journal article·2026-01-06Open access

Designing Poly(vinyl formal) Membranes for Controlled Diclofenac Delivery: Integrating Classical Kinetics with GRNN Modeling

Igor Garcia-Atutxa, Francisca Villanueva-Flores

Applied Sciences· Volume 16· Issue 2

Abstract

Controlled-release systems must translate material design choices into predictable pharmacokinetic (PK) profiles, yet purely mechanistic or purely data-driven models often underperform when tuning complex polymer networks. Here, we develop tunable poly(vinyl formal) membranes (PVFMs) for diclofenac delivery and integrate classical kinetic analysis with a Generalized Regression Neural Network (GRNN) to connect formulation variables to release behavior and PK-relevant targets. PVFMs were synthesized across a gradient of crosslink densities by varying HCl content; diclofenac release was quantified under standardized conditions with geometry and dosing rigorously controlled (thickness, effective area, surface-area-to-volume ratio, and areal drug loading are reported to ensure reproducibility). Release profiles were fitted to Korsmeyer–Peppas, zero-order, first-order, Higuchi, and hyperbolic tangent models, while a GRNN was trained on material descriptors and time to predict cumulative release and flux, including out-of-sample conditions. Increasing crosslink density monotonically reduced swelling, areal release rate, and overall release efficiency (strong linear trends; r ≈ 0.99) and shifted transport from anomalous to Super Case II at the highest crosslinking. Classical models captured regime transitions but did not sustain high accuracy across the full design space; in contrast, the GRNN delivered superior predictive performance and generalized to conditions absent from training, enabling accurate interpolation/extrapolation of release trajectories. Beyond prior work, we provide a material-to-PK design map in which crosslinking, porosity/tortuosity, and hydrophobicity act as explicit “knobs” to shape burst, flux, and near-zero-order behavior, and we introduce a hybrid framework where mechanistic models guide interpretation while GRNN supplies robust, data-driven prediction for formulation selection. This integrated PVFM–GRNN approach supports rational design and quality control of controlled-release devices for diclofenac and is extendable to other therapeutics given appropriate descriptors and training data.
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Research context

OpenAlex topics: Hydrogels: synthesis, properties, applications · 3D Printing in Biomedical Research · Polymer Surface Interaction Studies

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Escuela Politécnica Superior, Universidad Católica de Murcia (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain

Centro de Investigación en Ciencia Aplicada y Tecnología Avanzada (CICATA) Unidad Morelos, Instituto Politécnico Nacional (IPN), Boulevard de la Tecnología, 1036 Z-1, P 2/2, Atlacholoaya 62790, Morelos, Mexico

Funding

Convocatoria de Ciencia Básica y de Frontera 2025 of SECIHTI and the Secretaría de Investigación y Posgrado

References (48)

Show source-provided references
1. Microspheres for controlled release drug delivery10.1517/14712598.4.1.35 ↗
2. Polymeric controlled drug delivery10.1016/0169-409X(88)90019-1 ↗
3. Polymer-based drug delivery systems for anticancer drugs: A systematic review
4. López Ruiz, A., Ramirez, A., and McEnnis, K. (2022). Single and Multiple Stimuli-Responsive Polymer Particles for Controlled Drug Delivery. Pharmaceutics, 14.10.3390/pharmaceutics14020421 ↗
5. A concise review on smart polymers for controlled drug release10.1007/s13346-015-0274-7 ↗
6. Palza, H., Zapata, P.A., and Angulo-Pineda, C. (2019). Electroactive Smart Polymers for Biomedical Applications. Materials, 12.10.3390/ma12020277 ↗
7. Biomaterials of PVA and PVP in medical and pharmaceutical applications: Perspectives and challenges10.1016/j.biotechadv.2018.11.008 ↗
8. Hydrogels formed by crosslinked poly(vinyl alcohol) as sustained drug delivery systems10.1002/1521-4184(200203)335:2/3<89::AID-ARDP89>3.0.CO;2-4 ↗
9. Poly(vinyl alcohol co-vinyl acetate) as a novel scaffold for mammalian cell culture and controlled drug release10.1007/s10853-019-03402-1 ↗
10. Low-cost poly(vinyl formal) for heavy metal removal from water of a polluted river10.2166/wrd.2022.077 ↗
11. A Novel Approach of Polyvinyl Alcohol/Acrylic Acid Based Hydrogels for Controlled Delivery of Diclofenac Sodium10.2174/0113892010296120240327055943 ↗
12. Branco, A.C., Oliveira, A.S., Monteiro, I., Nolasco, P., Silva, D.C., Figueiredo-Pina, C.G., Colaço, R., and Serro, A.P. (2022). PVA-Based Hydrogels Loaded with Diclofenac for Cartilage Replacement. Gels, 8.10.3390/gels8030143 ↗
13. Mathematical modeling of drug delivery10.1016/j.ijpharm.2008.09.004 ↗
14. Zero-order therapeutic release from imprinted hydrogel contact lenses within in vitro physiological ocular tear flow10.1016/j.jconrel.2007.09.006 ↗
15. Heredia, N.S., Vizuete, K., Flores-Calero, M., Pazmiño, V.K., Pilaquinga, F., Kumar, B., and Debut, A. (2022). Comparative statistical analysis of the release kinetics models for nanoprecipitated drug delivery systems based on poly(lactic-co-glycolic acid). PLoS ONE, 17.10.1371/journal.pone.0264825 ↗
16. Modeling of drug release from biodegradable polymer blends10.1016/j.ejpb.2008.05.024 ↗
17. Modeling of drug release from polymeric delivery systems-A review10.1615/CritRevTherDrugCarrierSyst.v21.i5.10 ↗
18. Visan, A.I., and Negut, I. (2024). Integrating Artificial Intelligence for Drug Discovery in the Context of Revolutionizing Drug Delivery. Life, 14.10.3390/life14020233 ↗
19. A systems approach to modeling drug release from polymer microspheres to accelerate in vitro to in vivo translation10.1016/j.jconrel.2015.04.045 ↗
20. Artificial Intelligence’s Impact on Drug Discovery and Development from Bench to Bedside
21. Application of artificial neural networks in the design of controlled release drug delivery systems10.1016/S0169-409X(03)00119-4 ↗
22. An alternative approach based on artificial neural networks to study controlled drug release10.1002/jps.10569 ↗
23. Modeling of drug release from bulk-degrading polymers10.1016/j.ijpharm.2010.12.020 ↗
24. Higuchi equation: Derivation, applications, use and misuse10.1016/j.ijpharm.2011.03.051 ↗
25. In vitro release kinetics model fitting of liposomes: An insight10.1016/j.chemphyslip.2016.10.005 ↗
26. Modeling and comparison of dissolution profiles10.1016/S0928-0987(01)00095-1 ↗
27. Application of a general regression neural network for health index calculation of power transformers10.1016/j.ijepes.2017.06.008 ↗
28. Wang, S., Di, J., Wang, D., Dai, X., Hua, Y., Gao, X., Zheng, A., and Gao, J. (2022). State-of-the-Art Review of Artificial Neural Networks to Predict, Characterize and Optimize Pharmaceutical Formulation. Pharmaceutics, 14.10.3390/pharmaceutics14010183 ↗
29. Mechanisms of solute release from porous hydrophilic polymers10.1016/0378-5173(83)90064-9 ↗
30. Solute and penetrant diffusion in swellable polymers. II. Verification of theoretical models10.1002/polb.1986.090240215 ↗
31. Interpreting non-linear drug diffusion data: Utilizing Korsmeyer-Peppas model to study drug release from liposomes10.1016/j.ejps.2019.105026 ↗
32. Statistical Mechanics of Cross-Linked Polymer Networks II. Swelling10.1063/1.1723792 ↗
33. The determination of interaction parameter χ1 for polyvinyl alcohol and water from the diffusion data10.1016/0142-9418(93)90026-L ↗
34. Hastie, T., Tibshirani, R., and Friedman, J. (2009). The Elements of Statistical Learning: Data Mining, Inference, and Prediction, Springer. [2nd ed.].10.1007/978-0-387-84858-7 ↗
35. Characterization of drug release and diffusion mechanism through hydroxyethylmethacrylate/methacrylic acid pH-sensitive hydrogel10.1080/10717540490265298 ↗
36. Mathematical models in drug delivery: How modeling has shaped the way we design new drug delivery systems10.1016/j.jconrel.2014.06.041 ↗
37. Calculations of drug release rates from cylinders10.1016/0378-5173(81)90093-4 ↗
38. Factors influencing the drug release from calcium phosphate cements
39. The effect of crosslinkages in polymethyl methacrylate on the parameters and the mechanism of diffusional transfer10.1016/0032-3950(82)90181-2 ↗
40. Investigation of factors influencing release of solid drug dispersed in inert matrices10.1002/jps.2600541012 ↗
41. Modeling a system of phosphated cross-linked high amylose for controlled drug release. Part 2: Physical parameters, cross-linking degrees and drug delivery relationships10.1016/j.ijpharm.2008.12.010 ↗
42. Crosslinked poly(vinyl alcohol) hydrogels as swollen elastic networks10.1002/app.1977.070210704 ↗
43. Mathematical modeling of bioerodible, polymeric drug delivery systems10.1016/S0169-409X(01)00116-8 ↗
44. Polymers for controlled parenteral delivery of peptides and proteins10.1016/0169-409X(93)90047-8 ↗
45. Design and manufacture of a zero-order sustained-release pellet dosage form through nonuniform drug distribution in a diffusional matrix10.1023/A:1015823532764 ↗
46. Polymeric Nanoparticles as Drug Delivery Systems for Controlled Release10.1166/asem.2020.2495 ↗
47. Putro, J.N., Lunardi, V.B., Soetaredjo, F.E., Yuliana, M., Santoso, S.P., Wenten, I.G., and Ismadji, S. (2021). A Review of Gum Hydrocolloid Polyelectrolyte Complexes (PEC) for Biomedical Applications: Their Properties and Drug Delivery Studies. Processes, 9.10.3390/pr9101796 ↗
48. An Algorithm for Constrained Deconvolution Based on Reparameterization10.1002/jps.2600810214 ↗