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JAMA Cardiology Oct 2023One in 5 US adults older than 60 years takes fish oil supplements often for heart health despite multiple randomized clinical trials showing no data for cardiovascular...
IMPORTANCE
One in 5 US adults older than 60 years takes fish oil supplements often for heart health despite multiple randomized clinical trials showing no data for cardiovascular benefit for supplement-range doses. Statements on the supplement labels may influence consumer beliefs about health benefits.
OBJECTIVES
To evaluate health claims made on the labels of fish oil supplements in the US, and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations.
DESIGN, SETTING, AND PARTICIPANTS
This cross-sectional study used data from labels of on-market fish oil (and nonfish ω-3 fatty acid) supplements obtained from the National Institutes of Health Dietary Supplement Label Database. The study was conducted and data analyzed from February to June 2022.
MAIN OUTCOME AND MEASURES
The frequency and types of health claims made on fish oil labels (US Food and Drug Administration [FDA]-reviewed qualified health claim vs a structure/function claim) and the organ system referenced were evaluated. The total daily doses of combined EPA and DHA (EPA+DHA) were assessed for supplements from 16 leading manufacturers and retailers.
RESULTS
Across 2819 unique fish oil supplements, 2082 (73.9%) made at least 1 health claim. Of these, only 399 (19.2%) used an FDA-approved qualified health claim; the rest (1683 [80.8%]) made only structure/function claims (eg, "promotes heart health"). Cardiovascular health claims were the most common (1747 [62.0%]). Across 16 leading brands/manufacturers, 255 fish oil supplements were identified. Among these, substantial variability was found in the daily dose of EPA (median [IQR], 340 [135-647] mg/d), DHA (median [IQR], 270 [140-500] mg/d), and total EPA+DHA (median [IQR], 600 [300-1100] mg/d). Only 24 of 255 supplements (9.4%) evaluated contained a daily dose of 2 g or more EPA+DHA.
CONCLUSIONS
Results of this cross-sectional study suggest that the majority of fish oil supplement labels make health claims, usually in the form of structure/function claims, that imply a health benefit across a variety of organ systems despite a lack of trial data showing efficacy. Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements. Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.
PubMed: 37610733
DOI: 10.1001/jamacardio.2023.2424 -
Nature Nov 2023Recreating complex structures and functions of natural organisms in a synthetic form is a long-standing goal for humanity. The aim is to create actuated systems with...
Recreating complex structures and functions of natural organisms in a synthetic form is a long-standing goal for humanity. The aim is to create actuated systems with high spatial resolutions and complex material arrangements that range from elastic to rigid. Traditional manufacturing processes struggle to fabricate such complex systems. It remains an open challenge to fabricate functional systems automatically and quickly with a wide range of elastic properties, resolutions, and integrated actuation and sensing channels. We propose an inkjet deposition process called vision-controlled jetting that can create complex systems and robots. Hereby, a scanning system captures the three-dimensional print geometry and enables a digital feedback loop, which eliminates the need for mechanical planarizers. This contactless process allows us to use continuously curing chemistries and, therefore, print a broader range of material families and elastic moduli. The advances in material properties are characterized by standardized tests comparing our printed materials to the state-of-the-art. We directly fabricated a wide range of complex high-resolution composite systems and robots: tendon-driven hands, pneumatically actuated walking manipulators, pumps that mimic a heart and metamaterial structures. Our approach provides an automated, scalable, high-throughput process to manufacture high-resolution, functional multimaterial systems.
Topics: Humans; Elastic Modulus; Robotics; Printing, Three-Dimensional; Feedback; Biomimetic Materials
PubMed: 37968527
DOI: 10.1038/s41586-023-06684-3 -
Journal of Pharmaceutical Sciences May 2024Interest in minitablets (MTs) has grown exponentially over the last 20 years and especially the last decade, as evidenced by the number of publications cited in Scopus... (Review)
Review
Interest in minitablets (MTs) has grown exponentially over the last 20 years and especially the last decade, as evidenced by the number of publications cited in Scopus and PubMed. MTs offer significant opportunities for personalized medicine, dose titration and flexible dosing, taste masking, and customizing drug delivery systems. Advances in specialized MT tooling, manufacturing, and characterization instrumentation have overcome many of the earlier development issues. Breakthrough MT swallowability, acceptability, and palatability research have challenged the long-standing idea that only liquids are acceptable dosage forms for infants and young children. MTs have been shown to be a highly acceptable dosage form for infants, small children, and geriatric patients who have difficulty swallowing. This review discusses the current state of MT applications, acceptability in pediatric and geriatric populations, medication adherence, manufacturing processes such as tableting and coating, running powder and tablet characterization, packaging and MT dispensing, and regulatory considerations.
Topics: Infant; Humans; Child; Child, Preschool; Aged; Administration, Oral; Tablets; Drug Delivery Systems; Drug Packaging; Precision Medicine
PubMed: 38369020
DOI: 10.1016/j.xphs.2024.02.016 -
European Journal of Pharmaceutical... Mar 2024Microparticles have unique benefits in the formulation of multiparticulate and multi-unit type pharmaceutical dosage forms allowing improved drug safety and efficacy... (Review)
Review
Microparticles have unique benefits in the formulation of multiparticulate and multi-unit type pharmaceutical dosage forms allowing improved drug safety and efficacy with favorable pharmacokinetics and patient centricity. On the other hand, the above advantages are served by high and well reproducible quality attributes of the medicinal product where even flexible design and controlled processability offer success as well as possible longer product life-cycle for the manufacturers. Moreover, the specific demands of patients can be taken into account, including simplified dosing regimens, flexible dosage, drug combinations, palatability, and ease of swallowing. In the more than 70 years since the first modified-release formulation appeared on the market, many new formulations have been marketed and many publications have appeared in the literature. More unique and newer pharmaceutical technologies and excipients have become available for producing tailor-made particles with micrometer dimensions and beyond. All these have contributed to the fact that the sub-units (e.g. minitablets, pellets, microspheres) that make up a multiparticulate system can vary widely in composition and properties. Some units have mucoadhesive properties and others can float to contribute to a suitable release profile that can be designed for the multiparticulate formula as a whole. Nowadays, there are some available formulations on the market, which are able to release the active substance even for several months (3 or 6 months depending on the type of treatment). In this review, the latest developments in technologies that have been used for a long time are presented, as well as innovative solutions such as the applicability of 3D printing to produce subunits of multiparticulate systems. Furthermore, the diversity of multiparticulate systems, different routes of administration are also presented, touching the ones which are capable of carrying the active substance as well as the relevant, commercially available multiparticle-based medical devices. The versatility in size from 1 µm and multiplicity of formulation technologies promise a solid foundation for the future applications of dosage form design and development.
Topics: Humans; Drug Delivery Systems; Pharmaceutical Preparations; Excipients
PubMed: 38228279
DOI: 10.1016/j.ejps.2024.106704 -
The Science of the Total Environment Dec 2023The use of plastics for manufacturing of products and packaging has become ubiquitous. This is because plastics are cheap, pliable, and durable. However, these... (Review)
Review
The use of plastics for manufacturing of products and packaging has become ubiquitous. This is because plastics are cheap, pliable, and durable. However, these characteristics of plastics have also led to their disposal in landfill, where they persist. To overcome the environmental challenge posed by conventional plastics (CPs), biodegradable plastics (BDPs) are increasingly being used. However, BDPs form residual microplastics (MPs) at a rate that far exceeds that of CPs, and MPs have negative impacts on the soil environment. This review aimed to evaluate whether the move away from CPs to BDPs is having an overall positive impact on the environment considering the formation of MPs. Topics focused on in this review include the degradation of BDPs in the soil environment and the impacts of MPs originating from BDPs on soil physical and chemical properties, microbial communities, animals, and plants. The information collated in this review can provide scientific guidance for sustainable development of the BDPs industry.
Topics: Animals; Microplastics; Plastics; Soil; Soil Pollutants; Biodegradable Plastics; Microbiota
PubMed: 37683869
DOI: 10.1016/j.scitotenv.2023.166855 -
Biomedical Materials (Bristol, England) Nov 20233D printing technology is an increasing approach consisting of material manufacturing through the selective incremental delamination of materials to form a 3D structure... (Review)
Review
3D printing technology is an increasing approach consisting of material manufacturing through the selective incremental delamination of materials to form a 3D structure to produce products. This technology has different advantages, including low cost, short time, diversification, and high precision. Widely adopted additive manufacturing technologies enable the creation of diagnostic tools and expand treatment options. Coupled with its rapid deployment, 3D printing is endowed with high customizability that enables users to build prototypes in shorts amounts of time which translates into faster adoption in the medical field. This review mainly summarizes the application of 3D printing technology in the diagnosis and treatment of cancer, including the challenges and the prospects combined with other technologies applied to the medical field.
Topics: Humans; Printing, Three-Dimensional; Neoplasms
PubMed: 37918002
DOI: 10.1088/1748-605X/ad08e1 -
International Journal of Pharmaceutics Aug 2023The plasticity of materials plays a critical role in adequate powder tabletability, which is required in developing a successful tablet product. Generally, a more...
The plasticity of materials plays a critical role in adequate powder tabletability, which is required in developing a successful tablet product. Generally, a more plastic material can develop larger bonding areas when other factors are the same, leading to higher tabletability than less plastic materials. However, it was observed that, for a solid form of a compound with poorer tabletability, a mixture with microcrystalline cellulose (MCC) can actually exhibit better tabletability, a phenomenon termed tabletability flip. Hence, there is a chance that a solid form with poor tabletability could have been erroneously eliminated based on the expected tabletability challenges during tablet manufacturing. This study was conducted to investigate the generality of this phenomenon using two polymorph pairs, a salt and free acid pair, a crystalline and amorphous solid dispersion pair, and a pair of chemically distinct crystals. Results show that tabletability flip occurred in all six systems tested, including five pairs of binary mixtures with MCC and one pair in a realistic generic tablet formulation, suggesting the broad occurrence of the tabletability flip phenomenon, where both compaction pressure and the difference in plasticity between the pair of materials play important roles.
Topics: Drug Compounding; Tablets; Powders; Tensile Strength
PubMed: 37495026
DOI: 10.1016/j.ijpharm.2023.123262 -
Advanced Materials (Deerfield Beach,... Jan 2024The growth of multicellular organisms is a process akin to additive manufacturing where cellular proliferation and mechanical boundary conditions, among other factors,...
The growth of multicellular organisms is a process akin to additive manufacturing where cellular proliferation and mechanical boundary conditions, among other factors, drive morphogenesis. Engineers have limited ability to engineer morphogenesis to manufacture goods or to reconfigure materials comprised of biomass. Herein, a method that uses biological processes to grow and regrow magnetic engineered living materials (mELMs) into desired geometries is reported. These composites contain Saccharomyces cerevisiae and magnetic particles within a hydrogel matrix. The reconfigurable manufacturing process relies on the growth of living cells, magnetic forces, and elastic recovery of the hydrogel. The mELM then adopts a form in an external magnetic field. Yeast within the material proliferates, resulting in 259 ± 14% volume expansion. Yeast proliferation fixes the magnetic deformation, even when the magnetic field is removed. The shape fixity can be up to 99.3 ± 0.3%. The grown mELM can recover up to 73.9 ± 1.9% of the original form by removing yeast cell walls. The directed growth and recovery process can be repeated at least five times. This work enables ELMs to be processed and reprocessed into user-defined geometries without external material deposition.
PubMed: 38288578
DOI: 10.1002/adma.202309818 -
Pharmaceutics Jul 2023Currently, the field of medicine is drastically advancing, mainly due to the progress in emerging areas such as nanomedicine, regenerative medicine, and personalized...
Currently, the field of medicine is drastically advancing, mainly due to the progress in emerging areas such as nanomedicine, regenerative medicine, and personalized medicine. For example, the development of novel drug delivery systems in the form of nanoparticles is improving the liberation, absorption, distribution, metabolism, and excretion (LADME) properties of the derived formulations, with a consequent enhancement in the treatment efficacy, a reduction in the secondary effects, and an increase in compliance with the dosage guidelines. Additionally, the use of biocompatible scaffolds is translating into the possibility of regenerating biological tissues. Personalized medicine is also benefiting from the advantages offered by additive manufacturing. However, all these areas have in common the need to develop novel materials or composites that fulfill the requirements of each application. Therefore, the aim of this Special Issue was to identify novel materials/composites that have been developed with specific characteristics for the designed biomedical application.
PubMed: 37514123
DOI: 10.3390/pharmaceutics15071938 -
Small (Weinheim An Der Bergstrasse,... Jul 2023Microneedles have recently emerged as a powerful tool for minimally invasive drug delivery and body fluid sampling. To date, high-resolution fabrication of microneedle...
Microneedles have recently emerged as a powerful tool for minimally invasive drug delivery and body fluid sampling. To date, high-resolution fabrication of microneedle arrays (MNAs) is mostly achieved by the utilization of sophisticated facilities and expertise. Particularly, hollow microneedles have usually been manufactured in cleanrooms out of silicon, resin, or metallic materials. Such strategies do not support the fabrication of microneedles from biocompatible/biodegradable materials and limit the capability of multimodal drug delivery for the controlled release of different therapeutics through a combination of injection and sustained diffusion. This study implements low-cost 3D printers to fabricate relatively large needle arrays, followed by repeatable shrink-molding of hydrogels to form high-resolution molds for solid and hollow MNAs with controllable sizes. The developed strategy further enables modulating surface topography of MNAs to tailor their surface area and instantaneous wettability for controllable drug delivery and body fluid sampling. Hybrid gelatin methacryloyl (GelMA)/polyethylene glycol diacrylate (PEGDA) MNAs are fabricated using the developed strategy that can easily penetrate the skin and enable multimodal drug delivery. The proposed method holds promise for affordable, controllable, and scalable fabrication of MNAs by researchers and clinicians for controlled spatiotemporal administration of therapeutics and sample collection.
Topics: Administration, Cutaneous; Microinjections; Skin; Drug Delivery Systems; Biocompatible Materials
PubMed: 37026428
DOI: 10.1002/smll.202207131