bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of Grinding in Pharmaceutical Tablet Production
Authors: Andrews Gavin , Jones David , Zhai Hui , Abu Diak Osama , Walker Gavin 
Published: March 2010

Abstract
The importance of size reduction in relation to pharmaceutical active agents and excipients is well known. A variety of types of equipment are used for milling, such as ball mill and fluid energy mill. This article focuses on particle size reduction methods, characterization of particle size and shape, the importance of controlling particle characteristics to ensure the success of pharmaceutical powder processing, and the manufacture of elegant pharmaceutical products.
Cyclodextrin‐Based Nanomaterials in Pharmaceutical Field
Authors: Bilensoy Erem , Hincal A. Atilla 
Published: March 2010

Abstract
Cyclodextrins (CDs) have a wide range of application in the pharmaceutical field due to their unique structure, which allows them to include hydrophobic molecules in their apolar cavity and to mask the physicochemical properties of the included molecule. CDs have also been incorporated into nanoparticulate drug delivery systems for complexation of active ingredient and modification of CDs to render an amphiphilic character to these molecules. This article focuses on the issues concerning the use of CDs and derivatives as nanomaterials for drug delivery and application of CDs in nanoparticulate drug delivery systems.
Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety
Authors: Chowdhury D. F. 
Published: March 2010

AbstractNano‐pharmaceutical systems generally imply products that may in their own right or in combination with another moiety bring about therapeutic benefit. Nanosystems can be classified in a number of ways, for example, according to their elemental composition, according to size, structure, and function, or according to a structure‐function relationship. This article focuses on the manufacture, characterization, and safety of pharmaceutical nanosystems.
Good Manufacturing Practices (
GMP
) and Related
FDA
Guidelines
Authors: Harris James R. 
Published: March 2010

Abstract
All food‐ and drug‐related laws in the United States are contained in Title 21 of the Code for Federal Regulations (CFR). Apart from these laws, Food and Drug Administration (FDA) publishes guidance documents on good manufacturing practices (GMP) for drug manufacturers. This article focuses on laws contained in Title 21 of the CFR, and the related FDA guidelines for GMP.
Enforcement of Current Good Manufacturing Practices
Authors: Nolan Kenneth J. 
Published: March 2010

Abstract
The drug manufacturers in the U.S. should conform to current good manufacturing practice (cGMP) regulations contained in Title 21 of the U.S. Code of Federal Regulations (CFR), Parts 210 and 211. The Food and Drug Administration (FDA) and other regulatory agencies are responsible for the enforcement of the cGMP regulations. This article focuses on the cGMP regulations enforcement agencies and the techniques of enforcement.
Creating and Managing a Quality Management System
Authors: Arling Edward R. , Dowling Michelle E. , Frankel Paul A. 
Published: March 2010

Abstract
A comprehensive quality management system (QMS) has become an integral part of pharmaceutical and biopharmaceutical operations due to increased market demand and business competition. A well‐designed QMS, with mature, developed processes, provides the required infrastructure and support for successful manufacturing operations. This article provides an understanding of QMS to succeed in pharmaceutical manufacturing operation.
Stability and Shelf Life of Pharmaceutical Products
Authors: Velagaleti Ranga 
Published: March 2010

Abstract
The U.S. Pharmacopeia (USP) defines stability of pharmaceutical products as the extent to which a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of manufacture. Stability is determined by evaluation of the quality parameters with time under the influence of a variety of environmental factors such as temperature, humidity, and light. This article focuses on the stability and shelf life of pharmaceutical drug products.
Drug Stability
Authors: Ramirez‐Beltran Nazario D. , Rodriguez Harry , Estévez L. Antonio 
Published: March 2010

Abstract
The U.S. Food and Drugs Administration (FDA) and the International Conference on Harmonization (ICH) require that pharmaceutical companies present factual evidence supporting the shelf life for either existing or new products. The expiration date provides the consumer the confidence that the drug product will retain its identity, strength, quality, and purity throughout the expiration period. This article describes a set of practical tools to design a stability study as well as to discuss and illustrate how to determine the shelf life for a given drug product.
Pharmaceutical Product Stability
Authors: Webster Andrew A. 
Published: March 2010

AbstractPharmaceutical product stability may be defined as the capability of a particular formulation to remain within its physical, chemical, microbiological, therapeutic, and toxicological specifications while in a specific container closure system. There are many factors that can affect the stability of a pharmaceutical product. These include the stability of the active drug(s), interactions between active and inactive ingredients, the dosage form, manufacturing process, the container system, and environment for shipping, handling, and storage. This article focuses on the different types of pharmaceutical product stability, such as chemical degradation, physical degradation, and microbial degradation.
Alternative Accelerated Methods for Studying Drug Stability: Variable‐Parameter Kinetics
Authors: Alibrandi Giuseppe 
Published: March 2010

Abstract
Studies on drug stability have a central role in physicochemical profiling. A fast screening of new molecular entities and low‐time‐consuming detailed studies on selected candidates can avoid delay and consequent high cost in the first part of pharmaceutical investigation. This article focuses on variable‐parameter kinetics (VPaK) method for studying stability of drug products.
Analytical Method Validation: Principles and Practices
Authors: Chan Chung Chow 
Published: March 2010

Abstract
Validation of an analytical procedure is the process by which it is established that the performance characteristics of the procedure meet the requirements for its intended use. All analytical methods that are intended to be used for analyzing any clinical samples need to be validated. This article focuses on the requirements of analytical method validation and the options that are available to allow for optimal utilization of analytical resources in a development laboratory.
Pharmaceutical Manufacturing Validation Principles
Authors: Souto E. B. , Vasconcelos T. , Ferreira D. C. , Sarmento B. 
Published: March 2010

Abstract
The pharmaceutical industry has been a leader in the development of quality and safety procedures assuring that the risk of its work is reduced to a minimum. Validation is an integral part of quality assurance, involving the methodical study of systems, facilities, and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. This article focuses on the pharmaceutical industry validation system.
Fire Safety
Authors: Delichatsios Michael A. 
Published: March 2010

AbstractAs a chapter on fire safety in a combustion handbook may be either a high level generic document or a treatise on a specific area, this chapter takes the “middle road,” outlining the types of data required for fire safety design. The references [1–3] included provide both a generic perspective and aspects of actual practice, as well as sources of data needed for fire safety engineering. The chapter includes a description of context and purpose for fire safety engineering, a classification of the data, and list of data including possible sources and comments as needed. The references [1–13] address in part the reliability and confidence in these data. As a promising near future development, some recent efforts to make risk assessment more accessible and to integrate fire protection engineering with the building design using software agents, has been included. Additional related information regarding data on safety is included in Chapters18,20and23of this volume of the Handbook.
Non‐Optical Lithography
Authors: Sotomayor Torres Clivia M. , Ahopelto Jouni 
Published: March 2010

Abstract
An example of non‐optical lithographies is nanoimprint lithography. The state of the art in this versatile nanofabrication method is reviewed, including the scientific challenges, such as nano‐scale rheology and mechanical stability, and engineering challenges, such as the competing constraints for a high volume production. The latter is coupled to the flexibility and opportunities afforded by the wealth in polymer functionalisation, which makes this family of methods particularly suited for applications in optics, life sciences and material sciences. The chapter also includes an introduction to progress in metrology as well as 3D nanoimprinting.
Nanostructured Probes forIn VivoGene Detection
Authors: Bao Gang , Santangelo Phillip , Nitin Nitin , Rhee Won Jong 
Published: March 2010

AbstractThe ability to visualize in real time the expression dynamics and localization of specific RNAsin vivooffers tremendous opportunities for biological and disease studies, including the detection of cancer. Quantitative methods such as real‐time PCR and DNA microarrays rely on the use of cell lysates, and thus are not able to obtain important spatial and temporal information. Fluorescent proteins and other reporter systems cannot image endogenous RNA in living cells. Fluorescencein situhybridization (FISH) assays require washing to achieve specificity, and therefore can only be used with fixed cells. In this chapter we review the recent development of nanostructured probes for living cell RNA detection, and discuss the biological and engineering issues and challenges of quantifying gene expressionin vivo. In particular, we describe methods that use oligonucleotide probes, combined with novel delivery strategies, to image the relative level, localization and dynamics of RNA in live cells. Examples of detecting endogenous mRNAs, as well as imaging their subcellular localization, are given to illustrate the biological applications. Issues in probe design, delivery and target accessibility are also discussed. The nanostructured probes promise to open new and exciting opportunities in sensitive gene detection for a wide range of biological and medical applications.
Hydrogenases and Alternative Energy Strategies
Authors: Rüdiger Olaf , De Lacey António L. , Fernández Victor M. , Cammack Richard 
Published: March 2010

AbstractThis chapter considers the hydrogenases, the enzymes that produce and consume molecular hydrogen; how they work and how they might be exploited in a future hydrogen‐based economy. Hydrogenases are enzymes containing iron and in some cases nickel, which efficiently couple the proton‐hydrogen couple to the reduction or oxidation of electron carriers. They have many metabolic functions in the microbial world. Much has been learned from recent research about their active sites and mechanism of action. There are three known types of hydrogenase chemistry: that based on a dinuclear nickel‐iron site (NiFe‐and NiFeSe‐hydrogenases); on more complex iron‐containing clusters (FeFe‐hydrogenases); and an enzyme containing a mononuclear iron site, which catalyzes a specific direct hydrogenation of a cofactor (Hmd). Variations on the NiFe‐hydrogenases are involved in the sensing of H2in cell regulation. Where necessary, hydrogenases have structural features that avoid the inhibitory effects of oxygen, carbon monoxide and other pollutant gases which poison other catalysts such as platinum. The structures of the different types of hydrogenases have been determined and their catalytic mechanisms investigated by spectroscopy and electrochemistry. Genetic and biochemical studies are elucidating the complex metabolic pathways by whereby the different types of hydrogenase catalytic centers are assembled. Three possible energy strategies are suggested by hydrogenase research: (1) hydrogen biotechnology, using microorganisms to produce hydrogen by fermentation of organic wastes, with or without the assistance of photosynthesis; (2) biomimicry, using insights from the structures and mechanisms of hydrogenases to synthesize improved catalysts as a substitute for the limited resources of precious metals; and (3) harnessing hydrogenases on carbon electrodes in electrolysis cells for H2production or fuel cells to produce electricity from hydrogen at low concentrations and with low overpotentials and at rates comparable to those with platinum.
Photochemical and Photo‐induced Reactions in Supercritical Fluid Solvents
Authors: Tanko James M. 
Published: March 2010

Abstract
The sections in this article are

Introduction

“Solvent” Properties of Supercritical Fluids

Scope of This Chapter

Experimental Considerations

Photochemical Reactions in Supercritical Fluid Solvents

Geometric Isomerization

Photodimerization

Carbonyl Photochemistry

Photosensitization and Photo‐induced Electron Transfer

Photo‐oxidation Reactions

Photo‐initiated Radical Chain Reactions in Supercritical Fluid Solvents

Free Radical Brominations of Alkyl Aromatics in Supercritical Carbon Dioxide

Free Radical Chlorination of Alkanes in Supercritical Fluid Solvents

Conclusion

Acknowledgment
The Principles of and Reasons for Using Water as a Solvent for Green Chemistry
Authors: Breslow Ronald 
Published: March 2010

AbstractWater is an environmentally benign solvent. It also has special properties useful in chemical and biochemical reactions: the hydrophobic effect can lead to altered selectivities and rate accelerations. Although these are commonly seen in water solutions – which require water solubility of the reactants – we have reported one example in which such effects were seen in the water suspension of a poorly soluble reactant. Here we describe examples, chiefly from our own work, in which the hydrophobic effect was used in substrate binding, in aromatic chlorination, in acylations by esters, in mimics of metalloenzymes and of ribonuclease, and amino acid syntheses and reactions, heterocyclic carbene chemistry, aldol condensations, Diels–Alder reactions, carbonyl reductions, and selective oxidations. The hydrophobic effect was also used to determine the geometries of transition states for some important reactions. With these attractive special advantages, including the green chemistry advantages, water should become a more usual solvent in chemical manufacturing.
Toward greener separations of rare earths: Bifunctional ionic liquid extractants in biodiesel
Authors: Liu Yinghui , Zhu Lili , Sun Xiaoqi , Chen Ji 
Published: March 2010

AbstractIonic liquids (ILs) containing quaternary phosphonium cations and phosphonic acid anions were explored as novel extractants for rare earths (RE) separation. They were considered to be bifunctional ionic liquid extractants (bif‐ILEs), since both cations and anions of ILs were involved in the extraction. Trihexyl(tetradecyl)phosphonium bis 2,4,4‐trimethylpentylphosphinate (Cyphos IL 104), as a bif‐ILE, together with propylene carbonate (PC), dimethyl carbonate (DMC), and soybean oil methyl ester (SBME, biodiesel) as diluents was employed in the extraction of RE(III) from aqueous solutions. Acidified Cyphos IL 104 (HNO3‐Cyphos IL 104) exhibited high solubility in three diluents, and higher extraction efficiency than bis(2,4,4‐trimethylpentyl)phosphinic acid (Cyanex 272) because of the coextraction of RE(III) by quaternary phosphonium cation and phosphonic acid anion in organic phase. Additionally, this coextraction mechanism could eliminate the loss of IL. The physical properties and miscibility test results indicated that SBME was an excellent solvent for RE(III) extraction. © 2010 American Institute of Chemical Engineers AIChE J, 2010
Identification of uniquely expressed transcription factors in highly purified B‐cell lymphoma samples
Authors: Andréasson Ulrika , Edén Patrik , Peterson Carsten , Högerkorp Carl‐Magnus , Jerkeman Mats , Andersen Niels , Berglund Mattias , Sundström Christer , Rosenquist Richard , Borrebaeck Carl A.K. , Ek Sara 
Published: March 2010

AbstractTranscription factors (TFs) are critical for B‐cell differentiation, affecting gene expression both by repression and transcriptional activation. Still, this information is not used for classification of B‐cell lymphomas (BCLs). Traditionally, BCLs are diagnosed based on a phenotypic resemblance to normal B‐cells; assessed by immunohistochemistry or flow cytometry, by using a handful of phenotypic markers. In the last decade, diagnostic and prognostic evaluation has been facilitated by global gene expression profiling (GEP), providing a new powerful means for the classification, prediction of survival, and response to treatment of lymphomas. However, most GEP studies have typically been performed on whole tissue samples, containing varying degrees of tumor cell content, which results in uncertainties in data analysis. In this study, global GEP analyses were performed on highly purified, flow‐cytometry sorted tumor‐cells from eight subgroups of BCLs. This enabled identification of TFs that can be uniquely associated to the tumor cells of chronic lymphocytic leukemia (CLL), diffuse large B‐cell lymphoma (DLBCL), follicular lymphoma (FL), hairy cell leukemia (HCL), and mantle cell lymphoma (MCL). The identified transcription factors influence both the global and specific gene expression of the BCLs and have possible implications for diagnosis and treatment. Am. J. Hematol., 2010. © 2010 Wiley‐Liss, Inc.
C/EBPA gene mutation and C/EBPA promoter hypermethylation in acute myeloid leukemia with normal cytogenetics
Authors: Lu Ying , Chen Wengang , Chen Wei , Stein Anthony , Weiss Lawrence M. , Huang Qin 
Published: March 2010

AbstractIn the current study, we investigated C/EBPA gene mutations and promoter hypermethylation in a series of 53 patients with CN‐AML. In addition, we also analyzed two other frequent mutations (FLT3/ITD and NPM1) in these patients and correlated them with C/EBPA gene alterations. 13/53 patients were FLT3/ITD+/NPM1‐, 11/53 patients were FLT3/ITD+/NPM1+, 9/53 patients were FLT3/ITD‐/NPM1+, and 20/53 patients were FLT3/ITD‐/NPM1‐. Four of 53 cases displayed C/EBPA mutations, whereas 49 cases had only C/EBPA wild‐type alleles. Of the four positive cases, three patients had N‐terminal mutations only, whereas one patient had mutations in both the N‐ and C‐terminal region. Two of the four positive cases also harbored both FLT3/ITD and NPM1 mutation simultaneously, whereas the other two patients had neither FLT3/ITD nor NPM1 mutations. Furthermore, 7/53 cases displayed C/EBPA promoter hypermethylation. Interestingly, they were all in CN‐AML cases without FLT3/ITD or NPM1 mutations. None of the seven patients with C/EBPA promoter hypermethylation showed C/EBPA mutation. In conclusion, C/EBPA mutation and promoter hypermethylation can be detected at a relatively low frequency in de novo CN‐AML patients, suggesting they may contribute to leukemogenesis. C/EBPA mutation appears to be seen in “high‐risk” AML (FLT3/ITD+/NPM1+; FLT3/ITD+/NPM1‐ or FLT3/ITD‐/NPM1‐), while C/EBPA hypermethylation appears to be more common in AML with FLT3/ITD‐ /NPM1‐ and is not associated with C/EBPA mutation. Am. J. Hematol. 2010. © 2010 Wiley‐Liss, Inc.
Embedding a strategic approach to river restoration in operational management processes — experiences in England
Authors: Mainstone Chris P. , Holmes Nigel T. H. 
Published: March 2010

Abstract1. The restoration of riverine habitats that have been physically modified by man has gained momentum over the past two decades, driven by a number of objectives. Formalizing the planning and implementation of such activity, however, so that it demonstrably meets national and local environmental objectives without compromising essential societal needs such as flood risk management, has proved problematic.2. This paper addresses the operational realities of river restoration in the UK as experienced in England by the authors, and in doing so attempts to provide a vision for how strategic planning and implementation of restoration measures sensitive to these realities might be introduced. Specifically, the paper explores:

the prevailing perspectives on river restoration, shaped by both legislative drivers for ecosystem and biodiversity protection and the multiple uses made of rivers, their floodplains and catchments;

how decisions have tended to be made to date and how the government agencies for environmental protection and biodiversity conservation in England are planning to make decisions in the future;

the key obstacles to putting in place scientifically and technically robust, large‐scale, long‐term, economically viable plans for river restoration;

the potential for using rivers with special conservation designations for wildlife as a springboard for a strategic approach to river restoration more widely.

3. The issues hindering a strategic operational approach to river restoration in England are common to the rest of the UK and other developed countries grappling with the enormity of the river restoration challenge. To make real progress with river restoration, an operational decision‐making framework is needed that promotes progressive and strategic action but at the same time gives everyone confidence that such action is realistic and worthwhile. Copyright © 2010 John Wiley & Sons, Ltd.
Platinum and Palladium‐triazole Complexes as Highly Potential Antitumor Agents
Authors: Al‐Masoudi Najim A. , Abdullah Bayazeed H. , Essa Ali H. , Loddo Roberta , LaColla Paolo 
Published: March 2010

AbstractThe palladium complexes [(dppe)Pd(L)2PdCl2], [(dppe)Pd(L)2PtCl2], [(dppp)Pd(L)2PdCl2], [(dppm) Pd(L)2NiCl2], and [(dppm)Pd(L)2SnCl4] 15–19 were prepared. The antiproliferative activity of the newly synthesized complexes as well as their previously prepared analogues 3–14 and 20–26 were screened against a large panel of human cancer cell lines derived from haematological CD4+ human T‐cells containing an integrated HTLV‐1 genome (MT‐4). The complex 12a, b exhibited remarkable antiproliferative activity against MT‐4, CD4+ human acute T‐lymphoblastic leukemia (CCRF‐CEM), human splenic B‐lymphoblastoid cells (WIL‐2NS), human acute B‐lymphoblastic leukemia (CCRF‐SB), skin melanoma (SK‐MEL‐28), and prostate carcinoma (DU145) cell lines (CC50 = 0.5 μM, 0.4 ± 0.05 μM, 0.6 ± 0.05 μM, 0.4 ± 0.1 μM, and 0.8 ± 0.2 μM, respectively), meanwhile, 9a, b, 14a, b, and 23 showed significant activity against the CCRF‐SB cell lines (CC50 = 0.6 ± 0.06 μM, 0.7 ± 0.05 μM, 0.6 ± 0.05 μM, and 0.8 ± 0.15 μM, respectively). Further, 19 exhibited activity against the CCRF‐CEM cell line (CC50 = 0.4 ± 0.05 μM).
Ring Expansions of Tetrahydroprotoberberines and Related Dibenzo[c,g]azecines Modulate the Dopamine Receptor Subtype Affinity and Selectivity
Authors: Schulze Maria , Siol Oliver , Meise Werner , Lehmann Jochen , Enzensperger Christoph 
Published: March 2010

AbstractThe affinities of tetrahydroprotoberberines for dopamine receptors dramatically decrease after cleaving the central C‐N bond to the analogous ten‐membered dibenzo[c,g]azecines [1]. In the present work, we also synthesized eleven‐membered homologues of these heterocycles and measured the affinities of the resulting dibenzazaundecenes and their underlying homoberberines for human dopamine receptors as well as the cytotoxic effects of all target compounds on human glia cells. The tetracyclic iso‐C‐homoberberine‐derivatives revealed to be D4‐selective antagonists, while all other active compounds showed a significant D1/D5 selectivity. Distances in energy‐minimized conformations were measured in order to explain our findings.