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Pharmaceutical technology

Oriana Ciani, Maria Cucciniello, Francesco Petracca, Giovanni Apolone, Giampaolo Merlini, Silvia Novello, Paolo Pedrazzoli, Nicoletta Zilembo, Chiara Broglia, Enrica Capelletto, Marina Garassino, Elena Nicod, Rosanna Tarricone
INTRODUCTION: Mobile health technologies may enhance patient empowerment and data integration along the whole care continuum. However, these interventions pose relatively new regulatory, organisational and technological challenges that limit appropriate evaluation. Lung Cancer App (LuCApp) is a mobile application developed by researchers and clinicians to promote real-time monitoring and management of patients' symptoms. This protocol illustrates a clinical trial designed to evaluate the usability, effectiveness and cost-effectiveness of LuCApp versus standard of care...
February 15, 2019: BMJ Open
Ivana H Šrámková, Laura Carbonell-Rozas, Burkhard Horstkotte, Martina Háková, Jakub Erben, Jiří Chvojka, František Švec, Petr Solich, Ana M García-Campaña, Dalibor Šatínský
A novel application of the three-dimensional printing technology for the automation of solid phase extraction procedures in a low-pressure sequential injection analysis system is presented. A 3D printed device was used as a housing for nanofiber membranes in solid phase extraction. The applicability of the device is demonstrated with the extraction of substances of various physical-chemical properties. Pharmaceuticals including non-steroidal anti-inflammatory drugs, antihistaminics, and steroidal structures, as well as emerging pollutants such as bisphenols and pesticide metsulfuron methyl were used as model analytes to study the extraction performance of the nanofibers...
May 15, 2019: Talanta
Weiming Qi, Wenwu Zhu
In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed...
January 30, 2019: Zhongguo Yi Liao Qi Xie za Zhi, Chinese Journal of Medical Instrumentation
Valentin Steinwandter, Christoph Herwig
In the pharmaceutical industry, process validation tasks are based on the generated process raw and derived analytical results. Risks to fail in process validation, affect both, the patient's safety as well as the economic success of the manufacturing company. Hence, data integrity is highly critical in this area. Regulatory agencies, such as the FDA, reacted to past data integrity breaches, by publishing new guidelines on data integrity for the correct handling of data in the pharmaceutical context. In this contribution, we want to show how data integrity can be improved on a technological level, removing the need for trusted third parties and centralized systems for this task...
February 15, 2019: PDA Journal of Pharmaceutical Science and Technology
Kate McKeage
Ravulizumab (ravulizumab-cwvz; ULTOMIRIS™), a humanized monoclonal antibody, is a complement C5 inhibitor developed by Alexion Pharmaceuticals for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Like the first-generation C5 inhibitor, eculizumab, ravulizumab binds specifically and with high affinity to the complement protein C5, thereby preventing formation of the terminal complement complex C5b-9, which mediates cell lysis. In December 2018, intravenous ravulizumab received its first global approval in the USA for the treatment of adults with PNH, and is under regulatory review in the European Union and Japan in this indication...
February 14, 2019: Drugs
Shuzhen Ren, Mingyu Liu, Chao Hong, Guowen Li, Jiabin Sun, Jianying Wang, Lei Zhang, Yan Xie
Pharmaceutical cocrystals are a promising technology that can be used to improve the solubility of poor aqueous compounds. The objective of this study was to systematically investigate the solubility of myricetin (MYR) cocrystals, including their kinetic solubility, thermodynamic solubility, and intrinsic dissolution rate (IDR). The effects of pH, surfactant, ion concentration, and coformers on the cocrystal solubility were evaluated. Furthermore, single crystal structures of MYR, myricetin-isonicotinamide (MYR-INM) and myricetin-caffeine (MYR-CAF) cocrystals were analyzed to discuss the possible reasons for the enhancement of cocrystal solubility from the perspective of the spatial structure...
January 2019: Acta Pharmaceutica Sinica. B
Arnab Dawn
A supramolecular gel is a fascinating combination of flexibility and orderliness. While the supramolecular nature of crosslinking contributes towards the adaptivity and the reversibility of the system, orderliness at the molecular level amplifies the functional output and induces extraordinary selectivity into the system. Therefore, use of supramolecular gels as the soft template is an emerging area of research, which includes but not limited to catalysis of a chemical or a photochemical process, transcription of gel property to a substrate, or even controlling the nucleation of drug molecules...
February 12, 2019: International Journal of Molecular Sciences
Yan Xu, Xiaotian Qi, Pengfei Zheng, Carlo C Berti, Peng Liu, Guangbin Dong
Carbon-hydrogen (C-H) and carbon-carbon (C-C) bonds are the main constituents of organic matter. The recent advancement of C-H functionalization technology has vastly expanded our toolbox for organic synthesis1 . In contrast, C-C activation methods that allow editing of the molecular skeleton remain limited2- . So far, a number of methods have appeared for catalytic C-C activation, particularly with ketone substrates, which are typically promoted either by ring-strain release as a thermodynamic driving force4,6 or using directing groups5,7 to control the reaction outcome...
January 30, 2019: Nature
Louisa Pericleous, Mo Amin, Ron Goeree
Background Both public and private insurers provide drug coverage in Canada. All payers are under pressure to contain costs. It has recently been proposed that private plans leverage the public health technology assessment (HTA) evaluation process in their decision-making. Objectives The objectives of the current study were to examine use of public health technology assessments (HTAs) for private payer decision-making in the literature, to gather the perspectives of experts from both public and private insurers on this practice, and to summarize which value parameters of public evaluations can be used for private payer decision-making...
February 13, 2019: Journal of Medical Economics
James P Phelan, Simon B Lang, Jaehoon Sim, Simon Berritt, Andrew J Peat, Katelyn Billings, Lijun Fan, Gary A Molander
DNA-encoded library (DEL) technology is a powerful tool commonly used by the pharmaceutical industry for the identification of compounds with affinity to biomolecular targets. Success in this endeavor lies in sampling diverse chemical libraries. However, current DELs tend to be deficient in C(sp3 ) carbon counts. We report unique solutions to the challenge of increasing both the chemical diversity of these libraries and their C(sp3 ) carbon counts by merging Ni/photoredox dual catalytic C(sp2 )-C(sp3 ) cross-coupling as well as photoredox-catalyzed radical/polar crossover alkylation protocols with DELs...
February 12, 2019: Journal of the American Chemical Society
Aditya B Singaraju, Dherya Bahl, Lewis L Stevens
Brillouin light scattering (BLS), a technique theoretically described nearly a century back by the French physicist Léon Brillouin in 1922, is a light-scattering method for determining the mechanical properties of materials. This inelastic scattering method is described by the Bragg diffraction of light from a propagating fluctuation in the local dielectric. These fluctuations arise spontaneously from thermally populated sound waves intrinsic to all materials, and thus BLS may be broadly applied to transparent samples of any phase...
February 11, 2019: AAPS PharmSciTech
Kenneth W Locke, Daniel C Maneval, Michael J LaBarre
ENHANZE® drug delivery technology is based on the proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20; Halozyme Therapeutics, Inc.) that facilitates the subcutaneous (SC) delivery of co-administered therapeutics. rHuPH20 works by degrading the glycosaminoglycan hyaluronan (HA), which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption. Co-administration of rHuPH20 with partner therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been shown to reduce the burden on patients and healthcare providers compared with intravenous formulations...
December 2019: Drug Delivery
Xiaoxiao Gao, Jing Miao, Xinhua Guo, Yan Song, Tingting Lv, Luqi Huang, Wenyuan Gao, Xia Li
Gastrodia elata, as a natural plant with nourishing and edible value, its quality and pharmacological activity play a vital role in food and pharmaceutical production. In the present study, a novel approach for simultaneous determination of six components based on high performance liquid chromatography (HPLC) coupled with photodiode array detection (PDA) was developed for the quality evaluation of Gastrodia elata from different regions. Meanwhile, antioxidant and alpha-glucosidase inhibitory activities were estimated and compared...
February 11, 2019: Biomedical Chromatography: BMC
Stéphanie Sayen, Cristina Rocha, Cristiana Silva, Emmanuelle Vulliet, Emmanuel Guillon, C Marisa R Almeida
Application of anaerobically digested sludges and manure (digestates) to agricultural fields reduces the need for fertilizer application, but might also pose environmental risks due to the introduction of various pollutants -including metal trace elements and pharmaceuticals- to amended soils. The simultaneous presence of different contaminants can affect plant uptake, altering the performance of phytoremediation. This work aims to investigate and compare the single and combined effects of Enrofloxacin (Enro) and Cu on their plant uptake from digestate solutions...
January 25, 2019: Science of the Total Environment
Klemen Korasa, Franc Vrečer
Process analytical technology (PAT) has become an important factor in design, analysis and control of complex technological processes. In the present study, pellet coating process was monitored using four different PAT approaches, i.e. near-infrared (NIR) spectroscopy, Raman spectroscopy, in-line image analysis, and spatial filtering technique (SFT).Robustness and accuracy of a novel in-line image analyser was studied during the active ingredient coating process on the pilot scale in the first part of the study...
February 8, 2019: International Journal of Pharmaceutics
Birthe Sandargo, Clara Chepkirui, Tian Cheng, Lillibeth Chaverra-Munoz, Benjarong Thongbai, Marc Stadler, Stephan Hüttel
The Basidiomycota constitutes the second largest higher taxonomic group of the Fungi after the Ascomycota and comprises over 30.000 species. Mycelial cultures of Basidiomycota have already been studied since the 1950s for production of antibiotics and other beneficial secondary metabolites. Despite the fact that unique and selective compounds like pleuromutilin were obtained early on, it took several decades more until they were subjected to a systematic screening for antimicrobial and anticancer activities...
February 7, 2019: Biotechnology Advances
Kevin Kit Parker
Using induced pluripotent stem cells and microelectromechanical device technology Zhao et al. have developed 'organs on chips' representing the different chambers of the heart and used them to replicate healthy and diseased tissues in vitro. These systems offer investigators and the pharmaceutical industry a new tool in testing the safety and efficacy of new medicinal therapeutics.
February 7, 2019: Cell
Yonggang Zhang, Jun Guo, Tianming Yao, Yalei Zhang, Xuefei Zhou, Huaqiang Chu
There has been a developing technology in algae with pharmaceuticals wastewater. However, the effect and the underlying mechanism of pharmaceuticals on algae are not well understood. To investigate the effect and mechanism of pharmaceuticalson microalgae, four pharmaceuticals of clofibric acid (CLF), ciprofloxacin (CIP), diclofenac (DCF) and carbamazepine (CBZ) on C. pyrenoidosa culture were analyzed. At low concentrations (<10 mg/L), the pharmaceuticals, especially the DCF, exhibited positive effects on both the structure and function of algal cultures; algal growth (i...
February 7, 2019: Scientific Reports
Angela Rocchi, Fergal Mills
BACKGROUND: The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada's centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. OBJECTIVE:  To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization...
August 7, 2018: Journal of Population Therapeutics and Clinical Pharmacology
Judit Erdös, Sabine Ettinger, Julia Mayer-Ferbas, Cecilia de Villiers, Claudia Wild
The European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on "other technologies", that is medical devices and non-pharmaceutical procedures...
February 6, 2019: Wiener Medizinische Wochenschrift
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