-
Frontiers in Bioengineering and... 2020Physical disfigurement due to congenital defects, trauma, or cancer causes considerable distress and physical impairment for millions of people worldwide; impacting... (Review)
Review
Physical disfigurement due to congenital defects, trauma, or cancer causes considerable distress and physical impairment for millions of people worldwide; impacting their economic, psychological and social wellbeing. Since 3000 B.C., prosthetic devices have been used to address these issues by restoring both aesthetics and utility to those with disfigurement. Internationally, academic and industry researchers are constantly developing new materials and manufacturing techniques to provide higher quality and lower cost prostheses to those people who need them. New advanced technologies including 3D imaging, modeling, and printing are revolutionizing the way prostheses are now made. These new approaches are disrupting the traditional and manual art form of prosthetic production which are laborious and costly and are being replaced by more precise and quantitative processes which enable the rapid, low cost production of patient-specific prostheses. In this two part review, we provide a comprehensive report of past, present and emerging soft-tissue prosthetic materials and manufacturing techniques. In this review, part A, we examine, historically, the ideal properts of a polymeric material when applied in soft-tissue prosthetics. We also detail new research approaches to target specific tissues which commonly require aesthetic restoration (e.g. ear, nose and eyes) and discuss both traditional and advanced fabrication methods, from hand-crafted impression based approaches to advanced manufactured prosthetics. We discuss the chemistry and related details of most significant synthetic polymers used in soft-tissue prosthetics in Part B. As advanced manufacturing transitions from research into practice, the five millennia history of prosthetics enters a new age of economic, personalized, advanced soft tissue prosthetics and with this comes significantly improved quality of life for the people affected by tissue loss.
PubMed: 32300585
DOI: 10.3389/fbioe.2020.00121 -
Pharmacy (Basel, Switzerland) Mar 2021The global use of alcohol-based hand sanitizers (ABHS) as an important means of controlling the transmission of infectious disease has increased significantly as... (Review)
Review
The global use of alcohol-based hand sanitizers (ABHS) as an important means of controlling the transmission of infectious disease has increased significantly as governments and public health agencies across the world advocated hand hygiene as a preventative measure during the COVID-19 pandemic. Although the performance of these products is most commonly defined as a function of their alcohol concentration, they are multifaceted products in which an interplay of several factors is important in determining efficacy. This paper discusses the interplay between ABHS input (formulation) factors and output (product performance) factors in the context of a multidimensional perspective using a novel representative paradigm. In the model, represented in the form of a three-dimensional tetrahedron, each of the faces represents inputs in the manufacturing of the ABHS product, which are the type and amount of alcohol, the inactive ingredients, the formulation and the manufacturing practices. The four corners of the tetrahedron represent the product performance factors which include product efficacy, sensory characteristics, usage and compliance and product safety. The multidimensional approach to the formulation and evaluation of ABHS shows that several factors contribute to the effectiveness and utility of these products. The paradigm provides a useful framework for manufacturers of ABHS and related healthcare products.
PubMed: 33808754
DOI: 10.3390/pharmacy9010064 -
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 -
Critical Reviews in Food Science and... Jul 2016The use of live probiotic bacteria as food supplement has become popular. Capability of probiotic bacteria to be kept at room temperature becomes necessary for... (Review)
Review
The use of live probiotic bacteria as food supplement has become popular. Capability of probiotic bacteria to be kept at room temperature becomes necessary for customer's convenience and manufacturer's cost reduction. Hence, production of dried form of probiotic bacteria is important. Two common drying methods commonly used for microencapsulation are freeze drying and spray drying. In spite of their benefits, both methods have adverse effects on cell membrane integrity and protein structures resulting in decrease in bacterial viability. Microencapsulation of probiotic bacteria has been a promising technology to ensure bacterial stability during the drying process and to preserve their viability during storage without significantly losing their functional properties such acid tolerance, bile tolerance, surface hydrophobicity, and enzyme activities. Storage at room temperatures instead of freezing or low temperature storage is preferable for minimizing costs of handling, transportation, and storage. Concepts of water activity and glass transition become important in terms of determination of bacterial survival during the storage. The effectiveness of microencapsulation is also affected by microcapsule materials. Carbohydrate- and protein-based microencapsulants and their combination are discussed in terms of their protecting effect on probiotic bacteria during dehydration, during exposure to harsh gastrointestinal transit and small intestine transit and during storage.
Topics: Capsules; Cells, Immobilized; Colony Count, Microbial; Desiccation; Food Handling; Food Microbiology; Food Storage; Freeze Drying; Gastrointestinal Microbiome; Gastrointestinal Tract; Hydrophobic and Hydrophilic Interactions; Microbial Viability; Probiotics; Temperature
PubMed: 25853290
DOI: 10.1080/10408398.2013.798779 -
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 -
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 -
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 -
IEEE Transactions on Robotics : a... Dec 2016Concentric tube surgical robots are minimally invasive devices with the advantages of snake-like reconfigurability, long and thin form factor, and placement of actuation...
Concentric tube surgical robots are minimally invasive devices with the advantages of snake-like reconfigurability, long and thin form factor, and placement of actuation outside the patient's body. These robots can also be designed and manufactured to acquire targets in specific patients for treating specific diseases in a manner that minimizes invasiveness. We propose that concentric tube robots can be manufactured using 3-D printing technology on a patient- and procedure-specific basis. In this paper, we define the design requirements and manufacturing constraints for 3-D printed concentric tube robots and experimentally demonstrate the capabilities of these robots. While numerous 3-D printing technologies and materials can be used to create such robots, one successful example uses selective laser sintering to make an outer tube with a polyether block amide and uses stereolithography to make an inner tube with a polypropylene-like material. This enables a tube pair with precurvatures of 0.0775 and 0.0455 mm, which can withstand strains of 20% and 5.5% for the outer and inner tubes, respectively.
PubMed: 28713227
DOI: 10.1109/TRO.2016.2602368 -
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