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Zhejiang Canaan Technology Co., Ltd
Case of Budesonide Enteric coated Capsules (Part 1) - Analysis of Drug Packaging on Fluidized Bed
Date: 2025-10-09Read: 1
One pill is about the hope of millions of IgA nephropathy patients.
When budesonide enteric coated capsules were included in medical insurance but were difficult to obtain, we realized that the breakthrough in new drug development was only the first step, and whether it could be stably mass-produced was the key to truly determining the patient's medication lifeline.
In the global field of kidney disease treatment, budesonide enteric coated capsules are like a "precision guided" drug missile, becoming the preferred treatment for primary IgA nephropathy. It revolutionizes the targeted release of lesions, greatly avoiding the systemic side effects of traditional hormones and providing patients with safer and more effective treatment options. However, since the drug entered the medical insurance in 2025, the demand for it has rapidly increased,However, due to complex production processes and high equipment requirements, it faces severe capacity bottlenecks.
Canaan Technology, based on mature solid formulation equipment technology and years of project accumulation, has launched a product around this varietyA full chain solution from pellet coating to capsule moldingAnd provideKey process support from experimentation to mass productionTo assist pharmaceutical companies in stabilizing production expansion and ensuring patients' access to medication.
This article will revolve aroundDrug packaging on fluidized bedElaborate on the solution of budesonide enteric coated capsules.
C·Why is this medicine so special❔
The reason why budesonide enteric coated capsules are difficult to produce is that,Originating from its complex three-layer sustained-release structure and precise enteric coating process.It uses TARGIT ™ Patent technology ensures that drugs are only released at the terminal ileum (core lesion area of IgA nephropathy).
This design reduces the systemic exposure of the drug to less than 1% of traditional oral hormones, greatly improving medication safety,But it also places extremely high demands on the production process.
C· Behind the bottleneck of production capacity is the bottleneck problem of technology and equipment
The production of enteric coated preparations not only has a high technical threshold, but also relies on highly customized equipment. Especially the fluidized bed coating process directly determines the uniformity of coating, consistency of dissolution behavior, and final efficacy of microspheres.
Traditional devices often face:
✖ Insufficient fluidization of microspheres and uneven coating thickness;
✖ The craftsmanship relies on the experience of experienced craftsmen, and the batch stability is poor;
✖ Insufficient precision in temperature and humidity control affects the success rate of coating.
And these are precisely the technological cores that Canaan Technology is striving to break through.
C· Fluidized bed coating technology: four breakthroughs to ensure precise drug release
Regarding the production difficulties of budesonide enteric coated capsules, Canaan proposes four core solutions supported by technical equipment:
✅ Uniform air distribution technology
By utilizing digital micrometer level gap control technology with multiple guide tubes, the pellets can be fluidized in all directions and visualized, ensuring consistent movement trajectory and uniform coating weight gain for each pellet, thus guaranteeing precise drug release from the root.
✅ Intelligent control system
Break the dependence on human experience and achieve one click startup and batch consistency. The system comes with batch management and traceability functions to ensure process reproducibility and drug quality stability.
✅ Customized atomization system
We provide specialized atomization solutions for different coating liquid properties to ensure even distribution of droplets, suitable for difficult formulations, and provide customers with tailored services.
✅ High precision environmental control
Integrating multiple types of sensors to achieve precise control of key parameters such as temperature (± 1 ℃), air volume (± 5%), and humidity (± 0.5g/kg), providing a stable environment for the coating process.
C· Looking at the Advanced Path of Chinese Pharmaceutical Equipment from the Perspective of "One Pill"
The supply crisis of budesonide enteric coated capsules reflects the deep challenge of China's pharmaceutical industry moving from "imitation" to "innovation" and from "having drugs that can be treated" to "having drugs that can be used".
Canaan Technology is committed toDual output of overall process equipment solution and technical servicesTo help pharmaceutical companies break through production bottlenecks and accelerate the landing of domestic high-end formulations.
We look forward to, with the support of intelligent pharmaceutical equipment,
More life-saving drugs like budesonide can achieve stable and efficient production,
Let patients no longer be anxious about "discontinuing medication",
Let 'Healthy China 2030' truly become a reality accessible to every patient.
C· Not only providing equipment, but also providing validated process paths and case support
Canaan Technology knows very wellThe key to mass production of "high-end preparations" lies not only in equipment, but also in process know-how and project experienceTherefore, we:
✔ Building an integrated experimental platform and pharmaceutical research platform
At Canaan Technology Solid Formulation Testing Center, we provide one-stop services including pharmaceutical research, pharmaceutical technology innovation and development, drug productization development, process improvement and standard enhancement, consistency evaluation, laboratory equipment and engineers. Customers can complete the entire process simulation testing from drug research and development, testing to mass production, obtain reliable process parameters, and significantly shorten the production line construction cycle.
✔ Output mature case experience
We have assisted multiple pharmaceutical companies in completing pilot testing and large-scale production of various high-end formulations, covering prescription optimization, process transfer, and full line operation, ensuring seamless transition from "small-scale testing" to "mass production" of projects.
✔ Provide customized solutions
Canaan can flexibly configure equipment solutions to meet the production capacity needs of different customers, supporting rapid expansion and compliance declaration.