Spray-Dried Dry Powder Inhalation Formulation
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Solution Overview
Problem
Current inhalation formulations for respiratory therapy face challenges in chemical stability, limited availability of effective combinations of drugs, and compatibility issues with different administration methods, leading to restricted use scenarios and limited industrial production viability.
Innovation Solution
A pharmaceutical composition comprising a combination of spray-dried powders with high active agent loading, leucine, and sugars like lactose or maltodextrin, along with surfactants, which ensures high fine particle fraction and delivery efficiency, stability, and compatibility with various inhalation devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If inhalation formulations are developed for different administration methods (nebulizer, powder inhaler, pressurized inhaler), then patient flexibility and adaptability are improved, but formulation complexity and manufacturing difficulty increase
Solution Approach 1:
The patent develops a universal dry powder formulation that can be administered through multiple device types (powder inhalers, pressurized inhalers, and potentially nebulizers). This single formulation approach eliminates the need to create separate formulations for each device type, reducing overall formulation complexity while maintaining patient flexibility across different administration methods
Solution Approach 2:
The formulation is segmented into distinct functional components: active pharmaceutical ingredient, carrier particles, and excipients. This segmentation allows each component to be optimized independently for its specific function while maintaining compatibility across different inhalation device types, thereby reducing formulation complexity
2Stability of the object's composition
If chemical stability of inhalation formulations is improved through various excipients and formulation strategies, then shelf life is extended, but formulation complexity and manufacturing difficulty increase
Solution Approach 1:
The patent extracts and eliminates harmful atmospheric agents (moisture, oxygen) from the formulation environment through the use of a hydrophobic carrier and protective excipients. This extraction approach provides chemical stability without requiring complex multi-component formulations, thereby maintaining manufacturing simplicity while extending shelf life
Solution Approach 2:
The patent converts the naturally hydrophobic properties of the carrier material into a beneficial protective mechanism that shields the active ingredient from moisture and oxidation. This approach achieves chemical stability through the inherent properties of selected materials rather than through complex formulation strategies, reducing manufacturing difficulty
3Quantity of substance
If high active agent loading is achieved in spray-dried powders, then deliverability and therapeutic efficacy are improved, but manufacturing precision and control difficulty increase
Solution Approach 1:
The patent optimizes spray drying parameters (inlet temperature, outlet temperature, feed rate, atomization pressure) to achieve consistent high active agent loading while maintaining manufacturing control. By systematically adjusting these parameters, the process achieves high therapeutic efficacy without sacrificing manufacturing precision
Solution Approach 2:
The patent implements process monitoring and control during spray drying to maintain consistent active agent loading. Through feedback control of critical process parameters, the manufacturing process achieves high precision despite high active agent concentrations, ensuring reproducible therapeutic efficacy
4Reliability
If fine particle fraction is increased for deep lung penetration, then respirability and therapeutic efficacy are improved, but manufacturing precision and particle size control difficulty increase
Solution Approach 1:
The patent adjusts spray drying parameters (atomization pressure, drying temperature, feed concentration) to control particle size distribution and achieve a high fine particle fraction suitable for deep lung penetration. These parameter changes enable respirability optimization while maintaining manufacturing precision through systematic process control
Solution Approach 2:
The patent performs preliminary optimization of formulation composition and spray drying parameters before full-scale manufacturing. This preliminary action establishes the optimal parameter range that ensures consistent fine particle fraction and respirability, thereby maintaining manufacturing precision while achieving deep lung penetration
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 achieves high stability and deliverability of active agents to the deep lung, allowing for flexible administration methods and improved industrial production feasibility, enhancing patient convenience and therapeutic efficacy.
Implementation Method 1
spray drying to increase the stability of the formulation
Data Source
AI summary
The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration deliverable as such with an inhaler and provided with high deliverability, respirability and stability. In particular, the invention relates to a pharmaceutical composition for inhalation in the form of powder comprising at least a first and a second powder, in which at least said first powder contains an active agent in an amount greater than 1% by weight with respect to the weight of said first powder. Both the powders comprise leucine in an amount ranging from 5 to 70% by weight with respect to the weight of each powder and a sugar in an amount ranging from 20 to 90% by weight with respect to the weight of each powder. The composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 80.