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Rapid and convenient microsphere sizingFDA advocates building quality into a product through PAT.
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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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A Corn Starch/a-Lactose Monohydrate Compound as a Directly Compressible ExcipientThe tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components (separately and with drugs) and the individual constituents. The compaction properties were also investigated. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.
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The Effect of Mill Type on Two Dry-Granulated Placebo FormulationsThe authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility.
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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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Renaissance manWe have to make the politicians understand that if we don't take biotech seriously then tourism will be our premier industry in the future.
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Using High Temperature HPLC for Improved AnalysisOperating HPLC at higher than ambient temperatures can improve peak shapes and enable faster run times. Preheating the mobile phase is significant in high temperature liquid chromatography as the relationship between temperature and viscosity strongly influences the mobile phase flow profile and the diffusion characteristics. With temperature programming, thermal gradients mimic solvent gradients because of the changing polarity of the mobile phase and interactions with the stationary phase; often thermal gradients can replace solvent gradients.
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Drinking from a fire hoseThe pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.
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Rapid and convenient microsphere sizingFDA advocates building quality into a product through PAT.
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An LC Method for the Separation and Determination of Ethynodiol Diacetate and Ethinyl Estradiol in TabletsThe author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.
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Partnership powerTranScrip Partners' Flic Gabbay explains why an approach that provides expertise on an 'as needed basis' is flourishing.
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The role of bracketing and matrixing in efficient design of stability protocolsThis article looks at the use of bracketing and matrixing to lower the number of stability samples required and, consequently, reduce the cost of sample production, testing and management. There is a common misconception that regulatory authorities will not accept such methods, but there is actually an International Conference on Harmonization guideline (ICH Q1D) on the subject. In fact, many of these designs have already been accepted and FDA members were among the first to describe matrixing.
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Understanding immunogenicity responsesA discussion of the basic principles of immunity and the nature of antibodies.
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Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal ProductThe authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.
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Successful and stress-free LC method transfers – application compendiumThis compendium offers a resource to help tackle the common instrument challenges faced during method transfers to obtain consistent results and sustain regulatory compliance.
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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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Organizational polygamyPaul Gardiner and Andrea Sobrio explain why most companies need 'organizational polygamy' to maximize profit and best serve their customers.
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Learning from Lean SigmaLean Sigma approaches can reduce waste, cost, cycle time and variability in outputs.
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Advances and perspectives in intracellular biomolecule deliveryThe introduction of biomolecules into cells is a key technology for research in biological sciences.
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Criticality Management of a Drug Product and its Manufacturing ProcessCriticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.
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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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Criticality Management of a Drug Product and its Manufacturing ProcessCriticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.
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Why the future is in fragments?High-throughput screening (HTS) of compound libraries is the most widely adopted approach to hit discovery because it is the only generic way of addressing a variety of targets on an industrial scale.
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Using Robotics in the Aseptic Manufacturing Facility of the FutureSeveral steps need be taken to achieve lights-out, fully automated operations.
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Spherical Crystallization for Lean Solid-Dosage Manufacturing (Part II)In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.
