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Enhancing the in vitro assessment of nasal spraysNasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds.
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Understanding immunogenicity responsesA discussion of the basic principles of immunity and the nature of antibodies.
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Counterfeits: reducing the growing threatSteps companies can take to help safeguard patients and the pharma supply chain.
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Erythritol: A New Multipurpose ExcipientErythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.
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Implementing Successful Stability Testing OperationsStability studies are essential to every phase of a drug's life cycle. They not only document that a product will maintain its potency during its stated shelf life, but that it will do so under a variety of storage conditions as well.
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20th Anniversary Special Feature: Validation and qualificationHow has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future?
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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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.
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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.
