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...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.

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In the biological arena, new and highly useful fluorescent markers are used to stain or 'label' specific structures of interest. They have transformed the range and applicability for optical observation. These labels are excited and correspondingly emit at specific wavelengths; thus, different facets of a specimen can be 'selected' by controlling the wavelength of the delivered and captured light. For example, labels such as 4',6-diamidino-2-phenylindole (DAPI) are used to highlight the nucleus of a cell and MitoTracker Orange is used for mitochondria. Figure 1 shows an example of a multiple stained section, viewed in fluorescence. There has been an explosion in fluorescent labels for examining biological structures, in fixed and live cell preparations.

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This article describes how rapidly disintegrating tablets containing a large quantity of an intensely bitter drug were successfully developed with a suitable level of masking, tablet hardness, disintegration property, dissolution profile and mouth feel.

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Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets

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HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

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The closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter <231>, which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.

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This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.

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A new economical method for producing fast-melting lamina-like dosage forms.

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A 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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In 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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The 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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If delaying the project has little consequence then you should probably not run the project in the first place.

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Raman 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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Aggregation 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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Consideration 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 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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The 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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Pharmaceutical 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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So what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence.

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Creation 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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There 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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The 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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Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.

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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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The 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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Quality 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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This 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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Although 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.