A Critical Review on 3D-printed Dosage Forms

Aita, Ilias El; Ponsar, Hanna; Quodbach, Julian

doi:10.2174/1381612825666181206124206

Cited by 32 publications

(20 citation statements)

References 116 publications

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“…3D printing, as a manufacturing technique for individualized drug delivery systems (DDS), has gained a lot of interest in the past six years. Especially, FDM TM offers a high potential for patient-tailored dosage forms regarding dose, shape and release behavior on a low-cost basis [ 1 , 2 ]. Consequently, this is the most explored 3D-printing method for pharmaceutical applications.…”

Section: Introductionmentioning

confidence: 99%

Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

2020

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Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM is favored to allow the production of pharma-grade filaments for the printing of medicines. Filament diameter consistency is a quality of great importance to ensure printability and content uniformity of 3D-printed drug delivery systems. A systematical process analysis referring to filament diameter variations has not been described in the literature. The presented study aimed at a process setup optimization and rational process analysis for filament fabrication related to influencing parameters on diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality attributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage forms was investigated. Process optimization by implementing a winder with a special haul-off unit was necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for conduction of rational extrusion analysis. The results revealed that an increased screw speed led to diameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass uniformity of printed dosage forms. The specific feed load was identified as a key parameter for filament diameter consistency.

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Section: Introductionmentioning

confidence: 99%

Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

2020

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“…Porosity is the key asset of SLS for the pharmaceutical field because of its ability to produce fast disintegrating printlets unlike FDM or SLA [ 13 ]. The very fast disintegration times of ODP makes them very similar to the Spritam ® (11 s) [ 15 ], an ODT produced by an inkjet 3D printing technique, but with the important advantage that SLS is a solvent free process.…”

Section: Variability Of the Structurementioning

confidence: 99%

“…This state-of-the-art technology allows the production of objects of different sizes and shapes, according to a pre-established design. Therefore, it offers greater flexibility than conventional processes [ 12 , 13 , 14 ]. Although 3D printing is a well-established reality in the fields of architecture, aeronautics and recently medical devices, in the drug market there is only one pharmaceutical specialty produced by 3D printing and approved by the FDA (2015): Spritam ® (Levetiracetam) [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering (SLS), a New Chapter in the Production of Solid Oral Forms (SOFs) by 3D Printing

et al. 2021

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3D printing is a new emerging technology in the pharmaceutical manufacturing landscape. Its potential advantages for personalized medicine have been widely explored and commented on in the literature over recent years. More recently, the selective laser sintering (SLS) technique has been investigated for oral drug-delivery applications. Thus, this article reviews the work that has been conducted on SLS 3D printing for the preparation of solid oral forms (SOFs) from 2017 to 2020 and discusses the opportunities and challenges for this state-of-the-art technology in precision medicine. Overall, the 14 research articles reviewed report the use of SLS printers equipped with a blue diode laser (445–450 nm). The review highlights that the printability of pharmaceutical materials, although an important aspect for understanding the sintering process has only been properly explored in one article. The modulation of the porosity of printed materials appears to be the most interesting outcome of this technology for pharmaceutical applications. Generally, SLS shows great potential to improve compliance within fragile populations. The inclusion of “Quality by Design” tools in studies could facilitate the deployment of SLS in clinical practice, particularly where Good Manufacturing Practices (GMPs) for 3D-printing processes do not currently exist. Nevertheless, drug stability and powder recycling remain particularly challenging in SLS. These hurdles could be overcome by collaboration between pharmaceutical industries and compounding pharmacies.

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“…Among the many 3D techniques, only five of them, namely BJ, FDM, SLS, SLA, and semi-solid extrusion (SSE), have been explored for pharmaceutical application [ 15 ]. The U.S. Food and Drug Administration (FDA) approval of the first 3D-printed tablet, Spritam ® (levetiracetam), in August 2015 started a new era in pharmaceutical production and increased the interest in the technology for the production of various dosage forms [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

3D Printing of Thermo-Sensitive Drugs

et al. 2021

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Three-dimensional (3D) printing is among the rapidly evolving technologies with applications in many sectors. The pharmaceutical industry is no exception, and the approval of the first 3D-printed tablet (Spiratam®) marked a revolution in the field. Several studies reported the fabrication of different dosage forms using a range of 3D printing techniques. Thermosensitive drugs compose a considerable segment of available medications in the market requiring strict temperature control during processing to ensure their efficacy and safety. Heating involved in some of the 3D printing technologies raises concerns regarding the feasibility of the techniques for printing thermolabile drugs. Studies reported that semi-solid extrusion (SSE) is the commonly used printing technique to fabricate thermosensitive drugs. Digital light processing (DLP), binder jetting (BJ), and stereolithography (SLA) can also be used for the fabrication of thermosensitive drugs as they do not involve heating elements. Nonetheless, degradation of some drugs by light source used in the techniques was reported. Interestingly, fused deposition modelling (FDM) coupled with filling techniques offered protection against thermal degradation. Concepts such as selection of low melting point polymers, adjustment of printing parameters, and coupling of more than one printing technique were exploited in printing thermosensitive drugs. This systematic review presents challenges, 3DP procedures, and future directions of 3D printing of thermo-sensitive formulations.

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A Critical Review on 3D-printed Dosage Forms

Cited by 32 publications

References 116 publications

Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

Selective Laser Sintering (SLS), a New Chapter in the Production of Solid Oral Forms (SOFs) by 3D Printing

3D Printing of Thermo-Sensitive Drugs

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