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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.
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The Route to Process Understanding and ControlMeasuring, understanding and ultimately controlling manufacturing processes offers pharmaceutical companies a route to greatly enhance the business effectiveness of both their product development process and facilities. PAT creates technological, business process and regulatory frameworks to enable this. This paper looks at a PAT overview within the context of developing and manufacturing a tablet product, highlighting the potential of FT-NIR spectroscopy.
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Optimizing the Mixing ProcessImproved products and processes that are cleaner, less expensive, more manageable and take up less space are benefits that you would expect to be snapped up by any industry. But not so in pharmaceutical manufacturing, where traditional methods prevail.
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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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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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Optimising High-Potency ManufactureEffective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
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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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Hyperthermophilic Microorganisms and USP Hot Water SystemsThe author discusses why two of the industry's common practices for preventing microorganism contamination in USP hot-ware and purified-water systems may have no scientific basis.
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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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Using remote monitoring to boost performanceThe evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.
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The shape of things to comeParticle shape is an important parameter to monitor in the pharmaceutical sector, but has, historically, been too complicated to measure and be utilized on a routine basis. A newly developed digital technique could change this.
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Characterization with Atomic Force Microscopy, Topographic, and 3D RamanThe authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
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Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug DevelopmentThe author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.
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Advances in Pharmaceutical Process AnalysersProcess analysers have evolved from basic analogue devices with adjustable potentiometers, analogue current outputs and alarm relays into smart, powerful, two-way digital transmitters with advanced features, such as automatic calibration and self-diagnostics, that can transmit more information, more accurately. This article will discuss advances in process analytical devices and how they can be applied to both new and existing pharmaceutical facilities.
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Solubility, Polymorphism, Crystallinity, and Crystal Habit of Acetaminophen and Ibuprofen by Initial Solvent ScreeningSolubility, polymorphism, crystallinity, and crystal habit of acetaminophen and racemic (+/-)-ibuprofen were determined by initial screening of 23 solvents for scale-up. Solubility curves were constructed, and solubility at 25 degrees Celsius was plotted against the dielectric constants of various solvent as a fingerprint for solute identification. The total "form space" for acetaminophen and racemic (+/-)-ibuprofen were calculated to be 222 and 257, respectively. Various crystal habits and sizes for ibuprofen and acetaminophen were observed.
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USP Initiatives for the Safe Use of Medical GasesUSP monographs, if they are consistently observed and applied, can help reduce medical gas errors.
