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Pros And Cons Of Roll CompactionThere are two types of widely used dry granulation methods: slugging and roll compaction. Currently, roll compaction is preferred to slugging because it offers greater capacity and ease of process control.
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Preventing Tablet Tooling ProblemsTooling can be damaged by poor handling or problems in process design or material choice.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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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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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime ProxetilThis study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
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An Overview of the Validation Approach for Moist Heat Sterilization, Part IIPart II of this article describes the installation, operational, and performance qualification of an autoclave and discusses a system for change control.
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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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Physicochemical Approaches to Enhancing Oral AbsorptionThis article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.
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Finished Product Monographs in the European PharmacopoeiaThe European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.
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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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In-line UV Spectrometry Monitoring in Cleaning ValidationThe authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
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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.
