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A partially freeze-dried lyophilization technology for producing fast-melting tabletsA new economical method for producing fast-melting lamina-like dosage forms.
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A Raman spectroscopic method to monitor magnesium stearate in blends and tabletsA new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.
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Dispelling Cleaning Validation Myths: Part IIIn applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.
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Let's Collaborate on IT Best PracticesThe industry should develop a set of best practices for managing information technology systems and not wait for FDA to take the lead.
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Talking Point: Corporate procurementIf delaying the project has little consequence then you should probably not run the project in the first place.
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Applications of Raman spectroscopy in aqueous environmentsRaman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.
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Improving the stability of a suspensionAggregation or coagulation of drug particles in a parenteral suspension can pose a serious threat to product quality, particularly for products that require extended shelf life. In the worst case, aggregation can lead to the formation of a nonresuspendable sediment, known as caking. Controlling physical stability is difficult because of the complexity of this phenomenon. This article gives an overview of the factors that were found to be the most important in our search to improve the physical stability of a pharmaceutical suspension.
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Comparison of Atomization Conditions Between Different Spray Guns Used in Pharmaceutical Film CoatingConsideration of the key process variable will define the ease with which coating processes can be transferred from development to production. This study investigates those factors influencing atomization from two spray guns and examines how development-scale procedures on interchangeable drum coating equipment compare with those typically used in a production environment.
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In-Process Control Methods for the Manufacture of APIsIn-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality.
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Transforming Development Productivity Using Integrated AutomationThe FDA initiative —Process Analytical Technologies (PAT) — is slowly gaining momentum, creating a revolution in manufacturing and testing processes that aims to ensure product quality. Its growth will encourage faster testing techniques to bring analytical testing closer to on- and at-line testing during the product manufacturing process.
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Outsourcing Beyond the Comfort ZonePharmaceutical companies can evaluate the opportunities of global outsourcing by considering the strategic approaches of other industries and of the pharmaceutical companies already outsourcing outside the United States and Europe.
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Plugging the European brain drain to the USSo what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence.
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Scaling down biopharmaceutical operations Part 1: FermentationCreation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
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Making tissue culture commercially viableThere are over 250 operations in the EU in various stages of development involving tissue engineering, regeneration and subsequent attempts at commercialization.
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Virtual screening using chemical feature-based pharmacophores and virtual molecule librariesThe discovery of suitable lead structures for new drugs from an inexhaustibly large reservoir of theoretically possible compounds is one of the biggest challenges for the pharmaceutical industry. In the last few years, combinatorial chemistry methods have been developed to synthesize a huge amount of diverse new chemical entities (NCEs), which may subsequently be tested for biological activity in vitro.
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Nature versus nurtureOnce the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.
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Lost in the ATEX Maze?The EU ATEX Directive 1999/92/EC (ATEX 137) regarding the minimum requirements to protect the health and safety of workers potentially at risk from explosive atmospheres came into European law in January 2000. In the UK, the ATEX 137 Directive has been implemented as part of the Dangerous Substances and Explosive Atmospheres Regulations (DSEARs), which were issued in December 2002.
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Discrete Element Simulation for Fundamental Process UnderstandingThe pharmaceutical industry handles large volumes of granular materials such as powder blends for tablet production and filled capsules everyday (1, 2). Slight changes in ingredient properties or process operation conditions can have a major effect on a finished product's quality. Given the market and regulatory uncertainties that are commonly associated with drug product development, pharmaceutical companies typically have several drugs in various developmental stages at the same time. Because of this volume, the industry must have computer-based rapid-prototyping tools that can efficiently capture and resolve the technical aspects of drug product development so that companies can confidently make decisions about drug portfolio management and planning (3, 4).
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The development of PAT in biotech manufacturingQuality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.
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Marking and coding: the key to combating counterfeitingThis article looks at the different types of marking and coding techniques used in the pharmaceutical supply chain and their role in helping to prevent counterfeiting.
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Effect of raw materials on the formulation of norfloxacin tabletsAlthough physicochemical preformulation screening is practised universally within the pharmaceutical industry, physicomechanical screening is applied to a lesser extent and often only where a problem exists.
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Improving the stability of a suspensionAggregation or coagulation of drug particles in a parenteral suspension can pose a serious threat to product quality, particularly for products that require extended shelf life. In the worst case, aggregation can lead to the formation of a nonresuspendable sediment, known as caking. Controlling physical stability is difficult because of the complexity of this phenomenon. This article gives an overview of the factors that were found to be the most important in our search to improve the physical stability of a pharmaceutical suspension.
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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Pharmaceutical Dust Extraction and Vacuum CleaningDust extraction and centralized vacuum cleaning systems vary in their design, performance and costs. Different companies have different approaches to their design, however, there are some basic rules that must be followed if these systems are going to be immediately effective and avoid future problems.
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Is your IT infrastructure qualified?A new Good Automated Manufacturing Practice (GAMP) guide on IT Infrastructure Control & Compliance was launched in Chicago (IL, USA) 23 August 2005.1 The guide is intended to support pharmaceutical companies in their effort to establish a well-defined and compliant infrastructure. This article discusses different aspects of the guide that may support your organization in getting — and keeping — your infrastructure under control.
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Sugar spheres: a versatile excipient for oral pellet medications with modified release kineticsPellets are a multiparticle, solid form of medication. The individual pellets are almost spherical with diameters usually between 100 and 2000 ?m.
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Talking Point: The patent problem with metabolitesFDA data indicate expenditure by pharmaceutical companies on R&D has doubled since 1996. Why is intensive research yielding so few patented inventions and so few new drugs?
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A Mass Transfer of KnowledgeA comprehensive book about mass transfer benefits from the author's personal touch.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Glass Reactor Vessel — Value Sealing InnovationActive pharmaceutical ingredients (APIs) have become more potent, therefore the requirements of good manufacturing practice (GMP) are making ever more stringent demands on valve design and sealing. An absence of dead space, ease of cleaning and flushing is the norm for valves where cross contamination must be avoided at all costs. Sealing valves to glass reaction vessels has lagged behind valve sealing for steel vessels.
