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pharmaceutical development and technology

Robert D Worsham, Vaughan Thomas, Suzanne S Farid
Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations...
May 21, 2018: Biotechnology Journal
S Bockel, A Vallard, A Lévy, S François, M Bourdis, C Le Gallic, D Riccobono, P Annede, M Drouet, Y Tao, P Blanchard, É Deutsch, N Magné, C Chargari
Radiation-induced mucositis is a common toxicity, especially in patients with head and neck cancers. Despite recent technological advances in radiation therapy, such as intensity-modulated radiotherapy, radiation-induced mucositis is still causing treatment disruptions, negatively affecting patients' long and short term quality of life, and impacting medical resources use with economic consequences. The objective of this article was to review the latest updates in the management of radiation-induced mucositis, with a focus on pharmaceutical strategies for the prevention or treatment of mucositis...
May 15, 2018: Cancer Radiothérapie: Journal de la Société Française de Radiothérapie Oncologique
Zhongyao Cheng, Yumei Lian, Zul Kamal, Xin Ma, Jianjun Chen, Xinbo Zhou, Jing Su, Mingfeng Qiu
BACKGROUND: Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. OBJECTIVE: This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described...
May 17, 2018: Current Pharmaceutical Design
Nalini Raghavachari, Natàlia Garcia-Reyero
Currently, the study of the transcriptome is widely used to interpret the functional elements of the genome and molecular constituents of cells and tissues in an effort to unravel biological pathways associated with development and disease. The advent of technologies is now enabling the study of such comprehensive transcriptional characterization of mRNA, miRNA, lncRNA, and small RNA in a robust and successful manner. Transcriptomic strategies are gaining momentum across diverse areas of biological, plant sciences, medical, clinical, and pharmaceutical research for biomarker discovery, and disease diagnosis and prognosis...
2018: Methods in Molecular Biology
Robert Pickard, Thomas Chadwick, Yemi Oluboyede, Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Doreen McClurg, Jennifer Wilkinson, Laura Ternent, Holly Fisher, Katherine Walton, Elaine McColl, Luke Vale, Ruth Wood, Mohamed Abdel-Fattah, Paul Hilton, Mandy Fader, Simon Harrison, James Larcombe, Paul Little, Anthony Timoney, James N'Dow, Heather Armstrong, Nicola Morris, Kerry Walker, Nikesh Thiruchelvam
BACKGROUND: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. OBJECTIVE: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. DESIGN: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up...
May 2018: Health Technology Assessment: HTA
Mingxue Fan, Sicong Geng, Yang Liu, Jing Wang, Yiting Wang, Jian Zhong, Zhiqiang Yan, Lei Yu
BACKGROUND AND OBJECTIVE: Nanocrystal technology is an effective approach which can increase the dissolution rate of poorly water-soluble drugs by raising their saturation solubility, thus improving the drug bioavailability. With the development of nanocrystals, its preparation approaches have gradually matured, which can be generally divided into Bottom-up, Top-down and Combinative technologies. METHODS: A systematic literature review in the field of nanocrystal technology for the cancer treatment was scanned and collected data was detailedly analyzed and summarized...
May 15, 2018: Current Pharmaceutical Design
Hyerim Yang, Hyeongmin Kim, Sumin Jung, Hyeyeon Seo, Shofa Khoirun Nida, Seung-Yup Yoo, Jaehwi Lee
BACKGROUND: Nanocrystallization technologies have been widely studied in recent years, as the formulation of drug nanocrystals solves problems of poor drug solubility and bioavailability. However, drug nanocrystals in the size range of 1-1000 nm usually need to be accompanied by stabilizers, such as polymers or surfactants, to enhance their stability. Despite their simplicity, improved dissolution rate, and enhanced bioavailability, the limited stability of nanocrystal formulations has prevented further development...
May 15, 2018: Current Pharmaceutical Design
Erin J Walker, Gregory M Peterson, James Grech, Evie Paragalli, Jackson Thomas
BACKGROUND: Malaria is a deadly parasitic disease that affects more than 3 billion people worldwide, in predominantly resource-poor countries. Despite malaria being preventable and treatable, a large number of adults and children, mostly in Africa, die from this disease each year. One contributor to needless morbidity and mortality is the production and distribution of poor-quality antimalarial medicines; indeed, it is estimated that over 122,000 deaths of children under 5 years of age in sub-Saharan countries were caused by poor-quality antimalarial medicines, in 2013 alone...
May 15, 2018: BMC Public Health
Ratan V Bhat, Ulf Andersson, Shalini Andersson, Laurent Knerr, Udo Bauer, Anna Sundgren Andersson
Spanning over three decades of extensive drug discovery research, the efforts to develop a potent and selective GSK3 inhibitor as a therapeutic for the treatment of type 2 diabetes, Alzheimer's disease (AD), bipolar disorders and cancer have been futile. Since its initial discovery in 1980 and subsequent decades of research, one cannot underscore the importance of the target and the promise of a game changing disease modifier. Several pharmaceutical companies, biotech companies, and academic institutions raged in a quest to unravel the biology and discover potent and selective GSK3 inhibitors, some of which went through clinical trials...
May 11, 2018: Journal of Alzheimer's Disease: JAD
Daniel A Ollendorf, Richard H Chapman, Steven D Pearson
We find ourselves in an era of unprecedented growth in the development and use of so-called "orphan" drugs to treat rare diseases, which are poised to represent more than one-fifth of pharmaceutical expenditures by 2022. This widespread use has been facilitated by legislative and regulatory incentives in both the United States and abroad, yet US payers and health systems have not yet made a concerted effort to understand whether and how rare diseases require special considerations on their part and how to adapt traditional methods of health technology assessment and economic evaluation to accommodate these situations...
May 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Hiroyuki Yokota
The significance of proteomics in the pharmaceutical industry has increased since overcoming initial difficulties. This review discusses recent proteomics publications from pharmaceutical companies to identify new trends in proteomics applications to research and development. Applications of proteomics such as chemical proteomics, protein expression profiling, targeted protein quantitation, analysis of protein-protein interactions and post-translational modification are widely used by various sections of the industry...
May 9, 2018: Biochimica et Biophysica Acta
Kevin C J Yuen, Bradley S Miller, Beverly M K Biller
PURPOSE OF REVIEW: To discuss the rationale of developing long-acting growth hormone (LAGH) preparations, to describe the technologies designed to prolong GH action, and to address key issues regarding efficacy, safety, and monitoring while on treatment. REVIEW FINDINGS: Recombinant human GH is currently approved for daily use and has been shown to restore longitudinal growth, and improve body composition with relatively few side-effects in children and adults with GH deficiency, respectively...
May 4, 2018: Current Opinion in Endocrinology, Diabetes, and Obesity
Tim Diederichs, Quoc Hung Nguyen, Michael Urban, Robert Tampé, Mark Tornow
Membrane proteins involved in transport processes are key targets for pharmaceutical research and industry. Despite continuous improvements and new developments in the field of electrical readouts for the analysis of transport kinetics, a well-suited methodology for high-throughput characterization of single transporters with non-ionic substrates and slow turnover rates is still lacking. Here, we report on a novel architecture of silicon chips with embedded nanopore microcavities, based on a silicon-on-insulator technology for high-throughput optical readouts...
May 9, 2018: Nano Letters
Jun Yao, Pingfan Li, Lin Li, Mei Yang
According to recent research, nanotechnology based on quantum dots (QDs) has been widely applied in the field of bioimaging, drug delivery, and drug analysis. Therefore, it has become one of the major forces driving basic and applied research. The application of nanotechnology in bioimaging has been of concern. Through in vitro labeling, it was found that luminescent QDs possess many properties such as narrow emission, broad UV excitation, bright fluorescence, and high photostability. The QDs also show great potential in whole-body imaging...
May 4, 2018: Acta Biomaterialia
Oliver C Steinbach
The present industry update covers the period of 1 January-31 January 2018, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature. Several public offerings (Gecko, Insmed), licensing (Foresee) and commercialization agreements (Alnylam, Collegium Pharmaceutical) as well as patent filings (Elute) continue to prove the sustained investments in the drug delivery market. In increasing numbers, more effective ways to deliver the active ingredient to the right location and the right dose through devices (Boehringer Ingelheim's Respimat, Medtronics' SynchroMedII) or improved compound properties through formulation (Aquestive Therapeutics' PharmFilm, Noven Pharmaceuticals' transdermal patch) are reaching the market...
May 1, 2018: Therapeutic Delivery
Lyu-Ming Wang, Yuna Morioka, Kellie Jenkinson, Andrew E H Wheatley, Susumu Saito, Hiroshi Naka
Direct functionalization of amino groups in complex organic molecules is one of the most important key technologies in modern organic synthesis, especially in the synthesis of bio-active chemicals and pharmaceuticals. Whereas numerous chemical reactions of amines have been developed to date, a selective, practical method for functionalizing complex amines is still highly demanded. Here we report the first late-stage N-alkylation of pharmaceutically relevant amines with alcohols at ambient temperature. This reaction was achieved by devising a mixed heterogeneous photocatalyst in situ prepared from Cu/TiO2 and Au/TiO2 ...
May 2, 2018: Scientific Reports
Hideyuki Kondo, Masayoshi Shibatsuji, Naoyuki Yasuda
Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase...
January 1, 2018: Therapeutic Innovation & Regulatory Science
Angela M Wagner, Margaret P Gran, Nicholas A Peppas
Therapeutic proteins and peptides have revolutionized treatment for a number of diseases, and the expected increase in macromolecule-based therapies brings a new set of challenges for the pharmaceutics field. Due to their poor stability, large molecular weight, and poor transport properties, therapeutic proteins and peptides are predominantly limited to parenteral administration. The short serum half-lives typically require frequent injections to maintain an effective dose, and patient compliance is a growing issue as therapeutic protein treatments become more widely available...
March 2018: Acta Pharmaceutica Sinica. B
Wei Zhou, Hai Huang, Haiyan Zhu, Pei Zhou, Xunlong Shi
Background: Ginseng is a well-known traditional Chinese medicine that has been widely used in a range of therapeutic and healthcare applications in East Asian countries. Microbial transformation is regarded as an effective and useful technology in modification of nature products for finding new chemical derivatives with potent bioactivities. In this study, three minor derivatives of ginsenoside compound K were isolated and the inducing effects in the Wingless-type MMTV integration site (Wnt) signaling pathway were also investigated...
April 2018: Journal of Ginseng Research
Sven Stegemann
The advances in drug delivery technologies have enabled pharmaceutical scientists to deliver a drug through various administration routes and optimize the drug release and absorption. The wide range of drug delivery systems and dosage forms represent a toolbox of technology for the development of pharmaceutical drug products but might also be a source of medication errors and nonadherence. Patient centric drug product development is being suggested as an important factor to increase therapeutic outcomes. Areas covered: Patients have impaired health and potentially disabilities and they are not medical or pharmaceutical experts but are requested to manage complex therapeutic regimens...
May 9, 2018: Expert Opinion on Drug Delivery
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