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Developments in Scanning Electron Microscopy for Tablet and Granule CharacterizationRecent advances in SEM, particularly the incorporation of automation and software, have made simpler, lower-end SEM instruments easy to operate and have improved the capabilities of larger, sophisticated instruments.
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Zebrafish: a multifaceted approach for drug safety assessmentMany compounds fail in preclinical development because of safety-related problems, but identifying 'predictable' safety or toxicity liabilities earlier in the process could lead to improved design and selection of compounds that are more likely to be approved.
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An Integrated Approach to BioinformaticsDuring the last few decades, advances in molecular biology have allowed the increasingly rapid sequencing of large portions of genomes. The plethora of information, resulting from programmes such as the Human Genome Project, has necessitated the careful storage, organization and indexing of sequence information. This, in turn, has led to the development of numerous sequence databases such as GenBank and EMBL. This article examines how an integrated approach to bioinformatics could help researchers align their work, share data and, ultimately, significantly increase productivity.
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Upcoming technologies to facilitate more efficient biologics manufacturingThe number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
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Promoting a peaceful workplaceConflict between departments costs money, wastes time and hinders strategy implementation. But we can reduce it and manage it if we understand it, says Dr Brian D. Smith.
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Supply-Chain Security of Pharmaceutical Starting MaterialsIPEC Europe continues to promote the quality, safety and functionality of excipients used in pharmaceutical products.
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Managing the risks of PATOperational excellence awaits, but only if you can implement PAT successfully.
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Evaluating Practical Uses of Molecular Isotopic EngineeringThe authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
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Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution DataThe authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.
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Use of Artificial Neural Networks and Genetic Algorithms - Experiences from a Tablet FormulationThis article describes the formulation of a tablet for a specific purpose, primarily using fractional or full factorial designs. The formulation work generated a matrix that was processed by two software packages based on neural networks. When the dataset was divided into smaller subsets, the agreement between the predicted and observed tablet properties of the optimized formulations was reasonable.
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Manufacturing problemsMany industries, from aerospace to medical devices, conduct cleaning procedures.
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Hypothesis to acceptanceDuring the last 20 years, pharmaceutical R&D spending has increased 15-fold while new product approvals have increased only 0.70-fold.
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Keeping It Together: Reducing Powder Segregation in Vacuum ConveyingVacuum-conveying technology is commonly used in the pharmaceutical industry to move materials through the processing line, blend ingredients in various solutions, and handle tablets. The vacuum conveying of powders and granules, however, must be performed properly to avoid segregation, the separation of ingredients that results in an uneven mixture.
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Qualification of a Chromotographic ColumnIn this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.
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Predictive modelling: putting ICH guidelines to work in process validationWhen applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
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Bioanalysis of recombinant proteins by mass spectrometryBiotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.
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Pseudo-polymorphic conversion by near-infrared spectroscopyNear-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).
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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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Characterizing amorphous materials with gravimetric vapour sorption techniquesEven small amounts of amorphous materials can have a significant effect on the drug product. Are gravimetric vapour sorption techniques an effective solution to characterize amorphous materials?
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LC–MS/MS method for the determination of Vitamin D3 in human plasmaAn LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
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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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Effects of Polyethylene Glycol on Morphology, Thermomechanical Properties, and Water Vapor Permeability of Cellulose Acetate-Free FilmsThe authors provide a systematic evaluation of the effects of solvent systems, PEG molecular weight, and concentration of CA to PEG on the thermomechanical properties and permeabilities of CA-free films.
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Monitoring Granulation Drying Using Near-Infrared SpectroscopyA novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
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Bioanalysis of recombinant proteins by mass spectrometryBiotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.
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Fast dissolving disintegrating tablets with isomaltDuring the past years, there has been increasing demand for fast dissolving disintegrating tablets (FDDTs), such as orally disintegrating tablets (ODTs) and sublinguals.
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Rapid and convenient microsphere sizingFDA advocates building quality into a product through PAT.
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Upcoming technologies to facilitate more efficient biologics manufacturingThe number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
