Development and Optimization of 3D-Printed Orally Dissolving Films of Vitamin D₃ Using a Quality by Design Approach

Rana H, Pathak P, Patel V, Thakkar V, Dholakia M, Dalwadi S, et al. Multichannel 3D-printed bionanoparticles-loaded tablet (M3DPBT): designing, development, and in vitro functionality assessment. Future J Pharm Sci. 2024;10(1):124. https://doi.org/10.1186/S43094-024-00702-5.

Article  Google Scholar 

Rana H, Chavada D, Thakkar V. Amalgamation of nano and 3-D printing technology: design, optimization, and assessment. Annals of 3D Printed Medicine. 2024;13:100144. https://doi.org/10.1016/J.STLM.2024.100144.

Article  Google Scholar 

Rana H, Patel G, Thakkar V, Modi C. Designing of industry friendly pastilles of Rosuvastatin and Piperine integrating green chemistry and advanced statistical approach. Discover Chem. 2025;2(1):87. https://doi.org/10.1007/S44371-025-00172-5.

Article  Google Scholar 

Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharm Investig. 2013;3:67. https://doi.org/10.4103/2230-973X.114897.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Puranik P, Sheikh FA, Hussain U, Belgamwar V. A QbD approach to clozapine delivery: solid dispersion and oral thin film technology. Next Research. 2025;100593. https://doi.org/10.1016/J.NEXRES.2025.100593.

Article  Google Scholar 

Jacob S, Boddu SHS, Bhandare R, Ahmad SS, Nair AB. Orodispersible films: current innovations and emerging trends. Pharmaceutics. 2023;15:2753. https://doi.org/10.3390/PHARMACEUTICS15122753.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ortiz-Prado E, Vasconez-Gonzalez J, Izquierdo-Condoy JS, Suárez-Sangucho IA, Prieto-Marín JG, Villarreal-Burbano KB, et al. Cholecalciferol (vitamin D3): efficacy, safety, and implications in public health. Front Nutr. 2025;12:1579957. https://doi.org/10.3389/FNUT.2025.1579957/FULL.

Article  PubMed  PubMed Central  Google Scholar 

Rakuša ŽT, Pišlar M, Kristl A, Roškar R. Comprehensive stability study of vitamin D3 in aqueous solutions and liquid commercial products. Pharmaceutics. 2021;13:617. https://doi.org/10.3390/PHARMACEUTICS13050617.

Article  Google Scholar 

Sevinç Özakar R, Özakar E. Current overview of oral thin films. Turk J Pharm Sci. 2021;18:111. https://doi.org/10.4274/TJPS.GALENOS.2020.76390.

Article  PubMed  PubMed Central  Google Scholar 

Pawar R, Pawar A. 3D printing of pharmaceuticals: approach from bench scale to commercial development. Futur J Pharm Sci. 2022. https://doi.org/10.1186/S43094-022-00439-Z.

Article  PubMed  PubMed Central  Google Scholar 

Li Y, Zhao M, Zhao MY, Li B, Tian JL. Advances in oral dissolving film research in the food field. Food Production, Processing and Nutrition. 2025. https://doi.org/10.1186/S43014-024-00285-X.

Article  Google Scholar 

Carou-Senra P, Rodríguez-Pombo L, Awad A, Basit AW, Alvarez-Lorenzo C, Goyanes A. Inkjet printing of pharmaceuticals. Adv Mater. 2024. https://doi.org/10.1002/ADMA.202309164.

Article  PubMed  Google Scholar 

Bigi F, Haghighi H, Siesler HW, Licciardello F, Pulvirenti A. Characterization of chitosan-hydroxypropyl methylcellulose blend films enriched with nettle or sage leaf extract for active food packaging applications. Food Hydrocolloids. 2021;120:106979. https://doi.org/10.1016/J.FOODHYD.2021.106979.

Article  CAS  Google Scholar 

Pacheco MS, Barbieri D, da Silva CF, de Moraes MA. A review on orally disintegrating films (ODFs) made from natural polymers such as pullulan, maltodextrin, starch, and others. Int J Biol Macromol. 2021;178:504–13. https://doi.org/10.1016/J.IJBIOMAC.2021.02.180.

Article  CAS  PubMed  Google Scholar 

Zhang M, Yang B, Yuan Z, Sheng Q, Jin C, Qi J, et al. Preparation and performance testing of corn starch/pullulan/gallic acid multicomponent composite films for active food packaging. Food Chemistry: X. 2023;19:100782. https://doi.org/10.1016/J.FOCHX.2023.100782.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Gupta V, Biswas D, Roy S. A comprehensive review of biodegradable polymer-based films and coatings and their food packaging applications. Materials. 2022;15:5899. https://doi.org/10.3390/MA15175899.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Park S, Shou W, Makatura L, Matusik W, Fu K(K. 3D printing of polymer composites: materials, processes, and applications. Matter. 2022;5:43–76. https://doi.org/10.1016/J.MATT.2021.10.018.

Article  CAS  Google Scholar 

Khan FB, Kilor V, Sapkal N, Dule P. Formulation development of mouth dissolving printed film of ketorolac and in vitro evaluation. Int J Appl Pharm. 2022;14:128–36. https://doi.org/10.22159/IJAP.2022V14I5.45350.

Article  CAS  Google Scholar 

Munaz A, Vadivelu RK, St. John J, Barton M, Kamble H, Nguyen NT. Three-dimensional printing of biological matters. J Science: Adv Mater Devices. 2016;1:1–17. https://doi.org/10.1016/J.JSAMD.2016.04.001.

Article  Google Scholar 

Polamaplly P, Cheng Y, Shi X, Manikandan K, Kremer GE, Qin H. 3D printing and characterization of hydroxypropyl methylcellulose and methylcellulose for biodegradable support structures. Procedia Manuf. 2019;34:552–9. https://doi.org/10.1016/J.PROMFG.2019.06.219.

Article  Google Scholar 

Turković E, Vasiljević I, Drašković M, Obradović N, Vasiljević D, Parojčić J. An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films. Pharmaceutics. 2021;13. https://doi.org/10.3390/PHARMACEUTICS13040468/S1.

Martinez-Velasco JD, Filomena-Ambrosio A, Garzón-Castro CL. Technological tools for the measurement of sensory characteristics in food: a review. F1000Res. 2024;12:340. https://doi.org/10.12688/F1000RESEARCH.131914.2.

Article  PubMed  PubMed Central  Google Scholar 

Tenorová K, Masteiková R, Pavloková S, Kostelanská K, Bernatonienė J, Vetchý D. Formulation and evaluation of novel film wound dressing based on collagen/microfibrillated carboxymethylcellulose blend. Pharmaceutics. 2022;14:782. https://doi.org/10.3390/PHARMACEUTICS14040782.

Article  PubMed  PubMed Central  Google Scholar 

Fr S, Mullani AK, Patel T V A, Koushik MS A, Chethan S, Alshehri S, et al. Development and evaluation of mucoadhesive buccal films for sustained release of glipizide using natural proteins. Drug Dev Ind Pharm. 2025;51:930–42. https://doi.org/10.1080/03639045.2025.2518500.

Article  CAS  Google Scholar 

Alaei S, Omidian H. Mucoadhesion and mechanical assessment of oral films. Eur J Pharm Sci. 2021. https://doi.org/10.1016/j.ejps.2021.105727.

Article  PubMed  Google Scholar 

Takeuchi Y, Ikeda N, Tahara K, Takeuchi H. Mechanical characteristics of orally disintegrating films: comparison of folding endurance and tensile properties. Int J Pharm. 2020;589:119876. https://doi.org/10.1016/J.IJPHARM.2020.119876.

Article  CAS  PubMed  Google Scholar 

Landová H, Vetchý D, Gajdziok J, Doležel P, Muselík J, Dvořáčková K, et al. Evaluation of the influence of formulation and process variables on mechanical properties of oral mucoadhesive films using multivariate data analysis. Biomed Res Int. 2014;2014:179568. https://doi.org/10.1155/2014/179568.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Markl D, Zeitler JA. A review of disintegration mechanisms and measurement techniques. Pharm Res. 2017;34:890. https://doi.org/10.1007/S11095-017-2129-Z.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Dor PJM, Fix JA. In vitro determination of disintegration time of quick-dissolve tablets using a new method. Pharm Dev Technol. 2000;5:575–7. https://doi.org/10.1081/PDT-100102041.

Article  CAS  PubMed  Google Scholar 

Zambre D, Hussain U, Sheikh S, Jaiswal S, Belgamwar V. Stability-indicating HPLC analysis of Azilsartan Medoxomil potassium: a QbD-based method development and validation. J Chromatogr B. 2025;124599. https://doi.org/10.1016/J.JCHROMB.2025.124599.

Article  CAS  Google Scholar 

Namjoshi S, Dabbaghi M, Roberts MS, Grice JE, Mohammed Y. Quality by design: development of the quality target product profile (QTPP) for semisolid topical products. Pharmaceutics. 2020;12:287. https://doi.or

Comments (0)

No login
gif