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The Journal of Craniofacial Surgery May 2022Cranioplasty materials include metals (ie, titanium); ceramics (ie, hydroxyapatite); polymers (ie, poly-methyl-metha-acrylate [PMMA]); and plastics (ie, polyether ether... (Review)
Review
Cranioplasty materials include metals (ie, titanium); ceramics (ie, hydroxyapatite); polymers (ie, poly-methyl-metha-acrylate [PMMA]); and plastics (ie, polyether ether ketone). This paper aims to review their advantages and drawbacks. No ideal material currently exist, however, titanium implants are universally agreed to have lower infection rates than those reported for hydroxyapatite and PMMA implants; thus justifying their current wide use. These implants can be manufactured conventionally from medical grade titanium alloy Ti64 (titanium-aluminum-vanadium) in the form of plates ranging in thickness from 0.5 to 0.7 mm thick, or following the computer-aided design/manufacture principle. Surface finish of these implants is best achieved by electroplating.
Topics: Craniotomy; Dental Implants; Humans; Hydroxyapatites; Polymethyl Methacrylate; Prostheses and Implants; Plastic Surgery Procedures; Skull; Titanium
PubMed: 34334754
DOI: 10.1097/SCS.0000000000008040 -
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 -
BMC Health Services Research Sep 2023Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to...
BACKGROUND
Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled.
AIMS
To investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period.
METHODS
A retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer.
RESULTS
A total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved.
CONCLUSIONS
This study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP).
Topics: Humans; Sri Lanka; Retrospective Studies; Commerce; Drug Packaging; Pharmaceutical Preparations
PubMed: 37700302
DOI: 10.1186/s12913-023-09995-3 -
Disability and Rehabilitation.... Aug 2023Device manufacturers and technicians (MaTs) of augmentative and alternative communication (AAC) systems play key roles in the design and successful uptake of...
PURPOSE
Device manufacturers and technicians (MaTs) of augmentative and alternative communication (AAC) systems play key roles in the design and successful uptake of communication devices. This study aims to investigate MaT perspectives on AAC device design and effective use.
MATERIALS AND METHODS
To investigate their perspectives, a focus group of MaTs within Canada was conducted. Reflexive thematic analysis was used to analyze data.
FINDINGS
Three major themes resulted from analysis, which reflect MaT's views: AAC hardware and software flexibility, AAC knowledge and implementation, and social good versus financial resources.
CONCLUSIONS
This study provides insights into the complexities faced by MaTs in balancing technical support of system end-users and the financial resources necessary for that support. These insights indicate a need for increased financial resources and the expansion of individuals who qualify for AAC system candidacy. MaTs suggest that an increase in resources and candidacy could lead to more successful AAC implementation and a greater understanding of AAC for all stakeholders.
PubMed: 37528746
DOI: 10.1080/17483107.2023.2241515 -
ACS Nano Nov 2022Nanofabrication has been utilized to manufacture one-, two-, and three-dimensional functional nanostructures for applications such as electronics, sensors, and photonic... (Review)
Review
Nanofabrication has been utilized to manufacture one-, two-, and three-dimensional functional nanostructures for applications such as electronics, sensors, and photonic devices. Although conventional silicon-based nanofabrication (top-down approach) has developed into a technique with extremely high precision and integration density, nanofabrication based on directed assembly (bottom-up approach) is attracting more interest recently owing to its low cost and the advantages of additive manufacturing. Directed assembly is a process that utilizes external fields to directly interact with nanoelements (nanoparticles, 2D nanomaterials, nanotubes, nanowires, etc.) and drive the nanoelements to site-selectively assemble in patterned areas on substrates to form functional structures. Directed assembly processes can be divided into four different categories depending on the external fields: electric field-directed assembly, fluidic flow-directed assembly, magnetic field-directed assembly, and optical field-directed assembly. In this review, we summarize recent progress utilizing these four processes and address how these directed assembly processes harness the external fields, the underlying mechanism of how the external fields interact with the nanoelements, and the advantages and drawbacks of utilizing each method. Finally, we discuss applications made using directed assembly and provide a perspective on the future developments and challenges.
PubMed: 36269234
DOI: 10.1021/acsnano.2c07910 -
Journal of Prosthodontics : Official... Mar 2020Modification of intercuspal angulation (ICA) influences the amount of tooth structure removal, which may impact the retention and resistance form of the preparation....
PURPOSE
Modification of intercuspal angulation (ICA) influences the amount of tooth structure removal, which may impact the retention and resistance form of the preparation. This study evaluated the impact of ICA on the marginal gap of CAD/CAM crowns and the influence that tooth structure removal, caused by variation of ICA, has on the resistance and retention form of the preparation.
MATERIALS AND METHODS
Sixty ivorine molars were manufactured with various ICAs (100°, 110°, 120°, 140°, 160°, and 180°; 10 per group). The preparations were digitized using an intraoral scanner, and the crowns were designed using a design software. The designed crowns were then manufactured from lithium disilicate using a 3-axis milling machine, with the "detailed mode" selected for the manufacturing. The marginal gap of each crown was evaluated using a stereomicroscope at 20× magnification. Then, the marginal integrity and the resistance form of the preparation were assessed by tactile-visual evaluation, and they were given a categorical score. Crowns were then secured on their associated preparations using a temporary luting agent, and retention force was measured on a universal testing machine under tension with a 0.5 mm/min crosshead speed. Wilcoxon test followed by post-hoc tests (α = 0.05) were used to evaluate the impact of the ICA on the marginal gap and the retention form of the preparation. Fisher's exact test followed by post-hoc tests (α = 0.05) were used to assess the impact of the occlusal preparation design on the marginal integrity and the resistance form of the preparation.
RESULTS
The marginal gap was significantly larger for ICA-180 preparations (72 μm), compared to the other groups (ICA-180 vs ICA-100, ICA-110, ICA-120, and ICA-160 p = 0.0001; ICA-180 vs. ICA-140 p = 0.0017). None of the crowns for ICA-180 preparations had clinically acceptable resistance form. Preparations with ICAs of 100°, 110°, and 120° had a significantly higher value of retention than the other groups (ICA-100 vs. ICA-120 p = 0.0119; ICA-100 vs. ICA-140, ICA-160, and ICA-180 p < 0.0001; ICA-110 vs. ICA-140, ICA-160, and ICA-180 p = 0.0001; ICA-120 vs. ICA-180 p = 0.0017).
CONCLUSIONS
Crowns fabricated for preparations with various ICAs had clinically acceptable marginal adaptation. Variation in ICA impacts the loss of tooth structure. This loss of tooth structure may influence the resistance and retention form of the preparation.
Topics: Computer-Aided Design; Crowns; Dental Marginal Adaptation; Dental Porcelain; Dental Prosthesis Design
PubMed: 30636017
DOI: 10.1111/jopr.13016 -
Journal of Food Science and Technology Jan 2024To date majority of bakery products are manufactured using emulsifiers in paste or gel form that restricts and causes many problems of storage, processing, and handling... (Review)
Review
To date majority of bakery products are manufactured using emulsifiers in paste or gel form that restricts and causes many problems of storage, processing, and handling at the commercial level. Therefore, new developments are required to resolve the issues of the bakery industry. This review discusses the importance of α-tending emulsifiers in the bakery industry and the action of the α-form to produce superior quality products. Further, to produce desired results α-form of emulsifiers blend should be stable and functional at different operating and storage conditions. Emulsifiers in gel or paste form do not maintain the active α-gel phase over a longer storage period. Using emulsifiers blend in powder form can be a solution to all the mentioned difficulties. With the development of new technologies like spray drying and encapsulation has opened new doors to utilize emulsifiers blend in powder form. Few manufactures have tapped this opportunity and have developed improver powder that offers superior quality products as well as processing, storage, and handling benefits and is easy to use. Improver powder maintains its active and functional α-form when stored at ambient temperature. This development also increases the scope of dry premixes in the market and consumers can make products of their choice in the kitchen with minimal effort.
PubMed: 38192712
DOI: 10.1007/s13197-022-05644-5 -
Tissue Engineering. Part C, Methods Sep 2023Allogeneic chondrocyte therapies need to be developed to allow more individuals to be treated with a cell therapy for cartilage repair and to reduce the burden and cost...
Allogeneic chondrocyte therapies need to be developed to allow more individuals to be treated with a cell therapy for cartilage repair and to reduce the burden and cost of the current two-stage autologous procedures. Upscale manufacture of chondrocytes using a bioreactor could help provide an off-the-shelf allogeneic chondrocyte therapy with many doses being produced in a single manufacturing run. In this study, we assess a good manufacturing practice-compliant hollow-fiber bioreactor (Quantum) for adult chondrocyte manufacture. Chondrocytes were isolated from knee arthroplasty-derived cartilage ( = 5) and expanded in media supplemented with 10% fetal bovine serum (FBS) or 5% human platelet lysate (hPL) on tissue culture plastic (TCP) for a single passage. hPL-supplemented cultures were then expanded in the Quantum bioreactor for a further passage. Matched, parallel cultures in hPL or FBS were maintained on TCP. Chondrocytes from all culture conditions were characterized in terms of growth kinetics, morphology, immunoprofile, chondrogenic potential (chondrocyte pellet assays), and single telomere length analysis. Quantum expansion of chondrocytes resulted in 86.4 ± 38.5 × 10 cells in 8.4 ± 1.5 days, following seeding of 10.2 ± 3.6 × 10 cells. This related to 3.0 ± 1.0 population doublings in the Quantum bioreactor, compared with 2.1 ± 0.6 and 1.3 ± 1.0 on TCP in hPL- and FBS-supplemented media, respectively. Quantum- and TCP-expanded cultures retained equivalent chondropotency and mesenchymal stromal cell marker immunoprofiles, with only the integrin marker, CD49a, decreasing following Quantum expansion. Quantum-expanded chondrocytes demonstrated equivalent chondrogenic potential (as assessed by ability to form and maintain chondrogenic pellets) with matched hPL TCP populations. hPL manufacture, however, led to reduced chondrogenic potential and increased cell surface positivity of integrins CD49b, CD49c, and CD51/61 compared with FBS cultures. Quantum expansion of chondrocytes did not result in shortened 17p telomere length when compared with matched TCP cultures. This study demonstrates that large numbers of adult chondrocytes can be manufactured in the Quantum hollow-fiber bioreactor. This rapid, upscale expansion does not alter chondrocyte phenotype when compared with matched TCP expansion. Therefore, the Quantum provides an attractive method of manufacturing chondrocytes for clinical use. Media supplementation with hPL for chondrocyte expansion may, however, be unfavorable in terms of retaining chondrogenic capacity.
Topics: Adult; Humans; Chondrocytes; Cartilage; Cells, Cultured; Extracellular Matrix; Hematopoietic Stem Cell Transplantation; Cell Differentiation; Cell Proliferation
PubMed: 37395490
DOI: 10.1089/ten.TEC.2023.0037 -
Polymers May 2020Antibiotic resistance has increased markedly in Gram-negative bacteria, causing severe infections intractable with traditional drugs and amplifying mortality and... (Review)
Review
Antibiotic resistance has increased markedly in Gram-negative bacteria, causing severe infections intractable with traditional drugs and amplifying mortality and healthcare costs. Consequently, to find novel antimicrobial compounds, active on multidrug resistant bacteria, is mandatory. In this regard, cationic antimicrobial peptides (CAMPs)-able to kill pathogens on contact-could represent an appealing solution. However, low selectivity, hemolytic toxicity and cost of manufacturing, hamper their massive clinical application. In the recent years-starting from CAMPs as template molecules-less toxic and lower-cost synthetic mimics of CAMPs, including cationic peptides, polymers and dendrimers, have been developed. Although the pending issue of hemolytic toxicity and biodegradability is still left not completely solved, cationic antimicrobial polymers (CAPs), compared to small drug molecules, thanks to their high molecular weight, own appreciable selectivity, reduced toxicity toward eukaryotic cells, more long-term activity, stability and non-volatility. With this background, an updated overview concerning the main manufactured types of CAPs, active on Gram-negative bacteria, is herein reported, including synthetic procedure and action's mechanism. Information about their structures, antibacterial activity, advantages and drawbacks, was reported in the form of tables, which allow faster consultation and quicker learning concerning current CAPs state of the art, in order not to retrace reviews already available.
PubMed: 32456255
DOI: 10.3390/polym12051195 -
Gerodontology Mar 2021To investigate the impact of peroxide-based solutions in reducing viability and metabolic activity of multispecies biofilms on denture base acrylic resin surfaces and...
PURPOSE
To investigate the impact of peroxide-based solutions in reducing viability and metabolic activity of multispecies biofilms on denture base acrylic resin surfaces and for removing them from these surfaces.
BACKGROUND
Denture cleansers are effective in reducing monospecies biofilm; however, studies evaluating their action on multispecies biofilms are scarce.
MATERIALS AND METHODS
Sixty-nine denture base acrylic resin specimens (Ø 15 × 3 mm) were sterilised then contaminated with Candida albicans, Staphylococcus aureus and Pseudomonas aeruginosa to form multispecies biofilms. Biofilms were grown for 24 hours; subsequently, specimens were immersed in three different cleansing solutions (n = 9): nitradine (NI), fixodent (FX) and phosphate-buffered saline (Control), according to the respective manufacturer's instructions. After applying the hygiene protocols, viability of microorganisms was evaluated by counting colony-forming units and assessing metabolic activity. Moreover, biofilm removal capacity was estimated based on extension of cell-covered areas visualised in fluorescent microscopy micrographics.
RESULTS
Microbial counts were solution-dependent; NI was effective against all microorganisms (P < .05). FX exhibited moderate antimicrobial action, reducing P aeruginosa (P < .05) and S aureus (P < .05) viability by approximately 2 logs. Both peroxide-based solutions reduced metabolic activity (P < .001) and biofilm-covered areas on specimen surfaces (P < .001).
CONCLUSION
Under the experimental conditions tested, these results demonstrated that peroxide-based solutions had favourable antimicrobial activity but promoted no broad elimination of aggregated multispecies biofilm. NI might be more suitable as complementary chemical agent for controlling multispecies denture biofilm.
Topics: Anti-Infective Agents; Biofilms; Candida albicans; Denture Bases; Denture Cleansers; Dentures; Humans; Tablets
PubMed: 33000876
DOI: 10.1111/ger.12500