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New pharmaceutical product

Takahiro Fujioka, Anh T Hoang, Tetsuji Okuda, Haruka Takeuchi, Hiroaki Tanaka, Long D Nghiem
A new membrane fouling control technique using ozonated water flushing was evaluated for direct nanofiltration (NF) of secondary wastewater effluent using a ceramic NF membrane. Experiments were conducted at a permeate flux of 44 L/m²h to evaluate the ozonated water flushing technique for fouling mitigation. Surface flushing with clean water did not effectively remove foulants from the NF membrane. In contrast, surface flushing with ozonated water (4 mg/L dissolved ozone) could effectively remove most foulants to restore the membrane permeability...
April 19, 2018: International Journal of Environmental Research and Public Health
Claudia Lara-Espinoza, Elizabeth Carvajal-Millán, René Balandrán-Quintana, Yolanda López-Franco, Agustín Rascón-Chu
Pectins are plant cell wall natural heteropolysaccharides composed mainly of α-1-4 d-galacturonic acid units, which may or may not be methyl esterified, possesses neutral sugars branching that harbor functional moieties. Physicochemical features as pH, temperature, ions concentration, and cosolute presence, affect directly the extraction yield and gelling capacity of pectins. The chemical and structural features of this polysaccharide enables its interaction with a wide range of molecules, a property that scientists profit from to form new composite matrices for target/controlled delivery of therapeutic molecules, genes or cells...
April 18, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
Malgorzata Wrzesien, Leszek Krolicki, Lukasz Albiniak, Jerzy Olszewski
INTRODUCTION: The specificity of personnel exposure, which distinguishes nuclear medicine, is associated with the form of the radiation source used, and this often requires performing manual procedures while using radioactive isotopes. The variety of radionuclides and medical procedures, and the yearly increase in the number of patients, as well as the change of the individual dose limit for the lens of the eye from a value of 150 mSv per year to a level of 20 mSv, means that issues of eye lens routine dosimetry become interesting from the radiation protection point of view...
April 18, 2018: Journal of Radiological Protection: Official Journal of the Society for Radiological Protection
Halla Laufey Hauksdóttir, Thomas J Webster
Iron oxide nanoparticles (IONP) are already well-established in the medical field due to their ability to improve contrast in magnetic resonance imaging (MRI) and for their external magnetic control in the body. Moreover, selenium has been shown to kill numerous cancer cells at lower concentrations that IONP (e.g., 1 μg/ml). Selenium is a trace mineral of growing interest in cancer treatment since it is an essential nutrient in the human body and can interfere with thiolcontaining proteins necessary for cancer cells to function...
March 1, 2018: Journal of Biomedical Nanotechnology
Li-Qiang Fan, Ming-Wei Li, Yong-Jun Qiu, Qi-Ming Chen, Si-Jing Jiang, Yu-Jie Shang, Li-Ming Zhao
Gamma-amino butyric acid (GABA) is an important bio-product used in pharmaceuticals, functional foods, and a precursor of the biodegradable plastic polyamide 4 (Nylon 4). Glutamate decarboxylase B (GadB) from Escherichia. coli is a highly active biocatalyst that can convert L-glutamate to GABA. However, its practical application is limited by the poor thermostability and only active under acidic conditions of GadB. In this study, we performed site-directed saturation mutagenesis of the N-terminal residues of GadB from Escherichia coli to improve its thermostability...
April 13, 2018: Journal of Biotechnology
Peng Huang, Qingwen Sun, Weijun Shi, Wangchun Du, Xue Li, Ning Zhang
Infectious diseases caused by antibiotic multidrug-resistant microorganisms are major causes of morbidity and mortality in humans. Hence, there is an urgent need to search for new antimicrobial agents. Initially known as a defensive effector in the innate immunity of certain organs of the human body, human goose-type lysozyme 2 (hLysG2) has been shown to possess therapeutically useful potential against multidrug-resistant microorganisms. Developing a novel strategy for large-scale production that provides high yields of this protein with high purity, quality, and potency is critical for pharmaceutical applications...
April 13, 2018: Journal of Biotechnology
Catherine Le Galès
Putting an end to an innovation crisis, the reality of which is the subject of debate, recent pharmaceutical innovations, the result of a combination of scientific, industrial, financial, political and economic reasons, lead to a diversification of products and to a strong interest of pharmaceutical companies for the so-called "niche" products (targeted therapies, rare diseases, etc.). These new molecules are put on the market at much higher prices than in the past. In the absence of reliable information on the costs borne by manufacturers, and knowing that high levels of margins have been observed, these prices raise legitimate questions...
April 2018: Médecine Sciences: M/S
Russany Silva da Costa, Camilo Barroso Teixeira, Taís Vanessa Gabbay Alves, Roseane M Ribeiro-Costa, Alessandro A Casazza, Bahar Aliakbarian, Attilio Converti, José O C Silva Júnior, Patrizia Perego
Cupuassu (Theobroma grandiflorum Schum.) is a popular Amazonian fruit because of its intense aroma and nutritional value, whose lipid fraction is alternatively used in cosmetics. To preserve active principles and ensure their controlled release, extract was microencapsulated by spray drying. Influence of spray-drying conditions on microencapsulation of cupuassu seed by-product extract was investigated according to a 33 -Box Behnken factorial design, selecting inlet temperature, maltodextrin concentration and feed flowrate as independent variables, and total polyphenol and flavonoid contents, antiradical power, yields of drying and microencapsulation as responses...
April 16, 2018: Natural Product Research
Evan T Liechty, Andrew D Strongrich, Ehab M Moussa, Elizabeth Topp, Alina A Alexeenko
PURPOSE: Monitoring process conditions during lyophilization is essential to ensuring product quality for lyophilized pharmaceutical products. Residual gas analysis has been applied previously in lyophilization applications for leak detection, determination of endpoint in primary and secondary drying, monitoring sterilization processes, and measuring complex solvents. The purpose of this study is to investigate the temporal evolution of the process gas for various formulations during lyophilization to better understand the relative extraction rates of various molecular compounds over the course of primary drying...
April 11, 2018: Pharmaceutical Research
Stefano Colombo, Moritz Beck-Broichsitter, Johan Peter Bøtker, Martin Malmsten, Jukka Rantanen, Adam Bohr
Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals...
April 4, 2018: Advanced Drug Delivery Reviews
Guoqing Zhang, Fanyue Meng, Zhen Guo, Tao Guo, Hui Peng, Jian Xiao, Botao Liu, Vikaramjeet Singh, Shuangying Gui, Peter York, Wei Qian, Li Wu, Jiwen Zhang
γ-Cyclodextrin metal-organic frameworks (γ-CD-MOFs) are highly porous and bio-friendly novel materials formed by γ-CD as a organic ligand and potassium ion as a inorganic metal center. The aim of this study was to enhance the stability of vitamin A palmitate (VAP) using γ-CD-MOFs as the carrier. Herein, γ-CD-MOFs displayed VAP microencapsulating capacity of 9.77 ± 0.24% with molar ratio as nMOFs :nVAP = 3.2:1.0. It was important to find that the improved stability of VAP microencapsulated by γ-CD-MOFs without addition of any antioxidant(s) was better than that of the best available reference product in the market, with 1...
April 6, 2018: Journal of Microencapsulation
Eric Yu, Hari P R Mangunuru, Nakul S Telang, Caleb J Kong, Jenson Verghese, Stanley E Gilliland Iii, Saeed Ahmad, Raymond N Dominey, B Frank Gupton
Numerous synthetic methods for the continuous preparation of fine chemicals and active pharmaceutical ingredients (API's) have been reported in recent years resulting in a dramatic improvement in process efficiencies. Herein we report a highly efficient continuous synthesis of the antimalarial drug hydroxychloroquine (HCQ). Key improvements in the new process include the elimination of protecting groups with an overall yield improvement of 52% over the current commercial process. The continuous process employs a combination of packed bed reactors with continuous stirred tank reactors for the direct conversion of the starting materials to the product...
2018: Beilstein Journal of Organic Chemistry
Christine Rohde, Grégory Resch, Jean-Paul Pirnay, Bob G Blasdel, Laurent Debarbieux, Daniel Gelman, Andrzej Górski, Ronen Hazan, Isabelle Huys, Elene Kakabadze, Małgorzata Łobocka, Alice Maestri, Gabriel Magno de Freitas Almeida, Khatuna Makalatia, Danish J Malik, Ivana Mašlaňová, Maia Merabishvili, Roman Pantucek, Thomas Rose, Dana Štveráková, Hilde Van Raemdonck, Gilbert Verbeken, Nina Chanishvili
Phage therapy is increasingly put forward as a "new" potential tool in the fight against antibiotic resistant infections. During the "Centennial Celebration of Bacteriophage Research" conference in Tbilisi, Georgia on 26-29 June 2017, an international group of phage researchers committed to elaborate an expert opinion on three contentious phage therapy related issues that are hampering clinical progress in the field of phage therapy. This paper explores and discusses bacterial phage resistance, phage training and the presence of prophages in bacterial production strains while reviewing relevant research findings and experiences...
April 5, 2018: Viruses
Barry V L Potter
Steroid sulfatase is an emerging drug target for the endocrine therapy of hormone-dependent diseases, catalyzing estrogen sulfate hydrolysis to estrogen. Drug discovery, developing the core aryl O-sulfamate pharmacophore, has led to steroidal and non-steroidal drugs entering numerous clinical trials, with promising results in oncology and women's health. Steroidal estrogen sulfamate derivatives were the first irreversible active-site-directed inhibitors and one was developed clinically as an oral estradiol pro-drug and for endometriosis applications...
April 4, 2018: Journal of Molecular Endocrinology
Bastiaan J Venhuis, Angela E Oostlander, Domenico Di Giorgio, Ruth Mosimann, Ines du Plessis
Oncology drugs clearly have become a target for pharmaceutical crime. In 2016, falsified oncology drugs ranked fifth in the most commonly falsified drug category among the reports received by the Pharmaceutical Security Institute. Although the prevalence of illicit oncology drugs in the legal supply chains appears to be small, these drugs are difficult to detect, particularly in clinical practice. Forthcoming countermeasures to detect illicit drugs in high-income countries include compulsory antitampering devices and product verification technology for a risk-based selection of medicines...
April 2018: Lancet Oncology
Manvi Sharma, Aisha Vadhariya, Michael L Johnson, Zachary A Marcum, Holly M Holmes
BACKGROUND: While many new medications may offer advantages over existing drugs, some newer drugs are reformulations of existing products that provide little innovation or incremental benefit while driving up drug costs. Despite the lack of benefit of these medications, prescribers may be motivated by payments made by the pharmaceutical industry. The objective of the study was to determine the association between payments made to physicians by the pharmaceutical industry and prescriptions for certain selected costly brand name drugs...
April 2, 2018: BMC Health Services Research
Bhaven N Sampat, Kenneth C Shadlen
India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of "secondary" pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office...
2018: PloS One
Diana Brixner, Zoltán Kaló, Nikos Maniadakis, Kyoo Kim, Kalman Wijaya
OBJECTIVE: This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement...
March 29, 2018: Value in Health Regional Issues
Kashappa Goud Desai, Hirokazu Obayashi, James D Colandene, Douglas P Nesta
Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture...
March 27, 2018: Journal of Pharmaceutical Sciences
Kuang-Ting Cheng, Chih-Lung Wu, Bak-Sau Yip, Hui-Yuan Yu, Hsi-Tsung Cheng, Ya-Han Chih, Jya-Wei Cheng
P-113, which was originally derived from the human saliva protein histatin 5, is a histidine-rich antimicrobial peptide with the sequence AKRHHGYKRKFH. P-113 is currently undergoing phase II clinical trial as a pharmaceutical agent to fight against fungal infections in HIV patients with oral candidiasis. Previously, we developed a new procedure for the high-yield expression and purification of hG31P, an analogue and antagonist of human CXCL8. Moreover, we have successfully removed lipopolysaccharide (LPS, endotoxin) associated with hG31P in the expression with Escherichia coli ...
March 30, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
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