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Particle Engineering for Improved Dispersion in Dry Powder InhalersRespirable drug delivery is becoming increasingly popular because it provides a non-invasive route with rapid drug uptake, not only for the treatment of respiratory complaints, but also for the systemic delivery of substances that cannot be delivered orally.
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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert OpinionsEuropean expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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Segregation of Powders during Gravity Flow Through Vertical PipesThe authors establish a quantitative framework for understanding the correlation between the segregation of pharmaceutical powders and various physical and process parameters.
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Lyophilization is not a freeze-dried technologyIn view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.
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E-Procurement — Successfully Using and Managing Reverse AuctionsReverse auctions can benefit both buyers and suppliers of goods and services, but extensive preparation and careful management are required to obtain those benefits.
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Understanding past & proposed changes to USP Chapter on Total Organic CarbonThe implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.
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Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
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Nanostructured Lipid Carriers: A Novel Generation of Solid Lipid Drug CarriersNanostructured lipid carriers are a new type of delivery system offering improved performance in terms of drug loading and long-term stability with the ability to form highly concentrated dispersions...
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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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FDA's PAT initiativeFDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.
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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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Behavior of Uptake of Moisture by Drugs and ExcipientsThe influence of light on the rate of moisture gain was investigated in 36 drug substances and 18 excipients.
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What Will It Mean to the Patient?Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.
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Roller Compaction Feasibility for New Drug Candidates: Laboratory to Production ScaleThe authors provide a method to predict whether a material is suitable for dry granulation by roller compaction.
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Asset Management Tools for Minimizing Regulatory Risk and Maximizing EfficiencyResolving the asset headache - the author explains how effective asset management can enable pharmaceutical companies to boost operational profit, increase production uptime and adhere to regulatory standards.
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Near-Infrared Spectroscopy as a Process Analytical ToolImproving product quality and lowering costs are the key factors behind the decisions made in many industries. Ensuring product quality throughout the manufacturing process can be time-consuming, with materials and products 'quarantined' until test results are generated. Rapid testing by near-infrared (NIR) spectroscopy at all stages of the manufacturing process can reduce production time and provide assurances at each step of the process that product quality is being maintained.
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The influence of monoglycerides, mixtures and derivatives on the formation of pellets by extrusion/spheronizationThe previous studies on the incorporation of glyceryl monostearate into pellets by extrusion/spheronization has been extended to include a range of grades of this material plus a mixed medium chain partial glyceride and two glycerol esters of hydrogenated natural glycerides as described in this article.
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Configuring Software for Compliance with 21 CFR Part 11 Audit Trail RequirementsUntil specific audit trail requirements are available from the US Food and Drug Administration, manufacturers must define their own parameters for software system compliance and decide for themselves how to meet those requirements.
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Parallel trade still a grey area for GSKThe refusal to sell was motivated by a desire to maximize GSK's profits, and GSK had not shown that not having these profits would prejudice consumers by restricting GSK's R&D.
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Microstructured transdermal systems for intradermal vaccine and drug deliveryThe needle and syringe have long been the standard delivery technology for vaccines. However, a confluence of market factors is driving new interest in alternative delivery systems that hold the potential to meet one or more of the following goals: improved antigen utilization, higher quality immune response, better stability and improved patient acceptance. Of particular interest are microneedle systems, otherwise referred to as microstuctured transdermal systems (MTS), that provide for targeted delivery of the vaccine formulation directly to antigen-presenting cells within the epidermis. This article provides a brief overview of MTS technology with an emphasis on solid-coated MTS for vaccine delivery.
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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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Coming to Terms with ComplianceThe pressure on the pharmaceutical industry to manufacture products faster and more cost-effectively has never been greater. Additionally, companies must also meet stringent regulations set by authorities such as the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). This article explores the importance of complying with regulations and validation, how to maintain compliance and looks at some of the consequences of non-compliance.
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Synthetic Excipients Challenge All-Natural OrganicsSynthetic excipients frequently offer advantages over all-natural compounds.
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Improving Dose Content Uniformity Testing for MDIs and DPIsIt has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
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From the Formulator to the Tablet Manufacturing Floor: Desiderata and TroubleshootingTablet manufacturers often overlook critical basic concepts or established practices. The author draws from his own experiences and discusses how solid dosage manufacturers can improve production and product quality by optimizing major unit operations.
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Particle Engineering for Improved Dispersion in Dry Powder InhalersRespirable drug delivery is becoming increasingly popular because it provides a non-invasive route with rapid drug uptake, not only for the treatment of respiratory complaints, but also for the systemic delivery of substances that cannot be delivered orally.
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The Granulation Process 101: Basic Technologies for Tablet MakingThe author offers a primer for choosing the correct granulation process to improve yields, reduce tablet defects, and enhance productivity.
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Analytical Techniques for Oral Solid Dosage FormulationAnalytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
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Aqueous Cleaning and Solvent Substitution in Chemical Synthesis API ManufacturingOrganic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.
