Authors
Latest:
Coater Modul for MINILAB XPThe MINILAB XP by DIOSNA is a well-known laboratory processor. With our new Coater Modul we offer a unit with a fluid bed processor and a horizontal coater in one.
Latest:
Veltek Associates, Inc.VAI’s manufacturing and testing operations mirror current GMP/GLP standards.
Latest:
Don’t underestimate the "small stuff"Learn about the importance of considering human factors testing beyond the initial validation phase. Through two case studies, it illustrates how seemingly minor product changes can trigger regulatory scrutiny. The message is clear: proactive testing and expert guidance are essential to navigate regulatory requirements effectively.
Latest:
Using Solar Energy for Process HeatingRenewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
Latest:
Vcaps® EntericLatest:
Considerations when Quantifying Amorphous Contents in Milled Powders with CalorimetryInterpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
Latest:
Morphologically-Directed Raman Spectroscopy: Uncovering the Good, the Bad, and the Ugly in Drug FormulationsMDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
Latest:
Gluing Pills Technology for the Production of Multi-Layer TabletsThis novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.
Latest:
Gluing Pills Technology for the Production of Multi-Layer TabletsThis novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.
Latest:
Improving the Dissolution of Poorly Soluble APIs with Inorganic Solid DispersionsSolid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.
Latest:
Improving the Dissolution of Poorly Soluble APIs with Inorganic Solid DispersionsSolid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.
Latest:
Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
Latest:
Exploring a Modern Control Strategy for Wurster CoatingA process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
Latest:
Self-Guided Control of a Fluid Bed Granulation ProcessAdvanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.
Latest:
Self-Guided Control of a Fluid Bed Granulation ProcessAdvanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.
Latest:
Exploring a Modern Control Strategy for Wurster CoatingA process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
Latest:
New Nexera Prep Better Prep!Shimadzu has introduced its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). “Preparative HPLC” is a process in which specific substances are separated and purified from samples.
Latest:
Wet Granulation Resolves Tablet Reformulation ChallengesA case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.
Latest:
Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
Latest:
Deviation Investigation Format and Content: A Guide for Inspection SuccessThis article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Latest:
Countering the Loss in Efficiency Caused by Mandated Serialization Complianceigital tracking of overall equipment effectiveness can improve efficiency.
Latest:
Chemspec Europe 2022 35th International Exhibition for Fine and Speciality ChemicalsChemspec Europe is the fine and speciality chemicals exhibition held in Frankfurt, Germany, providing a powerful industry platform for product sourcing, networking opportunity and knowledge transfer via a comprehensive conference programme.
Latest:
Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
Latest:
Navigate your Efficient-Pro journey with professional supportThis asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds. Readers will learn about the tailored assistance provided at every stage, including troubleshooting, recommendations
Latest:
Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable StudiesSolid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
Latest:
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Latest:
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Latest:
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
