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Manufacturing Method (manufacturing + method)
Selected AbstractsChemInform Abstract: Conversion of the Laboratory Synthetic Route of the N-Aryl-2-benzothiazolamine R116010 to a Manufacturing Method.CHEMINFORM, Issue 7 2002Wim Aelterman Abstract ChemInform is a weekly Abstracting Service, delivering concise information at a glance that was extracted from about 100 leading journals. To access a ChemInform Abstract of an article which was published elsewhere, please select a "Full Text" option. The original article is trackable via the "References" option. [source] Comparison of bovine in vivo bioavailability of two sulfamethazine oral boluses exhibiting different in vitro dissolution profilesJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2006M. N. MARTINEZ The bolus (or oblet) is a dosage form that can be used for the oral administration of pharmaceutical compounds to ruminating species. Unlike traditional tablets, oral boluses may contain quantities of drug on the order of grams rather than milligrams. Due to its size, it is only recently that USP-like in vitro dissolution methods have been developed for this dosage form. However, whether or not these dissolution tests can predict product in vivo performance has yet to be determined. The importance of this issue is apparent when the U.S. Food and Drug Administration Center for Veterinary Medicine is faced with the decision of whether to require additional in vivo bioequivalence study data to support the approval of changes in product chemistry or manufacturing method. The current study was undertaken to determine whether an in vivo/in vitro correlation can be established for bovine sulfamethazine oral boluses and to acquire insight into the magnitude of changes in in vitro product performance that can occur before corresponding changes are seen in in vivo blood level profiles. Based upon the results of this investigation, it is concluded that marked changes in in vitro sulfamethazine bolus performance can be tolerated before resulting in altered in vivo blood level profiles. However, the data also suggest that rumenal absorption may occur for some compounds. Therefore the degree to which variation in product in vitro dissolution profiles can be tolerated may be compound specific. [source] Verarbeitung hochfester Aluminiumlegierungen durch umformende VerfahrenMATERIALWISSENSCHAFT UND WERKSTOFFTECHNIK, Issue 7 2009R. Neugebauer ECAP; rolling; extrusion; incremental forming Abstract Basierend auf experimentell ermittelten Werkstoffkennwerten wird ein Vergleich des Umformverhaltens der beiden Aluminiumlegierungen im Anlieferungszustand (EN AW-7075 T651) sowie im modifizierten Zustand (EN AW-7075 ECAP) bei der Verarbeitung mit herkömmlichen Umformverfahren (Walzen, Fließpressen) angestellt. Zudem werden die Verfahrensgrenzen des Umformgrades durch Variation der Werkzeuggeometrien experimentell lokalisiert. Dabei ist ebenfalls Untersuchungsgegenstand, den Einfluss des Verfahrens auf das Umformvermögen zu ermitteln. Davon ausgehend werden Werkzeugkonzepte entwickelt, die eine Umformung des hochfesten Aluminiums unter Erzeugung von hydrostatischen Druckzuständen in der Umformzone ermöglichen. Sowohl die Simulation als auch die Versuche zeigten Materialversagen der ultrafeinkörnigen Werkstoffe beim Fließpressen. Das Walzen als inkrementelles Umformverfahren ermöglichte hingegen eine schadensfreie Herstellung der Werkstücke. Forming of high-strength aluminium alloys A comparison of the forming behavior of both aluminum alloys in as-received condition (EN AW-7075 T651) as well as modified condition (EN AW-7075 ECAP) when processed with conventional forming processes (rolling, extrusion) is conducted on the base of experimentally determined material characteristics. In the following the process limits of the true strain are located by variegating the tool geometry. The influence of the manufacturing method on the plasticity is also a subject matter to analysis. Based upon the outcome of this analysis special tool conceptions are being developed, which allow the forming of highest-strength aluminum while creating hydrostatical pressure states in the deformed zone. Both simulation and experiments showed material failure of the ultra-fine-grained materials when extruded whereas rolling, being the incremental forming process, allowed damage-free manufacturing of components. [source] Stress relaxation behavior of glass fiber-reinforced polyester composites prepared by the newly proposed rubber pressure moldingPOLYMER COMPOSITES, Issue 10 2008Kamal K. Kar Stress-relaxation behavior of glass fiber-reinforced polyester composites, prepared by a recently developed manufacturing method called rubber pressure molding (RPM), is investigated with special reference to the effect of environmental temperature (,70°C to +100°C), fiber volume fraction (30,60%), and initial load level (1,5 kN). It is found that the stress-relaxation rate decreases with an increase in the applied load of composites and a decrease in temperature. Below glass transition temperature, the rate of stress relaxation increases with an increase in volume fraction of fibers in the composites, whereas above glass transition temperature, it increases with a decrease in the volume fraction of fibers. The experimental results for a given composites are summarized by four values, the slopes of the two straight lines (two separate relaxation processes), and their intercepts upon the stress axis. Both the slopes are dependent upon the applied load, temperature, and volume fraction of fibers in the composites. Relaxation times in both primary and secondary are calculated over the wide range of temperatures, loads, and volume fraction of fibers in the composites. It depends strongly on the temperature, but does not depend strongly on the applied load and volume fraction of fibers. The performances of the composites are also evaluated through conventional compression-molding process. The rate of stress relaxation is small when the composites are made of newly proposed RPM technique when compared with the conventional process. POLYM. COMPOS., 2008. © 2008 Society of Plastics Engineers [source] An initial investigation on torsional properties of nickel-titanium instruments produced with a new manufacturing methodAUSTRALIAN ENDODONTIC JOURNAL, Issue 2 2009Gianluca Gambarini md Abstract A new manufacturing process involving twisting of a ground blank combined with heat treatment has been recently developed to produce nickel-titanium rotary files for root canal preparation. The aim of this study was to compare torsional resistance of prototype instruments produced using the new manufacturing method versus traditional nickel-titanium instruments produced by the customary grinding process. Twenty prototypes instruments of the same design and dimensions were divided in two groups of 10 each, according to the different manufacturing method. A file-testing apparatus specifically designed to perform torsional testing was used in accordance with the International Organization for Standardization 3630-1. The results indicated that instruments manufactured by the new manufacturing process demonstrated significantly higher average maximum torque levels than those manufactured by the existing grinding process (P < 0.05). Since instruments design and dimensions of the instruments were the same, the different manufacturing process could be the only explanation for this improvement in torsional resistance. [source] Preclinical Manufacture of Anti-HER2 Liposome-Inserting, scFv-PEG-Lipid Conjugate.BIOTECHNOLOGY PROGRESS, Issue 1 2005Analytical methods optimized for micellar F5cys-MP-PEG(2000)-DPSE protein-lipopolymer conjugate are presented. The apparent micelle molecular weight, determined by size exclusion chromatography, ranged from 330 to 960 kDa. The F5cys antibody and conjugate melting points, determined by differential scanning calorimetry, were near 82 °C. Traditional methods for characterizing monodisperse protein species were inapplicable to conjugate analysis. The isoelectric point of F5cys (9.2) and the conjugate (8.9) were determined by capillary isoelectric focusing (cIEF) after addition of the zwitterionic detergent CHAPS to the buffer. Conjugate incubation with phospholipase B selectively removed DSPE lipid groups and dispersed the conjugate prior to separation by chromatographic methods. Alternatively, adding 2-propanol (29.4 vol %) and n -butanol (4.5 vol %) to buffers for salt-gradient cation exchange chromatography provided gentler, nonenzymatic dispersion, resulting in well-resolved peaks. This method was used to assess stability, identify contaminants, establish lot-to-lot comparability, and determine the average chromatographic purity (93%) for conjugate lots, described previously. The F5cys amino acid content was confirmed after conjugation. The expected conjugate avidity for immobilized HER-2/neu was measured by bimolecular interaction analysis (BIAcore). Mock therapeutic assemblies were made by conjugate insertion into preformed doxorubicin-encapsulating liposomes for antibody-directed uptake of doxorubicin by HER2-overexpressing cancer cells in vitro. Together these developed assays established that the manufacturing method as described in the first part of this study consistently produced F5cys-MP-PEG(2000)-DSPE having sufficient purity, stability, and functionality for use in preclinical toxicology investigations. [source] | |||||||||||||