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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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Belgium: Will its enviable geographic position continue to ensure success in pharma?Belgium is one of the largest centres for pharmaceutical distribution and has the second highest number of pharma exports per capita worldwide.
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A new tool to battle counterfeitsJeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.
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Successful packaging of aseptically prefilled productsWhy correctly calibrating a drug with its packaging is the key to success.
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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer ToolThe authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
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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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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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Selecting Lactose for a Capsule-Based Dry Powder InhalerDry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
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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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Human error costs industry billionsOne of the greatest risks to the success of a business is human error caused by employees' misunderstanding of key aspects of their job roles, and this risk is commonly overlooked or underestimated.
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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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Evaluating the Impact of the Falsified Medicines Directive in SwitzerlandAs the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.
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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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Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample SizesThe ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
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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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Dynamic avalanching accurately assesses flowability and qualityCefaclor is a β-lactam cephalosporin antibiotic that has a wide particle size distribution. Because of the nonporous nature of the material, the specific surface area value accounts for a significant amount of fine particles possibly present in the samples under analysis.
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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.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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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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Simplifying data managementPaper is no longer a sufficient format for information storage and interchange in the pharmaceutical industry; documents are inflexible and costly for production and storage.
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The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PATThe author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer ToolThe authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
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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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Innovations in dissolution testingHaving been directly involved in the evolution of dissolution testing since its introduction in the early 1970s and variously representing Hanson, Van Kel, Sotax and Erweka prior to developing our own range of dissolution testers in 2002, I would have to say that advances in dissolution testing technology have been one of the biggest breakthroughs in solid dosage form testing over the last decade.
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Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
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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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Belgium: Will its enviable geographic position continue to ensure success in pharma?Belgium is one of the largest centres for pharmaceutical distribution and has the second highest number of pharma exports per capita worldwide.
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Nanotechnology: the next silver bullet?A number of commentators during the past few years have speculated that nanotechnology is the wave of the future in biotech and pharma.
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Resealed Erythrocytes: A ReviewErythrocytes, the most abundant cells in the human body, have potential carrier capabilities for the delivery of drugs.
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Is There Such a Thing as a Best-in-Class Lab? Benchmarking of QC OperationsThis article investigates what defines a best-in-class QC lab based on experience of implementing operational improvement projects in world-class labs. It includes an assessment of a benchmarking process, a case study of improvements made as a result at one company and findings on what constitutes best-in-class for QC labs.
