3D printed furosemide and sildenafil tablets: Innovative production and quality control

Lafeber, Iris; Tichem, J.M.; Ouwerkerk, Neils; Unen, A.D. van; Uitert, J.J.D. van; Bijleveld-Olierook, H.C.M.; Kweekel, Dina M.; Zaal, W.M.; Brun, P.P.H. Le; Guchelaar, H.J.; Schimmel, Kirsten J. M.

doi:10.1016/j.ijpharm.2021.120694

Cited by 20 publications

(15 citation statements)

References 36 publications

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“…Dose accuracy was defined with content uniformity [30][31][32][33]39,52,54] or drug content assay [34][35][36][40][41][42][43][44][45][55][56][57][58]. Alternatively, one study determined the uniformity of dosage units using the mass variation method of the European Pharmacopoeia (Ph.…”

Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

“…While the definition of low-and high-dose is debatable, this study specifically looked at the absolute doses of 2.0-12.0 mg of metoprolol tartrate and 80-240 mg of theophylline per printed tablet, with respective API concentrations of 10% w/w and 35% w/w. Similarly, the printed mass could be correlated to the dosage strength [33,39,53]. Adjusting the amount of printed filament could also be used to accurately adjust the dosage strength.…”

Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

“…Dose flexibility has also been achieved by altering the drug concentration in the tablet matrix [39,49], though a higher drug concentration could reduce the printability of the tablet matrix [49]. For inkjet printing and drop-on-solid 3D printing, the concentration of the drug in the printing ink can be altered to adjust to printed dose [52,55,56].…”

Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

“…In extension, the current lack of personalized oral dosages were also often mentioned [31,36,[55][56][57]59]. Furthermore, poor patient acceptability of the current treatment options [38,39], improving currently available formulations [43,44], drug combinations [34] and the lack of oral drug products [45] were mentioned as reasons for choosing the model drug.…”

Section: Eligible Active Pharmaceutical Ingredientsmentioning

confidence: 99%

“…The identified model drugs were often indicated for the treatment of cardiovascular events and diseases [30,33,35,36,39,46,48,52,54,57,59]. Drugs used for the treatment of epilepsy and related diseases [31,37,43,53,56], and pain reduction and peri-operative treatment drugs [34,41,45,51] were also often used as model drugs in the studies.…”

Section: Target Population and Diseasementioning

confidence: 99%

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3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

et al. 2022

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3D printing of pediatric-centered drug formulations can provide suitable alternatives to current treatment options, though further research is still warranted for successful clinical implementation of these innovative drug products. Extensive research has been conducted on the compliance of 3D-printed drug products to a pediatric quality target product profile. The 3D-printed tablets were of particular interest in providing superior dosing and release profile similarity compared to conventional drug manipulation and compounding methods, such as oral liquids. In the future, acceptance of 3D-printed tablets in the pediatric patient population might be better than current treatments due to improved palatability. Further research should focus on expanding clinical knowledge, providing regulatory guidance and expansion of the product range, including dosage form possibilities. Moreover, it should enable the use of diverse good manufacturing practice (GMP)-ready 3D printing techniques for the production of various drug products for the pediatric patient population.

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Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

Section: Pediatric-centered Formulation Designmentioning

confidence: 99%

Section: Eligible Active Pharmaceutical Ingredientsmentioning

confidence: 99%

Section: Target Population and Diseasementioning

confidence: 99%

See 3 more Smart Citations

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

et al. 2022

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Development and Bioequivalence of 3D‐Printed Medication at the Point‐of‐Care: Bridging the Gap Toward Personalized Medicine

Lyousoufi

Lafeber

Kweekel

et al. 2023

Clin Pharma and Therapeutics

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Personalized medicine is currently hampered by the lack of flexible drug formulations. Especially for pediatric patients, manual compounding of personalized drug formulations by pharmacists is required. Three‐Dimensional (3D) printing of medicines, which enables small‐scale manufacturing at the point‐of‐care, can fulfill this unmet clinical need. This study investigates the feasibility of developing a 3D‐printed tablet formulation at the point‐of‐care which complies to quality requirements for clinical practice, including bioequivalence. Development, manufacturing, and quality control of the 3D‐printed tablets was performed at the manufacturing facility and laboratory of the department of Clinical Pharmacy and Toxicology at Leiden University Medical Center. Sildenafil was used as a model drug for the tablet formulation. Along with the 3D‐printed tablets a randomized, an open‐label, 2‐period, crossover, single‐dose clinical trial to assess bioequivalence was performed in healthy adults. Bioequivalence was established if areas under the plasma concentration curve from administration to the time of the last quantifiable concentration (AUC0‐t) and maximum plasma concentration (Cmax) ratios were within the limits of 80.00–125.00%. The manufacturing process provided reproducible 3D‐printed tablets that adhered to quality control requirements and were consequently used in the clinical trial. The clinical trial was conducted in 12 healthy volunteers. The 90% confidence intervals (CIs) of both AUC0‐t and Cmax ratios were within bioequivalence limits (AUC0‐t 90% CI: 87.28–104.14; Cmax 90% CI: 80.23–109.58). For the first time, we demonstrate the development of a 3D‐printed tablet formulation at the point‐of‐care that is bioequivalent to its marketed originator. The 3D printing of personalized formulations is a disruptive technology for compounding, bridging the gap toward personalized medicine.

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Semi-solid Extrusion 3D Printing for the Development of Dosage Forms for Special Patient Groups

Gkaragkounis

Fatouros

2023

Advanced Clinical Pharmacy - Research, Development and Practical Applications

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3D printed furosemide and sildenafil tablets: Innovative production and quality control

Cited by 20 publications

References 36 publications

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

Development and Bioequivalence of 3D‐Printed Medication at the Point‐of‐Care: Bridging the Gap Toward Personalized Medicine

Semi-solid Extrusion 3D Printing for the Development of Dosage Forms for Special Patient Groups

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