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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.
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Considerations for Cleaning Lipid NanoparticlesThis article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.
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Embryonic stem cells: the moral dilemma of patentability and fundingHuman embryonic stem cells are of immense interest to researchers because of their ability to potentially develop into any kind of tissue.
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Prefilled Syringes: Challenges, Innovations And MarketThe pharma industry is constantly seeking drug delivery technologies that can increase compliance, improve the quality of delivered care, reduce medication errors and reduce the possibility of admixture-related contamination.
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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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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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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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Large-Scale Manufacture of Therapeutic Human Stem CellsLarge-scale manufacturing of human stem cells for therapeutic use is a leap in technology and science for the current biotechnology industry.
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The Pharmaceutical Development of Inhalation Medicines and the Value of OutsourcingA knowledgeable and experienced contract service provider can help in the development and success of an inhalation drug product.
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Qualification and Validation of Single-Use Shipping SystemsIn this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.
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The Death of the Drug DossierFor nearly 40 years, drug dossiers have supported the quality, safety and risk/benefits of medicinal products. However, electronic technological advances mean that the dossier will soon be a thing of the past - being replaced by e-documents that can be reviewed and approved online by regulators, under the scrutiny of patient groups and with the final blessing of purchasers, as this article examines.
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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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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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The combination drugs debate: unstable and unpatentableCombination products have been researched and administered for many years, some successfully and others not.
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Identification and Quantification of Trace-Level Protein ImpuritiesThe authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
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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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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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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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The Formulation and Evaluation of Topical Berberine-Hydrochloride ProductsThe authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.
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Western CMOs Rise Again, Face New ChallengesIncreased competition from CMOs in Asia means that Western CMOs need to understand fundamental changes in the market.
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Filling of Asthma Inhalers with Liquid Nitrogen: Cryogenic Product Cooling of Aerosol PropellantsThis case study describes how a major pharmaceutical manufacturer was equipped with four filling lines, for metered dose inhalers, supplied with a nitrogen cooling system to prevent spontaneous vaporization of the propellant gas. By doing so, a cost-effective and environmentally friendly solution was provided to a hazardous situation, which also complied with regulatory directives.
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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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Lies That Environmental Monitoring Systems TellEnvironmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
