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pharmaceutical development and technology

Ya-Qi Wang, Jiao-Jiao Jiao, Zhen-Feng Wu, Qin Zheng, Ming Yang
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
S S Chung, J S Zheng, S R Burket, B W Brooks
Though antibiotic resistance (ABR) represents a major global health threat, contributions of landfill leachate to the life cycle of antibiotics and ABR development are poorly understood in rapidly urbanizing regions of developing countries. We selected one of the largest active landfills in Asia and two landfills that have been closed for 20 years to examine antibiotic occurrences in leachates and associated hazards during wet and dry season sampling events. We focused on some of the most commonly used human antibiotics in Hong Kong, one of the most populous Asian cities and the fourth most densely populated cities in the world...
March 15, 2018: Environment International
Sarah J Trenfield, Atheer Awad, Alvaro Goyanes, Simon Gaisford, Abdul W Basit
3D printing (3DP) is forecast to be a highly revolutionary technology within the pharmaceutical sector. In particular, the main benefits of 3DP lie in the production of small batches of medicines, each with tailored dosages, shapes, sizes and release characteristics. The manufacture of medicines in this way may finally lead to the concept of personalised medicines becoming a reality. In the shorter term, 3DP could be extended throughout the drug development process, ranging from preclinical development and clinical trials, through to frontline medical care...
March 10, 2018: Trends in Pharmacological Sciences
Ana Claudia Pompeu Raminelli, Valeria Romero, Mohammad H Semreen, Gislaine Ricci Leonardi
The clinical efficacy of the topical tretinoin is widely studied and has been well established for many therapeutic interventions, among some, photoaging, acne, and melasma. However, the side effects, mainly cutaneous irritation, erythema, xerosis and peeling, remain major obstacle to the patient compliance. Besides, the insight regarding the drug delivery profile is essential to understand the therapeutic action of the drug. Herein we highlight further advances and an update on tretinoin delivery systems such as liposomes, niosomes, solid lipid nanoparticles, nanostructured lipid carriers, cyclodextrins, nanostructured polymers and other technological systems that reduce its side effects and improve the permeation profile to potentiate efficacy and drug safety on the skin...
March 12, 2018: Current Medicinal Chemistry
Nélio Drumond, Sven Stegemann
The oral cavity is frequently used to administer pharmaceutical drug products. This route of administration is seen as the most accessible for the majority of patients and supports an independent therapy management. For current oral dosage forms under development, the prediction of their unintended mucoadhesive properties and esophageal transit profiles would contribute for future administration safety, as concerns regarding unintended adhesion of solid oral dosage forms (SODF) during oro-esophageal transit still remain...
February 24, 2018: Colloids and Surfaces. B, Biointerfaces
Takashi Otaki, Yuta Tanabe, Takashi Kojima, Masaru Miura, Yukihiro Ikeda, Tatsuo Koide, Toshiro Fukami
In recent years, to guarantee a quality-by-design approach to the development of pharmaceutical products, it is important to identify properties of raw materials and excipients in order to determine critical process parameters and critical quality attributes. Feedback obtained from real-time analyses using various process analytical technology (PAT) tools has been actively investigated. In this study, in situ monitoring using low-frequency (LF) Raman spectroscopy (10-200cm-1 ), which may have higher discriminative ability among polymorphs than near-infrared spectroscopy and conventional Raman spectroscopy (200-1800 cm-1 ), was investigated as a possible application to PAT...
March 7, 2018: International Journal of Pharmaceutics
Fabio Tonin, Isabel W C E Arends
Ursodeoxycholic acid (UDCA) is a pharmaceutical ingredient widely used in clinics. As bile acid it solubilizes cholesterol gallstones and improves the liver function in case of cholestatic diseases. UDCA can be obtained from cholic acid (CA), which is the most abundant and least expensive bile acid available. The now available chemical routes for the obtainment of UDCA yield about 30% of final product. For these syntheses several protection and deprotection steps requiring toxic and dangerous reagents have to be performed, leading to the production of a series of waste products...
2018: Beilstein Journal of Organic Chemistry
Witold Jamroz, Mateusz Kurek, Ewelina Lyszczarz, Witold Brniak, Renata Jachowicz
In the last few years there has been a huge progress in a development of printing techniques and their application in pharmaceutical sciences and particularly in the pharmaceutical technology. The variety of printing methods makes it necessary to systemize them, explain the principles of operation, and specify the possibilities of their use in pharmaceutical technology. This paper aims to review the printing techniques used in a drug development process. The growing interest in 2D and 3D printing methods results in continuously increasing number of scientific papers...
May 2017: Acta Poloniae Pharmaceutica
(no author information available yet)
In recent years, wide ranging biomedical innovation has provided powerful new approaches for prevention, diagnosis and management of diseases. In order to translate such innovation into effective practice, physicians must frequently update their knowledge base and skills through continuing medical education and training. Medical Professional Societies, run as not-for-profit organizations led by peers, are uniquely placed to deliver balanced, disease oriented and patient centred education. The medical industry has a major role in the development of new, improved technology, devices and medication...
February 28, 2018: European Heart Journal
Takashi Azuma
 Pharmaceuticals are indispensable to contemporary life. Recently, the emerging problem of pharmaceutical-based pollution of river environments, including drinking water sources and lakes, has begun to receive significant attention worldwide. Because pharmaceuticals are designed to perform specific physiological functions in targeted regions of the human body, there is increasing concern regarding their toxic effects, even at low concentrations, on aquatic ecosystems and human health, via residues in drinking water...
2018: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
N Bostijn, M Hellings, M Van Der Veen, C Vervaet, T De Beer
UltraViolet (UV) spectroscopy was evaluated as an innovative Process Analytical Technology (PAT) - tool for the in-line and real-time quantitative determination of low-dosed active pharmaceutical ingredients (APIs) in a semi-solid (gel) and a liquid (suspension) pharmaceutical formulation during their batch production process. The performance of this new PAT-tool (i.e., UV spectroscopy) was compared with an already more established PAT-method based on Raman spectroscopy. In-line UV measurements were carried out with an immersion probe while for the Raman measurements a non-contact PhAT probe was used...
July 12, 2018: Analytica Chimica Acta
Abigail M Gasper, Kathy Magdic, Dianxu Ren, Laura Fennimore
Heart failure is a significant burden to the healthcare system. Approximately 5.7 million adults in the United States were diagnosed with heart failure between 2009 and 2012 (). The American Heart Association projects that direct costs for heart failure may be as high as $77.7 billion by 2030 (). Technological and pharmaceutical advancements have delayed the progression of the disease; however, it is predicted that close to half of individuals with heart failure will die within 5 years of the initial diagnosis (; )...
March 2018: Home Healthcare Now
Sabine Szunerits, Rabah Boukherroub
Advances in materials science and bionanotechnology have allowed the refinements of current drug delivery systems, expected to facilitate the development of personalized medicine. While dermatological topical pharmaceutical formulations such as foams, creams, lotions, gels, etc., have been proposed for decades, these systems target mainly skin-based diseases. To treat systemic medical conditions as well as localized problems such as joint or muscle concerns, transdermal delivery systems (TDDSs), which use the skin as the main route of drug delivery, are very appealing...
2018: Frontiers in Bioengineering and Biotechnology
Wenbo Liu, Nora B Sutton, Huub H M Rijnaarts, Alette A M Langenhoff
This is the first study examining pharmaceutical removal under anoxic conditions with MnO2 . This study compares the abiotic removal of seven pharmaceuticals with reactive MnO2 particles in the presence of oxygen (oxic conditions) and in the absence of oxygen (anoxic conditions). Due to the novelty of pharmaceutical removal under anoxic conditions, the influence of phosphate buffer, pH, and MnO2 morphologies is also examined. Results show that over 90% of diclofenac is removed under anoxic conditions. Additionally, we found that (1) anoxic conditions are beneficial for diclofenac removal with MnO2 , (2) phosphate buffer affects the pharmaceutical removal efficiencies, (3) higher pharmaceutical removal is obtained at acidic pH compared to that at neutral or alkaline conditions, and (4) amorphous MnO2 removes pharmaceuticals better than crystalline MnO2 ...
February 28, 2018: Environmental Science and Pollution Research International
Simone Schadt, Bojan Bister, Swapan K Chowdhury, Christoph Funk, Cornelis E C A Hop, W Griffith Humphreys, Fumihiko Igarashi, Alexander D James, Mark Kagan, S Cyrus Khojasteh, Angus N R Nedderman, Chandra Prakash, Frank Runge, Holger Scheible, Douglas K Spracklin, Piet Swart, Susanna Tse, Josh Yuan, R Scott Obach
Since the introduction of MIST guidance by FDA in 2008 there have been major changes in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and non-clinical studies to generate these information. In this cross-industry article we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites...
February 27, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Giovanna Peruzzi, Giorgia Sinibaldi, Giulia Silvani, Giancarlo Ruocco, Carlo Massimo Casciola
Traditional drug delivery systems, where pharmaceutical agents are conveyed to the target tissue through the blood circulation, suffer of poor therapeutic efficiency and limited selectivity largely due to the low permeability of the highly specialised biological interface represented by the endothelial layer. Examples concern cancer therapeutics or degenerative disorders where drug delivery is inhibited by the blood-brain barrier (BBB). Microbubbles injected into the bloodstream undergo volume oscillations under localised ultrasound irradiation and possibly collapse near the site of interest, with no effect on the rest of the endothelium...
February 16, 2018: Colloids and Surfaces. B, Biointerfaces
Muralikrishna Narra, Srinivas Kota, Yashodhara Velivela, Raghu Ellendula, V Rao Allini, Sadanandam Abbagani
Chloroplast transformation vectors require an expression cassette flanked by homologous plastid sequences to drive plastome recombination. The rrn 16- rrn 23 plastome region was selected and using this region, a new species-specific plastid transformation vector CuIA was developed with pKS+ II as a backbone by inserting the rrn 16- trnI and trnA - rrn 23 sequences from Cucumis sativus L. An independent expression cassette with aadA gene encoding aminoglycoside 3'-adenylyltransferase with psbA controlling elements is added into the trnI - trnA intergenic region that confers resistance to spectinomycin...
March 2018: 3 Biotech
Peter J Neumann, Richard J Willke, Louis P Garrison
Concerns about rising spending on prescription drugs and other areas of health care have led to multiple initiatives in the United States designed to measure and communicate the value of pharmaceuticals and other technologies for decision making. In this section we introduce the work of the International Society for Pharmacoeconomics and Outcomes Research Special Task Force on US Value Assessment Frameworks formed to review relevant perspectives and appropriate approaches and methods to support the definition and use of high-quality value frameworks...
February 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Hyunah Cho, Udayabhanu Jammalamadaka, Karthik Tappa
Nanogels are hydrogels formed by connecting nanoscopic micelles dispersed in an aqueous medium, which give an opportunity for incorporating hydrophilic payloads to the exterior of the micellar networks and hydrophobic payloads in the core of the micelles. Biomedical and pharmaceutical applications of nanogels have been explored for tissue regeneration, wound healing, surgical device, implantation, and peroral, rectal, vaginal, ocular, and transdermal drug delivery. Although it is still in the early stages of development, due to the increasing demands of precise nanogel production to be utilized for personalized medicine, biomedical applications, and specialized drug delivery, 3D printing has been explored in the past few years and is believed to be one of the most precise, efficient, inexpensive, customizable, and convenient manufacturing techniques for nanogel production...
February 16, 2018: Materials
Hau Van Duong, Trang The Lieu Chau, Nhan Thi Thanh Dang, Duc Van Nguyen, Son Lam Le, Thang Sy Ho, Tuyen Phi Vu, Thi Thi Van Tran, Thanh-Dinh Nguyen
Inspired by nature, collagen is an outstanding polypeptide utilized to exploit its bioactivity and material design for healthcare technologies. In this study, we describe the self-aggregation of water-dispersible nanocollagen helices upon solidification to fabricate different forms of natural collagen materials. Chemically extracted native collagen fibrils are uniform anisotropic nanoparticles with an average diameter of about 50 nm and a high aspect ratio. The as-prepared collagen nanofibrils are soluble in sodium acetate-acetic acid buffer and are dispersible in water, thus generating collagen liquids that are used as distinct biopolymer precursors for materials development...
February 20, 2018: Biomaterials Science
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