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Development of PVA Copolymer CapsulesThe bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.
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Preclinical Dose-Formulation StabilityWhen designing stability protocols, formulation, storage, and dosing conditions must be assessed.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods.Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.
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21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current RuleFDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.
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Outsourcing Pharmaceutical Infrastructure OperationsKey considerations for outsourcing energy services.
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Achieving Localised Delivery With Magnetic VectoringWe find out more about the possibilities of nanotechnology and magnetism, and how a novel approach could improve localised drug delivery.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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Spreading of Semisolid Formulations: An UpdateSpreadability of a semisolid forrmulation is affected by factors such as formulation characteristics, rate and time of shear, temperature, site of application, and the presence of various additives.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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Spray Drying of Amorphous DispersionsSpray drying is a key process for manufacturing amorphous dispersions because of its breadth of applicability. The wide range of potential atomization techniques and controllable drying kinetics enables amorphous spray-dried dispersions (SDDs) to be produced from a wide variety of active pharmaceutical ingredients (APIs).
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Innovations of Membrane Chromatography for Biomolecular PurificationThe high dynamic binding capacity of membrane chromatography makes this system suitable for several biopurification applications.
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Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.
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Outsourcing Pharmaceutical Infrastructure OperationsKey considerations for outsourcing energy services.
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Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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The Affordable Care Act's Impact on Innovation in BiopharmaThe biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
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Choosing Cleanroom ClothingPTE quizzes Jaime Cassar, cleanroom category manager at Kimberly-Clark Professional Europe, about the importance of sterile garments for cleanroom environments.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Variable Air Velocity within Stability Chambers A Possible Cause of Out-of-Trend Stability ResultsStability data that do not follow the expected trend in comparison with other stability batches or previous results collected during a stability study are considered out-of-trend (OOT) results. OOT stability results recently have gained the attention of regulatory agencies and as a result, the approach for identifying and investigating OOT results has become a topic of increased discussion. One example is a 2003 article by the PhRMA Chemistry, Manufacturing, and Controls Statistics and Stability Expert Teams, which was intended to initiate dialogue on how to address OOT results (1).
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What Does Drug Packaging Tell Us About its Contents?The content and quality of information supplied with drug products are among the most specifically defined areas associated with the products for sale. For patient or drug user, the information is presented in patient information leaflets (PILs) placed in the package. The readability testing of PILs is an important stage in the process of making the texts contained in the summary of product characteristics comprehensible to users, as this article discusses.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Atomic Force MicroscopyAn analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.
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Mapping Sensor Placement and NumbersThis Rotronic Technical Note covers the basics of how to choose the correct number of sensors and where to place them for a proper cGMP mapping study.
