scholarly journals Synergistic application of continuous granulation and selective laser sintering 3D printing for the development of pharmaceutical dosage forms with enhanced dissolution rates and physical properties

Author(s):  
Rishi Thakkar ◽  
Yu Zhang ◽  
Jiaxiang Zhang ◽  
Mohammed Maniruzzaman

AbstractThis study demonstrated the first case of combining novel continuous granulation with powder-based pharmaceutical 3-dimensional (3D) printing processes to enhance the dissolution rate and physical properties of a poorly water-soluble drug. Powder bed fusion (PBF) and binder jetting 3D printing processes have gained much attention in pharmaceutical dosage form manufacturing in recent times. Although powder bed-based 3D printing platforms have been known to face printing and uniformity problems due to the inherent poor flow properties of the pharmaceutical physical mixtures (feedstock). Moreover, techniques such as binder jetting currently do not provide any solubility benefits to active pharmaceutical ingredients (APIs) with poor aqueous solubility (>40% of marketed drugs). For this study, a hot-melt extrusion-based versatile granulation process equipped with UV-Vis process analytical technology (PAT) tools for the in-line monitoring of critical quality attributes (i.e., solid-state) of indomethacin was developed. The collected granules with enhanced flow properties were mixed with vinylpyrrolidone-vinyl acetate copolymer and a conductive excipient for efficient sintering. These mixtures were further characterized for their bulk properties observing an excellent flow and later subjected to a PBF-3D printing process. The physical mixtures, processed granules, and printed tablets were characterized using conventional as well as advanced solid-state characterization. These characterizations revealed the amorphous nature of the drug in the processed granules and printed tablets. Further, the in vitro release testing of the tablets with produced granules as a reference standard depicted a notable solubility advantage (100% drug released in 5 minutes at >pH 6.8) over the pure drug and the physical mixture. Our developed system known as DosePlus combines innovative continuous granulation and PBF-3D printing process which can potentially improve the physical properties of the bulk drug and formulations in comparison to when used in isolation. This process can further find application in continuous manufacturing of granules and additive manufacturing of pharmaceuticals to produce dosage forms with excellent uniformity and solubility advantage.Abstract Figure

2021 ◽  
Vol 249 ◽  
pp. 14012
Author(s):  
Koyel Sen ◽  
Tanu Mehta ◽  
Anson W.K.Ma ◽  
Bodhisattwa Chaudhuri

3D printing is emerging as one of the most promising methods to manufacture Pharmaceutical dosage forms as it offers multiple advantages such as personalization of dosage forms, polypill, fabrication of complex dosage forms etc. 3D printing came into existence in 1980s but its use was extended recently to pharmaceutical industry along with the approval of first 3D printed tablet Spritam by FDA in 2015. Spritam was manufactured by Aprecia pharmaceuticals using binder jetting technology. Binder jet 3D printing involves a hopper for powder discharge and printheads for ink jetting. The properties of tablets are highly dependent upon the discharge quality of powder mixture from the hopper and jetting of the ink/binder solution from the printhead nozzle. In this study, numerical models were developed using Discrete element method (DEM) to gain better understanding of the binder jet 3D printing process. The DEM modeling of hopper discharge was performed using in-house DEM code to study the effect of raw material attributes such as powder bed packing density (i.e. particle size, particle density etc) on the printing process, especially during powder bed preparation. This DEM model was further validated experimentally, and the model demonstrated good agreement with experimental results.


2019 ◽  
Vol 56 (4) ◽  
pp. 801-811
Author(s):  
Mircea Dorin Vasilescu

This work are made for determine the possibility of generating the specific parts of a threaded assembly. If aspects of CAD generating specific elements was analysed over time in several works, the technological aspects of making components by printing processes 3D through optical polymerization process is less studied. Generating the threaded appeared as a necessity for the reconditioning technology or made components of the processing machines. To determine the technological aspects of 3D printing are arranged to achieve specific factors of the technological process, but also from the specific elements of a trapezoidal thread or spiral for translate granular material in supply process are determined experimentally. In the first part analyses the constructive generation process of a spiral element. In the second part are identified the specific aspects that can generation influence on the process of realization by 3D DLP printing of the two studied elements. The third part is affected to printing and determining the dimensions of the analysed components. We will determine the specific value that can influence the process of making them in rapport with printing process. The last part is affected by the conclusions. It can be noticed that both the orientation and the precision of generating solid models have a great influence on the made parts.


Author(s):  
Sahand Hajifar ◽  
Ramanarayanan Purnanandam ◽  
Hongyue Sun ◽  
Chi Zhou

Abstract 3D printing is a promising technique to fabricate flexible parts and reduce the supply chain. Various materials, such as metal powders, plastics, ultraviolet (UV) sensitive resins, can be fabricated from 3D printing and form the final printed part. Currently, most researchers either focus on exploring printable materials with good property or focus on the process quality control given a certain type of material. However, for many 3D printing processes, the printing process and product properties are dependent on both the material properties and process settings. To the best of the authors’ knowledge, the quantitative analysis of the interactions of material properties and printing process settings are rarely studied. In this paper, we treat the material preparation and 3D printing as different manufacturing stages, and we explore the multi-stage effects in 3D printing. In particular, we add carbon fiber to the CLEAR resin to alter the material properties for a stereolithography (SLA) 3D printing process. It is observed that the part properties are jointly affected by material properties and printing process settings. Therefore, the material property and process settings should be jointly considered for optimizing 3D printing processes.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 124 ◽  
Author(s):  
Mohammad A. Azad ◽  
Deborah Olawuni ◽  
Georgia Kimbell ◽  
Abu Zayed Md Badruddoza ◽  
Md. Shahadat Hossain ◽  
...  

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.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Mika Salmi

Most of the 3D printing applications of preoperative models have been focused on dental and craniomaxillofacial area. The purpose of this paper is to demonstrate the possibilities in other application areas and give examples of the current possibilities. The approach was to communicate with the surgeons with different fields about their needs related preoperative models and try to produce preoperative models that satisfy those needs. Ten different kinds of examples of possibilities were selected to be shown in this paper and aspects related imaging, 3D model reconstruction, 3D modeling, and 3D printing were presented. Examples were heart, ankle, backbone, knee, and pelvis with different processes and materials. Software types required were Osirix, 3Data Expert, and Rhinoceros. Different 3D printing processes were binder jetting and material extrusion. This paper presents a wide range of possibilities related to 3D printing of preoperative models. Surgeons should be aware of the new possibilities and in most cases help from mechanical engineering side is needed.


China Foundry ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. 335-343
Author(s):  
Zhao-fa Zhang ◽  
Li Wang ◽  
Lin-tao Zhang ◽  
Peng-fei Ma ◽  
Bing-heng Lu ◽  
...  

2021 ◽  
Vol 890 ◽  
pp. 152-156
Author(s):  
Mirela Ciornei ◽  
Răzvan Ionuț Iacobici ◽  
Ionel Dănuț Savu ◽  
Dalia Simion

The application of the 3D printing processes is continuously increasing due to their large number of technical and economic advantages when produce prototypes, but in the mass fabrication as well, especially for metal printing of low dimension products. The process produces pollution as all technological processes. Noise, fume and polymer wastes are the main elements which exit from the process and they are not products. The types and the volumes of those pollution emissions depend on the process parameters. The paper presents the results of FDM process emissions analysis. It was recorded the noise for different stages of the printer functioning. It was measured the volume and the contents of the fume produced during the extrusion of the polymer, for PLA polymer and for ABS polymer filaments. Specific risks were analysed and conclusions were reported. The measurement was done for a random chosen product and the results were compared with the pollutant emissions from traditional technological processes applied to erect the same type of product. It has been concluded that the noise emitted during the FDM printing is about 82-85% of the noise produced when apply milling to create similar shapes and dimensions (it was recorded values for the sound pressure in a large range: 42-68 dB, depending on the working regime). Regarding the fume emission, the intensity of emission was up to 40% higher in the FDM process comparing to the milling process. That was explained as being a direct result of the fluid-viscous state in which the material is put during the printing process. When discuss about the risks, most of the main identified risks in the milling and/or extrusion process were almost inexistent in the FDM printing. Electrical injuries and heat injuries are the main risks to which the operator is exposed. Mechanical injuries are sensitively lower than in the traditional processes, as milling The FDM process is safer and produces lower material wastes. It can be concluded that the FDM printing process has lower impact with the environment and with the operator.


Materials ◽  
2021 ◽  
Vol 14 (11) ◽  
pp. 2737
Author(s):  
Izabela Rojek ◽  
Dariusz Mikołajewski ◽  
Marek Macko ◽  
Zbigniew Szczepański ◽  
Ewa Dostatni

Technological and material issues in 3D printing technologies should take into account sustainable development, use of materials, energy, emitted particles, and waste. The aim of this paper is to investigate whether the sustainability of 3D printing processes can be supported by computational intelligence (CI) and artificial intelligence (AI) based solutions. We present a new AI-based software to evaluate the amount of pollution generated by 3D printing systems. We input the values: printing technology, material, print weight, etc., and the expected results (risk assessment) and determine if and what precautions should be taken. The study uses a self-learning program that will improve as more data are entered. This program does not replace but complements previously used 3D printing metrics and software.


2017 ◽  
Vol 37 (2) ◽  
pp. 162-169 ◽  
Author(s):  
Julien Gardan

Purpose This paper aims to present a technical approach to evaluate the quality of textures obtained by an inkjet during binder jetting in 3D printing on a powder bed through contours detection to improve the quality of the surface printed according to the result of the assembly between the inkjet and a granular product. Design/methodology/approach The manufacturing process is based on the use of computer-aided design and a 3D printer via binder jetting. Image processing measures the edge deviation of a texture on the granular surface with the possibility of implementing a correction in an active assembly through a “design for manufacturing” (DFM) approach. Example application is presented through first tests. Findings This approach observes a shape alteration of the printed image on a 3D printed product, and the work used the image processing method to improve the model according to the DFM approach. Originality/value This paper introduces a solution for improving the texture quality on 3D printed products realized via binder jetting. The DFM approach proposes an active assembly by compensating the print errors in upstream of a product life cycle.


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