Abstract
Three dimensional (3D) printing as an advanced manufacturing technology is progressing to be established in the pharmaceutical industry to overcome the traditional manufacturing regime of 'one size fits for all'. Using 3D printing, it is possible to design and develop complex dosage forms that can be suitable for tuning drug release. Polymers are the key materials that are necessary for 3D printing. Among all 3D printing processes, extrusion-based (both fused deposition modeling (FDM) and pressure-assisted microsyringe (PAM)) 3D printing is well researched for pharmaceutical manufacturing. It is important to understand which polymers are suitable for extrusion-based 3D printing of pharmaceuticals and how their properties, as well as the behavior of polymer–active pharmaceutical ingredient (API) combinations, impact the printing process. Especially, understanding the rheology of the polymer and API–polymer mixtures is necessary for successful 3D printing of dosage forms or printed structures. This review has summarized a holistic materials–process perspective for polymers on extrusion-based 3D printing. The main focus herein will be both FDM and PAM 3D printing processes. It elaborates the discussion on the comparison of 3D printing with the traditional direct compression process, the necessity of rheology, and the characterization techniques required for the printed structure, drug, and excipients. The current technological challenges, regulatory aspects, and the direction toward which the technology is moving, especially for personalized pharmaceuticals and multi-drug printing, are also briefly discussed.
Highlights
Additive manufacturing, commonly known as three dimensional printing (3D printing), is seeing increased use in several different industries such as aerospace, motor vehicles, industrial machines, consumer products, electronics, military, medical, dental, etc. [1,2,3]
Filaments composed of different combinations of polymers, created with HME, exhibited better mechanical and rheological properties suitable for fused deposition modeling (FDM) 3D printing compared to the individual polymer formulations [71]
Rheological properties of the polymers and polymer–active pharmaceutical ingredient (API) mixture play a vital role in predicting the processability of FDM and pressure-assisted microsyringe (PAM) 3D printing and the properties of the final pharmaceutical products such as drug release
Summary
Commonly known as three dimensional printing (3D printing), is seeing increased use in several different industries such as aerospace, motor vehicles, industrial machines, consumer products, electronics, military, medical, dental, etc. [1,2,3]. Polymers are used in the 3D printing of pharmaceuticals for different purposes such as to control the dosage shape, size, drug release, etc. Polymers’ multifaceted utilization in solid dosage drug delivery systems solidifies its importance in pharmaceutical 3D printing applications. Long et al discussed appropriate polymers and key parameters required for FDM 3D printing and its usage in the printing of personalized tablets and drug delivery devices [50]. There is no detailed discussion on how polymers should be selected based on materials characteristics, how their rheology impact on the printing process, and the required characterization for the 3D printed pharmaceuticals. The objective of this review is to discuss all these in detail to guide the researchers in selecting the right polymers and extrusion process to 3D print pharmaceuticals. A comparison between FDM and PAM 3D printing, the current challenges, regulatory aspects, and opportunities for extrusion-based printing are discussed
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