Authors
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Establishing Material Compatibility, Process Conditions, and Bubble Points of FiltersThe authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.
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Peer-Reviewed Technical Note: Quality by Design in Freeze-DryingCycle design and robustness testing using advanced process analytical technology.
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Effect of Formulation and Process Variables on Matrix Erosion and Drug Release from a Multiunit Erosion Matrix of a Poorly Soluble DrugBy optimizing formulation and process varibles, pellets can be prepared that can release a poorly soluble drug for 12-24 h following zero-order kinetics.
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Quality by Design for analytical methods for use with orally inhaled and nasal drug productsThe design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
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Narrowing the gap between clinical capsule formulations and commercial film-coated tabletsBased on formulation simplicity and blinding capability, hard gelatin capsules are preferrable compared with other oral solid dosage forms, including tablets, in the early clinical phases of drug development.
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A Case for Developing a Standards-Based Approach to Plug-and-Play EquipmentIndustry needs a standard to connect systems and equipment sooner rather than later.
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Inside IPEC: Excipient Pedigree as a Supply Chain ToolIt's time to maintain a thorough traceable excipient trail.
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Analysis of the Indian Pharmaceutical IndustryIndia's pharmaceutical industry, which is one of the country's major economic sectors, is poised to make signficant gains on the global market.
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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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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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Orally disintegrating tablets: the path to improved patient compliance and enhanced life cycle managementOrally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.
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Hot-melt extrusion: an emerging drug delivery technologyHot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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Joining the parallel lines...some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence...
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Fast dissolving disintegrating tablets with isomaltDuring the past years, there has been increasing demand for fast dissolving disintegrating tablets (FDDTs), such as orally disintegrating tablets (ODTs) and sublinguals.
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Formulation of Lactose for Inhaled Delivery SystemsDry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.
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Better, wetter: an alternative approach to calcium carbonate granulationNew research suggests calcium carbonate tablets are stronger and less porous when manufactured using a wet, rather than a dry, granulation process.
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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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Dual Injection (U)HPLC for Analysis of PharmaceuticalsThis application demonstrates the efficiency, throughput, and reliability of a dual injection system for finished pharmaceutical products and in-process APIs.
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Dispensing Biopharmaceuticals with Piston and Peristaltic PumpsPiston pumps have been a traditional liquid-filling technology for biopharmaceutical manufacturers, but new challenges, stricter validation requirements, and design innovations have led manufacturers to consider peristaltic filling technology.
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Biopharmaceutical Form and FunctionA timely new book explains techniques for conformational analysis.
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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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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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Process Considerations During API DevelopmentThis article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...
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Characterizing amorphous materials with gravimetric vapour sorption techniquesEven small amounts of amorphous materials can have a significant effect on the drug product. Are gravimetric vapour sorption techniques an effective solution to characterize amorphous materials?
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Hot-melt extrusion: an emerging drug delivery technologyHot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
Latest:
Better, wetter: an alternative approach to calcium carbonate granulationNew research suggests calcium carbonate tablets are stronger and less porous when manufactured using a wet, rather than a dry, granulation process.
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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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Learning from Lean SigmaLean Sigma approaches can reduce waste, cost, cycle time and variability in outputs.
