3D Printing as a Promising Tool in Personalized Medicine

Vaz, Vanessa Marcia; Kumar, Lalit

doi:10.1208/s12249-020-01905-8

Cited by 246 publications

(177 citation statements)

References 147 publications

(43 reference statements)

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“…It is supported that excipient, and especially binders, play a significant role in the physical properties of tablets. Fillers with high water solubility, humectants with high water content and binders with high viscosity in solution can increase the hardness and binding strength of tablets, and consequently prolong their disintegration time [ 37 ].…”

Section: 3d-printing Techniquesmentioning

confidence: 99%

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

et al. 2021

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The aim of this review is to present the factors influencing the mechanical properties of 3D-printed oral dosage forms. It also explores how it is possible to use specific excipients and printing parameters to maintain the structural integrity of printed drug products while meeting the needs of patients. Three-dimensional (3D) printing is an emerging manufacturing technology that is gaining acceptance in the pharmaceutical industry to overcome traditional mass production and move toward personalized pharmacotherapy. After continuous research over the last thirty years, 3D printing now offers numerous opportunities to personalize oral dosage forms in terms of size, shape, release profile, or dose modification. However, there is still a long way to go before 3D printing is integrated into clinical practice. 3D printing techniques follow a different process than traditional oral dosage from manufacturing methods. Currently, there are no specific guidelines for the hardness and friability of 3D printed solid oral dosage forms. Therefore, new regulatory frameworks for 3D-printed oral dosage forms should be established to ensure that they meet all appropriate quality standards. The evaluation of mechanical properties of solid dosage forms is an integral part of quality control, as tablets must withstand mechanical stresses during manufacturing processes, transportation, and drug distribution as well as rough handling by the end user. Until now, this has been achieved through extensive pre- and post-processing testing, which is often time-consuming. However, computational methods combined with 3D printing technology can open up a new avenue for the design and construction of 3D tablets, enabling the fabrication of structures with complex microstructures and desired mechanical properties. In this context, the emerging role of computational methods and artificial intelligence techniques is highlighted.

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Section: 3d-printing Techniquesmentioning

confidence: 99%

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

et al. 2021

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“…Despite the tremendous potential 3D printing has to offer for parenteral applications, regulatory guidance on characterization and assessment methods as well as process validation methodology remains scarce. While dozens of 3D printed medical devices have received FDA approval such as dental crowns and bone plates, only one pharmaceutical drug product, Spritam® medication, has been approved by the FDA [ 149 , 150 ]. Clinical trials are underway for other 3D printed medical devices, such as 3D printed patient-specific intramedullary guide and 3D printed denture framework.…”

Section: Future Perspectives and Challengesmentioning

confidence: 99%

Recent Advances in 3D Printing for Parenteral Applications

Ivone

Yang

Shen

2021

AAPS J

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3D printing has emerged as an advanced manufacturing technology in the field of pharmaceutical sciences. Despite much focus on enteral applications, there has been a lack of research focused on potential benefits of 3D printing for parenteral applications such as wound dressings, biomedical devices, and regenerative medicines. 3D printing technologies, including fused deposition modeling, vat polymerization, and powder bed printing, allow for rapid prototyping of personalized medications, capable of producing dosage forms with flexible dimensions based on patient anatomy as well as dosage form properties such as porosity. Considerations such as printing properties and material selection play a key role in determining overall printability of the constructs. These parameters also impact drug release kinetics, and mechanical properties of final printed constructs, which play a role in modulating immune response upon insertion in the body. Despite challenges in sterilization of printed constructs, additional post-printing processing procedures, and lack of regulatory guidance, 3D printing will continue to evolve to meet the needs of developing effective, personalized medicines for parenteral applications.

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“…Given this lack of age-appropriate strengths and dosage forms, several tools for personalized medicine in pediatrics could be considered, such as minitablets or 3D-printing medicines [ 15 , 16 ], but pharmaceutical compounding represents a more commonly used alternative. This approach has the advantage of easily providing adequate strength and dosage form which can often be used without manipulations [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms

et al. 2021

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The pediatric population suffers from a lack of age-appropriate medicines leading to unsafe situations when off-labelled or unlicensed drugs are used. Assessing the best option to administrate medicines when manipulations are required is essential in order to improve child care. This study aimed to compare the accuracy of the administered dose provided by three dosage forms and their techniques of administration. Different techniques of administration were assessed, covering three oral dosage forms (commercially available tablets, capsules, oral suspensions) using two APIs not available in a children-adapted dosage form. Techniques of administration were simulated and administered doses were determined using HPLC-UV. Means were compared to the target dose while distributions of doses were compared between each technique. For both APIs, mean administered doses obtained with capsules and tablets were significantly different from the target dose, whereas there was no statistical difference with oral suspensions. Distributions of doses showed significant difference between the three dosage forms. This study demonstrates that manipulations of solid oral dosage forms provide dramatic underdosing leading to unsafe situations. Compounded oral suspension is the best option to avoid underdosing and dose variation. This solution should be prioritized when age-appropriate commercial medicines are not available.

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3D Printing as a Promising Tool in Personalized Medicine

Cited by 246 publications

References 147 publications

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

Recent Advances in 3D Printing for Parenteral Applications

Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms

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