluid (BALF) and blood/serum and involve the inhibition of p38 mitogen activating protein kinase (MAPK) activity. The 17-OHPC powder formulation may be used in a method to treat IL-17 cytokine and/or p38 MAPK mediated auto-immune and auto-inflammatory diseases. Such diseases may include glucocorticoid (GC) insensitive related diseases or conditions. In alternate embodiment, the formulation may include the combined use of budesonide (BUD) and/or fluticasone with 17-OPHC.