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Advanced Materials (Deerfield Beach,... Mar 2024Clustered regularly interspaced short palindromic repeats/associated protein 9 (CRISPR/Cas9) gene-editing technology shows promise for manipulating single or multiple... (Review)
Review
Clustered regularly interspaced short palindromic repeats/associated protein 9 (CRISPR/Cas9) gene-editing technology shows promise for manipulating single or multiple tumor-associated genes and engineering immune cells to treat cancers. Currently, most gene-editing strategies rely on viral delivery; yet, while being efficient, many limitations, mainly from safety and packaging capacity considerations, hinder the use of viral CRISPR vectors in cancer therapy. In contrast, recent advances in non-viral CRISPR/Cas9 nanoformulations have paved the way for better cancer gene editing, as these nanoformulations can be engineered to improve safety, efficiency, and specificity through optimizing the packaging capacity, pharmacokinetics, and targetability. In this review, the advance in non-viral CRISPR delivery is highlighted, and there is a discussion on how these approaches can be potentially used to treat cancers in addressing the aforementioned limitations, followed by the perspectives in designing a proper CRISPR/Cas9-based cancer nanomedicine system with translational potential.
Topics: Humans; Gene Editing; CRISPR-Cas Systems; Genetic Therapy; Genetic Vectors; Neoplasms
PubMed: 37437039
DOI: 10.1002/adma.202300665 -
International Journal of Molecular... Oct 2023Materials with a "nano" structure are increasingly used in medicine and biotechnology as drug delivery systems, bioimaging agents or biosensors in the monitoring of... (Review)
Review
Materials with a "nano" structure are increasingly used in medicine and biotechnology as drug delivery systems, bioimaging agents or biosensors in the monitoring of toxic substances, heavy metals and environmental variations. Furthermore, in the food industry, they have found applications as detectors of food adulteration, microbial contamination and even in packaging for monitoring product freshness. Carbon dots (CDs) as materials with broad as well as unprecedented possibilities could revolutionize the economy, if only their synthesis was based on low-cost natural sources. So far, a number of studies point to the positive possibilities of obtaining CDs from natural sources. This review describes the types of carbon dots and the most important methods of obtaining them. It also focuses on presenting the potential application of carbon dots in biotechnology and food technology.
Topics: Carbon; Quantum Dots; Drug Delivery Systems; Biotechnology; Food Technology
PubMed: 37834430
DOI: 10.3390/ijms241914984 -
British Journal of Clinical Pharmacology Nov 2023Medications have been a part of space travel dating back to the Apollo missions. Currently, medical kits aboard the International Space Station (ISS) contain medications... (Review)
Review
Medications have been a part of space travel dating back to the Apollo missions. Currently, medical kits aboard the International Space Station (ISS) contain medications and supplies to treat a variety of possible medical events. As we prepare for more distant exploration missions to Mars and beyond, risk management planning for astronaut healthcare should include the assembly of a medication formulary that is comprehensive enough to prevent or treat anticipated medical events, remains safe and chemically stable, and retains sufficient potency to last for the duration of the mission. Emerging innovation and technologies in pharmaceutical development, delivery, quality maintenance, and validation offer promise for addressing these challenges. The present editorial will summarize the current state of knowledge regarding innovative formulary optimization strategies, pharmaceutical stability assessment techniques, and storage and packaging solutions that could enhance drug safety and efficacy for future exploration spaceflight missions.
PubMed: 37940128
DOI: 10.1111/bcp.15957 -
Polymers Jul 2023The recycling of biomass into high-value-added materials requires important developments in research and technology to create a sustainable circular economy. Lignin, as... (Review)
Review
The recycling of biomass into high-value-added materials requires important developments in research and technology to create a sustainable circular economy. Lignin, as a component of biomass, is a multipurpose aromatic polymer with a significant potential to be used as a renewable bioresource in many fields in which it acts both as promising biopolymer and bioactive compound. This comprehensive review gives brief insights into the recent research and technological trends on the potential of lignin development and utilization. It is divided into ten main sections, starting with an outlook on its diversity; main properties and possibilities to be used as a raw material for fuels, aromatic chemicals, plastics, or thermoset substitutes; and new developments in the use of lignin as a bioactive compound and in nanoparticles, hydrogels, 3D-printing-based lignin biomaterials, new sustainable biomaterials, and energy production and storage. In each section are presented recent developments in the preparation of lignin-based biomaterials, especially the green approaches to obtaining nanoparticles, hydrogels, and multifunctional materials as blends and bio(nano)composites; most suitable lignin type for each category of the envisaged products; main properties of the obtained lignin-based materials, etc. Different application categories of lignin within various sectors, which could provide completely sustainable energy conversion, such as in agriculture and environment protection, food packaging, biomedicine, and cosmetics, are also described. The medical and therapeutic potential of lignin-derived materials is evidenced in applications such as antimicrobial, antiviral, and antitumor agents; carriers for drug delivery systems with controlled/targeting drug release; tissue engineering and wound healing; and coatings, natural sunscreen, and surfactants. Lignin is mainly used for fuel, and, recently, studies highlighted more sustainable bioenergy production technologies, such as the supercapacitor electrode, photocatalysts, and photovoltaics.
PubMed: 37571069
DOI: 10.3390/polym15153177 -
Cancer Letters Jan 2024Small extracellular vesicles (sEVs) such as exosomes are nanoscale membranous particles (<200 nm) that have emerged as crucial targets for liquid biopsy and as... (Review)
Review
Small extracellular vesicles (sEVs) such as exosomes are nanoscale membranous particles (<200 nm) that have emerged as crucial targets for liquid biopsy and as promising drug delivery vehicles. They play a significant role in tumor progression as intercellular messengers. They can serve as biomarkers for tumor diagnosis and as drug carriers for cancer treatment. This article reviews recent studies on sEVs in oncology and explores their potential as biomarkers and drug delivery vehicles. Following tumorigenesis, sEVs in the tumor microenvironment (TME) and circulatory system undergo modifications to regulate various events in the TME, including angiogenesis, epithelial-mesenchymal transition (EMT), and tumor immunity, with either pro- or anti-tumor effects. sEVs have been investigated for use as diagnostic and prognostic biomarkers for a variety of tumors, including lung cancer, melanoma, breast cancer, prostate cancer, and hepatocellular carcinoma. sEVs can be used for cancer therapy by packaging drugs or proteins into them through pre- and post-isolation modification techniques. The clinical trials of sEVs as biomarkers and drug carriers are also summarized. Finally, the challenges in the use of sEVs are described and the possible approaches to tackling them are suggested. Overall, sEVs will advance the precision cancer medicine and has shown great potential in clinical applications.
Topics: Male; Humans; Lung Neoplasms; Extracellular Vesicles; Drug Carriers; Liver Neoplasms; Biomarkers; Tumor Microenvironment
PubMed: 37972701
DOI: 10.1016/j.canlet.2023.216481 -
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 -
Internal and Emergency Medicine Mar 2024The fight against obesity is largely based on recommendations about lifestyle and therapies to initiate weight loss and, hopefully, to achieve and maintain an ideal...
The fight against obesity is largely based on recommendations about lifestyle and therapies to initiate weight loss and, hopefully, to achieve and maintain an ideal weight. The failure of this approach is witnessed by the steady increasing rates of obesity worldwide. Lifestyle modifications yield mild weight loss with poor results in the long-term. The pharmaceutical industry is engaged to produce the best anti-obesity drugs, and this market is projected to grow massively. Guidelines on pharmacological and surgical approach to obesity are continuously developed, taking into account that benefits are counterbalanced by high costs, are limited to the period of drug intake, and potential adverse effects are possible, such as pancreatitis, gastroparesis, and bowel obstruction. Meantime, people living with obesity might simply think that taking the "magic pill" or undergoing bariatric surgery can change their life. In the long term, this tendency might lead to scarce cost-effectiveness, increasing adverse effects and inequities in the most vulnerable age classes. Furthermore, the main actors responsible for generating an obesogenic world will continue undisturbed to produce negative effects. Obesity is not only generated from voluntary individual behaviors, and no guideline can truly counteract the detrimental effects of environmental factors driving the progressive rise of obesity globally. Unsustainable food production, packaging and marketing, environmental pollution, widely diffused endocrine disrupting chemicals, and climate change are largely neglected by health professionals and generate food insecurity and malnutrition. The complexity of obesity cannot be managed only pointing to individual responsibilities of people living with obesity. There is a missing link here, and this war cannot be won in the absence of effective primary prevention measures involving changes in food production and marketing, and decreased release of toxic chemicals into the environment.
Topics: Humans; Obesity; Bariatric Surgery; Weight Loss
PubMed: 38411858
DOI: 10.1007/s11739-024-03559-x -
Experimental Biology and Medicine... Nov 2023The US drug labeling document contains essential information on drug efficacy and safety, making it a crucial regulatory resource for Food and Drug Administration (FDA)...
The US drug labeling document contains essential information on drug efficacy and safety, making it a crucial regulatory resource for Food and Drug Administration (FDA) drug reviewers. Due to its extensive volume and the presence of free-text, conventional text mining analysis have encountered challenges in processing these data. Recent advances in artificial intelligence (AI) for natural language processing (NLP) have provided an unprecedented opportunity to identify key information from drug labeling, thereby enhancing safety reviews and support for regulatory decisions. We developed RxBERT, a Bidirectional Encoder Representations from Transformers (BERT) model pretrained on FDA human prescription drug labeling documents for an enhanced application of drug labeling documents in both research and drug review. RxBERT was derived from BioBERT with further training on human prescription drug labeling documents. RxBERT was demonstrated in several tasks using regulatory datasets, including those involved in the National Institutes of Technology Text Analysis Challenge Dataset (NIST TAC dataset), the FDA Adverse Drug Event Evaluation Dataset (ADE Eval dataset), and the classification of texts from submission packages into labeling sections (US Drug Labeling dataset). For all these tasks, RxBERT reached 86.5 1-scores in both TAC and ADE Eval classification, respectively, and prediction accuracy of 87% for the US Drug Labeling dataset. Overall, RxBERT was shown to be as competitive or have better performance compared to other NLP approaches such as BERT, BioBERT, etc. In summary, we developed RxBERT, a transformer-based model specific for drug labeling that outperformed the original BERT model. RxBERT has the potential to be used to assist research scientists and FDA reviewers to better process and utilize drug labeling information toward the advancement of drug effectiveness and safety for public health. This proof-of-concept study also demonstrated a potential pathway to customized large language models (LLMs) tailored to the sensitive regulatory documents for internal application.
Topics: United States; Humans; Artificial Intelligence; Drug Labeling; Prescription Drugs; Data Mining; Drug-Related Side Effects and Adverse Reactions
PubMed: 38166420
DOI: 10.1177/15353702231220669 -
Polymers Nov 2023Petroleum-derived plastics are materials of great importance for the contemporary lifestyle, and are widely used commercially because they are low cost, resistant,... (Review)
Review
Petroleum-derived plastics are materials of great importance for the contemporary lifestyle, and are widely used commercially because they are low cost, resistant, malleable, and weightless, in addition to their hydrophobic character. However, some factors that confer the qualities of these materials also cause problems, mainly environmental, associated with their use. The COVID-19 pandemic aggravated these impacts due to the high demand for personal protective equipment and the packaging sector. In this scenario, bioplastics are environmentally positive alternatives to these plastics due to their applicability in several areas ranging from packaging, to biomedicine, to agriculture. Polyhydroxyalkanoates (PHAs) are biodegradable biopolymers usually produced by microorganisms as an energy reserve. Their structural variability provides a wide range of applications, making them a viable option to replace polluting materials. PHAs can be applied in various biotechnology sectors, such as producing drug carriers and scaffolds for tissue engineering. This review aimed to survey works published in the last five years on the study and biotechnological application of PHAs in the biomedical sector, exploring the versatility and advantages of their use and helping to understand how to enhance their application.
PubMed: 38006129
DOI: 10.3390/polym15224405 -
Journal of Pharmaceutical and... Feb 2024To ensure the efficacy, safety, and quality of drugs, several national and international guidelines and regulatory requirements exist. The most important international... (Review)
Review
To ensure the efficacy, safety, and quality of drugs, several national and international guidelines and regulatory requirements exist. The most important international regulatory framework for quality is the collection of the guidelines ICH Q1-Q14 (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), which form the basis for the development and approval of medicinal products. Additionally, international and national pharmacopoeias and national regulatory authorities like Food and Drug Administration (FDA) and European Directory for the Quality of Medicines and HealthCare (EDQM) have to be considered during the lifecycle of a drug. Further, regular updates and optimization of processes and methods together with periodic audits and inspections of the manufacturing plants help to ensure compliance with the complex regulatory requirements for medicinal products. Although the pharmaceutical world seems to be very well regulated and controlled, several drug recalls per year have to be announced and conducted to remove defect products from the market and protect the patient from any potential health risk. This review article provides an overview of the most common reasons for such recalls presenting several historical and current cases with a detailed discussion of root causes. A specific focus lies on quality issues like drug degradation, impurity and nitrosamine contamination, lack of drug stability, occurrence and transformation of polymorphs, contamination with particulates and foreign matters, amongst others. The role of APIs, excipients and packaging will be discussed as well as the analytical challenges to detect, control and mitigate such quality issues. A final chapter will discuss the current situation and an outlook on emerging topics and future challenges for drug quality.
Topics: Humans; Pharmaceutical Preparations; Drug Packaging; Drug Stability
PubMed: 38103416
DOI: 10.1016/j.jpba.2023.115880