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Changes in US Policy: What Generic Pharmaceutical Companies Need to KnowIn this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2
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HPLC Method Development and Validation for Pharmaceutical AnalysisThis article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical method validation.
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Positron Emission Particle Tracking Studies of a Wurster Process for Coating ApplicationsWurster coating provides excellent film uniformity and god active-component distribution. The authors describe the results of a study using the Wurster method with positron emission particle tracking technology.
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Improving Protein Capture for Transgenic Drug ProcessingOne of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.
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Taming the Regulatory Beast: Regulation versus FunctionalismMass spectrometrists working in pharmaceutical development tend to approach the issue of regulatory compliance with some trepidation...
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Cleanroom Pressurization MethodologyFacilities with rigidly controlled environmental parameters can take steps to meet precise and repeatable conditions.
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Defining and Managing Raw Manufacturing DataProtecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
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Keeping Supply Chains HealthyToday's fast-paced global market place has created a critical need for efficient international supply systems in the healthcare sector...
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Organic Impurities in Chemical Drug SubstancesChemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances. Future developments and suggestions for those working in quality control and raw material selection are discussed.
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Experimental and computational methods for understanding pharmaceutical flows, Part II: Large-scale production equipmentFlow problems, such as process performance and reliability, can be improved using a combination of experimental and computational methods.
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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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The Hidden Economic of Calibration ManagementThe importance of calibrating instruments used in manufacturing processes is well known, particularly for highly regulated industries such as pharmaceutical production. This article discusses software applications used to support calibration management, and the potential economic gain to be had by replacing a standalone software application with a capable enterprise system.
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The Need for Effective Document Change Management in the Pharmaceutical IndustryWith the advent of regulations such as 21 CFR Part 11 and the introduction of the electronic common technical document, it is becoming increasingly important to be able to enhance and fully utilize data management systems. Document change management is a vital tool in the construction and organization of valuable information, and can play a key role in the all-important process of getting a product to market.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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New Developments in Spray-Dried LactoseRecent advances in spray-drying technology have led to the production of new directly compressible lactose grades with distinct advantages.
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Residual Solvent Analysis in PharmaceuticalsResidual solvents in pharmaceuticals are organic, volatile chemicals that are either used or produced during the manufacture of actives, excipients or drug products. These chemicals may be hazardous to human health; however, their acceptance limits and classification vary among the three major pharmacopoeia. In this article, the author discusses the regulatory status of the various classifications of residual solvents with regard to the European, US and Japanese pharmacopoeia.
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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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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.
