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Pharmaceutical technology

Maarten L De Mol, Nico Snoeck, Sofie L De Maeseneire, Wim K Soetaert
The struggle of humans versus pathogens is a never ending battle. Since the discovery of antibiotics humans have tipped the scales in their favour, but today bacteria are nullifying this advantage by developing resistance mechanisms against these molecules. The plethora of different antibiotics active against pathogens is shrinking while the discovery of new molecules is arduous. Especially the development of drugs active against Gram- pathogens continues slowly. New strategies to discover novel, potent antibiotics are hence needed...
October 17, 2018: Biotechnology Advances
Alexandre Camiré, Julie Espinasse, Bruno Chabot, André Lajeunesse
Emerging contaminants present a challenge for water preservation, threatening humans' health and all ecosystems. They consist of a variety of molecules ranging from pharmaceutical and personal care products to pesticides and endocrine disruptors detectable in wastewater, sewage effluent, surface water, drinking water, and ground waters at trace level concentrations (e.g., ng/L, μg/L). Conventional wastewater treatment plants (WWTPs) possess low efficiency to remove them. Therefore, new technologies capable of removing such residues are needed...
October 19, 2018: Environmental Science and Pollution Research International
Zhipeng Zeng, Cong Dong, Pengfei Zhao, Zhijia Liu, Lixin Liu, Hai-Quan Mao, Kam W Leong, Xiaohu Gao, Yongming Chen
Flash nanoprecipitation (FNP) by fast mixing of drug-containing organic solvent and water in a microchamber is a powerful and scalable technology to produce solid drug nanoparticles with high payload. The embedded therapeutic drugs, however, are largely limited to hydrophobic small molecules. By transferring proteins into organic solvent via hydrophobic ion pairing, the scope of FNP applications is expanded. This platform technology is capable of producing protein nanoparticles with tunable sizes (from ≈30 nm to sub-micrometers), high-production scale (grams per hour), high drug loading efficiency (>90%), and excellent reproducibility, opening a new paradigm for formulation of biological pharmaceuticals...
October 19, 2018: Advanced Healthcare Materials
Marlene Gyldmark, Kristian Lampe, Jörg Ruof, Johannes Pöhlmann, Ansgar Hebborn, Finn Børlum Kristensen
OBJECTIVES: The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model...
October 18, 2018: International Journal of Technology Assessment in Health Care
Saad Haider, Michael B Black, Bethany B Parks, Briana Foley, Barbara A Wetmore, Melvin E Andersen, Rebecca A Clewell, Kamel Mansouri, Patrick D McMullen
Efficient high-throughput transcriptomics (HTT) tools promise inexpensive, rapid assessment of possible biological consequences of human and environmental exposures to tens of thousands of chemicals in commerce. HTT systems have used relatively small sets of gene expression measurements coupled with mathematical prediction methods to estimate genome-wide gene expression and are often trained and validated using pharmaceutical compounds. It is unclear whether these training sets are suitable for general toxicity testing applications and the more diverse chemical space represented by commercial chemicals and environmental contaminants...
2018: Frontiers in Pharmacology
Shraddha Sapkota, Tao Huan, Tran Tran, Jiamin Zheng, Richard Camicioli, Liang Li, Roger A Dixon
Background : Among the neurodegenerative diseases of aging, sporadic Alzheimer's disease (AD) is the most prevalent and perhaps the most feared. With virtually no success at finding pharmaceutical therapeutics for altering progressive AD after diagnosis, research attention is increasingly directed at discovering biological and other markers that detect AD risk in the long asymptomatic phase. Both early detection and precision preclinical intervention require systematic investigation of multiple modalities and combinations of AD-related biomarkers and risk factors...
2018: Frontiers in Aging Neuroscience
Stuart Linley, Andrew Holmes, Timothy Leshuk, Wanis Nafo, Neil R Thomson, Adil Al-Mayah, Kevin McVey, Kanwartej Sra, Frank X Gu
Targeted nanoparticle binding has become a core feature of experimental pharmaceutical product design which enables more efficient payload delivery and enhances medical imaging by accumulating nanoparticles in specific tissues. Environmental remediation and geophysical monitoring encounter similar challenges which may be addressed in part by the adoption of targeted nanoparticle binding strategies. This study illustrates that engineered nanoparticles can bind to crude oil-impacted silica sand, a selective adsorption driven by active targeting based on an amphiphilic polymer coating...
October 8, 2018: Chemosphere
Leonardo Vazquez, Andre Teixeira da Silva Ferreira, Fernanda Sampaio Cavalcante, Israel José P Garcia, Katia Regina Netto Dos Santos, Leandro Augusto de Oliveira Barbosa, Marcius da Silva Almeida, Julio Alberto Mignaco, Carlos Frederico Leite Fontes
Eight molecules, four peptides (SPs) and four lipopeptides (LPs) derived by rational design from surfactin, a well-known secreted biosurfactant from Bacillus subtilis, were produced employing Fmoc-based solid-phase synthesis. These new peptides were tested to evaluate their potential biosurfactant and biological activities, aiming at possible applications in industrial, biological, pharmaceutical, and medical use. Five molecules (SP1, SP2, SP4, LP5, and LP8) presented potential for medical uses, mainly due to their drug delivery properties as suggested by their synergistic activity with the antibiotic vancomycin against Staphylococcus aureus...
October 16, 2018: Journal of Peptide Science: An Official Publication of the European Peptide Society
Louise E Curley, Zimei Wu, Darren Svirskis
Objectives: The role of the pharmacist has evolved and continues to evolve. The traditional role of the dispenser has been replaced with a patient-centered profession. This requires integration and application of pharmaceutical knowledge and skills to solve patient therapeutic problems and advance patient care. Therefore, having evidence-based teaching strategies for learning within pharmaceutical sciences is essential. New and maturing technologies enable traditional principles of pharmaceutical science to be visualized...
2018: Frontiers in Pharmacology
Magnus Edinger, Jette Jacobsen, Daniel Bar-Shalom, Jukka Rantanen, Natalja Genina
Printing technologies, both 2D and 3D, have gained considerable interest during the last years for manufacturing of personalized dosage forms, tailored to each patient. Here we review the research work on 2D printing techniques, mainly inkjet printing, for manufacturing of film-based oral dosage forms. We describe the different printing techniques and give an overview of film-based oral dosage forms produced using them. The main part of the review focuses on the non-destructive analytical methods used for evaluation of qualitative aspects of printed dosage forms, e...
October 11, 2018: International Journal of Pharmaceutics
Alexandra Beletsi, Vassiliki Koutrafouri, Eleftheria Karampli, Elpida Pavi
OBJECTIVES: To examine and compare the use of health technology assessment (HTA) for the reimbursement of new medicines in selected European Union member states with decades of experience in the use of HTA and in countries that have used it regularly since 2000. METHODS: The selected countries were categorized into "earlier" adopters (group A: England, Germany, France, and Sweden) and more "recent" adopters (group B: Poland, Bulgaria, Hungary, and Romania)...
October 10, 2018: Value in Health Regional Issues
Priya N O Kasimbeg, Fook Chiong Cheong, David B Ruffner, Jaroslaw M Blusewicz, Laura A Philips
Characterizing protein aggregates in the presence of silicone oil is a long standing challenge for the pharmaceutical industry. Silicone oil is often used as a lubricant in devices that deliver and store therapeutic protein products, and has been linked to protein aggregation, which can compromise a drug's effectiveness or cause autoimmune responses in patients. Most traditional technologies cannot quantitatively distinguish protein aggregates and silicone oil in their native formulations for sizes less than 5 μm...
October 10, 2018: Journal of Pharmaceutical Sciences
Neelam Sultan, Shazia Anwer Bukhari, Irfan Ali, Muhammad Asif, Zunaira Umar, Muhammad Sajid Hamid Akash
Zika virus belongs to family of viruses 'Flaviviridae' and spreads mostly by daytime-active Aedes mosquitoes. The resulting infection is known as Zika fever. It is usually asymptomatic or often causes mild symptoms, which are very similar to dengue fever. The Aedes aegypti mosquito is also responsible for dengue and chikungunya viruses. Zika virus can spread by crossing the placental barrier from a pregnant mother to a fetus, which can result in microcephaly, severe brain malformations including Guillain-Barre syndrome (GBS), and other birth defects...
2018: Critical Reviews in Eukaryotic Gene Expression
Guanglan Di, Zhiliang Zhu, Qinghui Huang, Hua Zhang, Jianyao Zhu, Yanling Qiu, Daqiang Yin, Jianfu Zhao
Pharmaceuticals have been frequently detected in various water bodies, posing potential threat to human health and ecological environment. In this work, ZnFe-LDH derived mixed metal oxides (ZnO/ZnFe2 O4 , ZnFeMMO) were innovatively adopted to modulate the g-C3 N4 photocatalytic performance for the enhanced degradation of ibuprofen (IBF) and sulfadiazine (SDZ) as targeted pollutants. Characterization analyses indicated that the g-C3 N4 /ZnFeMMO composites were in the feature of rationally-designed microarchitecture, increased specific surface area, improved light absorbance and efficient charge separation, thereby resulting in promoted photocatalytic activities...
February 10, 2019: Science of the Total Environment
Andrew J Radcliffe, Jon L Hilden, Zoltan K Nagy, Gintaras V Reklaitis
The principal method of drug delivery is by oral solid doses, the production of which often necessitates multiple post-crystallization unit operations to ensure content uniformity and/or enhance bioavailability. As an alternative to conventional dose production methods, applications of additive manufacturing technologies based on solvent- or melt-based formulations have demonstrated the potential for improvements to process efficiency, flexibility and dosing precision. Here we explore the use of particulate suspensions in a dropwise additive manufacturing process as a method for dosing active ingredients in crystalline form, which may be difficult to achieve via powder processing due to poor flow properties...
October 8, 2018: Journal of Pharmaceutical Sciences
Paul J Jannetto, Anders Helander, Uttam Garg, Gregory C Janis, Bruce Goldberger, Hemamalini Ketha
BACKGROUND: Since 2013, an unprecedented surge in fentanyl overdose deaths has been caused by heroin laced with illicitly produced fentanyl and/or fentanyl analogs (FAs) sold as heroin. The US Drug Enforcement Agency's National Forensic Laboratory Information System reported a >300% increase in fentanyl encounters from 4697 in 2014 to 14440 in 2015. In 2015, the CDC reported 9580 deaths caused by synthetic opioids, primarily fentanyl, a 72% increase from 2014. The European Monitoring Centre for Drugs and Drug Addiction has also encountered several new FAs in the heroin supply...
October 10, 2018: Clinical Chemistry
Fanny Chapelin, Christian M Capitini, Eric T Ahrens
Over the past two decades, immune cell therapy has emerged as a potent treatment for multiple cancers, first through groundbreaking leukemia therapy, and more recently, by tackling solid tumors. Developing successful therapeutic strategies using live cells could benefit from the ability to rapidly determine their in vivo biodistribution and persistence. Assaying cell biodistribution is unconventional compared to traditional small molecule drug pharmacokinetic readouts used in the pharmaceutical pipeline, yet this information is critical towards understanding putative therapeutic outcomes and modes of action...
October 11, 2018: Journal for Immunotherapy of Cancer
Juergen Schmider, Krishan Kumar, Chantal LaForest, Brian Swankoski, Karen Naim, Patrick M Caubel
Automation of pharmaceutical safety case processing represents a significant opportunity to impact the strongest cost driver for a company's overall pharmacovigilance budget. A pilot was undertaken to test the feasibility of employing artificial intelligence and robotic process automation to automate processing of adverse event reports. The pilot paradigm was used to simultaneously test proposed solutions of 3 commercial vendors. The result confirmed feasibility of using artificial intelligence-based technology to support extraction from adverse event source documents and evaluation of case validity...
October 10, 2018: Clinical Pharmacology and Therapeutics
Shambhunath Choudhary, Audrey Walker, Kathleen Funk, Charlotte Keenan, Imran Khan, Kimberly Maratea
The Standard for the Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies that enables the U.S. Food and Drug Administration (FDA) to modernize and streamline the review process. As a result, patients may benefit from speedier approval of new drugs. However, SEND implementation and compliance can be challenging and require effective cooperation between pharmaceutical companies and contract research organizations. In order to improve Society of Toxicologic Pathology (STP) members' awareness about SEND, including the steps, obstacles, and mistakes to avoid in its implementation while applying for FDA approval, the Career Development and Outreach Committee of the STP sponsored a career development lunchtime series panel discussion entitled "The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promise" in conjunction with the STP 37th Annual Symposium...
October 7, 2018: Toxicologic Pathology
Oscar Martínez-Avila, Antoni Sánchez, Xavier Font, Raquel Barrena
2-Phenylethanol (2-PE) and 2-phenethyl acetate (2-PEA) are valuable generally recognized as safe flavoring agents widely used in industry. Perfumes, pharmaceuticals, polishes, and personal care products, are some of the final products using these compounds as additives due to their rose-like odor. Also, 2-PE is used in disinfectants, pest control, and cleaning products due to its biocide capability. Although most of these additives production are derived from chemical synthesis, the current trend of consumers to prefer natural products has contributed to the development of biotechnological approaches as an alternative way to obtain natural 2-PE and 2-PEA...
October 6, 2018: Applied Microbiology and Biotechnology
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