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Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.
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[...]of the significant cost of development, companies seek to recoup finances through data exclusivity and patent protection of intellectual property, such as the drug product's formulation. Bio/pharma companies reformulate existing therapies for a whole host of reasons, such as treating underserved or neglected disease areas, improving patient adherence (particularly for target patient groups, such as paediatrics), reducing the potential of drug abuse, and providing alternative options in crisis situations-as has been apparent during the COVID-19 pandemic. Pentamidine is an anti-infective agent that can be used to treat an earlier stage of the disease;however, it is unable to penetrate the blood-brain barrier sufficiently to treat the secondary stage of HAT. [...]it was hypothesized that a combined pentamidine-Pluronic formulation may be a suitable approach to provide patients with a single therapeutic option for treatment of all stages of HAT. [...]it was concluded that the pharmacokinetic data attained supports the use of safety and tolerability data from the conventional risperidone formulation for further testing of VAL401 (4).
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PurposeThis study aims to focus on the preparation and characterization of the silver nanowire (AgNWs), as well as their application as antimicrobial and antivirus activities either with incorporation on the waterborne coating formulation or on their own.Design/methodology/approachPrepared AgNWs are characterized by different analytical instruments, such as ultraviolet-visible spectroscope, scanning electron microscope and X-ray diffraction spectrometer. All the paint formulation's physical and mechanical qualities were tested using American Society for Testing and Materials, a worldwide standard test procedure. The biological activities of the prepared AgNWs and the waterborne coating based on AgNWs were investigated. And, their effects on pathogenic bacteria, antioxidants, antiviral activity and cytotoxicity were also investigated.FindingsThe obtained results of the physical and mechanical characteristics of the paint formulation demonstrated the formulations' greatest performance, as well as giving good scrub resistance and film durability. In the antimicrobial activity, the paint did not have any activity against bacterial pathogen, whereas the AgNWs and AgNWs with paint have similar activity against bacterial pathogen with inhibition zone range from 10 to 14 mm. The development of antioxidant and cytotoxicity activity of the paint incorporated with AgNWs were also observed. The cytopathic effects of herpes simplex virus type 1 (HSV-1) were reduced in all three investigated modes of action when compared to the positive control group (HSV-1-infected cells), suggesting that these compounds have promising antiviral activity against a wide range of viruses, including DNA and RNA viruses.Originality/valueThe new waterborne coating based on nanoparticles has the potential to be promising in the manufacturing and development of paints, allowing them to function to prevent the spread of microbial infection, which is exactly what the world requires at this time.
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The company's Lyoguard trays are being used in the production of mAbs;diagnostics tests for COVID-19 virus or antibodies;and some of the key raw materials used in messenger RNA (mRNA) vaccines, including synthetic oligonucleotides, adjuvants, and lipid nanoparticles, he says. [...]it's a question of capacity. Another problem is the fact that lyophilization involves very slow cooling, at a rate of one degree Kelvin per second, says Bill Williams, a professor at the University of Texas and inventor of the thin-film freezing process, which he developed years ago at the Dow Chemical Co. TFF Pharma licensed his technology and commercialized it in 2019. Williams and his team, with corporate and US government funding, are now focusing on research designed to optimize use of thin-film freezing to improve the processing and delivery of biologics, including vaccines, along with the cold chain.
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Globally, concerns regarding the COVID-19 pandemic its prevention have become important. Because of COVID-19 and other microbial diseases, enhance research work has emerged revealing new antimicrobial and antiviral materials and techniques. Tremendous growth in nanotechnology has opened up the door to fabricating numerous nanomaterials. These nanomaterials are employed as antimicrobial and antiviral agents for various applications with 99.99% effectiveness compared with conventional techniques. Nanoparticles possess unique physicochemical characteristics for multiple applications. This chapter details the use of nanoparticles for antifungal, antimicrobial, and antiviral applications. It describes various kinds of nanoparticles, such as nanometals, metal oxides, polymeric nanomaterials, and carbon-based nanomaterials. © 2023 Elsevier Inc. All rights reserved.
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Horticultural crops, especially fruits and vegetables, are highly consumed as food and food products. These items are consumed either uncooked, partially cooked, or fully cooked, according to their nature and the cooking process. A large amount of waste is generated from fruit-and vegetable-based industries and household kitchens. According to the FAO, waste generated from fruits and vegetable processing is estimated by 25–30% of the total product. This waste is rich in active compounds and has high nutritional content. Utilization of this waste into beneficial by-products could represent an essential strategy for reducing significant dietary and economic loss as well as the negative environmental impacts. The most common wastes include pomace, peels, rind, and seeds are fabulously rich in valuable bioactive compounds such as carotenoids, enzymes, phenolics, essential oils, vitamins, and many other compounds. These bioactive compounds show their application in various industries, including food industries to develop edible films, health industries for probiotics, and other industries for valuable and natural products. The utilization of these low-cost waste for producing the high value-added product is a novel step in its sustainable utilization. Tangerine is commonly produced and consumed as fresh or processed worldwide. The Mediterranean area produces the best and high-quality tangerine in the world. It is a high vitamin C source and rich in nutrients and provides many medicinal and health benefits. According to the new information released by the FAO, considering the influences of the novel coronavirus (COVID-19), populations with extreme starvation in the world will perhaps increase. Consequently, countries should gain proficiencies and try to reduce trade-related costs, for example, by reducing food waste and losses. Therefore, the present chapter intends to summarize the different types of waste originating from Tangerine (Citrus reticula L.) and highlight their potential in developing edible films, probiotics, nanoparticles, carbon dots, microbial media, biochar, and biosorbents. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.
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"Lyophilization may be necessary to decrease prohibitive storage temperature requirements, allowing for shipment and storage in areas of the world where refrigeration isn't as easily accessed. "The challenge posed by the COVID-19 vaccines at the fill/finish stage of manufacturing stems from the fact that these candidates are dispersions," adds Eatmon, who explains that the dispersion factor makes the vaccines sensitive to shear stress because they are a lipid nanoparticle rather than a solution. [...]the manufacturer or CDMO/ CMO must pay close attention to foaming during liquid formulation filling and must reduce the rate of vial filling to accommodate excipients that foam, she notes. Other than the API, excipients sometimes include: antibiotics, to prevent contamination by bacteria;adjuvants that help stimulate a stronger immune response;and stabilizers, to keep the vaccine potent during transportation and storage," he notes, further explaining that the types of API used all help to ensure the product's stability, and that each type plays a different role while in storage. cdmo/cmo readiness Fill/finish operations are predominantly outsourced to CDMOs/CMOs, which are well suited to handle COVID-19 vaccines as these products start to hit the market.
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During the past 2 years, messenger RNA (mRNA) nanovaccine has shown its remarkable antiviral efficacy, rapid manufacture, and good safety profile for preventing coronavirus infection. Meanwhile, intracellular delivery of mRNA-based cancer vaccine starts to show great potential to elicit antitumor immunity. mRNA encoding tumor antigens, delivery vehicles, and immune adjuvants are the key components of mRNA cancer vaccine. To achieve robust antitumor efficacy, mRNA encoding tumor antigens need to be efficiently delivered and translated in dendritic cells with concurrent innate immune stimulation to promote antigen presentation. Compared with other types of tumor vaccines, mRNA nanovaccine is featured by efficient antigen expression, high potential for rapid development, low-cost manufacture, and safe administration. In this chapter, we mainly focus on the mRNA synthesis, mRNA modification, delivery vectors with immune-stimulating features, and tumor antigen selection and discuss the future direction of mRNA nanovaccine in cancer immunotherapy. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023.
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The outbreak of the COVID 19 pandemic confirmed the importance of personal protective equipment including the respiratory face masks as barriers to pathogens. Taking into account that face masks are mainly composed of polypropylene (PP) non-woven materials this study explores the possibility of in situ biosynthesis of silver-based nanoparticles as an antimicrobial agent on PP material. A pomegranate peel extract was used as a "green" agent for synthesis and stabilization of nanoparticles. Hydrophobicity of PP fibers was overcome by modification with corona discharge at atmospheric pressure. In order to improve the binding of silver ions, corona modified PP material was impregnated with biopolymer chitosan in the presence of crosslinker 1,2,3,4-butanetetracarboxylic acid. SEM analysis revealed the presence of spherical Ag-based nanoparticles on the fiber surface with an average size of approximately 69 nm. The higher the concentration of the precursor salt, the higher the silver content after the reduction. Larger amounts of Ag-based nanoparticles provided stronger antimicrobial activity against bacteria Escherichia coli and Staphylococcus aureus, and yeast Candida albicans.
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The heart, liver, lungs, brain and kidney are the five most highly perfused organs. Incidentally, they are the ones prone to many diseases and disorders. There has been a phenomenal rise in lung diseases in the recent past which can be attributed to rising levels of environmental pollution, smoking and other lifestyle problems. The cytokine storm experienced in the COVID-19-affected population was a recent challenge faced by physicians around the globe. Scientists have tried different methods and delivery systems for effective delivery of drugs to the lungs. Pectin-based drug delivery systems have also been tried and tested suc- cessfully. This chapter will focus on the bumps and humps in the use of pectin as an effective polymer in delivering therapeutics to the lungs and management of various respiratory disorders. © The Author (s), under exclusive license to Springer Nature Singapore Pte Ltd. 2023.
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Coronavirus disease (COVID-19) is an infectious disease caused by coronavirus. Devel-oping specific drugs for inhibiting replication and viral entry is crucial. Several clinical trial studies are underway to evaluate the efficacy of anti-viral drugs for COVID-19 patients. Nanomedicine formulations can present a novel strategy for targeting the virus life cycle. Nano-drug delivery systems can modify the pharmacodynamics and pharmacokinetics properties of anti-viral drugs and reduce their adverse effects. Moreover, nanocarriers can directly exhibit anti-viral effects. A number of nanocarriers have been studied for this purpose, including liposomes, dendrimers, exosomes and decoy nanoparticles (NPs). Among them, decoy NPs have been considered more as nanodecoys can efficiently protect host cells from the infection of SARS-CoV-2. The aim of this review article is to highlight the probable nanomedicine therapeutic strategies to develop anti-viral drug delivery systems for the treatment of COVID-19.Copyright © 2023 Bentham Science Publishers.
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Reducing the molecule complexity is achieved by reducing the molecule size after enzymatic digestion to produce smaller fragments more amenable to LC separation and tandem mass spectrometry (MS/MS) sequencing. Non-denaturing CEX chromatography, size-exclusion chromatogra- phy (SEC), hydrophobic interaction chromatography (HIC), and protein A modes can be easily coupled to reversed-phase LC (RPLC) because of the high aqueous conditions, enabling the versatile 4D-LC-MS systems with the use of alternative modes to 1D CEX, such as SEC or Protein A (6,7). [...]the nanopar-ticle size and free drug concentration are determined at the particle Level, whereas the encapsulated drug and lipids forming the layer are commonly characterized at the molecuar level after denaturing the lipid nanoparticle (LNP) via a surfactant. [...]MDLC-MS setups present a formidable opportunity to unify the characterization of drug delivery systems at the molecular and particle evels, which would enable their high throughput analysis.
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Based on signal amplification strategy of dendritic mesoporous silica nanospheres loaded with CdSe/ZnS quantum dots (DMSN@QDs), an ultrasensitive electrochemiluminescence (ECL) immunosensor with magnetic separation was constructed for the detection of SARS-CoV-2 nucleocapsid protein (NP). DMSN, a mesoporous material with abundant radial pores, large specific surface area and high porosity, can increase the loading capacity of QDs and hinder their aggregation as the nanocarrier. DMSN@QDs with good ECL efficiency were used as signal labels to construct a sandwich immunosensor. The designed ECL immunosensor displayed a good linear relationship for NP concentrations ranging from 0.005 ng mL(-1) to 50 ng mL(-1), with a limit of detection of 3.33 pg mL(-1). The ECL immunosensor was successfully applied to detect NP in human serum samples with satisfactory recovery. This strategy provided a new method for detecting NP and expanded the application field of DMSN.
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Nucleic acids, as a next generation of biotechnology drugs, not only can fundamentally treat diseases, but also own significant platform characteristics in view of technology and production. Therefore, nucleic acid-based drugs have broad clinical applications in biomedical fields. However, nucleic acids are degradable and unstable, and have very low intracellular delivery efficiency in vitro and in vivo, which greatly limits their applications. In recent years, ionizable lipid-based lipid nanoparticles have shown promising application potentials and have been successfully applied to COVID-19 (Coronavirus Disease 2019) vaccines in clinic. Lipid nanoparticles demonstrate high in vivo delivery efficiency and good safety profile due to their unique structural and physicochemical properties, which provides many possibilities for their clinical applications for nucleic acid delivery in the future. This review focused on the characteristics of nucleic acid drugs and their delivery barriers, and discussed the approved nucleic acid drugs to illustrate the key aspects of the success of their delivery carrier system. In addition, problems to be solved in the field were highlighted.Copyright © 2023, Chinese Pharmaceutical Association. All rights reserved.
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Advances in technology are accelerating the development and manufacture of this established class of vaccines. Because they contain only a portion of the pathogen, subunit vaccines typically have fewer side effects and can be given to a wider group of people, including those with compromised immune systems and chronic health conditions. In addition to having transparent and scenario-based forecasting in place to anticipate risk-based future global demand scenarios, managing cold-chain requirements regarding storage and transportation remains a key capability, especially considering the variety of temperature classes (i.e., cool-chain to deep-frozen, all the way down to liquid nitrogen temperatures)," comments Christian Rochel, head of supply chain for biologies at Lonza's Visp, Switzerland facility. Magers points to progress in genomics for the identification of vaccine candidates and incorporation of three-dimensional (3D) structure, domain organization, and dynamics of surface proteins analysis into vaccine design as aiding development efforts. Manufacturing advances of note for Magers include expanding use of different expression systems including mammalian, insect, microbial, and fungal cell lines;incorporation of single-use technologies and equipment and closed systems into manufacturing processes;exploration of continuous manufacturing and quality-by-design approaches;and the introduction of novel analytical methods (e.g., mass spectrometry, particle analysis methods, and capillary electrophoresis) in conjunction with an emphasis on replacing in-vivo potency assays. Since the first subunit vaccine was approved for hepatitis B, Novavax has advanced the technology for this class of vaccines through its use of a nanoparticle core to present the protein subunits to the immune system in a way that results in robust, durable responses that offer protection in the face of genetic drift, according to the company's spokesperson.
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Abatract: In recent years studies of nanomaterials have been explored in the field of microbiology due to the increasing evidence of antibiotic resistance. Nanomaterials could be inorganic or organic, and they may be synthesized from natural products from plant or animal origin. The therapeutic applications of nano-materials are wide, from diagnosis of disease to targeted delivery of drugs. Broad-spectrum antiviral and antimicrobial activities of nanoparticles are also well evident. The ratio of nanoparticles surface area to their volume is high and that allows them to be an advantageous vehicle of drugs in many respects. Effective uses of various materials for the synthesis of nanoparticles impart much specificity in them to meet the requirements of specific therapeutic strategies. The potential therapeutic use of nanoparticles and their mechanisms of action against infections from bacteria, fungi and viruses were the focus of this review. Further, their potential advantages, drawbacks, limitations and side effects are also included here. Researchers are characterizing the exposure pathways of nano-medicines that may cause serious toxicity to the subjects or the environment. Indeed, societal ethical issues in using nano-medicines pose a serious question to scientists beyond anything.
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OBJECTIVE: Alternative medicine plays an important role today in searching for therapeutics for cancer and viral infection. So, a scientific validation to characterize constituents in the alternative medicines and therapeutic testing is warranted using modern instrumentation. METHODS: In the present study, an old herbomineral formulation, KanthaRasavillai [KRV], was characterized using UV-vis spectrometry, FT-IR, XRD, SEM, and TEM study. Also, In vitro and in vivo studies were done to evaluate their antiviral and anticancer activity. FT-IR and XRD studies revealed a cocktail of nanoparticles of mercury, magnetic oxide, cinnabar, and arsenic.ResultsBased on SEM, TEM, and XRD report, KRV contains nanoparticles in the size range of 9.1nm to 25.0 nm. FT-IR analysis exposed the presence of several anti-cancerous bioactive compounds.Further in vitro testing against HCV virus proved KRV to inhibit HCV virus a close relative to SARS-CoV-2. MTT assay confirmed the anticancer effect of KRV against Huh-7 and MCF-7 cell lines. CONCLUSION: The anticancer and antiviral properties in the ancient herbomineral drug with a cocktail of metal nanoparticles acknowledge the traditional medical practice as a pioneering approach for present-day ailments. However, the study concludes that the use of KRV depends on safety dosage and genuine preparation as described by ancient saints.
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Lipid nanoparticles (LNPs) are widely used as delivery systems for mRNA vaccines. The stability and bilayer fluidity of LNPs are determined by the properties and contents of the various lipids used in the formulation system, and the delivery efficiency of LNPs largely depends on the lipid composition. For the quality control of such vaccines, here we developed and validated an HPLC-CAD method to identify and determine the contents of four lipids in an LNP-encapsulated COVID-19 mRNA vaccine to support lipid analysis for the development of new drugs and vaccines.
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The recent development of RNA-based therapeutics in delivering nucleic acids for gene editing and regulating protein translation has led to the effective treatment of various diseases including cancer, inflammatory and genetic disorder, as well as infectious diseases. Among these, lipid nanoparticles (LNP) have emerged as a promising platform for RNA delivery and have shed light by resolving the inherent instability issues of naked RNA and thereby enhancing the therapeutic potency. These LNP consisting of ionizable lipid, helper lipid, cholesterol, and poly(ethylene glycol)-anchored lipid can stably enclose RNA and help them release into the cells' cytosol. Herein, the significant progress made in LNP research starting from the LNP constituents, formulation, and their diverse applications is summarized first. Moreover, the microfluidic methodologies which allow precise assembly of these newly developed constituents to achieve LNP with controllable composition and size, high encapsulation efficiency as well as scalable production are highlighted. Furthermore, a short discussion on current challenges as well as an outlook will be given on emerging approaches to resolving these issues.
Subject(s)
Lipids , Nanoparticles , RNA, Small Interfering/genetics , LiposomesABSTRACT
Since the global outbreak of coronavirus disease 2019 (COVID-19), it has spread rapidly around the world. The nucleocapsid (N) protein is one of the most abundant SARS-CoV-2 proteins. Therefore, a sensitive and effective detection method for SARS-CoV-2 N protein is the focus of research. Here, we developed a surface plasmon resonance (SPR) biosensor based on the dual signal-amplification strategy of Au@Ag@Au nanoparticles (NPs) and graphene oxide (GO). Additionally, a sandwich immunoassay was utilized to sensitively and efficiently detect SARS-CoV-2 N protein. On the one hand, Au@Ag@Au NPs have a high refractive index and the capability to electromagnetically couple with the plasma waves propagating on the surface of gold film, which are harnessed for amplifying the SPR response signal. On the other hand, GO, which has the large specific surface area and the abundant oxygen-containing functional groups, could provide unique light absorption bands that can enhance plasmonic coupling to further amplify the SPR response signal. The proposed biosensor could efficiently detect SARS-CoV-2 N protein for 15 min and the detection limit for SARS-CoV-2 N protein was 0.083 ng/mL, with a linear range of 0.1 ng/mL~1000 ng/mL. This novel method can meet the analytical requirements of artificial saliva simulated samples, and the developed biosensor had a good anti-interference capability.