Selective laser sintering 3D printing - an overview of the technology and pharmaceutical applications.

Published on May 13, 2020in Drug Development and Industrial Pharmacy2.365
· DOI :10.1080/03639045.2020.1764027
Naseem A. Charoo12
Estimated H-index: 12
,
Sogra F. Barakh Ali8
Estimated H-index: 8
(A&M: Texas A&M University)
+ 4 AuthorsZiyaur Rahman25
Estimated H-index: 25
(A&M: Texas A&M University)
Sources
Abstract
Food and Drug Administration (FDA) has approved a drug product (Spritam(R)) and many medical devices manufactured by 3-dimensional printing (3DP) processes for human use. There is immense potential to print personalized medicines using 3DP. Many 3DP methods have been reported in the literature for pharmaceutical applications. However, selective laser sintering (SLS) printing has remained least explored for pharmaceutical applications. There are many advantages and challenges in adopting a SLS method for fabrication of personalized medicines. Solvent free nature, availability of FDA approved thermoplastic polymer/excipients (currently used in hot melt-extrusion process), minimal/no post-processing step, etc. are some of the advantages of the SLS printing process. Major challenges of the technology are requirement of at least one thermoplastic component in the formulation and thermal stability of drug and excipients. This review provides an overview of the SLS printing method, excipient requirements, process monitoring, quality defects, regulatory aspects and potential pharmaceutical applications.
📖 Papers frequently viewed together
176 Citations
7 Authors (Atheer Awad, ..., Abdul Basit)
62 Citations
104 Citations
References65
Newest
#1Sarah J. Trenfield (UCL: University College London)H-Index: 15
#2Hui Xian Tan (UCL: University College London)H-Index: 2
Last. Abdul Basit (AU: Ashford University)H-Index: 86
view all 7 authors...
Abstract Three-dimensional printing (3DP) is a revolutionary technology in pharmaceuticals, enabling the personalisation of flexible-dose drug products and 3D printed polypills (polyprintlets). A major barrier to entry of this technology is the lack of non-destructive quality control methods capable of verifying the dosage of multiple drugs in polyprintlets at the point of dispensing. In the present study, 3D printed films and cylindrical polyprintlets were loaded with flexible, therapeutic dosa...
27 CitationsSource
Purpose The objective of this article is to review the critical material attributes of pharmaceutical excipients employed in solid dosage manufacturing and link them to critical quality attributes (CQAs). Material attributes can have a profound impact on CQAs of product.
1 CitationsSource
#1Atheer Awad (UCL: University College London)H-Index: 13
#2Aliya Yao (UCL: University College London)H-Index: 1
Last. Abdul Basit (AU: Ashford University)H-Index: 86
view all 6 authors...
Visual impairment and blindness affects 285 million people worldwide, resulting in a high public health burden. This study reports, for the first time, the use of three-dimensional (3D) printing to create orally disintegrating printlets (ODPs) suited for patients with visual impairment. Printlets were designed with Braille and Moon patterns on their surface, enabling patients to identify medications when taken out of their original packaging. Printlets with different shapes were fabricated to of...
34 CitationsSource
#1Nour Allahham (AU: Ashford University)H-Index: 2
#2Fabrizio Fina (UCL: University College London)H-Index: 9
Last. Alvaro Goyanes (AU: Ashford University)H-Index: 32
view all 8 authors...
The aim of this work was to explore the feasibility of using selective laser sintering (SLS) 3D printing (3DP) to fabricate orodispersable printlets (ODPs) containing ondansetron. Ondansetron was first incorporated into drug-cyclodextrin complexes and then combined with the filler mannitol. Two 3D printed formulations with different levels of mannitol were prepared and tested, and a commercial ondansetron orally disintegrating tablet (ODT) product (Vonau® Flash) was also investigated for compari...
33 CitationsSource
#1Sogra F. Barakh Ali (Texas A&M Health Science Center)H-Index: 8
#2Eman M. Mohamed (Beni-Suef University)H-Index: 8
Last. Ziyaur Rahman (Texas A&M Health Science Center)H-Index: 25
view all 7 authors...
Abstract The focus of the study was to understand the effects of formulation and process variables on the printlets quality manufactured by selective laser sintering (SLS) 3D printing. The Box-Behnken response surface methodology was used to evaluate effects of individual variables and combinations thereof. The formulation and process variables studied were printing chamber temperature (°C, X1), laser scanning speed (mm/sec, X2) and lactose monohydrate concentration (%, X3). The responses studie...
22 CitationsSource
#1Owen Tao (McGill University)H-Index: 3
#2Jacqueline Kort-Mascort (McGill University)H-Index: 4
Last. Simon D. Tran (McGill University)H-Index: 30
view all 8 authors...
Three-dimensional (3D) printing is an emerging technology in the field of dentistry. It uses a layer-by-layer manufacturing technique to create scaffolds that can be used for dental tissue engineering applications. While several 3D printing methodologies exist, such as selective laser sintering or fused deposition modeling, this paper will review the applications of 3D printing for craniofacial tissue engineering; in particular for the periodontal complex, dental pulp, alveolar bone, and cartila...
30 CitationsSource
#1Xiaoming Xu (CDER: Center for Drug Evaluation and Research)H-Index: 17
#2Akhtar Siddiqui (CDER: Center for Drug Evaluation and Research)H-Index: 14
Last. Muhammad Ashraf (FDA: Food and Drug Administration)H-Index: 8
view all 9 authors...
In this study, the effect of formulation variables and process parameters on the abuse-deterrent (AD) characteristics of a matrix tablet manufactured using hot-melt extrusion (HME) was investigated. The formulation variables included polyethylene oxide (PEO) grades and its input level, while the HME process parameters varied were barrel temperature profile and die diameter. Depending on the diameter of the extrudate (2.5 mm or 5.0 mm), two different downstream processes were used to prepare the ...
7 CitationsSource
#1Hai-Bang LyH-Index: 20
#2Eric MonteiroH-Index: 9
Last. Binh Thai PhamH-Index: 58
view all 7 authors...
The presence of defects like gas bubble in fabricated parts is inherent in the selective laser sintering process and the prediction of bubble shrinkage dynamics is crucial. In this paper, two artificial intelligence (AI) models based on Decision Trees algorithm were constructed in order to predict bubble dissolution time, namely the Ensemble Bagged Trees (EDT Bagged) and Ensemble Boosted Trees (EDT Boosted). A metadata including 68644 data were generated with the help of our previously developed...
39 CitationsSource
#1Li Feng (WIT: Wuhan Institute of Technology)H-Index: 1
#2Yan Wang (WIT: Wuhan Institute of Technology)H-Index: 2
Last. Qinya Wei (WIT: Wuhan Institute of Technology)H-Index: 1
view all 3 authors...
In this study, Polyamide 12 (PA12) powder recycled after selective laser sintering (SLS) was made into filaments for fused deposition modelling (FDM). Compared with fresh PA12, the melt flow rate (MFR) of the recycled PA12 powder decreased by 77%, but the mechanical properties were only slightly reduced. In FDM, the printing speed and building orientation were changed, and the performance of the printed parts was tested. If the printing speed is too fast or too slow, the mechanical properties of...
19 CitationsSource
#1Atheer Awad (UCL: University College London)H-Index: 13
#2Fabrizio Fina (UCL: University College London)H-Index: 9
Last. Abdul Basit (AU: Ashford University)H-Index: 86
view all 7 authors...
Selective laser sintering (SLS) is a single-step three-dimensional printing (3DP) process that can be leveraged to engineer a wide array of drug delivery systems. The aim of this work was to utilise SLS 3DP, for the first time, to produce small oral dosage forms with modified release properties. As such, paracetamol-loaded 3D printed multiparticulates, termed miniprintlets, were fabricated in 1 mm and 2 mm diameters. Despite their large surface area compared with a conventional monolithic tablet...
62 CitationsSource
Cited By15
Newest
#1Yanis A. Gueche (CNRS: Centre national de la recherche scientifique)H-Index: 2
#2Noelia M. Sanchez-Ballester (CNRS: Centre national de la recherche scientifique)H-Index: 12
Last. Ian Soulairol (CNRS: Centre national de la recherche scientifique)H-Index: 8
view all 5 authors...
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...
Source
#1Merima Sirbubalo (University of Sarajevo)H-Index: 3
#2Amina Tucak (University of Sarajevo)H-Index: 3
Last. Almir Dervisevic (University of Sarajevo)H-Index: 3
view all 11 authors...
Microneedles (MNs) represent the concept of attractive, minimally invasive puncture devices of micron-sized dimensions that penetrate the skin painlessly and thus facilitate the transdermal administration of a wide range of active substances. MNs have been manufactured by a variety of production technologies, from a range of materials, but most of these manufacturing methods are time-consuming and expensive for screening new designs and making any modifications. Additive manufacturing (AM) has b...
Source
#1I. Lafeber (LUMC: Leiden University Medical Center)
#2J.M. Tichem (LUMC: Leiden University Medical Center)
Last. Kirsten J. M. Schimmel (LUMC: Leiden University Medical Center)H-Index: 7
view all 11 authors...
Abstract Three-dimensional (3D) printing of pharmaceuticals has the potential to revolutionise personalised medicine but is as yet largely unexplored. A proof-of-concept study of a novel heated, piston-driven semi-solid extrusion 3D printer was performed by producing furosemide and sildenafil tablets for paediatric patients. The average weight of the tablets was 141.1 mg (RSD 1.26%). The acceptance values of the content uniformity were 4.2-10.6 (concentration RSD 0.41-0.63%), 4.8-8.9 (concentrat...
1 CitationsSource
Additive manufacturing, enabling rapid prototyping and so-called on-demand production, has become a common method of creating parts or whole devices. On a 3D printer, real objects are produced layer by layer, thus creating extraordinary possibilities as to the number of applications for this type of devices. The opportunities offered by this technique seem to be pushing new boundaries when it comes to both the use of 3D printing in practice and new materials from which the 3D objects can be prin...
Source
#1Sedigheh Borandeh (Aalto University)H-Index: 2
#1Sedigheh Borandeh (Aalto University)H-Index: 14
Last. Jukka Seppälä (Aalto University)H-Index: 68
view all 4 authors...
Abstract Additive manufacturing (AM) is gaining interests in drug delivery applications, offering innovative opportunities for the design and development of systems with complex geometry and programmed controlled release profile. In addition, polymer-based drug delivery systems can improve drug safety and efficacy and patient compliance and are the key materials in AM. Therefore, combining AM and polymers can be beneficial to overcome the existing limitations in the development of controlled rel...
5 CitationsSource
#1Pavel M. Talianov (SPbU: Saint Petersburg State University)
#2Sergey S. Rzhevskii (SPbU: Saint Petersburg State University)
Last. Alina Manshina (SPbU: Saint Petersburg State University)H-Index: 18
view all 6 authors...
The laser induced curing of acryloxy terminated ethyleneoxide dimethylsiloxane-ethyleneoxide ABA block copolymer (PDMS-AO) and (3-glycidoxypropyl)trimethoxysilane (GPTMS) was carried out with 2-hydroxy-2-methylpropiophenone as radical photoinitiator and p-(octyloxyphenyl)phenyliodonium hexafluoroantimonate as cationic photoinitiator, respectively. The cross-linking mechanisms for both mixtures were determined through monitoring of photocuring by SSNMR, FTIR and Raman spectroscopies. The obtained...
Source
#1Piotr Kulinowski (Pedagogical University of Kraków)H-Index: 1
#2Piotr Malczewski (Pedagogical University of Kraków)H-Index: 3
Last. Przemysław Dorożyński (Medical University of Warsaw)H-Index: 12
view all 7 authors...
Abstract The paper presents the unique approach to 3D printing by Selective Laser Sintering of high dose controlled release pharmaceutical dosage form, which contains almost exclusively drug substance - just crystalline paracetamol as a model drug substance and small amount of dye were used. Comprehensive printlet characterization, that included pore space analysis, drug release and subsequent dissolution modeling as well as exploratory analysis, revealed various degrees of freedom for tuning it...
2 CitationsSource
#1Yanis A. GuecheH-Index: 2
Last. Ian SoulairolH-Index: 8
view all 7 authors...
Material suitability needs to be considered for the 3D printing of solid oral dosage forms (SODFs). This work aims to assess the suitability of a CO2 laser (λ = 10.6 μm) for selective laser sintering of SODFs containing copovidone and paracetamol. First, physicochemical characterization of powders (two grades of copovidone, two grades of paracetamol and their mixtures at various proportions) was conducted: particle size distribution, morphology, infrared absorbance, flowability, and compactness....
3 CitationsSource
#1Yan Yang (Zhejiang University of Technology)H-Index: 7
#1Yan Yang (Zhejiang University of Technology)H-Index: 3
Last. Wei-Guang Shan (Zhejiang University of Technology)H-Index: 15
view all 4 authors...
Abstract Selective laser sintering (SLS) sinters a powder layer by layer with a laser beam to prepare 3D printlets, which are widely used in the field of tissue engineering and personalized implants. To promote the SLS printing of oral solid preparations, the printability of commonly used drugs and excipients was evaluated using a 450 nm low energy laser. It was found that yellow drugs could absorb laser energy and sinter, while white drugs and pharmaceutical excipients had SLS printability when...
8 CitationsSource
#1Vanessa Marcia Vaz (Manipal University)H-Index: 1
#2Lalit Kumar (Manipal University)H-Index: 12
Personalized medicine has the potential to revolutionize the healthcare sector, its goal being to tailor medication to a particular individual by taking into consideration the physiology, drug response, and genetic profile of that individual. There are many technologies emerging to cause this paradigm shift from the conventional "one size fits all" to personalized medicine, the major one being three-dimensional (3D) printing. 3D printing involves the establishment of a three-dimensional object, ...
5 CitationsSource