Key Takeaways & Executive Findings
- •• • The optimal DES system (proline-lactic acid, 1:12) increased curcumin solubility to 0.789 mg/mL, a >700-fold enhancement over water, enabling effective incorporation of a poorly soluble natural compound into a hydrogel dressing; this solubility enhancement is critical for achieving therapeutic drug concentrations in topical formulations. • • The optimized printing formulation (1% CSMA, 5% GelMA, 0.1% LAP, 0.02% tartrazine, 20% DES, 100 μm layer height, 25 s exposure) produced dressings with a 2.5 N adhesion force at 25 min and ~500% swelling at 6 h, indicating strong mucosal retention and exudate absorption capacity, which are essential for maintaining contact with ulcerated tissue and managing wound moisture. • • In vitro biocompatibility tests showed L929 cell viability >90% and no significant DES cytotoxicity, confirming the safety of the amino acid-based DES components for biomedical applications; this is a prerequisite for clinical translation, as cytotoxic excipients would negate therapeutic benefits. • • In an SD rat oral ulcer model, the curcumin-loaded gel reduced ulcer area by 40% versus controls and decreased neutrophil density and inflammatory infiltration, demonstrating in vivo efficacy; however, the study acknowledges limitations including model relevance to human disease, long-term biosafety of degradation products, and 3D printing scalability and cost challenges that must be addressed for clinical adoption.
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Abstract
Oral ulcers are among the most prevalent inflammatory lesions of the oral mucosa, characterized by localized burning pain, dysphagia, and high recurrence rates. Conventional dressings, such as ordinary drug films, are low-cost and accessible but create a dry environment that delays epithelial cell migration and impedes healing. This study developed an amino acid-based deep eutectic solvent (DES) gel dressing loaded with curcumin, combining DES and 3D printing technology to create a localized drug delivery platform with efficient drug loading, controlled release, and excellent biocompatibility. The optimal DES system (proline-lactic acid, 1:12) increased curcumin solubility over 700-fold (0.789 mg/mL) compared to water. The optimal printing formulation and process parameters were 1% CSMA, 5% GelMA, 0.1% LAP, 0.02% tartrazine, 20% DES content, 100 μm layer height, and 25 s layer-by-layer exposure time. The resulting gel dressing exhibited excellent mechanical properties, with a 2.5 N adhesion force at 25 min and an approximately 500% swelling ratio at 6 h. In vitro biocompatibility showed L929 cell survival rates above 90%, with no significant cytotoxicity from the DES system. In an SD rat oral ulcer model, the gel achieved localized sustained curcumin release, reducing ulcer area by 40% compared to controls, and effectively decreased neutrophil density and inflammatory infiltration. The study successfully prepared a curcumin-loaded amino acid-based DES gel dressing with good wound adaptability and precise drug release behavior, offering an efficient and safe therapeutic strategy for oral ulcers. However, limitations include differences between the SD rat model and human pathophysiology, long-term biosafety concerns regarding degradation products and DES metabolism, and challenges in cost and scalability for 3D printing clinical translation.
1. Introduction
Oral ulcers represent one of the most common inflammatory conditions of the oral mucosa, imposing significant patient burden through localized pain, difficulty eating, and high recurrence rates. Existing commercial treatments, such as ordinary drug films, are inexpensive and widely available but suffer from a critical drawback: they create a dry environment that delays epithelial cell migration and slows the healing process. Furthermore, these conventional dressings often adhere poorly to moist mucosal surfaces and fail to provide sustained drug release, necessitating frequent reapplication and resulting in suboptimal therapeutic outcomes. The need for an improved dressing that maintains a moist wound environment, adheres firmly, and delivers drugs in a controlled manner remains unmet.
This study addresses these bottlenecks by integrating deep eutectic solvents (DES) with 3D printing technology to fabricate an amino acid-based gel dressing loaded with curcumin, a poorly soluble natural anti-inflammatory compound. The DES system, composed of proline and lactic acid at a 1:12 molar ratio, dramatically enhances curcumin solubility by over 700-fold, enabling homogeneous incorporation into a GelMA/CSMA composite matrix. The 3D printing process was optimized to achieve precise spatial control and mechanical integrity, yielding a dressing with a 2.5 N adhesion force at 25 min and ~500% swelling at 6 h. In vitro assays confirmed >90% L929 cell viability, and in vivo testing in an SD rat oral ulcer model demonstrated a 40% reduction in ulcer area with decreased neutrophil infiltration. This platform offers a promising strategy for translating poorly soluble natural actives into effective clinical therapies for oral ulcers, though challenges in long-term safety and scalable manufacturing remain.
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GUAN Xiaoduo, YAN Wenzheng, LI Huijie, YANG Gensheng, YANG Qingliang, HE Yue (2026). Preparation, In Vitro Performance, and Therapeutic Efficacy Against Oral Ulcers of Curcumin-Loaded Printable Amino Acid-Based Deep Eutectic Gel Dressings. Chinese Traditional and Herbal Drugs. https://doi.org/10.7501/j.issn.0253-2670.2026.15.20261509
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Frequently Asked Questions
What is the long-term biosafety profile of the DES components and the degradation products of the GelMA/CSMA matrix in vivo?
The study acknowledges that long-term biosafety has not been thoroughly evaluated. While in vitro tests showed >90% L929 cell viability and no significant DES cytotoxicity, the potential toxicity of degradation products and the metabolic fate of DES components (proline and lactic acid) in vivo remain unknown. Lactic acid is a normal metabolite, but high local concentrations could alter pH and tissue response. Proline is an amino acid, generally safe, but its accumulation or interaction with the wound microenvironment requires investigation. The authors explicitly state that systematic evaluation of long-term biosafety is a necessary future direction before clinical translation.
How does the adhesion force of 2.5 N at 25 min compare to commercially available oral ulcer dressings, and is it sufficient for retention on mucosal surfaces under physiological conditions?
The reported adhesion force of 2.5 N at 25 min indicates strong mucoadhesive properties, likely due to the combination of GelMA/CSMA and the DES components. However, the study does not provide a direct comparison with commercial products. For oral mucosal application, adhesion must withstand saliva flow, tongue movement, and swallowing. While 2.5 N is substantial, the dynamic environment of the oral cavity may require even higher adhesion or the use of additional protective layers. The 500% swelling at 6 h suggests the dressing can absorb exudate and maintain a moist environment, but excessive swelling could weaken adhesion over time. Further testing under simulated oral conditions (e.g., artificial saliva flow) is needed to validate clinical suitability.
What are the critical challenges in scaling up the 3D printing process for commercial production, and what is the estimated cost per unit compared to conventional dressings?
The study identifies cost and scalability as major hurdles for clinical translation. The optimized printing parameters (100 μm layer height, 25 s exposure per layer) imply a relatively slow process, which may limit throughput. The use of specialized materials (GelMA, CSMA, LAP photoinitiator, tartrazine) and the need for precise control of DES content add to the cost. Additionally, maintaining print quality uniformity across large batches is challenging. The authors note that standardized production processes and cost reduction are future research directions. Without a detailed cost analysis, it is difficult to estimate parity with conventional dressings, but the complexity suggests a higher upfront cost, potentially offset by improved therapeutic outcomes and reduced frequency of application.
How does the in vivo efficacy in the SD rat model translate to human oral ulcers, given differences in pathophysiology and local microenvironment?
The study explicitly acknowledges that the SD rat oral ulcer model differs from human conditions in terms of pathogenesis and local microenvironment, which may affect the accuracy of efficacy predictions. Rat oral mucosa has a different thickness, keratinization pattern, and immune response compared to humans. The 40% reduction in ulcer area and decreased neutrophil infiltration are promising, but human ulcers often have more complex etiologies (e.g., recurrent aphthous stomatitis, viral infections, autoimmune conditions). Therefore, the results should be interpreted with caution, and further validation in larger animal models or human clinical trials is necessary to confirm translational potential.
What is the release kinetics of curcumin from the DES gel dressing, and does the 40% ulcer area reduction correlate with sustained drug levels at the wound site?
The abstract states that the gel achieved localized sustained curcumin release, but specific release kinetics (e.g., cumulative release percentage over time, release mechanism) are not detailed in the provided text. The 40% reduction in ulcer area suggests that the released curcumin reached therapeutic concentrations. However, without quantitative release data, it is unclear whether the release profile is optimal. The DES likely enhances curcumin solubility and may modulate release through interactions with the GelMA/CSMA matrix. Future studies should include in vitro release assays and pharmacokinetic analysis of curcumin in wound tissue to establish a clear dose-response relationship and optimize the formulation for maximal efficacy.
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