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Pharmaceutical microbiology

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https://www.readbyqxmd.com/read/28075032/-microbiological-findings-and-antibacterial-therapy-in-stevens-johnson-syndrome-toxic-epidermal-necrolysis-patients-from-a-swedish-burn-center
#1
Ilaria Tocco-Tussardi, Fredrik Huss, Benjamin Presman
BACKGROUND: Superimposed infections/sepsis are the major cause of morbidity/mortality in Stevens-Johnson syndrome/Toxic Epidermal Necrolysis (SJS/TEN). It is a delicate balance between avoiding new pharmaceuticals and prophylactically treat an incipient infection. The objective of this study was to investigate the rates and types of infection-microbials and antibiotics involved in SJS/TEN patients. METHODS: Microbiology and clinical data were collected for SJS/TEN patients admitted to our Burn Centre from January 2010 through January 2016...
January 11, 2017: Journal of Cutaneous Pathology
https://www.readbyqxmd.com/read/28028873/development-of-a-qualitative-real-time-pcr-for-microbiological-quality-control-testing-in-mammalian-cell-culture-production
#2
Kerstin Kleinschmidt, Erik Wilkens, Stefanie P Glaeser, Peter Kämpfer, Alexandra Staerk, David Roesti
AIMS: The aim of this study was to develop and evaluate a real-time PCR technology for microbiological control methods to examine individualized cell therapeutics, an emerging class of pharmaceutical formulations. METHODS AND RESULTS: Oligonucleotide primers and hybridization probe for bacterial detection targeting the 16S rRNA gene and were adapted based on Nadkarni et al.; 2002. For detection of yeast and molds, primers and probe were designed from conserved sequences of the 18S rRNA gene in this study...
December 28, 2016: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/28017464/a-review-of-pat-strategies-in-secondary-solid-oral-dosage-manufacturing-of-small-molecules
#3
REVIEW
Stephan Laske, Amrit Paudel, Otto Scheibelhofer
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, etc.) analysis. This supports rational process modeling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art...
November 22, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28003626/methods-of-rapid-microbiological-assay-and-their-application-to-pharmaceutical-and-medical-device-fabrication
#4
REVIEW
Hideharu Shintani
 There are several rapid microbiological methods becoming available that have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended...
2016: Biocontrol Science
https://www.readbyqxmd.com/read/27974628/quantitative-microbial-risk-assessment-of-pharmaceutical-products
#5
Mostafa Essam Eissa
Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice (GMP) and efficient control on bioburden level of product components are critical parameters that influence microbiological cleanliness of medicinal products. However, since microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27887966/forgotten-antibiotics-a-follow-up-inventory-study-in-europe-the-usa-canada-and-australia
#6
Céline Pulcini, Simone Mohrs, Bojana Beovic, Inge Gyssens, Ursula Theuretzbacher, Otto Cars
The objective of this study was to update a 2011 survey, conducted on behalf of the ESCMID Study Group for Antibiotic Policies (ESGAP), studying the availability of old but clinically useful antibiotics in North America, Europe and Australia. This follow-up survey was performed in 2015 in 40 countries among specialists from the pharmaceutical, infectious diseases and microbiology sectors in North America, Europe and Australia in order to assess the availability through usual marketing processes of 36 systemic antibiotics (addition of 3 antibiotics compared with the 2011 survey) selected for their ability to treat infections caused by resistant bacteria and their unique value for specific criteria...
January 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/27828683/scientific-and-technological-capabilities-in-health-related-areas-opportunities-challenges-and-interactions-with-the-industrial-sector
#7
Marco Antonio Vargas, Jorge Britto
Characterization of the scientific and technological infrastructure in health and its interactions with the industrial sector provides key elements for understanding the dynamics of innovation in health. This study conducts an exploratory analysis of the potentialities and limitations associated with scientific and technological capabilities in the health area in Brazil and the different links between the scientific and industrial sectors in health. The analysis points to important growth in internationally indexed research output, especially in certain areas such as pharmaceutics, public health, genetics, morphology, physiology, and microbiology...
November 3, 2016: Cadernos de Saúde Pública
https://www.readbyqxmd.com/read/27789803/container-closure-integrity-testing-practical-aspects-and-approaches-in-the-pharmaceutical-industry
#8
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for Quality Control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27778222/strategies-for-efficient-and-economical-2-3-butanediol-production-new-trends-in-this-field
#9
REVIEW
Aneta M Białkowska
2,3-Butanediol (2,3-BD) is a promising bulk chemical with a potentially wide range of applications e.g., in the manufacture of printing inks, perfumes, synthetic rubber, fumigants, antifreeze agents, fuel additives, foodstuffs and pharmaceuticals. Its high heating value and ability to increase the octane number of fuels make 2,3-BD a promising drop-in fuel. It can also be converted to methyl-ethyl ketone (MEK), which is considered an effective liquid fuel additive. After combination with MEK and hydrogenation reaction, 2,3-BD can be converted to octane, which is used to produce high-quality aviation fuel...
December 2016: World Journal of Microbiology & Biotechnology
https://www.readbyqxmd.com/read/27770946/natural-collagenic-skeleton-of-marine-sponges-in-pharmaceutics-innovative-biomaterial-for-topical-drug-delivery
#10
Rita Langasco, Barbara Cadeddu, Marilena Formato, Antonio Junior Lepedda, Massimo Cossu, Paolo Giunchedi, Roberto Pronzato, Giovanna Rassu, Renata Manconi, Elisabetta Gavini
The growing interest in the use of recyclable and biodegradable natural materials has become a relevant topic in pharmaceutics. In this work, we suggest the use and valorization of natural horny skeleton of marine sponges (Porifera, Dictyoceratida) as bio-based dressing for topical drug delivery. Biomaterial characterization focusing on morpho-functional traits, swelling behavior, fluid uptake performances, glycosaminoglycans content and composition and microbiological quality assessment was carried out to investigate the collagenic skeleton properties...
January 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/27766214/an-overview-on-novel-microbial-determination-methods-in-pharmaceutical-and-food-quality-control
#11
Mahboob Nemati, Aliasghar Hamidi, Solmaz Maleki Dizaj, Vahid Javaherzadeh, Farzaneh Lotfipour
Traditional microbiological methods tend to be labor-intensive and time-consuming. Rapid and novel methods in microbiological tests provide more sensitive, precise and reproducible results compared with conventional methods. In microbiology, the most rapid testing methods belong to the field of biotechnology such as PCR, ELISA, ATP bioluminescence and etc. Nevertheless impedance microbiology, biosensors and analytical procedures to determine microbial constituents are of significance. The present review article was conducted using internet databases and related scientific literatures and articles that provide information on developments in the rapid methods in microbiology...
September 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/27765254/dairy-products-and-the-maillard-reaction-a-promising-future-for-extensive-food-characterization-by-integrated-proteomics-studies
#12
REVIEW
Simona Arena, Giovanni Renzone, Chiara D'Ambrosio, Anna Maria Salzano, Andrea Scaloni
Heating of milk and dairy products is done using various technological processes with the aim of preserving microbiological safety and extending shelf-life. These treatments result in chemical modifications in milk proteins, mainly generated as a result of the Maillard reaction. Recently, different bottom-up proteomic methods have been applied to characterize the nature of these structural changes and the modified amino acids in model protein systems and/or isolated components from thermally-treated milk samples...
March 15, 2017: Food Chemistry
https://www.readbyqxmd.com/read/27658320/development-of-a-novel-physico-chemically-and-microbiologically-stable-oral-solution-of-flecainide-for-pediatrics
#13
Ana Santoveña, Irma Charola, Javier Suárez-González, Nuria Teigell-Pérez, Susana García-van Nood, Mabel Soriano, José B Fariña
There is as yet no commercialized preparation for oral administration of flecainide acetate (FA) to children. In such cases, manipulation of commercial tablets is the usual practice in pharmacy services of hospitals and compounding pharmacies, to provide a suitable dosage form for this vulnerable pediatric population group. In this study we have formulated FA as an oral solution, as an alternative to the suspension elaborated from commercial tablets. Due to this sensitivity of young patients, we have used the pure active pharmaceutical ingredient (API) and the lowest permitted levels of pediatric excipients...
September 23, 2016: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/27645284/remotely-controlled-micromanipulation-by-buckling-instabilities-in-fe3o4-nanoparticle-embedded-poly-n-isopropylacrylamide-surface-arrays
#14
Vinicio Carias, Zohreh Nemati Porshokouh, Kristen Stojak Repa, Javier Alonso, Hariharan Srikanth, Jürgen Rühe, Ryan Toomey, Jing Wang
The micromanipulation of biological samples is important for microbiology, pharmaceutical science, and related bioengineering fields. In this work, we report the fabrication and characterization of surface-attached microbeam arrays of 20 μm width and 25 μm height made of poly(N-isopropylacrylamide), a thermoresponsive polymer, with embedded spherical or octopod Fe3O4 nanoparticles. Below 32 °C, the microbeams imbibe water and buckle with an amplitude of approximately 20 μm. Turning on an AC-magnetic field induces the microbeam array to expel water due to the heating effect of the nanoparticles (magnetic hyperthermia), leading to a reversible transition from a buckled to nonbuckled state...
October 5, 2016: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/27593691/multicentre-study-on-incubation-program-for-environmental-monitoring-and-aseptic-process-simulation
#15
Guinet Marie Frédéric Roland, Berthoumieu Nicole, Dutot Philippe, Triquet Julien, Ratajczak Mehdi, Thibaudon Michel, Bechaud Philippe, Arliaud Christophe, Miclet Edith, Giordano Florine, Larcon Marjorie, Arthaud Catherine
Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendation for incubation time and incubation temperature and, consequently, the environmental monitoring and aseptic process simulation incubation strategy should be supported by validation data. To avoid any bias coming from in vitro studies or from single manufacturing in situ site studies, we performed a collaborative study at four manufacturing sites with four samples at the same location...
September 4, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516491/evaluation-of-the-recovery-rate-of-different-swabs-for-microbial-environmental-monitoring
#16
Marcel Goverde, Julian Willrodt, Alexandra Staerk
Contact plates, dipslides and swabs are used for the microbiological monitoring of surfaces in controlled environments such as pharmaceutical clean rooms. In the present study, three different swab types using two different methods (direct streaking on agar versus elution followed by membrane filtration) were evaluated. In a first study, representative surfaces in pharmaceutical clean rooms were artificially inoculated using three different environmental strains (in vitro study). In a second study, a naturally inoculated floor was swabbed with the same three swab types, again using the two different recovery methods (in situ study)...
August 11, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27499389/nystatin-and-lidocaine-pastilles-for-the-local-treatment-of-oral-mucositis
#17
Filipa C Silva, Joana Marto, Ana Salgado, Paula Machado, Alexandra Silva, António J Almeida
Oral mucositis is a common adverse reaction to radiotherapy and chemotherapy in oncology. Its treatment requires oral formulations that enhance therapy compliance, improve administration and ensure drug effectiveness. Solid dosage forms that act by slow dissolution, such as pastilles, are an effective alternative to mouthwashes, for their versatility, ease of administration and extended residence time in the oral cavity. The present work describes the development and stability studies of an innovative formulation of nystatin and lidocaine pastilles for the treatment of oral mucositis...
August 8, 2016: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/27459305/the-theory-and-application-of-space-microbiology-china-s-experiences-in-space-experiments-and-beyond
#18
Changting Liu
Microorganisms exhibit high adaptability to extreme environments of outer space via phenotypic and genetic changes. These changes may affect astronauts in the space environment as well as on Earth because mutant microbes will inevitably return with the spacecraft. But the role and significance of these phenotypic changes and the underlying mechanisms are important unresolved questions in the field of space biology. By reviewing, especially the Chinese studies, we propose a space microbial molecular effect theory, that is, the space environment affects the nature of genes and the molecular structure of microorganisms to produce phenotypic changes...
July 26, 2016: Environmental Microbiology
https://www.readbyqxmd.com/read/27455567/-choosing-antibiotic-in-microbiological-analysis-of-infections-of-urinary-excretion-system
#19
G V Tetz, V V Tetz, T M Voroshilova, E I Smirnova, K M Kardava, T A Karamian, N V Zaslavskaia, D S Vikina, M A Zaitseva, K M Artemenko, A S Kaufman
The effectiveness of application of test-system "Choice of antibiotic" was evaluated as a tool for incubation of maximal amount of bacteria from pathological material under acute cystitis. The results of meta-genome analysis established that test-system permits supporting growth of practically all bacteria detected in urine, including ones relating to "uncultivated for the present". The comparison of results of standard detection of sensitivity of bacteria to antibiotics and identification of effective pharmaceutical according the results of application of test-system "Choice of antibiotic" as well was implemented It is demonstrated that test- system permits choosing antibiotic during 6-20 hours wiihout isolation of pure strain...
February 2016: Klinicheskaia Laboratornaia Diagnostika
https://www.readbyqxmd.com/read/27449060/comparison-of-various-molecular-methods-for-rapid-differentiation-of-intestinal-bifidobacteria-at-the-species-subspecies-and-strain-level
#20
Piotr Jarocki, Marcin Podleśny, Elwira Komoń-Janczara, Jagoda Kucharska, Agnieszka Glibowska, Zdzisław Targoński
BACKGROUND: Members of the genus Bifidobacterium are anaerobic Gram-positive Actinobacteria, which are natural inhabitants of human and animal gastrointestinal tract. Certain bifidobacteria are frequently used as food additives and probiotic pharmaceuticals, because of their various health-promoting properties. Due to the enormous demand on probiotic bacteria, manufacture of high-quality products containing living microorganisms requires rapid and accurate identification of specific bacteria...
2016: BMC Microbiology
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