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Hot-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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Orally 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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In this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.

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A European Commission directive requires suppliers to incorporate information on medicines in formats suitable for blind and partially sighted people, although the associated standard has not been introduced yet. This article looks at some of the issues that will need to be addressed when the standard is adopted.

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A procedures system must be well designed and managed to be effective and efficient.

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Pharmaceutical manufacturers will be-and are already&mdashfacing enormous challenges to implement the serialization regulations within the given timeframe.

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One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.

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The permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.

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The permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.

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Predicting the flow characteristics of powders during manufacture is especially important for the pharmaceutical engineer. Getting the powder flow wrong can be highly disruptive to plant performance and productivity, particularly where equipment has to be taken off-line and stripped down for cleaning out blockages. The flow behaviour of the individual ingredients may be well known, but as these are blended and reacted their flow properties can change.

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There have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.

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Large stability studies for drug products and devices with multiple strengths, packaging configurations and orientations can cost millions of dollars for the analytical testing alone.

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The pharmaceutical industry in Asia is gearing up to be at the centre of the global market. Most pharmaceutical companies in the region expect this shift to happen fast. Not only is Asia set to become the largest pharmaceutical market in the world, but many Asian territories will be the powerhouses of the industry. By 2020, the worldwide pharmaceuticals market could be worth around $1.3 trillion, with China being the second or third biggest market.

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UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.

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Water interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.

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Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

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A 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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While the Gulf region has already become well-known for its globally accepted infrastructure, and large projects in tourism and other service areas, major investments in healthcare or pharmaceuticals have failed to develop as well.

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When the United States Pharmacopeia (USP) announced a delay to the proposed implementation date of July 2007 for General Chapter <467> Residual Solvents, pharmaceutical companies supplying the US market welcomed the interim reprieve. However, meeting the new implementation date will prove challenging as the requirement applies to all existing products covered by the USP and companies must still work hard to prepare for July 2008 when <467> will finally come in.

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Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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There have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.

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With appropriate standardization from an interfacing point of view, separation science will find a broader audience in PAT.

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Robotization of end-of-line packaging systems enables manufacturers to maintain high production rates while accommodating flexible and varied product packaging requirements.

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More than ever, drug makers need to be fleet and flexible-and they need their software to be the same.

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Sterile 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.