Releasing fast and slow: Non-destructive prediction of density and drug release from SLS 3D printed tablets using NIR spectroscopy.

Autor: Trenfield SJ; UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK., Xu X; UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK., Goyanes A; UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.; Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, R + D Pharma Group (GI-1645), Universidade de Santiago de Compostela, 15782, Spain., Rowland M; Pfizer Ltd., Drug Product Design, Discovery Park, Ramsgate Road, Sandwich CT13 9ND, UK., Wilsdon D; Pfizer Ltd., 280 Shennecossett Road, Groton, CT 06340, United States., Gaisford S; UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK., Basit AW; UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics: X [Int J Pharm X] 2022 Dec 17; Vol. 5, pp. 100148. Date of Electronic Publication: 2022 Dec 17 (Print Publication: 2023).
DOI: 10.1016/j.ijpx.2022.100148
Abstrakt: Selective laser sintering (SLS) 3D printing is a revolutionary 3D printing technology that has been found capable of creating drug products with varied release profiles by changing the laser scanning speed. Here, SLS 3D printed formulations (printlets) loaded with a narrow therapeutic index drug (theophylline) were produced using SLS 3D printing at varying laser scanning speeds (100-180 mm/s). The use of reflectance Fourier Transform - Near Infrared (FT-NIR) spectroscopy was evaluated as a non-destructive approach to predicting 3D printed tablet density and drug release at 2 h and 4 h. The printed drug products formulated with a higher laser speed exhibited an accelerated drug release and reduced density compared with the slower laser scanning speeds. Univariate calibration models were developed based on a baseline shift in the spectra in the third overtone region upon changing physical properties. For density prediction, the developed univariate model had high linearity (R 2 value = 0.9335) and accuracy (error < 0.029 mg/mm 3 ). For drug release prediction at 2 h and 4 h, the developed univariate models demonstrated a linear correlation (R 2 values of 0.9383 and 0.9167, respectively) and accuracy (error < 4.4%). The predicted vs. actual dissolution profiles were found to be statistically similar (f 2  > 50) for all of the test printlets. Overall, this article demonstrates the feasibility of SLS 3D printing to produce drug products containing a narrow therapeutic index drug across a range of drug release profiles, as well as the potential for FT-NIR spectroscopy to predict the physical characteristics of SLS 3D printed drug products (drug release and density) as a non-destructive quality control method at the point-of-care.
Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2022 The Authors.)
Databáze: MEDLINE
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