Authors
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Investigation of Out-of-Specification ResultsThe authors summarize the results of the September 2000 PhRMA workshop discussions about conducting out-of-specification investigations.
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Nanotechnology Applications for Drug DeliveryNanotechnology is believed to hold enormous promise for the future of medicine and healthcare...
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Trends in Impurity Analysis: Determination of Extractables, Leachables, Residual Solvents, and Unknowns by Mass SpectrometryAdvances in mass spectrometry have made it a valuable tool for use in the quality-control laboratory.
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Ion Exchange Resinates — The Technology Behind the MysteryIn this article, the author explains some of the technology behind using ion-exchange resins for drug delivery...
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The effect of storage conditions on the physical stability of tabletsWater interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.
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The Decline of Six SigmaThe Six Sigma approach would appear to be ideally suited to pharmaceutical processes, yet the industry has been very slow to adopt it. This article looks at the possible reasons for this, and suggests an alternative methodology that takes advantage of Six Sigma tools and techniques, backed by good statistical principles.
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Using Earned-Value Analysis to Better Manage ProjectsEVA takes into account a project's schedule and budget to determine the true cost performance.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Implementing and Maintaining a Drug Safety SystemThe collection, investigation and monitoring of suspected adverse drug reactions (SADRs), and associated product use and complaint information, is a regulatory requirement for all manufacturers of pharmaceuticals for human use.1 This process, called pharmacovigilance or drug safety, appears to be fairly standardized between different pharmaceutical companies and usually contains the elements outlined in Figure 1.
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The Preparation of Spherical Granules by Extrusion/Spheronization without Microcrystalline CelluloseThe process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.
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Dropping Method Solution for Formulating Solid DispersionsThe use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.
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The Clean Room Technology Market in the European Pharmaceutical/Biotechnology IndustryIn the pharmaceutical and biotechnology sectors, the clean room business is flourishing. Accounting for approximately 25% of the world's clean room expenditure, Europe's drug manufacturing industry is using these facilities to produce an increasing amount of biologics and biopharmaceuticals, and meet the strict legislative requirements for aseptic processing. This article reviews the current and future state of the market for clean rooms in Europe and comments on their applications.
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Topical delivery of oily actives using solid lipid particlesLipid-based drug delivery systems - such as liposomes, micro-and nanoemulsions, self-emulsified drug delivery systems, and solid lipid micro-and nanoparticles - are becoming more popular because lipid materials are easily characterized, contain a high range of well-defined/tolerated surfactant molecules and can be developed for several administration routes.
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Understanding Lyophilization Formulation DevelopmentThe author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.
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Particle size analysisAn expert on diffraction systems offers insight on particle size specifications and analysis.
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Optimizing Cross-Organizational Team Performance and ManagementTreating a cross-organizational team as a full-fledged partnership helps complete a project on time and on budget.
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Cyclodextrins as Sustained-Release CarriersCyclodextrins can improve the physiochemical properties of various sustained-release formulations.
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Field-Flow Fractionation With Multiangle Light ScatteringAbsolute macromolecular characterization is a separation technique that combines AF-FFF with MALS instruments...
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Protecting Intellectual Property Prior to CommercializationThis article looks at the different approaches to patenting in Europe and the US...
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Inside the Outsourcing Relationship: Real Life Lessons from Contract Manufacturing Services Partners… the real glue that holds the partnership - and project - together, even more so than a formal contract or quality agreement, is the ability to communicate regularly and honestly with each other.
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The Relationship between Saturated Hydrogen Peroxide, Water Vapour and TemperatureHydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
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Patients Wade into the European Pricing DebateAn important third party is struggling to make its voice heard in European pharma discussions.
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Milling Made Easy: Nanoindentation as a Predictor of Bulk PropertiesSize reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Common Cleanroom MythsMyths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.
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Making A Mark In Emerging MarketsMarc Prieur of Aptar pharma describes success stories in emerging markets.
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Technical Note: The Effect of Alcoholic Beverages on Sustained ReleaseThe authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.
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Developing and Sustaining a Quality CultureEmployee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.
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Optical Character Recognition and Code VerificationInspection systems play a big part in ensuring product quality.
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Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze DryingA new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
