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| Breaking down the barriers
| The expanding role for X-ray powder diffraction in the pharmaceutical industry. | | | The counterfeit detective
| | As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them? | | | Handling difficult samples in bio-analytical chemical analysis
| | There are two ways in which 'difficult' samples are usually categorized: either by the problems posed by the physical nature of the post-vivo sample matrix containing the chemical entity to be analysed, or... | | | The Problem with Stents
| | Our company is involved in developing and manufacturing APIs that can be utilized with drug-eluting stents (DES). Despite ensuring constancy in pharmaceutical composition, we are experiencing issues with variations in drug release during in vitro studies. We are working closely with a stent manufacturer to develop the system, but could surface analysis techniques investigate the problem further? | | | Tablet discolouration
| | We are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve? | |  MORE ARTICLES
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| Assuring sterility with ASTM F 838-83
| | Although realized in 1983, ASTM's standrad test method for determining bacterial retention of membrane filters used for liquid filtration is still hugely beneficial to today's pharmaceutical industry. | | | California
| | California's forward-thinking reputation, well-funded research universities and world leadership in the potentially life-saving field of stem cell research and green energy provide a progressive and positive business environment for biotech companies. | | | Michigan
| | Although California remains the country's biotech leader, Michigan anticipates that the wind is shifting direction, albeit slowly | | | Bio news
| | A round up of the bio news from Europe's biopharmaceutical industry. | | | Florida
| | According to Deputy Director, Alexander Bothmann, of Enterprise Florida Inc., in Germany, the 'Sunshine State' is: "Committed to building a world-class biotechnology sector by investing in research facilities, fostering the growth of local biotech companies and welcoming progressive newcomers, such as the Scripps Research Institute, the Burnham Institute for Medical Research and Torrey Pines Institute for Molecular Studies." | | | MORE ARTICLES
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| Meeting the Challenge of Scaling Up High Dose ODTs
| | The application of oral disintegrating technologies to higher dose actives is a natural extension of this ease of delivery dosage form. | | | PVA copolymer: the new coating agent
| | The 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. | | | Creating PVA copolymer capsules
| | When drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process. | | | The Problem with Stents
| | Our company is involved in developing and manufacturing APIs that can be utilized with drug-eluting stents (DES). Despite ensuring constancy in pharmaceutical composition, we are experiencing issues with variations in drug release during in vitro studies. We are working closely with a stent manufacturer to develop the system, but could surface analysis techniques investigate the problem further? | | | Solid dosage forms from self-emulsifying lipidic formulations
| | Spraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier… | | | MORE ARTICLES
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| Quick API delivery
| | The authors consider the advantages of using rapidly dissolving films to accurately and effectively deliver pharmaceutical ingredients, with an emphasis on the importance of controlling moisture content and drug loading during formulation development. | | | A partially freeze-dried lyophilization technology for producing fast-melting tablets
| | A new economical method for producing fast-melting lamina-like dosage forms. | | | A Raman spectroscopic method to monitor magnesium stearate in blends and tablets
| | A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate. | | | Testing Inhalers
| | This article investigates how the industry can test inhalers in a way that is most representative of typical use. | | | Predicting powder flow
| | 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. | | | MORE ARTICLES
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| Developing nanoparticle formulations or poorly soluble drugs
| | Rapid advances in drug discovery have led to the identification of a number of compounds with good therapeutic potential. | | | PVA copolymer: the new coating agent
| | The 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. | | | Modulation of drug release from hydrophilic matrices
| | Different chemistries and viscosities of HPMC can be combined to modulate release profile and, in some cases, result in a more robust formulation. | | | The counterfeit detective
| | As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them? | | | Enhancing the in vitro assessment of nasal sprays
| | Nasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds. | | | MORE ARTICLES
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| 20th Anniversary Special Feature: The impact of regulations
| | During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries. | | | Proactive protection
| | The number of online pharmacies continues to increase exponentially and the global supply chain is at risk of infiltration by counterfeit ingredients. A more proactive approach is needed to ensure consumer safety. | | | Drinking from a fire hose
| | The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry. | | | Effective complaint handling, investigations and adverse event reporting
| | The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization. | | | Jake Sorofman Q&A
| | Q: You have many years of experience in marketing and business development. What are the most significant changes you have observed in this time? | | | MORE ARTICLES
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| Enhancing the in vitro assessment of nasal sprays
| | Nasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds. | | | Enhanced brain drug delivery and targeting
| | The blood–brain barrier (BBB) forms an interface between the circulating blood and the brain, and functions as a tremendously effective barrier for the delivery of potential neurotherapeutics into the brain parenchyma. Conversely, the BBB possesses various carrier-mediated transport systems for the uptake of small molecules, such as essential nutrients and vitamins. These transporters have become an attractive target for drug/prodrug design in an attempt to ferry drug molecules across the BBB. Central nervous system (CNS) drug delivery is often limited by poor brain penetration of the potential drug candidate. As a result of its unique barrier properties, the BBB poses a huge challenge for the delivery of potential neurotherapeutics into the brain parenchyma.1 It is estimated that only 2% of small-molecule drugs and ,0.1% of novel protein and peptide pharmaceuticals developed for CNS diseases reach therapeutic concentrations in the brain.2,3 Many of the pharmacologically active drugs tend to fail.. | | | Solid dosage forms from self-emulsifying lipidic formulations
| | Spraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier… | | | The Problem with Stents
| | Our company is involved in developing and manufacturing APIs that can be utilized with drug-eluting stents (DES). Despite ensuring constancy in pharmaceutical composition, we are experiencing issues with variations in drug release during in vitro studies. We are working closely with a stent manufacturer to develop the system, but could surface analysis techniques investigate the problem further? | | | Tablet discolouration
| | We are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve? |
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| 20th Anniversary Special Feature: The transformation and future trends of laboratory data management
| | Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management. | | | Preventive maintenance strategies for the pharmaceutical industry
| | Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry. | | | Multimodal HPLC screening of polysaccharide-based chiral stationary phases
| | High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest. | | | | A Raman spectroscopic method to monitor magnesium stearate in blends and tablets
| | A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate. | | | Dissolution testing and good manufacturing practices
| | Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities. | | | MORE ARTICLES
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| Mergers and Acquisitions 18/12/2008
| | Some of the latest M&As from across the globe including Hovione and Pfizer, NextGen and eXeTek, and Roche and Memory Pharmaceuticals. | | | Company news 18/12/2008
| | Some of the latest company news from BASF, Vetter and Whitehouse Scientific. | | | A new class of anti-inflammatory drug?
| | A new approach to the treatment of pain, inflammation and fever has been developed in Germany using chemical substances belonging to the dual mPGES-1/5-LO-Inhibitors. | | | A renewed vision for EU pharma?
| | The European Commission has revealed a 'renewed vision' for the pharmaceutical sector to help combat the health, economic and scientific challenges that lay ahead, which includes allowing drugmakers to disseminate information about prescription-only medicines to the general public. | | | Pharma must speed up transformation
| | With the threat of a broad recession looming, leaders of the largest global pharmaceutical companies must act swiftly to ensure sustained growth, according to Ernst & Young's biannual pharmaceutical report. | | | MORE ARTICLES
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| Rapid and convenient microsphere sizing
| | FDA advocates building quality into a product through PAT. | | | PAT — a team effort
| | The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes. | | | Making data analysis lean
| | Six sigma, process analytical technology (PAT) and related initiatives are driving greater use of statistical analysis methods to increase process understanding and improve manufacturing capabilities. | | | Calorimetry — the fully scalable PAT tool
| | To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT. | | | Research initiatives to support science-based pharmaceutical manufacturing
| | Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes. | | | MORE ARTICLES
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| In-Process Control Methods for the Manufacture of APIs
| | In-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality. | | | Analysing Raw Materials and Formulations Using High Resolution Ultrasonic Spectroscopy
| | HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry. | | | Specifications of chemical substances for pharmaceutical use | | A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions. | | | Physicochemical Approaches to Enhancing Oral Absorption
| | This 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. | | | Development of PVA Copolymer Capsules
| | The bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations. | | | MORE ARTICLES
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| Proactive protection
| | The number of online pharmacies continues to increase exponentially and the global supply chain is at risk of infiltration by counterfeit ingredients. A more proactive approach is needed to ensure consumer safety. | | | The counterfeit detective
| | As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them? | | |
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