Soongon Tech AutoBio2000 supported China Pharmaceutical University in publishing an AFM paper (IF=19)
2026-03-04Recently, Professor Jianping Zhou and Professor Yang Ding’s research team from the School of Pharmacy at China Pharmaceutical University published a research article titled “Kinetics-By-Design: On-Demand Fabrication of Personalized Drug-Release Profiles Using Multi-Material 3D Printing” in the top-tier international journal Advanced Functional Materials (IF = 19).
The first author of the paper, Peihong Chen, co-founded Shenzhen YuanYi Intelligent Pharmaceutical Technology Co., Ltd,China. together with Shenzhen Soongon Technology Co., Ltd. The company focuses on intelligent design and manufacturing of 3D-printed pharmaceuticals, continuously advancing the research and application of 3D printing technology in the pharmaceutical field.
Soongon Technology (YuanYi Intelligence) provided critical technical and resource support for the successful completion of this study. The AutoBio 2000 Direct Ink Writing (DIW) 3D printer, serving as the core experimental platform, enabled the team to construct a three-dimensional “kinetics-by-design” framework. This allowed for personalized and programmable drug-release profiles of highly water-soluble narrow therapeutic index (NTI) drugs, offering a groundbreaking technological solution for precision pharmaceutics research.
Research Background: Addressing the Controlled Release Challenges of Highly Water-Soluble Narrow Therapeutic Index (NTI) Drugs
In modern medicine, precise drug delivery has long been a central goal for scientists. This is particularly critical for narrow therapeutic index (NTI) drugs such as 4-aminopyridine (4-AP), where even slight fluctuations in plasma concentration may lead to therapeutic failure or toxic reactions. Conventional administration methods often fail to meet the demands of personalized therapy, whereas the emergence of 3D printing technology has introduced new possibilities for addressing this challenge.
Currently, the administration of 4-AP presents significant limitations. Immediate-release formulations often produce sharp plasma concentration peaks, increasing the risk of seizure episodes. Although sustained-release formulations reduce this risk, they typically provide fixed and uniform release profiles. Such designs cannot accommodate inter-patient variability nor deliver more complex, adaptive release kinetics required by vulnerable populations, such as patients with chronic kidney disease. Therefore, there remains a lack of a scalable platform capable of moving beyond dose personalization toward on-demand customization of dynamically programmed release kinetics.
On the other hand, highly water-soluble drugs present additional challenges. While high solubility facilitates drug absorption, it also makes precise control of release kinetics more difficult. In traditional dosage forms, water-soluble drugs are uniformly dispersed within the matrix, and their release behavior is largely governed by intrinsic physicochemical properties, such as solubility, pH sensitivity, and ionization degree. As a result, modulation of intermediate dissolution stages is difficult, and achieving precise, programmable release profiles remains a major challenge.
Conventional pharmaceutical processes primarily rely on iterative formulation adjustments and process optimization to regulate the release profiles of water-soluble drugs. This approach is labor-intensive, time-consuming, and poorly suited for rapid personalized medication production. The advent of 3D printing technology offers a promising alternative, with the potential to shift release control from formulation composition to structural design. However, current 3D printing strategies still exhibit notable limitations.
First, even in geometrically complex printed constructs, drugs are typically uniformly distributed within the matrix, and release behavior remains dominated by the intrinsic dissolution rate of the active pharmaceutical ingredient (API), preventing fine-tuning during intermediate stages. In essence, most existing 3D printing systems remain compositionally homogeneous, and the potential of spatially resolved multi-material architectures to achieve complex release control has not yet been fully realized.
Second, some advanced designs, such as channel-containing dosage forms, attempt to influence release by modulating hydrodynamics. However, this strategy may act as a double-edged sword. Many such systems employ erodible matrices that undergo swelling or structural degradation during dissolution, dynamically altering the surface-area-to-volume (SA/V) ratio, disrupting local hydrodynamics, and making release profiles unpredictable. Even in non-erodible matrices, external channels may be blocked by food particles or gastrointestinal contents, introducing further variability.
In response to these limitations, the research team innovatively proposed the core concept of “structure-encoded release kinetics.” Leveraging the multi-material printing capability of the AutoBio2000 system developed by Soongon Tech (Yuanyi Smart Medicine), the control of drug release is shifted from traditional formulation composition to spatial architecture. This strategy breaks through the conventional formulation-dependent development paradigm and establishes a new structural framework for programmable drug delivery.
Figure 1: Schematic of the “Kinetics-By-Design” three-layer framework. The top left illustrates the construction of a stable microenvironment within the DLS, where truncated body deformations caused by drying are graded and optimized via the angle θ, enabling stable small-batch fabrication. The top right shows that by adjusting the surface-area-to-volume ratio, personalized release can be achieved and predictive models can be built. The bottom left depicts BGPs, which form an inert barrier layer to achieve anisotropic diffusion and allow personalized release regulation within 16 hours. The bottom right shows PMPs, which embed drug free structures (DFS) as “kinetic gates,” enabling lag-time adjustment and dynamic control of acceleration-deceleration phases, producing segmented multi-stage release profiles to meet personalized dosing requirements.
“Kinetics-By-Design” Three-Layer Framework Overview
“Kinetics-By-Design” is an innovative drug release control strategy supported by multi-material 3D printing technology. It establishes a three-layer framework aimed at precisely controlling drug release through structural design rather than composition, offering a novel solution for personalized drug therapy.
This framework uses 4-AP as a model drug and systematically addresses the challenges of releasing highly water-soluble and pH-sensitive drugs. The first layer, the drug-loaded structure (DLS), serves as the foundational unit. Through rational formulation design and process optimization, it eliminates pH dependence, resolves drying-induced truncated cone effects, and achieves highly reproducible fabrication. This structure possesses excellent mechanical strength and drug release characteristics, allowing personalized release within 4 hours by adjusting the surface-area-to-volume ratio.
The second layer, the barrier-guided preparation (BGPs), introduces anisotropic diffusion, converting path length and release area into programmable variables. Using multi-material 3D printing, an inert barrier layer is constructed around the drug-loaded structure to create a unidirectional release path, achieving predictable sustained release over 8–20 hours. The release profile conforms well to a general model (R² = 0.992).
The third layer, the path-modulated preparation (PMPs), further incorporates internal “kinetic gates.” By embedding drug-free structures within the drug-loaded matrix, it enables lag-time adjustment and dynamic control of acceleration-deceleration phases. This design renders the drug release profiles highly flexible and diverse, capable of meeting complex clinical treatment requirements and providing more precise means for individualized therapy.
Overall, the “Kinetics-By-Design” three-layer framework transforms drug release from traditional formulation-dependent mechanisms to structurally controllable processes through clever structural design and advanced 3D printing technology. It offers an effective solution for the challenges of releasing highly water-soluble and pH-sensitive drugs, holds promise for advancing personalized drug therapy, and may improve therapeutic outcomes and quality of life for patients.
Figure 2: Formulation screening and optimization results of DLS. This includes the effects of varying Soluplus and PVP K90 contents on DLS dissolution performance, mechanical strength, swelling behavior, surface wettability, ink extrusion pressure, printing pressure, and tablet weight uniformity, as well as dissolution profiles under different pH conditions.
Figure 3: Environmental stability and manufacturing fidelity of DLS. It shows the effects of varying FA content on DLS dissolution profiles in different pH media, the impact of TEC removal on DLS dissolution performance and mechanical strength, quantitative assessment and resolution of the truncated cone effect, dissolution profiles of DLS under different paddle speeds and pH conditions, the influence of drug loading on DLS release rate, and the results of DSC, PXRD, and FT-IR analyses.
Figure 4: DLS quality control and kinetic modeling. Volume–weight linear regression shows R² = 0.9997, indicating that the surface-area-to-volume (SA/V) ratio is the dominant factor governing release kinetics. Fill angles of [0°, 90°] and [45°, 135°] are configured to ensure isotropic mechanical strength.
Figure 5: BGPs enabling long-term personalized release. It illustrates the unidirectional release principle and fabrication process of BGPs, dissolution and swelling profiles of BGPs with different release areas and diffusion paths, dissolution profiles of BGPs with different geometries but similar surface areas, dissolution profiles under varying pH and paddle speed conditions, and on-demand personalized dissolution profiles achieved by modifying BGP structures.
Figure 6: Dynamic release characteristics of PMPs. It shows the dynamic release profiles of PMPs with different “kinetic gate” designs, including lag time and acceleration–deceleration phases. By comparing the release curves of PMPs with different designs, it visually demonstrates the ability of PMPs to achieve full-profile control and the precise regulatory effect of the “kinetic gates” on drug release.
Figure 7: Microstructure of the formulations and their dynamic evolution during processing and dissolution. It presents SEM images of the surfaces and cross-sections of DLS, DFS, and BS, revealing their distinct microstructures; 3D surface morphologies of DLS, DFS, and BS at different stages (post-printing, post-drying, post-dissolution, and post-dissolution followed by drying); changes in arithmetic mean roughness (Ra) and maximum profile height (Rz) of DLS, DFS, and BS before and after drying; surface roughness parameters of DLS, DFS, and BS at post-printing, post-drying, post-dissolution, and post-dissolution followed by drying; and 3D surface morphologies showing potential defects during printing, such as surface collapse caused by bubbles or filament breakage. Multi-scale imaging methods elucidate the relationship between macroscopic formulation performance and their microstructure.
Application Value and Future Perspectives
The “Kinetics-By-Design” framework offers breakthroughs for personalized medicine and drug development. In the field of personalized medicine, it enables tailoring drug release profiles according to individual patient differences, achieving precise dosing and effectively mitigating the risks of toxicity and therapeutic failure associated with narrow therapeutic index drugs. At the same time, by enabling sustained drug release, it improves patient adherence and helps achieve better control of chronic diseases.
In drug development, this framework can accelerate the new drug development process by combining computer simulations with 3D printing to rapidly fabricate and test drug formulations, thereby shortening development timelines. Moreover, it addresses the challenges of releasing highly water-soluble and pH-sensitive drugs, expanding their applicability, reducing healthcare costs, and improving medical efficiency. Looking forward, the team plans to integrate AI-driven modeling with process analytical technologies to further enable the scalable production of clinically relevant personalized medicines.
The video shows the small-batch continuous production of 80 tablets using the Auto Bio2000.
Title: Kinetics‑By‑Design: On‑Demand Fabrication of Personalized Drug‑Release Profiles Using Multi‑Material 3D Printing — published in Advanced Functional Materials (2026).
DOI link: https://doi.org/10.1002/adfm.202527954
First author: Peihong Chen (陈培鸿), email: 15992585225@163.com
Corresponding authors: Jianping Zhou (周建平) and Yang Ding (丁杨)
