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3D Printing and Additive Manufacturing Feb 2023This research concerns on the application of combined thermomechanical-inherent strain method (TMM-ISM) in predicting the distortion of additively manufactured...
This research concerns on the application of combined thermomechanical-inherent strain method (TMM-ISM) in predicting the distortion of additively manufactured component. The simulation and experimental verification were conducted in the form of vertical cylinder using selective laser melting, which was subsequently cut in the middle section. The setup and procedure of simulation approaches followed the actual process parameters such as laser power, layer thickness, scan strategy, and temperature dependent material, including flow curve retrieved from specialized computational numerical software. The investigation began with virtual calibration test using TMM, followed by manufacturing process simulation using ISM. Based on the maximum deformation result of simulated calibration and accuracy consideration from previous equivalent study, the inherent strain values used in ISM analysis were obtained using self-developed optimization algorithm with direct pattern search Nelder-Mead method in finding the minimum error of distortion using MATLAB. The error minima were measured between transient TMM-based simulation and simplified formulation in calculating the inherent strain values with respect to longitudinal and transverse laser directions. Furthermore, the combined TMM-ISM distortion results were compared to fully TMM with equivalent mesh number and verified based on experimental investigation conducted by renowned researcher. It can be concluded that the result of slit distortion from TMM-ISM and TMM showed good agreement with the error percentage of 9.5% and 3.5%, respectively. However, the computational time for combined TMM-ISM was reduced tremendously with only 63 min if compared to TMM with 129 min in running full simulation on solid cylindrical component. Hence, combined TMM-ISM-based simulation can be considered as an alternative method to replace time-consuming and cost-intensive calibration preparation and analysis.
PubMed: 36998800
DOI: 10.1089/3dp.2021.0197 -
JAMA Network Open Aug 2020Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.
IMPORTANCE
Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.
OBJECTIVE
To determine whether there were clear and substantive differences in major quality attributes between difficult-to-make solid oral dosage form pharmaceutical products marketed in the US.
DESIGN, SETTING, AND PARTICIPANTS
This quality improvement study analyzed US Food and Drug Administration-collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia. These drug products were immediate-release solid oral dosage forms considered difficult to make on the basis of product quality history. This sampling included 35 innovator and 217 generic drug samples manufactured by 46 different firms containing 17 different active ingredients. Statistical analysis was performed from February to November 2019.
MAIN OUTCOMES AND MEASURES
All products were tested within their shelf life on the basis of the legally recognized tests of the US Pharmacopeia for the major quality attributes of dosage unit uniformity and dissolution. These tests measure dosage consistency and drug release, respectively. The consistency of either attribute was used to calculate a process performance index to describe the variability in manufacturing.
RESULTS
All 252 drug product samples met the US market standards for dosage unit uniformity and dissolution, although the process performance index (Ppk) for dissolution fell below the level of 4-sigma capability (ie, <1 error per 1600) for 11 different manufacturers and for generics in 4 of 5 regions, including the US. As part of a retrospective analysis, manufacturers performing above the median Ppk for either dissolution or dosage unit uniformity submitted fewer product quality defect reports (mean field alert reports of 0.22 and 0.63, respectively) than those falling at or below the median Ppk for these attributes (mean field alert reports of 2.1 and 1.7, respectively).
CONCLUSIONS AND RELEVANCE
All samples met the US market standards for dosage unit uniformity and dissolution, indicating acceptability for use by patients regardless of manufacturer or region. To our knowledge, this is the largest sampling study of pharmaceutical manufacturers for the US market and these data provide objective insight into the quality of prescription drugs with high manufacturing risks.
Topics: Capsules; Drugs, Generic; Pharmaceutical Preparations; Quality Control; Quality Improvement; Tablets; United States
PubMed: 32833019
DOI: 10.1001/jamanetworkopen.2020.13920 -
BMJ Open Sep 2022This study aims to develop and validate a novel implicit tool to assist clinicians in resource-limited settings to promptly assess suitability for modification of solid... (Review)
Review
Development and validation of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) Algorithm using data of patients with medication dysphagia from a neurology ward and nursing home in Singapore.
OBJECTIVES
This study aims to develop and validate a novel implicit tool to assist clinicians in resource-limited settings to promptly assess suitability for modification of solid oral dosage forms (SODFs) during medication prescribing, review and/or administration for patients with dysphagia.
DESIGN
Literature review and a group discussion were conducted to elicit items for the construction of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) algorithm. For its validation, inter-rater reliability among three independent users was evaluated. Accuracy of users' ratings was also evaluated against the screening results using the handbook.
SETTING AND PARTICIPANTS
Three pharmacists were involved in the development and another three were involved in the validation of the INGEST algorithm using anonymised medication records of 50 patients in a nursing home and a hospital ward; only SODFs that were modified prior to administration were evaluated.
RESULTS
Following literature review, considerations included by consensus in the INGEST algorithm were the presence of special coating or modified release characteristics of the SODF medications, hazardous nature and taste of the active ingredients, manufacturer's advice and use of tube feeding. Of the 381 SODF medications evaluated, 26 (6.8%) were identified by at least one pharmacist to be inappropriate for modification. Gwet's AC among the three pharmacists in identifying SODF medications inappropriate for modification was 0.75 (p<0.001, 95% CI 0.63 to 0.87), and 0.80 (p<0.001, 95% CI 0.71 to 0.89) in identifying SODF medications appropriate for modification, suggesting substantial inter-rater agreement. Overall accuracy of each pharmacist's ratings was high, ranging from 93.7% to 95.6%.
CONCLUSIONS
The implicit INGEST algorithm has potential for use by clinicians in nursing home and hospital settings for determining suitability of SODF medications for modification. Further studies should be conducted to assess its external validity and utilisation in daily practice for improving clinical outcomes for patients with SODF dysphagia.
Topics: Algorithms; Deglutition Disorders; Drug-Related Side Effects and Adverse Reactions; Hospitals; Humans; Inappropriate Prescribing; Neurology; Nursing Homes; Pharmaceutical Preparations; Pharmacists; Reproducibility of Results; Singapore
PubMed: 36153038
DOI: 10.1136/bmjopen-2022-061774 -
International Journal of Molecular... Aug 2022Development of nanomaterials for drug delivery has received considerable attention due to their potential for achieving on-target delivery to the diseased area while the... (Review)
Review
Development of nanomaterials for drug delivery has received considerable attention due to their potential for achieving on-target delivery to the diseased area while the surrounding healthy tissue is spared. Safe and efficiently delivered payloads have always been a challenge in pharmaceutics. Niosomes are self-assembled vesicular nanocarriers formed by hydration of a non-ionic surfactant, cholesterol or other molecules that combine to form a versatile drug delivery system with a variety of applications ranging from topical delivery to targeted delivery. Niosomes have advantages similar to those of liposomes with regards to their ability to incorporate both hydrophilic and hydrophobic payloads. Moreover, niosomes have simple manufacturing methods, low production cost and exhibit extended stability, consequently overcoming the major drawbacks associated with liposomes. This review provides a comprehensive summary of niosomal research to date, including the types of niosomes and critical material attributes (CMA) and critical process parameters (CPP) of niosomes and their effects on the critical quality attributes (CQA) of the technology. Furthermore, physical characterisation techniques of niosomes are provided. The review then highlights recent applications of specialised niosomes in drug delivery. Finally, limitations and prospects for this technology are discussed.
Topics: Cholesterol; Drug Delivery Systems; Liposomes; Particle Size; Pulmonary Surfactants; Surface-Active Agents
PubMed: 36077066
DOI: 10.3390/ijms23179668 -
Animal Nutrition (Zhongguo Xu Mu Shou... Dec 2021Fat added to poultry and swine feeds often contains abundant free fatty acids (FFA) that can impair digestible energy (DE). Placement of the fatty acid (FA) hydrocarbon... (Review)
Review
Fat added to poultry and swine feeds often contains abundant free fatty acids (FFA) that can impair digestible energy (DE). Placement of the fatty acid (FA) hydrocarbon chain in the helix core reformed from amylose creates a complex of both nutrients. Resulting modifications create a new structure termed the V-helix that becomes resistant to α-amylase. Granules in grain naturally contain minimal amounts of these complexes with more being generated during food manufacturing when moisture and heat release amylose in the presence of FFA. A paucity of FFA usually exists in complete feeds without sources of poor-quality fat. Animal fats and by-product meals from rendering are prominent in their saturated FFA content which favorably complex within the helix. V-helix-FA complexes may arise during their concurrent encounter of FFA together with amylose during feed manufacture, particularly pelleting. FFA in the gastrointestinal tract (GIT) are speculated to further form complexes when present together with amylose. Although amylose may be dissolved in the gastric and small intestinal milieu, FFA separately coalesce into hydrophobic fat droplets along with other dietary lipids. Formation of complexes is likely restricted until FFA are released into the aqueous phase during fat digestion. Although α-amylase may be prominent, V-helix-FA complexes being resistant to enzymic attack pass into the large intestine. Subsequent microbial catabolism of V-helices may generate volatile fatty acids that are absorbed by the mucosa; however, an inability to use FFA once released leads to their excretion and basis for decreased DE. Immature microbial populations with young animals usually lack the capacity to fully catabolize the V-helix, further extending the loss in DE.
PubMed: 34738043
DOI: 10.1016/j.aninu.2021.04.009 -
Biomedical Engineering Letters Nov 2018Additive manufacturing (AM) is an alternative metal fabrication technology. The outstanding advantage of AM (3D-printing, direct manufacturing), is the ability to form... (Review)
Review
Additive manufacturing (AM) is an alternative metal fabrication technology. The outstanding advantage of AM (3D-printing, direct manufacturing), is the ability to form shapes that cannot be formed with any other traditional technology. 3D-printing began as a new method of prototyping in plastics. Nowadays, AM in metals allows to realize not only net-shape geometry, but also high fatigue strength and corrosion resistant parts. This success of AM in metals enables new applications of the technology in important fields, such as production of medical implants. The 3D-printing of medical implants is an extremely rapidly developing application. The success of this development lies in the fact that patient-specific implants can promote patient recovery, as often it is the only alternative to amputation. The production of AM implants provides a relatively fast and effective solution for complex surgical cases. However, there are still numerous challenging open issues in medical 3D-printing. The goal of the current research review is to explain the whole technological and design chain of bio-medical bone implant production from the computed tomography that is performed by the surgeon, to conversion to a computer aided drawing file, to production of implants, including the necessary post-processing procedures and certification. The current work presents examples that were produced by joint work of Polygon Medical Engineering, Russia and by TechMed, the AM Center of Israel Institute of Metals. Polygon provided 3D-planning and 3D-modelling specifically for the implants production. TechMed were in charge of the optimization of models and they manufactured the implants by Electron-Beam Melting (EBM), using an Arcam EBM A2X machine.
PubMed: 30603218
DOI: 10.1007/s13534-018-0080-5 -
Pharmaceutics Oct 2022The relevance of the polymorphic form, particle size, and processing of mannitol for the mechanical properties of solid oral dosage forms was examined. Thus, particle...
The relevance of the polymorphic form, particle size, and processing of mannitol for the mechanical properties of solid oral dosage forms was examined. Thus, particle and powder properties of spray granulated β D-mannitol, β D-mannitol, and δ D-mannitol were assessed in this study with regards to their manufacturability. D-mannitol is a commonly used excipient in pharmaceutical formulations, especially in oral solid dosage forms, and can be crystallized as three polymorphic forms, of which β is the thermodynamically most stable form and δ is a kinetically stabilized polymorph. A systematic analysis of the powders as starting materials and their respective roller compacted granules is presented to elucidate the multidimensional effects of powder and granules characteristics such as polymorphic form, particle size, and preprocessing on the resulting tablets' mechanical properties. In direct compression and after roller compaction, δ polymorph displayed superior tableting properties over β mannitol, but was outperformed by spray granulated β mannitol. This could be primarily correlated to the higher specific surface area, leading to higher bonding area and more interparticle bonds within the tablet. Hence, it was shown that surface characteristics and preprocessing can prevail over the impact of polymorphism on manufacturability for oral solid dosage forms.
PubMed: 36297563
DOI: 10.3390/pharmaceutics14102128 -
Sensors (Basel, Switzerland) Feb 2021In order to respond the growing interest towards radio frequency identification textile transponders, the authors propose a new approach to design radio frequency...
In order to respond the growing interest towards radio frequency identification textile transponders, the authors propose a new approach to design radio frequency identification (RFID) devices by introducing the RFIDtex concept. The coupling system of inductive loops is implemented in the textronic structure with the RFID interface in order to split the transponder into two independently manufactured components. Then both modules can be easily integrated into the RFIDtex tag. The presented simulation and measurement results prove the concept of manufacturing a relatively small antenna in the form of a meandered dipole sewn in with a single thread, and further, that can be connected to the RFID chip through the coupling system without galvanic junctions. The achieved parameters clearly indicate that the tag can correctly communicate with the read/write device as well as the coupling between its both parts works properly, and the impedance matching is possible in this case. The possibility of confectioning products with electronic identification tags at the textile factory site and improved resistance to the impact of environmental conditions are the main advantage of the proposed approach to the RFID devices designing. The RFIDtex transponder idea proposed by the authors was restricted in the patent no PL 231291 B1.
PubMed: 33562566
DOI: 10.3390/s21041093 -
The Saudi Dental Journal May 2021This study compared biointeractivity (pH of soaking water and calcium ions), porosity, water sorption, solubility, compressive strength, lap shear strength, as well as...
AIM
This study compared biointeractivity (pH of soaking water and calcium ions), porosity, water sorption, solubility, compressive strength, lap shear strength, as well as the apatite forming ability of three calcium silicate-based capping materials: Mineral trioxide aggregate (MTA), Biodentine (BD) and Tech Biosealer capping (BS).
METHODS
One hundred and five discs of the tested materials were prepared in compliance with the manufacturer's instructions. The materials' pastes were placed in Teflon molds and allowed to set before testing. The pH and Ca ions were measured by a potentiometric method. Porosity, water sorption, and solubility were calculated through the measurement of initial mass, mass, saturated mass and dry mass. Apatite forming ability was measured by an Environmental Scanning Electron Microscope that was connected to a secondary electron detector for energy dispersive X-ray analysis. Meanwhile compressive strength was measured by a computer controlled universal testing machine. Lap shear strength was measured by computer software on the testing machine. All data were statistically analyzed.
RESULTS
The tested materials showed Ca ions release and alkalization, which decreased with soaking time. The BD exhibited a very high Ca release at both short (3 h) and long times (28 days). Significant high values of open and apparent porosities, water sorption, and solubility were measured for BS, which was followed by the MTA then BD ( < .05). The BD had significant higher compressive and lap shear bond strength than the MTA and BS ( < .05).
CONCLUSION
MTA, BD and BS are biointeractive bioactive materials that possess the ability to release ions and form calcium phosphate deposits. Unlike BD, BS is incapable of alternating MTA in pulp capping due to its high porosities, water sorption and solubility, as well as poor compressive and lap shear bond strength.
PubMed: 34025083
DOI: 10.1016/j.sdentj.2020.02.001