Abstract
The objective of the present study was to develop digital light processing (DLP) 3D printed sustained release ibuprofen (IBU) tablets using 3D DLP printers for evaluation in in vitro release and in vivo pharmacokinetic studies with their in vitro–in vivo correlation. The resin formulation and printing parameters were optimized using quality by design (QbD) approach, and IBU tablets were printed using DLP printers which works at 385 and 405 nm wavelengths. Our results demonstrated that formulation consisting of polyethylene glycol diacrylate (PEGDA) 700, water, IBU, and riboflavin printed at 40-s bottom layer exposure time and 30-s exposure time produced tablets using both 385 and 405 nm wavelengths. In vitro dissolution studies showed > 70% drug release at the end of 24 h when printed at 405 nm wavelength with no significant difference between tablets printed at 385 nm. In vivo pharmacokinetic evaluation of the optimized 3D printed tablets printed at 405 nm at oral dose of 30 mg/kg in rats showed sustained release of IBU with significantly (p < 0.05) higher Cmax of 30.12 ± 2.45 µg/mL and AUC(0–24 h) of 318.97 ± 16.98 (µg/mL × h) compared to marketed IBU tablet (control). In vivo–in vitro correlation studies showed 80% of drug was absorbed in vivo within 3 h from the pulverized 3D printed tablet, whereas intact 3D tablet showed sustained release of IBU with > 75% IBU release in 24 h in vitro. Overall, IBU tablets fabricated using DLP printing demonstrated sustained release and enhanced systemic absorption with no significant difference in their release profile at different wavelengths.
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Funding
The authors are thankful to the National Institute on Minority Health and Health Disparities of the National Institutes of Health (grant/award number U54 MD007582) and the NSFCREST Center for Complex Materials Design for Multidimensional Additive Processing (CoManD) (grant/award number:1735968) for providing the funding for this research work.
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Keb Mosley-Kellum: substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work and drafting the work or revising it critically for important intellectual content.
Arvind Bagde: substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work and drafting the work or revising it critically for important intellectual content.
Shawn Spencer: substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work.
Satyanarayan Dev: substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work.
Mandip Singh: final approval of the version to be published and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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The Institutional Animal Care and Use Committee (IACUC) at Florida A&M University, FL approved all animal protocols that were observed in this study (Protocol number: 020-04).
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Mosley-Kellum, K., Bagde, A., Spencer, S. et al. Development of 3D DLP Printed Sustained Release Ibuprofen Tablets and Their Pharmacokinetic Evaluation in Rats. AAPS PharmSciTech 24, 88 (2023). https://doi.org/10.1208/s12249-023-02544-5
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DOI: https://doi.org/10.1208/s12249-023-02544-5