scholarly journals Impact of Processing Parameters on the Quality of Pharmaceutical Solid Dosage Forms Produced by Fused Deposition Modeling (FDM)

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 633 ◽  
Author(s):  
Muqdad Alhijjaj ◽  
Jehad Nasereddin ◽  
Peter Belton ◽  
Sheng Qi

Fused deposition modeling (FDM) three-dimensional (3D) printing is being increasingly explored as a direct manufacturing method to product pharmaceutical solid dosage forms. Despite its many advantages as a pharmaceutical formulation tool, it remains restricted to proof-of-concept formulations. The optimization of the printing process in order to achieve adequate precision and printing quality remains to be investigated. Demonstrating a thorough understanding of the process parameters of FDM and their impact on the quality of printed dosage forms is undoubtedly necessary should FDM advance from a proof-of-concept stage to an adapted pharmaceutical manufacturing tool. This article describes the findings of an investigation into a number of critical process parameters of FDM and their impact on quantifiable, pharmaceutically-relevant measures of quality. Polycaprolactone, one of the few polymers which is both suitable for FDM and is a GRAS (generally regarded as safe) material, was used to print internally-exposed grids, allowing examination of both their macroscopic and microstructural reproducibility of FDM. Of the measured quality parameters, dimensional authenticity of the grids was found to poorly match the target dimensions. Weights of the grids were found to significantly vary upon altering printing speed. Printing temperature showed little effect on weight. Weight uniformity per batch was found to lie within acceptable pharmaceutical quality limits. Furthermore, we report observing a microstructural distortion relating to printing temperature which we dub The First Layer Effect (FLE). Principal Component Analysis (PCA) was used to study factor interactions and revealed, among others, the existence of an interaction between weight/dosing accuracy and dimensional authenticity dictating a compromise between the two quality parameters. The Summed Standard Deviation (SSD) is proposed as a method to extract the optimum printing parameters given all the perceived quality parameters and the necessary compromises among them.

Author(s):  
Jagadish ◽  
Sumit Bhowmik

Fused deposition modeling (FDM) is one of the emerging rapid prototyping (RP) processes in additive manufacturing. FDM fabricates the quality prototype directly from the CAD data and is dependent on the various process parameters, hence optimization is essential. In the present chapter, process parameters of FDM process are analyzed using an integrated MCDM approach. The integrated MCDM approach consists of modified fuzzy with ANP methods. Experimentation is performed considering three process parameters, namely layer height, shell thickness, and fill density, and corresponding response parameters, namely ultimate tensile strength, dimensional accuracy, and manufacturing time are determined. Thereafter, optimization of FDM process parameters is done using proposed method. The result shows that exp.no-4 yields the optimal process parameters for FDM and provides optimal parameters as layer height of 0.08 mm, shell thickness of 2.0 mm and fill density of 100%. Also, optimal setting provides higher ultimate TS, good DA, and lesser MT as well as improving the performance and efficiency of FDM.


2021 ◽  
Vol 14 (5) ◽  
pp. 418
Author(s):  
Andrea Gabriela Crișan ◽  
Alina Porfire ◽  
Rita Ambrus ◽  
Gábor Katona ◽  
Lucia Maria Rus ◽  
...  

Three-dimensional printing (3DP) by fused deposition modeling (FDM) has gained momentum as a promising pharmaceutical manufacturing method due to encouraging forward-looking perspectives in personalized medicine preparation. The current challenges the technology has for applicability in the fabrication of solid dosage forms include the limited range of suitable pharmaceutical grade thermoplastic materials. Hence, it is important to investigate the implications of variable properties of the polymeric carrier on the preparation steps and the final output, as versatile products could be obtained by using the same material. In this study, we highlighted the influence of polyvinyl alcohol (PVA) particle size on the residence time of the mixtures in the extruder during the drug-loaded filament preparation step and the consequent impact on drug release from the 3D printed dosage form. We enhanced filament printability by exploiting the plasticizing potential of the active pharmaceutical ingredient (API) and we explored a channeled tablet model as a design strategy for dissolution facilitating purposes. Our findings disclosed a new perspective regarding material considerations for the preparation of PVA-based solid dosage forms by coupling hot melt extrusion (HME) and FDM-3DP.


Author(s):  
ZAINAB EASSA JASSIM

Increasing requests for modified and personalized pharmaceutics and medical materials makes the implementation of additive manufacturing increased rapidly in recent years. 3D printing has been involved numerous advantages in case of reduction in waste, flexibility in the design, and minimizing the high cost of intended products for bulk production of. Several of 3D printing technologies have been developed to fabricate novel solid dosage forms, including selective laser sintering, binder deposition, stereolithography, inkjet printing, extrusion-based printing, and fused deposition modeling. The selection of 3D printing techniques depends on their compatibility with the printed drug products. This review intent to provide a perspective on the incentives and possible applications of 3D printed pharmaceuticals, besides a practical viewpoint on how 3D printing could be included across the pharmaceutical field.


2021 ◽  
Vol 14 (2) ◽  
pp. 143
Author(s):  
Julius Krause ◽  
Laura Müller ◽  
Dorota Sarwinska ◽  
Anne Seidlitz ◽  
Malgorzata Sznitowska ◽  
...  

In the treatment of pediatric diseases, suitable dosages and dosage forms are often not available for an adequate therapy. The use of innovative additive manufacturing techniques offers the possibility of producing pediatric dosage forms. In this study, the production of mini tablets using fused deposition modeling (FDM)-based 3D printing was investigated. Two pediatric drugs, caffeine and propranolol hydrochloride, were successfully processed into filaments using hyprolose and hypromellose as polymers. Subsequently, mini tablets with diameters between 1.5 and 4.0 mm were printed and characterized using optical and thermal analysis methods. By varying the number of mini tablets applied and by varying the diameter, we were able to achieve different release behaviors. This work highlights the potential value of FDM 3D printing for the on-demand production of patient individualized, small-scale batches of pediatric dosage forms.


Author(s):  
Arash Alex Mazhari ◽  
Randall Ticknor ◽  
Sean Swei ◽  
Stanley Krzesniak ◽  
Mircea Teodorescu

AbstractThe sensitivity of additive manufacturing (AM) to the variability of feedstock quality, machine calibration, and accuracy drives the need for frequent characterization of fabricated objects for a robust material process. The constant testing is fiscally and logistically intensive, often requiring coupons that are manufactured and tested in independent facilities. As a step toward integrating testing and characterization into the AM process while reducing cost, we propose the automated testing and characterization of AM (ATCAM). ATCAM is configured for fused deposition modeling (FDM) and introduces the concept of dynamic coupons to generate large quantities of basic AM samples. An in situ actuator is printed on the build surface to deploy coupons through impact, which is sensed by a load cell system utilizing machine learning (ML) to correlate AM data. We test ATCAM’s ability to distinguish the quality of three PLA feedstock at differing price points by generating and comparing 3000 dynamic coupons in 10 repetitions of 100 coupon cycles per material. ATCAM correlated the quality of each feedstock and visualized fatigue of in situ actuators over each testing cycle. Three ML algorithms were then compared, with Gradient Boost regression demonstrating a 71% correlation of dynamic coupons to their parent feedstock and provided confidence for the quality of AM data ATCAM generates.


2021 ◽  
Vol 338 ◽  
pp. 01005
Author(s):  
Damian Dzienniak ◽  
Jan Pawlik

Additive manufacturing has been gaining popularity and availability year by year, which has resulted in its dynamic development. The most common 3D printing method as of today, FDM (Fused Deposition Modeling), owing to its peculiarity, does not always guarantee producing objects with low surface roughness. The authors of the present article have taken on the analysis of the impact of FDM printing on the roughness of the filament thus processed. They also investigate the relationship between the roughness of the unprocessed filament (made of polycaprolactam, that is, polyamide 6 or PA6) with admixtures of other materials (carbon fiber, glass fiber) and the surface quality of the manufactured object. The main subject of the analysis is the side surfaces of 3D prints, as it is their quality that is usually directly dependent on many factors connected with the process of the laying of the consecutive layers. The authors check step by step whether there exists a pronounced relationship between the roughness of the original filament material and the roughness of the obtained surface.


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