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The Square Root of N Plus One Sampling RuleManufacturers who use the square root of N plus one rule as part of their overall sampling plan may be surprised to learn of its inadequacies and whether it truly represents the entire batch.
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The way forward for process monitoring and controlWhen it comes to quality assurance and quality control in pharmaceutical solid dose manufacture, Fourier-Transform Near Infrared spectroscopy may be the answer.
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Studies of PLGA MicrospheresIn this article, the authors describe a study into the factorial effect of selected process parameters on the pharmaceutical characteristics of poly(DL-lactide-co-glycolide) microspheres containing methotrexate. A study of the microspheres' stability at refrigerated temperatures is also examined.
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Drying: moving from batch to continuous processesThe requirements of a granule drying process haven?t really changed much in recent years: pharmaceutical companies still need a process/technology that is capable of drying the produced granules as fast as possible, without affecting critical quality attributes (CQAs), such as particle size and homogeneity.
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Oral Low Molecular Weight Heparin Absorption From Solution and Solid Dosage Forms in Rat, Dog, and Monkey ModelsThe delivery agent-mediated transport of low moleular weight heparin across Caco-2 cells is accomplished without opening the junctions or adversely affecting the structural integrity of the cell monolayer.
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Improving Feeder Performance in Continuous Pharmaceutical OperationsDesigning loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.
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Analysis of Environmental Microbiology Data from Cleanroom SamplesCurrent microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
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Integrating PAT into biopharmaceutical research: a case studyThis case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease.
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Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological IndicatorsIn anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.
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Stabilization of Interferon alpha-2b in a Topical CreamThe authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.
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High-Resolution Ultrasonic Spectroscopy: Analysis of MicroemulsionsThis article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
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LC-MS today and tomorrowLiquid chromatography-mass spectrometry (LC-MS) is a highly sensitive and specific analytical chemistry technique that is very commonly used in pharmacokinetic studies of new chemical entities.
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Quality by Design for Generic DrugsThe authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
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Pros And Cons Of Roll CompactionThere are two types of widely used dry granulation methods: slugging and roll compaction. Currently, roll compaction is preferred to slugging because it offers greater capacity and ease of process control.
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Preventing Tablet Tooling ProblemsTooling can be damaged by poor handling or problems in process design or material choice.
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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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The benefits of risk-based analyses during system validationWhen validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.
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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime ProxetilThis study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
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An Overview of the Validation Approach for Moist Heat Sterilization, Part IIPart II of this article describes the installation, operational, and performance qualification of an autoclave and discusses a system for change control.
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Is another ODT excipient necessary?Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.
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Physicochemical Approaches to Enhancing Oral AbsorptionThis article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.
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Finished Product Monographs in the European PharmacopoeiaThe European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.
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Granulation: evolving slowly but surelyGranulation is the most crucial step in the manufacture of solid dosage forms.
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The Importance Of Filter TestingGraham Rideal of Whitehouse Scientific explains the importance of filter testing and offers some considerations with regards to choosing filter test methods.
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Establishing a Minimum Incubation Time for Biological IndicatorsThe industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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Pharma's FacebookSocial media is big news. From Facebook to Twitter, individuals are embracing the opportunity to participate in online publishing at an unprecedented rate. Communities of users interact globally, minutetominute within huge databases of content that they themselves create.
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Coding technologies: breaking down the barriersTablet coding or identification is based either on the detection system being overt (visual to the naked eye) or covert (non-visual). The coding of tablets is obvious at an overt level because of size, shape, colour and logo design.
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The combination drugs debate: Incompatibility problems can be overcomeCombining drugs with synergistic mechanisms of action yields some indisputable benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few.
