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| 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? | | | USP faces up to analytical reality
| | 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. | | | Monitoring processing-induced crystallinity changes
| | The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared. | | | Analysis of adrenoreceptor agonists and antagonists
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| Getting the most out of producing therapeutic biologics
| | | | Managing initial recovery processes with multilayer depth filtration
| | Monoclonal antibodies and recombinant proteins have increased their importance and gained success as therapeutic agents in the treatment of various diseases. | | | The new biopharmaceutical blueprint
| | As 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. | | | The role of analytical science in the debate over biosimilars
| | As the US biopharmaceutical industry and regulators debate new requirements for biosimilars, industry leaders are turning to analytical science to define intellectual property and business development strategies. Emerging techniques are providing previously unseen protein characterization details, giving both innovator and generics companies new weapons in the battle for future market share. | | | 20th Anniversary Special Feature: Outsourcing biologics manufacturing
| | Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture. | | | MORE ARTICLES
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| 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? | | | Recent developments in dry coating
| | | | 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? | | | 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. | | | 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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| 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? | | | 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.. | | | A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquids
| | The stability of drugs in solid forms such as powders, tablets and capsules is usually determined very thoroughly by the drug's manufacturer. Based on stability study data, the shelf-life of a drug substance or a drug product is assigned. In addition to dispensing solid dosage forms to patients, pharmacists are frequently asked to compound oral liquid preparations for which the shelf-life or beyond-use date are assigned based on the pharmacist's best judgment — often without the benefit of stability data. | | | The challenge of 21st century influenza
| | Conventional 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. | | | MORE ARTICLES
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| Managing the future
| | The adoption of computers into every aspect of the pharmaceutical industry has been enormous. Some estimates would put productivity and efficiency gains across the pharmaceutical industry at 2–3 times what they were previously. However, they are only just beginning to have an effect in the areas of training and document management, which have traditionally been managed by people and paper systems. With increasingly strict regulations and the growing complexity of processes and training requirements, there are even greater efficiency gains, as well as cost savings, to be achieved by adopting electronic document management systems (eDMS), learning management systems (LMS) and systems for the electronic signing of documents. | | | The new biopharmaceutical blueprint
| | As 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. | | | 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. | | | Artificial intelligence the key to process understanding
| | In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity. | | | Computer system validation ? increasing supplier value
| | All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream. | | | MORE ARTICLES
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| 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? | | | The road to resource efficiency
| | However, companies should always be prioritizing prevention, elimination and reduction over recycling and recovery as the most effective ways of making resource efficiency savings. | | | MORE ARTICLES
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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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| Europe and India seek improved safety
| | A collaboration between Europe and India will strengthen efforts to improve the quality and safety of medicines in both locations, and will include the development of joint inspections of manufacturing sites. | | | Can tomatoes stop us from ageing?
| | Tomatoes could be the new weapon in the fight against sun damage, according to research conducted by two UK universities. | | | An end to exchange rate concerns?
| | Pharmaceutical companies are being offered the opportunity to purchase foreign currency up to 12 months before the money has to change hands, which could remove concerns regarding fluctuations in the currency market. | | | British university research under threat
| | Pharma's extensive collaborative research links with the UK university science base are now under threat because of costs and issues regarding intellectual property ownership. | | | New research area to provide new treatments?
| | Research into the link between allergies and the development of tumours has become an established research discipline that could have benefits for future cancer treatments. | | | MORE ARTICLES
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| China captivates the clinical trial sector
| | | | The counterfeit problem
| | The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide. | | | East meets West
| | Most CROs are entering China with expectations that a significant local market opportunity will develop as major pharmaceutical companies establish research development operations there... | | | 20th Anniversary Special Feature: Outsourcing biologics manufacturing
| | Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture. | | |
Outsourcing still the way forward
| | During the past two decades, outsourcing has become increasingly prevalent as the way to gain competitive advantage. This trend has led to a significant increase in the number of services and functions available for outsourcing, and there are emerging opportunities for niche outsourcing to contractors that provide specialized sets of tools and access to cutting-edge technology. | | | MORE ARTICLES
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| 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. | | | 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. | | | 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.
| | | From data to knowledge: the challenge in bioprocess development
| | In biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements. | | | 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. | | | MORE ARTICLES
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| Packaged solutions for flexible production
| | Pharmaceutical manufacturers are under increasing pressure to shorten time-to-market, produce treatments with unpredictable product lifetimes, provide greater flexibility and, at the same time, comply with ever more stringent quality, validation, stability and traceability constraints. While this is encouraging for the contract manufacturing sector, it creates the need for even greater manufacturing flexibility. | |
| Pharmaceutical packaging and labelling for blind and partially sighted people
| | 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. | | | Environmental packaging waste regulations
| | It will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green. | | | Coding and marking technologies for the pharmaceutical industry
| | The right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security. | | | A Virtual Future
| | Virtual labels eliminate the need for troublesome transfer ribbons or inkjet fluids, which are inherent with traditional labelling technologies. | | | 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. | | | Selecting Lactose for a Capsule-Based Dry Powder Inhaler
| | Dry 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. | | | MORE ARTICLES
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| Out of Africa: the pharma challenge
| | Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task. | | | Developing cold chain solutions
| | | | Who's afraid of parallel trade?
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| How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media. | | | Robots pack a punch
| | Never has greater pressure been applied to pharmaceutical manufacturers. Shelf space competition for branded drugs has reached aggressive proportions and now even prescription drugs vie for pricing and delivery. Against this is a backdrop of ever-increasing downward price pressures, and a spectrum of progressively more stringent legislative and quality requirements. Finally, regional markets now demand different tamper evidence technology, anticounterfeiting measures and safeguards against interference by biological terrorists. Much of which points to the need for innovation in packaging — not just in terms of pack styles and sizes, but also cost. | | | Packaged solutions for flexible production
| | Pharmaceutical manufacturers are under increasing pressure to shorten time-to-market, produce treatments with unpredictable product lifetimes, provide greater flexibility and, at the same time, comply with ever |
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