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Inhaled preparations have become a popular track for the delivery of respiratory diseases, macromolecular drugs, and vaccines due to their advantages of direct administration to the lungs, fast onset of effect, and minimal systemic side effects. However, behind the hot research and development, a large number of projects are stuck at the threshold of process amplification, powder quality, and safety and compliance . From laboratory experiments to commercial production, dry powder inhalants have put forward strict requirements on particle size, particle size distribution, material stability, and production safety. Traditional open spray drying has become increasingly difficult to meet the development needs of high-end inhalation preparations. How to break through process barriers and achieve stable, safe, and scalable powder production has become a common topic in the industry.
The global market continues to expand
Global inhaled preparations market sales in 2024
$ 44.45 billion
It is expected to reach US$63.9 billion in 2031 , with a compound annual growth rate (CAGR) of 5.4% (2025-2031)
*Data source: Statistics and forecasts from QYR (QYResearch)
Inhaled preparations are in a double dividend period of global expansion and the outbreak in China. As domestic technology matures and favorable policies are released, local companies will usher in strategic opportunities to seize market share and achieve leapfrog development.
“Powder Anxiety” for Inhaled Preparations
The core of inhalation preparations, especially dry powder inhalers (DPI), is " powder ". Drugs must be accurately delivered deep into the lungs with a specific particle size distribution (usually 1-5 μm ) to be effective. If the particle size is too large, the drug will be deposited in the mouth and throat, which is not only ineffective but may also cause side effects; if the particle size is too small, the drug may be exhaled out of the body and unable to reside in the lungs.
*The picture shows the measured particle size in Qiao Feng’s inhalation preparation experiment
This means that each parameter of the powder's particle size distribution, shape, density, and fluidity is directly related to efficacy and safety. But the reality is that from milligram-level samples in laboratory beakers to kilogram-level mass production on the production line, the stability of powder quality has always been an insurmountable hurdle.
1Particle size control is difficult
Traditional open spray drying is greatly affected by environmental humidity and temperature fluctuations, and the particle size distribution fluctuates significantly between batches, making it difficult to meet the strict requirements for FPF (fine particle fraction) of inhalation preparations.
2Difficulty in recycling organic solvents
Many inhalation formulations involve organic solvent systems. Open systems cannot effectively recycle solvents, which is wasteful and poses safety risks. They also face increasingly stringent environmental compliance pressures.
3Deactivation of heat-sensitive materials
Inhalation preparations of biological macromolecules such as peptides and proteins are extremely sensitive to temperature. Traditional high-temperature drying methods can easily lead to the degradation of active ingredients and greatly reduce their bioavailability.
4Cross-contamination risk
In the R&D and production mode of multiple varieties and small batches, the thoroughness of equipment cleaning directly affects the purity of the product, and the dust escape from the open system increases the risk of cross-contamination.
Closed loop: a technology path revisited
Faced with the above dilemma, the industry began to turn its attention back to a "new solution to the old technology" - closed cycle spray drying . Different from the traditional open system, closed cycle spray drying uses inert gas (such as nitrogen) as the circulation medium to form a closed negative pressure mechanism circulation system during the entire drying process. This seemingly simple change has brought about a multi-dimensional process improvement:
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A jump in security
Closed circulation of organic solvents eliminates the risk of explosion, and the solvent recovery rate can reach more than 95%
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Controllable quality
The inert atmosphere isolates oxygen and moisture, significantly improving the activity retention rate of heat-sensitive drugs.
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Precise particle size
The temperature and humidity controllability is much higher than that of the open system, the particle size distribution is narrower, and the FPF index is more stable.
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Compliance friendly
Fully sealed design, 316L stainless steel, CIP online cleaning, meeting GMP compliance requirements
Shanghai Qiao Feng: The "hidden champion" of domestic equipment
With closed cycle spray drying technology as the core, we are committed to making the production of inhaled preparations safer and more compliant. Its closed-cycle spray drying production solution focuses on five core advantages:
1 Nitrogen protection fully closed cycle
Safe and explosion-proof, isolates oxidation and protects drug activity. Nitrogen is used as the circulating medium to achieve fully enclosed operation and fundamentally eliminate the risk of organic solvent explosion.
2 Efficient recovery of organic solvents
The solvent recovery rate is ≥95% and the powder recovery rate is ≥98% . The solvent residue can be adjusted and adapted to various solvent limit indicators, significantly reducing material loss and achieving green, safe and cost reduction.
3 Precise control of powder particle size
Stably matches the 1-5 μm particle size range of the key indicators of inhalation preparations to ensure that the fine particle fraction (FPF) reaches the standard and ensures the final drug performance of the preparation.
4 Modular design
The seamless connection between small-scale testing, pilot testing and industrialization, and the process is stable and can be scaled up, helping companies shorten the cycle from R&D to industrialization and reduce the risk of scale-up.
5 GMP level standardized equipment
Equipped with an intelligent control system, the process parameters can be traced throughout the entire process, meeting GMP-level standardization requirements and providing a solid guarantee for drug production quality management.
It is not only the delivery of hardware equipment, but also the provider of exclusive process solutions . Help customers open up the matching relationship between prescription-equipment-process .
Above the powder, see the future
The domestic substitution of inhaled preparations is not just a matter of formulation, nor is it just a matter of particle size. It requires systematic collaboration of particle engineering, equipment manufacturing, process control, and GMP compliance. When the industry moves from "can do it" to "can do it stably, on a large scale, and in compliance", the upgrade of production equipment will become a key variable.
With closed cycle spray drying technology as its core, Shanghai Qiao Feng is committed to opening up the critical path from laboratory to industrialization for inhalation preparation companies.
Make the production of inhaled preparations safer and more compliant.
Let innovative inhalation preparations be launched faster.
Let every microgram of medicine reach exactly where it should go.
Tel: 17317246351
Mailbox: sales@qfn17.com
URL: http://m.huafenglvye.com
Address: Shanghai fengxian canal north road no. 1185
