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Analysing Raw Materials and Formulations Using High Resolution Ultrasonic SpectroscopyHR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.
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Solubility, Polymorphism, Crystallinity, Crystal Habit, and Drying Scheme of (R, S)-(±)-Sodium Ibuprofen DihydrateThe racemic compound (R, S)-(±)-ibuprofen is a popular and well understood active pharmaceutical ingredient, but it has several disadvantageous formulation properties such as poor solubility, low melting point, and potential esterification with excipients containing an hydroxyl group. The authors investigate the use of an (R, S)-(±)-ibuprofen salt to evaluate these problems using various analytical methods to determine the polymorphism, crystallinity, and drying scheme.
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Speeding up the move to PATThe big challenge for pharmaceutical companies is to mathematically model their production processes, combining both data from the laboratory and the production process.
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Vibration Technology for Active Dry-Powder InhalersA new active dry powder inhaler has been developed using vibration frequencies to aerosolize powders.
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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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A new system for the rapid transfer of sterile liquid through a containment wallSterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.
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Sustainability at Work: Solar EnergyNew Age Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, implements a solar-energy project at its Pennsylvania facility.
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The Benefits of Process Information Management in R&D - A Case StudyThis case study examines the benefits of introducing process information management software to a pharmaceutical pilot plant. The advantages illustrate the potential for process development and commercial manufacturing improvements that are available to the pharmaceutical industry.
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How Banning Titanium Dioxide Might Impact PharmaThe impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Planning and Designing a Pharmaceutical Facility: A Process Designer's ViewPlanning manufacturing capacity in the pharmaceutical industry is not for the faint-hearted. How can process designers help their clients to overcome some of the problems they face when planning to introduce new capacity? This article sets out to explain some of the techniques that are being employed in the early stages of project development.
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Uniformity of Bioprocessing Equipment ManufacturingThe American society of Mechanical Engineers's Council on Codes and Standards has formed 10 subcommittees to update and broaden the scope of the BPE standards.
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Excipient-Excipient Interactions in Pharmaceutical Systems Intended for Topical ApplicationBioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.
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The state of validation in the European UnionSince the formation of the European Union (EU) in 1993, each member state has brought along its own regulatory baggage, namely the standards and regulations that their companies are formally required to comply with. These standards and regulations still apply for any pharmaceutical products a native manufacturer decides to market within their homeland. When the same manufacturer markets its pharmaceutical products to consumers in other EU member states, the regulatory directives of the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) apply as well.
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Formulation Variables on Pellets Containing Self-Emulsifying SystemsThis high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.
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Adsorption of small drug particles at the surface of large excipientsApplications of adsorption of small drug particles at the surface of large excipients were introduced, and different factors affecting adsorption process were discussed and summarized. Several examples of adsorbing drugs to excipients to increase dissolution rate were exhibited in this article.
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Automating HPLC and GC Analytical Method ValidationA newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.
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Adsorption of small drug particles at the surface of large excipientsApplications of adsorption of small drug particles at the surface of large excipients were introduced, and different factors affecting adsorption process were discussed and summarized. Several examples of adsorbing drugs to excipients to increase dissolution rate were exhibited in this article.
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Brussels ReportWhile Europe's political leaders were paying lip-service to creating a more competitive Europe at their spring summit in Brussels, European pharmaceutical technologists were tackling the serious business of turning political rhetoric into practical reality.
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Formulation Variables on Pellets Containing Self-Emulsifying SystemsThis high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.
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Continued Process Verification for Cleaning Validation– Challenges and PitfallsContinued process verification for a cleaning validation program begins once the validation study is complete.
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Manufacturing High-Potency Drugs Using IsolatorsThe author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.
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Removal of Particles by Ultrafiltration SystemsPure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.
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Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution DataThe authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.
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Avoiding Contamination Risks in Aseptic ProcessesHow to avoid invisible and airborne contamination.
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Rise of the robotsThere is a rapidly growing ageing population that requires sophisticated medical devices and newer drugs. This is likely to result in an increase in the use of robotics to improve manufacturing efficiency. This article looks at the role of SCARA robots in pharmaceutical plants and laboratories.
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More Than Skin DeepRecent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.
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The End of the 21 CFR Part 11 Controversy and Confusion?More than 6 years have elapsed since the US Food and Drug Administration's (FDA's) 21 CFR Part 11 regulations regarding the use of electronic records and electronic signatures came into effect.1 In February 2003, FDA issued new draft guidance concerning the scope and application of Part 11, which describes how the agency intends to interpret and enforce the requirements during its ongoing re-examination of the regulations.2 Many people in the pharmaceutical industry have welcomed this new guidance and see it as a positive development that will lead to a simplified FDA approach to Part 11 and a significant reduction in the industry's compliance burden.
