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Microbial pharmaceutical quality

Shelby R Hayes, Ashley J Vargas
: Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea.Cochrane Database Syst Rev2015, Issue 12. Art. No.: CD004827. BACKGROUND: Antibiotics are frequently prescribed in children. They alter the microbial balance within the gastrointestinal tract, commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via restoration of the gut microflora...
August 26, 2016: Explore: the Journal of Science and Healing
Veena Das, Sanjeev Satyanarayan, Shanta Satyanarayan
Gum arabic is multifunctional and used in food products, pharmaceutical, confectionery, cosmetic, printing and textile industry. Gum arabic has an excellent market and its production is being increased to meet the market demand. In the process, huge quantity of solid waste is generated during its refining process. An attempt has been made to vermicompost this organic waste using Eudrilus eugeniae. This research work is first of its kind. Literature on this substrate has not been reported anywhere else for vermicomposting...
September 2016: Environmental Monitoring and Assessment
Hideharu Shintani
Microbial testing performed in support of pharmaceutical and biopharmaceutical production falls into three main categories: detection (qualitative), enumeration (quantitative), and characterization/identification. Traditional microbiological methods are listed in the compendia and discussed by using the conventional growth-based techniques, which are labor intensive and time consuming. In general, such tests require several days of incubation for microbial contamination (bioburden) to be detected, and therefore management seldom is able to take proactive corrective measures...
2016: Biocontrol Science
Ailton Cesar Lemes, Luisa Sala, Joana da Costa Ores, Anna Rafaela Cavalcante Braga, Mariana Buranelo Egea, Kátia Flávia Fernandes
Bioactive peptides are considered the new generation of biologically active regulators that not only prevent the mechanism of oxidation and microbial degradation in foods but also enhanced the treatment of various diseases and disorders, thus increasing quality of life. This review article emphasizes recent advances in bioactive peptide technology, such as: (i) new strategies for transforming bioactive peptides from residual waste into added-value products; (ii) nanotechnology for the encapsulation, protection and release of controlled peptides; and (iii) use of techniques of large-scale recovery and purification of peptides aiming at future applications to pharmaceutical and food industries...
2016: International Journal of Molecular Sciences
Christopher J Hernandez, Jason D Guss, Marysol Luna, Steven R Goldring
The human microbiome has been shown to influence a number of chronic conditions associated with impaired bone mass and bone quality, including obesity, diabetes, and inflammatory bowel disease. The connection between the microbiome and bone health, however, has not been well studied. The few studies available demonstrate that the microbiome can have a large effect on bone remodeling and bone mass. The gut microbiome is the largest reservoir of microbial organisms in the body and consists of more than a thousand different species interacting with one another in a stable, dynamic equilibrium...
September 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Yun-Ya Yang, Gurpal S Toor, P Chris Wilson, Clinton F Williams
Septic systems, a common type of onsite wastewater treatment systems, can be an important source of micropollutants in the environment. We investigated the fate and mass balance of 17 micropollutants, including wastewater markers, hormones, pharmaceuticals and personal care products (PPCPs) in the drainfield of a septic system. Drainfields were replicated in lysimeters (1.5m length, 0.9m width, 0.9m height) and managed similar to the field practice. In each lysimeter, a drip line dispersed 9L of septic tank effluent (STE) per day (equivalent to 32...
October 1, 2016: Science of the Total Environment
Carolina Chiellini, Stefano Mocali, Renato Fani, Iolanda Ferro, Serenella Bruschi, Alessandro Pinzani
No abstract text is available yet for this article.
August 2016: Journal of Microbiological Methods
V Rajkumar, Arun K Verma, G Patra, S Pradhan, S Biswas, P Chauhan, Arun K Das
Aloe vera has been used worldwide for pharmaceutical, food, and cosmetic industries due to its wide biological activities. However, quality improvement of low fat meat products and their acceptability with added Aloe vera gel (AVG) is scanty. The aim of this study was to explore the feasibility of using fresh AVG on physicochemical, textural, sensory and nutritive qualities of goat meat nuggets. The products were prepared with 0%, 2.5%, and 5% fresh AVG replacing goat meat and were analyzed for proximate composition, physicochemical and textural properties, fatty acid profile and sensory parameters...
May 2016: Asian-Australasian Journal of Animal Sciences
Tahisa Marcela Pedroso, Hérida Regina Nunes Salgado
Antimicrobials have unquestionable importance in the control of many diseases; however the constant concern with evolution of resistant microorganisms is increasing. Ertapenem sodium is a β-lactam antibiotic of the carbapenem class that has a broader activity spectrum than most other β-lactam antimicrobials and is more resistant to the enzyme β-lactamase, which is the main mechanism of resistance of many bacteria. The progress of microbial resistance to existing antibiotics is alarming. Thus we need to preserve antimicrobials that still have activity against these pathogens...
2016: Critical Reviews in Analytical Chemistry
Ozlem Ates
Exopolysaccharides (EPSs) produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture, and medicine. EPSs are mainly associated with high-value applications, and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility...
2015: Frontiers in Bioengineering and Biotechnology
Claudia Mueller, Elke Dietel, Severin R Heynen, Heiko Nalenz, Pierre Goldbach, Hanns-Christian Mahler, Johannes Schmidt, Ulla Grauschopf, Karin Schoenhamnmer
MabThera is an essential component of the standard-of-care regimens in the treatment of non-Hodgkin lymphoma and Chronic Lymphatic Leukemia. MabThera for subcutaneous injection is a novel line extension that has been approved by the European Medicines Agency for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. This study aimed to evaluate in-use stability data of MabThera subcutaneous drug-product solution in single-use syringes for subcutaneous administration according to the European Medicines Agency guideline...
May 2015: International Journal of Pharmaceutical Compounding
Michael J Akers
There are serious consequences if contamination control is not enforced and contaminated products/preparations are released to the market. The greatest risk of microbial contamination is exposure of sterile (also termed "critical") sites to potential sources of contamination. Contamination control basically involves at least fourteen entities to control or that help to determine the extent (quality) of control. Some of these entities are covered in this article; others will be covered in subsequent articles by the author...
May 2015: International Journal of Pharmaceutical Compounding
Joshua Z Goldenberg, Lyubov Lytvyn, Justin Steurich, Patricia Parkin, Sanjay Mahant, Bradley C Johnston
BACKGROUND: Antibiotics are frequently prescribed in children. They alter the microbial balance within the gastrointestinal tract, commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via restoration of the gut microflora. OBJECTIVES: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. SEARCH METHODS: MEDLINE, EMBASE, CENTRAL, CINAHL, AMED, and the Web of Science (inception to November 2014) were searched along with specialized registers including the Cochrane IBD/FBD review group, CISCOM (Centralized Information Service for Complementary Medicine), NHS Evidence, the International Bibliographic Information on Dietary Supplements as well as trial registries...
2015: Cochrane Database of Systematic Reviews
Chanikul Chutrakul, Sukanya Jeennor, Sarocha Panchanawaporn, Pattsarun Cheawchanlertfa, Sarinya Suttiwattanakul, Mayura Veerana, Kobkul Laoteng
Microbial lipids are promising alternative sources of long chain-polyunsaturated fatty acids (LC-PUFAs) for food, feed, nutraceutical and pharmaceutical sectors. Dihomo-γ-linolenic acid (C20:3Δ(8,11,14); DGLA) is an important LC-PUFAs with anti-inflammatory and anti-proliferative effects. To generate a DGLA-producing strain, fatty acid reconstitution in Aspergillus oryzae was performed by metabolic engineering through co-expression of codon-optimized Pythium Δ(6)-desaturase and Δ(6)-elongase, which had high conversion rates of substrates to respective products as compared to the native enzymes...
January 20, 2016: Journal of Biotechnology
Raphael Bar
UNLABELLED: Statistical tools are required to organize and present microbial environmental monitoring data for the purpose of evaluating it against regulatory action limits and of determining if the microbial monitoring process is in a state of control. This paper applies a known methodology of a simple and straightforward construction of control XmR (X data and moving range) charts of individual microbial counts as they are or of contamination rates derived from them, irrespective of the type of the parent data distribution and without the need to transform the data into a normal distribution...
November 2015: PDA Journal of Pharmaceutical Science and Technology
Radka Kodešová, Martin Kočárek, Aleš Klement, Oksana Golovko, Olga Koba, Miroslav Fér, Antonín Nikodem, Lenka Vondráčková, Ondřej Jakšík, Roman Grabic
The presence of human and veterinary pharmaceuticals in the environment is recognized as a potential threat. Pharmaceuticals have the potential to contaminate soils and consequently surface and groundwater. Knowledge of contaminant behavior (e.g., sorption onto soil particles and degradation) is essential when assessing contaminant migration in the soil and groundwater environment. We evaluated the dissipation half-lives of 7 pharmaceuticals in 13 soils. The data were evaluated relative to the soil properties and the Freundlich sorption coefficients reported in our previous study...
February 15, 2016: Science of the Total Environment
Roman Mathaes, Hanns-Christian Mahler, Jean-Pierre Buettiker, Holger Roehl, Philippe Lam, Helen Brown, Joerg Luemkemann, Michael Adler, Joerg Huwyler, Alexander Streubel, Silke Mohl
Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process...
February 2016: European Journal of Pharmaceutics and Biopharmaceutics
Hend Zeitoun, Mervat Kassem, Dina Raafat, Hamida AbouShlieb, Nourhan Fanaki
BACKGROUND: Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. RESULTS: Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of bacterial contaminants...
2015: BMC Microbiology
Alessandro Morais Saviano, Fabiane Lacerda Francisco, Celina Silva Ostronoff, Felipe Rebello Lourenço
The aim of this study was to develop, optimize, and validate a microplate bioassay for relative potency determination of linezolid in pharmaceutical samples using quality-by-design and design space approaches. In addition, a procedure is described for estimating relative potency uncertainty based on microbiological response variability. The influence of culture media composition was studied using a factorial design and a central composite design was adopted to study the influence of inoculum proportion and triphenyltetrazolium chloride in microbial growth...
September 2015: Journal of AOAC International
Noe Miyashita, Makoto Tanaka, Ryusuke Gotoda
The application of rapid microbiological methods (RMM) to bacterial monitoring in pharmaceutical manufacturing processes is now a key topic, since timely microbiological data are critical for product release, continuous process improvement and quality control. An automated, highly sensitive detection system has been developed which can measure the amount of ATP in a sample in 2 h with one hundredfold more sensitive than the conventional ATP method. One of the major subjects for adoption and implementation of RMM is how to set the criterion value for practical microbial control...
2015: Biological & Pharmaceutical Bulletin
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