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Direct Compression: Microcrystalline Cellulose Grade 12 versus Classic Grade 102Although the most commonly used microcrystalline cellulose grade in direct-compression applications is the fine grade 102, the use of coarse grade 12 may offer better weight and content uniformity results.
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The Role of Reverse Engineering in the Development of Generic FormulationsBeing the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.
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A guide for testing biopharmaceuticals Part II: acceptance criteria and analytical method maintenanceThe first part of this article discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1 This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.
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Why use LIMS and related softwareA laboratory information management system (LIMS) can control, manage, organize and document information thus saving time and money.
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Using a Dual-Drug Resinate Complex for Taste MaskingBox-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.
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Carrageenans: Analysis of Tablet Formation and Properties (Part II)The tablet formation of six different carrageenans was analysed by 3D modelling, Heckel analysis, the pressure–time function and energy calculations. It was found that the fibres experienced plastic deformation, which was accompanied by a great deal of elasticity. Measurement of elastic recovery in dependence on maximum relative density and time showed that relaxation is completed a considerable amount of time after tabletting. Shrinking of the fibres occurred in parallel with elastic recovery as a result of the reorganization of the fibre structure. The tabletting behaviour of carrageenans makes them suitable for the soft tabletting of pressure sensitive materials.
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A practical approach to PAT implementationThe PAT guidance indicates a variety of risk-based approaches to managing the introduction of on-line analysers into existing processes with the aim of minimizing the regulatory burden for the manufacturer and encouraging innovation.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Design, Development and Optimization Using Computational Fluid DynamicsInterest in more advanced drug delivery systems has increased, with an acceleration in the discovery and development of novel therapeutic macromolecules for targeted applications. Computational fluid dynamics is a design tool that allows producers of these and other products to evaluate different models rapidly and cost-effectively.
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Improving chromatographic QA/QC resultsThe latest generation of HPLC instruments offers a new level of data security. Improvements in embedded instrument control programs and mass storage functionality offer 'no data loss' guarantee. This level 5 instrument control makes data acquisition audit-safe and increases laboratory technicians' efficiency, freeing them up from any reanalysis work.
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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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An overview of LIMS in the pharmaceutical industryTo produce an application or solution for a specific domain, a vendor must demonstrate a thorough understanding of the domain and its specific challenges.
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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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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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The Future of Compaction Pharmaceutical Tableting in the Twenty-First CenturyCurrently, high-production rates and continuous production processes favor existing tableting technologies. However, if tablet development becomes rate-limiting in the future, alternative technologies may prove attractive.
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Cold Comfort for PharmaCold chain management is becoming pivotal to success in the pharmaceutical industry.
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Standards-Setting Activities on ImpuritiesUSP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
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Viral filtration of plasma-derived human IgGHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.
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Tablet Relaxation and Physiocomechanical Stability of Lactose, Microcrystalline Cellulose, and Dibasic Calcuim PhosphateThe authors discuss the physiocomechanical characteristics of three commonly used pharmaceutical excipients and describe the effects of variables on their physiocomechanical stability.
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Reducing Time to Market with A Science-Based Product Management StrategyTo progress compounds from candidacy to IND rapidly, manufacturers can adopt a strategy that involves front-loading as many studies as possible to reduce the number of potential problems, finding the best solid form for manufacture through a polymorph study or screen, developing a manufacturing process and formulation that preserves this form, and adopting process analytical technology and quality-by-design principles.
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Tooling Preparation Practices and their Effect on Tablet PickingPicking may occur when granulation becomes imbedded on a punch surface and does not freely release when the compressing event has finished.
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Narrowing in on spreadsheetsThe pharmaceutical sector is a billion dollar industry with a huge responsibility towards its customers and investors. The main tools for fulfilment of this responsibility are ensurance of compliance and maintenance of control. It is a time-consuming job to uphold these responsibilities, and many important decisions regarding this subject are taken every day. It is important to make carefully considered decisions and follow them up. It is also essential to stop once in a while and reconsider their validity and relevance.
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Reducing Time to Market with A Science-Based Product Management StrategyTo progress compounds from candidacy to IND rapidly, manufacturers can adopt a strategy that involves front-loading as many studies as possible to reduce the number of potential problems, finding the best solid form for manufacture through a polymorph study or screen, developing a manufacturing process and formulation that preserves this form, and adopting process analytical technology and quality-by-design principles.
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Biopharmaceuticals market overviewPharma companies are forming alliances with less established biotech companies, which significantly drive the technological innovation and the overall market growth.
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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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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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Parallel trade and free movementThe principle of free movement of goods entrenched in the European Treaty makes it difficult for anyone to stop trading of a product between member states
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A novel aid for the preparation of pellets by extrusion/spheronizationMicrocrystalline cellulose is the main excipient used in the industrial manufacture of pellets by extrusion/spheronization, but pellets containing this spheronizing aid do not readily disintegrate and are expensive.
