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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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Let's talk the same languageThe potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.
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Establishing Material Compatibility, Process Conditions, and Bubble Points of FiltersThe authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.
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The science behind sorbent selectionDrug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents.
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Monitoring dissolved ozone in the pharmaceutical industryEmerging technologies now enable continuous on-line monitoring and control of ozone systems, providing precise and reliable results, revolutionizing the way dissolved ozone is measured.
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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Current status in buccal drug deliveryThe adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
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PVA copolymer: the new coating agentThe use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.
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Quality by Design for analytical methods for use with orally inhaled and nasal drug productsThe design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
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FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based ApproachThe US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
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Advances in the Regulated Pharmaceutical Use of Dimethyl Sulfoxide USP, Ph.Eur.The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
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Monitoring Granulation Drying Using Near-Infrared SpectroscopyA novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
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Quality by Design for analytical methods for use with orally inhaled and nasal drug productsThe design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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Current status in buccal drug deliveryThe adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
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LCMS-9030 Q-TOF: Effortless performanceThe LCMS-9030 of Shimadzu is a research grade mass spectrometer designed to deliver high-resolution, accurate mass detection with incredibly fast data acquisition rates, allowing scientists to identify and quantify more compounds with greater confidence.
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Innovating Lifecycle Management with Data-Driven and Enabling TechnologiesPharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.
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Supporting critical Phase I–IV clinical studies by outsourcing supporting elementsThe pharmaceutical industry has experienced a number of difficulties during recent years. Greater competition from generics (more than 60% of prescription drugs are supplied from the generic market) and increased gaps in the drug pipeline that result in acquisitions or strategic alliances has led to a feeling of uncertainty in the bio/pharma marketplace. There have also been changes in the marketplace with a shift from primary care to specialty drugs, the introduction of personalized medicine driving the need for biomarker/diagnostic technology and the introduction of biopharmaceuticals.
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20th Anniversary Special Feature: the rise of AsiaRanjit Barshikar, GMP/Quality Consultant and former Vice President of Global Quality for Ranbaxy Laboratories analyses the past, present and future of Asia's pharmaceutical industry. Read more...
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Solid dosage forms from self-emulsifying lipidic formulationsSpraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier…
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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The challenge of 21st century influenzaConventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.
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Compliance in an Outsource Manufacturing Model: What to Look ForThe authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
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The science behind sorbent selectionDrug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents.
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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20th Anniversary Special Feature: The time for process understandingWhen Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.
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Taking the modular approachDespite the fact that regulatory compliance is fundamental to the pharmaceutical industry, too many manufacturers lose millions of euro in revenue because of poorly or incorrectly validated facilities. With increasingly demanding global regulations and guidance, rising manufacturing costs and dwindling product portfolios, it is vital to achieve efficient and effective compliance of facilities, processes and equipment to retain market competitiveness.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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The road to free validationAt first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.
