scholarly journals DEM based investigation of powder packing in 3D printing of pharmaceutical tablets

2021 ◽  
Vol 249 ◽  
pp. 14012
Author(s):  
Koyel Sen ◽  
Tanu Mehta ◽  
Anson W.K.Ma ◽  
Bodhisattwa Chaudhuri
Keyword(s):  
3D Printing ◽  
Particle Density ◽  
Numerical Models ◽  
Dosage Forms ◽  
Raw Material ◽  
Pharmaceutical Dosage Forms ◽  
Printing Process ◽  
Powder Bed ◽  
Pharmaceutical Tablets ◽  
Powder Packing

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.

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

2021 ◽  
Author(s):  
Rishi Thakkar ◽  
Yu Zhang ◽  
Jiaxiang Zhang ◽  
Mohammed Maniruzzaman
Keyword(s):  
Solid State ◽  
3D Printing ◽  
Physical Properties ◽  
Dosage Forms ◽  
Flow Properties ◽  
Printing Process ◽  
Powder Bed ◽  
Printing Processes ◽  
Binder Jetting ◽  
Physical Mixtures

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

A Comparative Chemometric Study for Quantitative Determination of Duloxetine Hydrochloride in the Presence of its Toxic Impurity 1-Naphthol

2020 ◽  
Vol 16 (8) ◽  
pp. 1030-1036 ◽  
Author(s):  
Basma H. Anwar ◽  
Nessreen S. Abdelhamid ◽  
Maimana A. Magdy ◽  
Ibrahim A. Naguib
Keyword(s):  
Least Squares ◽  
Multivariate Calibration ◽  
Dosage Forms ◽  
Hplc Method ◽  
Raw Material ◽  
Support Vector ◽  
Pharmaceutical Dosage Forms ◽  
Advantages And Disadvantages ◽  
Duloxetine Hydrochloride ◽  
Significant Difference

Background: Duloxetine hydrochloride (DUL) is a serotonin-norepinephrine reuptake inhibitor. It is used for treating depression and anxiety. It is available in the market as a capsule called Cymbatex®, which is used for the treatment of depression. 1-naphthol is a potential impurity of DUL. It is hepatotoxic to humans and has potential toxicity to freshwater fish. Objective: Duloxetine hydrochloride was determined in the presence of its toxic impurity 1-naphthol in raw material and in pharmaceutical dosage forms using three multivariate calibration chemometric methods. Methods: Classical Least Squares (CLS), Partial Least-Squares (PLS) and linear support vector regression (SVR) were developed using UV spectral data. The three methods were compared among each other and the advantages and disadvantages were discussed. For good results, a two-factor four-level experimental design was used, resulting in a training set of 16 mixtures containing different ratios of each component. The test set consisting of nine mixtures was necessary to test the ability of the proposed methods to predict DUL in the presence of its impurity, 1-naphthol. Results: The results show the success of the three developed methods to determine DUL in the presence of small levels of its toxic impurity with good accuracy and selectivity. The results of the dosage form were compared statistically to that of the reported HPLC method, with no significant difference in accuracy and precision. Conclusion: The suggested calibration models are suitable for routine analysis of the drug in bulk and pharmaceutical dosage forms. Compared to the CLS and PLS models, the SVR model gives the best results regarding the accuracy with a lower prediction error and better generalization ability. However, the CLS and PLS models are found to be simpler and faster in usage and management.

X-Ray Diffraction and Fluorescence in the Analysis of Pharmaceutical Excipients

1981 ◽  
Vol 25 ◽  
pp. 383-388
Author(s):  
A. J. Durbetaki ◽  
T. F. Quail
Keyword(s):  
Fluorescence Spectroscopy ◽  
Dosage Forms ◽  
X Ray Diffraction ◽  
Pharmaceutical Dosage Forms ◽  
X Ray ◽  
Pharmaceutical Excipients ◽  
Pharmaceutical Tablets

The majority of pharmaceutical dosage forms are marketed as tablets which are formulated to satisfy various basic requirements. The analysis of the resultant multicomponent pharmaceutical and product is usually a lengthy task.This paper describes the complementary use of X-ray diffraction (XRD) and X-ray fluorescence spectroscopy (XRS) to characterize and quantify excipients in pharmaceutical tablets.

3D Printing Analysis by Powder Bed Printer (PBP) of a Thoracic Aorta Under Simufact Additive

2021 ◽  
pp. 774-785
Author(s):  
Hacene Ameddah ◽  
Hammoudi Mazouz
Keyword(s):  
3D Printing ◽  
Thoracic Aorta ◽  
3D Modeling ◽  
Vascular Diseases ◽  
Complex Geometries ◽  
Aortic Diseases ◽  
Printing Process ◽  
Powder Bed ◽  
Design Protocol ◽  
Printing Method

In recent decades, vascular surgery has seen the arrival of endovascular techniques for the treatment of vascular diseases such as aortic diseases (aneurysms, dissections, and atherosclerosis). The 3D printing process by addition of material gives an effector of choice to the digital chain, opening the way to the manufacture of shapes and complex geometries, impossible to achieve before with conventional methods. This chapter focuses on the bio-design study of the thoracic aorta in adults. A bio-design protocol was established based on medical imaging, extraction of the shape, and finally, the 3D modeling of the aorta; secondly, a bio-printing method based on 3D printing that could serve as regenerative medicine has been proposed. A simulation of the bio-printing process was carried out under the software Simufact Additive whose purpose is to predict the distortion and residual stress of the printed model. The binder injection printing technique in a Powder Bed Printer (PBP) bed is used. The results obtained are very acceptable compared with the results of the error elements found.

A Critical Review on 3D-printed Dosage Forms

2019 ◽  
Vol 24 (42) ◽  
pp. 4957-4978 ◽  
Author(s):  
Ilias El Aita ◽  
Hanna Ponsar ◽  
Julian Quodbach
Keyword(s):  
3D Printing ◽  
Drug Release ◽  
Critical Evaluation ◽  
Dosage Forms ◽  
Review Article ◽  
Current Status ◽  
Comprehensive Overview ◽  
Pharmaceutical Dosage Forms ◽  
Advantages And Disadvantages ◽  
Pharmaceutical Application

Background: In the last decades, 3D-printing has been investigated and used intensively in the field of tissue engineering, automotive and aerospace. With the first FDA approved printed medicinal product in 2015, the research on 3D-printing for pharmaceutical application has attracted the attention of pharmaceutical scientists. Due to its potential of fabricating complex structures and geometrics, it is a highly promising technology for manufacturing individualized dosage forms. In addition, it enables the fabrication of dosage forms with tailored drug release profiles. Objective: The aim of this review article is to give a comprehensive overview of the used 3D-printing techniques for pharmaceutical applications, including information about the required material, advantages and disadvantages of the respective technique. Methods: For the literature research, relevant keywords were identified and the literature was then thoroughly researched. Conclusion: The current status of 3D-printing as a manufacturing process for pharmaceutical dosage forms was highlighted in this review article. Moreover, this article presents a critical evaluation of 3D-printing to control the dose and drug release of printed dosage forms.

Binder-Jet 3D Printing of Indomethacin-laden Pharmaceutical Dosage Forms

2020 ◽  
Vol 109 (10) ◽  
pp. 3054-3063
Author(s):  
Shing-Yun Chang ◽  
Si Wan Li ◽  
Kavin Kowsari ◽  
Abhishek Shetty ◽  
Leila Sorrells ◽  
...  
Keyword(s):  
3D Printing ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms

scholarly journals XPS and SEM characterization for powder recycling within 3d printing process

2021 ◽  
Author(s):  
Nima E. Gorji ◽  
Robert O'Connor ◽  
Dermot Brabazon
Keyword(s):  
3D Printing ◽  
Photoelectron Spectroscopy ◽  
Manufacturing Process ◽  
Surface Composition ◽  
Composition Analysis ◽  
Printing Process ◽  
Powder Bed ◽  
Powder Recycling ◽  
The Cost

In recent years, recycling the powder leftover within the additive manufacturing process has been attractive for both research, development and industry production. Powder recycling can significantly enhance the sustainability of the manufacturing process, reduce the cost and avoid producing metallic waste as a potential environmental hazard. The first step in reusing the recycled powders in the 3D printing process is to characterize the microstructure and surface quality of the powder for oxidation and impurity analysis. Here, scanning electron microscopy (SEM) and x-ray photoelectron spectroscopy (XPS) have been used for the morphology and surface composition analysis of the 316L powders within the Aconity 3D printer. A new powder collection strategy has been introduced to collect powders from different locations in the powder bed: from the top most and surface of the parts and powder bed after the print terminated, from between the printed parts at different heights. The XPS measurements revealed that oxidation is a common in all the powders compared to virgin powder and more oxidation was detected from the powders collected on the very top of the leftover powder and from surface of the bed. The size of the particles does not change much but larger particles remained at the topmost surface. This finding would help in designing a protocol for collecting the recycled powder from the powder bed and it is suggested to follow a a procedure of collecting powders from the different sections of the powder bed in order to avoid mixing the most and least affected particles.

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