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Scale-up trials of foam-granulation technology — high shearThe authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
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Mefenamic acid: new polymorph or crystal defect?Mefenamic acid has variable bioavailability and tabletting issues because of its hydrophobic nature and poor material characteristics. Recrystallization of mefenamic acid was performed from three different solvent–solvent mixtures under differing conditions. The crystals obtained were screened for the existence of new crystal properties or polymorphic forms, then characterized further.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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A Raman spectroscopic method to monitor magnesium stearate in blends and tabletsA new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.
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Manual versus Automated Actuation of Nasal Sprays: Applications for Droplet SizingAutomated actuation of nasal sprays removes operator bias during measurement of particle size, spray-plume geometry, and delivered dose.
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The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
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PAT — a team effortThe biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.
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The Use of Acrylic Resins for Improved Aqueous Enteric CoatingRecent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets
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Avoiding pitfalls in scaling up biopharmaceutical productionThe scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.
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Artificial intelligence the key to process understandingIn recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.
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Polymers for CNS drug deliveryThere is a tremendous need to enhance delivery of potential therapeutics to the brain for treatment of central nervous system (CNS) disorders. The blood brain barrier (BBB) restricts and controls the exchange of compounds between the CNS and the blood, which requires discovery of new modalities allowing for effective drug delivery to the CNS. Polymer nanotechnology has now become one of the most attractive areas of pharmaceutical research. This review focuses on the current progress in polymeric nanoparticles, where the specific arrangement of the polymeric matter at the nanoscale is utilized to design drug delivery systems that provide safe and efficient transport of CNS drugs across the BBB.
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Avoiding pitfalls in scaling up biopharmaceutical productionThe scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.
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Pharmaceutical LIMS — finding your way to the best solutionVendors who insist on using older and outdated technologies will eventually suffer increased pressure to follow the lead of those who adopt new technologies.
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The Effect of Vaporous Phase Hydrogen Peroxide on Sterility Test DevicesClosed and disposable sterility testing devices reduce the risk of false positive results during sterility testing. To further prevent such results, some pharmaceutical manufacturers use the device inside a sterility testing isolator, which is decontaminated using sterilant gases or vapours. In this study, closed, disposable sterility test devices were exposed to two 90 minute vaporous phase hydrogen peroxide (VPHP) decontamination cycles within a sterility testing isolator and tested for device integrity, bacteriostasis/fungistasis and non-volatile residue content. The results showed that the VPHP used to decontaminate the isolator before sterility testing did not affect the device.
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The Application of Robotics to Aseptic Environmental Surface MonitoringThis article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
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FMEA toolThis downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.
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The Application of Robotics to Aseptic Environmental Surface MonitoringThis article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
Latest:
Artificial intelligence the key to process understandingIn recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.
Latest:
A Look at 30 Years of Change in Pharmaceutical AutomationAutomation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.
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Filter Integrity Testing in Liquid Applications, Revisited Part IIIn the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.
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Carriers for DPIs: formulation and regulatory challengesThe presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.
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Calorimetry — the fully scalable PAT toolTo date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.
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Therapeutic antibodies: the next generationThe identification of an increasing number of drug targets coupled with advances in manufacturing technology could lead to many more blockbuster therapeutic antibodies.
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Scale-up trials of foam-granulation technology — high shearThe authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
Latest:
Systematic Troubleshooting for LC/MS/MSMeeting the challenges of large-scale LC/MS/MS such as elminating carr-over and matrix effects can increase sensitivity and improve turnaround times.
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The Application of Robotics to Aseptic Environmental Surface MonitoringThis article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
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Determination by Analytical Sieving: Particle-Size Distribution, Part IIIThe author discusses the use of analytical sieving to determine the size distribution of granular and course powders and describes proper sieve construction and USP General Test {786}.
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A Look at 30 Years of Change in Pharmaceutical AutomationAutomation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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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.
