Abstract
Additive manufacturing (AM), also known as three-dimensional (3D) printing, enables fabrication of custom-designed and personalized 3D constructs with high complexity in shape and composition. AM has a strong potential to fabricate oral tablets with enhanced customization and complexity as compared to tablets manufactured using conventional approaches. Despite these advantages, AM has not yet become the mainstream manufacturing approach for fabrication of oral solid dosage forms mainly due to limitations of AM technologies and lack of diverse printable drug formulations. In this review, AM of oral tablets are summarized with respect to AM technology. A detailed review of AM methods and materials used for the AM of oral tablets is presented. This article also reviews the challenges in AM of pharmaceutical formulations and potential strategies to overcome these challenges.
Highlights
The majority of the drugs are administered orally in the form of a solid dosage form.Oral tablets offer dose precision, chemical and microbial stability, controlled drug release profiles, and ease of administration [1,2,3]
We summarize Additive manufacturing (AM) technologies used in oral tablet fabrication, widely used materials in additively manufactured oral tablet formulations, and tablets printed for each AM technology
This technology generally operates at room temperature when paste is used, which removes the risk of thermal degradation of active pharmaceutical ingredients (APIs) in the formulation; there is a risk of phase separation and it can be challenging to achieve uniform drug loading within the tablet
Summary
The majority of the drugs are administered orally in the form of a solid dosage form. AM could potentially be instrumental for early-phase drug development scenarios including evaluation of oral dosage forms for preclinical studies (including dose flexibility), exploration of custom designs (shape, porosity, and composition), and on-demand manufacturing (at clinical site) as well as an overall reduction in utilization of resources. Despite these potential advantages, there is a big gap in additively manufactured oral tablets in the market after the first 3D-printed tablet in the market, Spritam® , was approved by the United States Food and Drug Administration (FDA) in. We present the challenges in AM of pharmaceutical formulations and potential strategies to overcome these challenges
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