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The extrusion and spheronization of chitosanChitosan is of pharmaceutical interest because of its positive attributes with respect to toxicity, biocompatibility and bioavailability.
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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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Improved Mass Determination of Poly(ethylene glycols) by Electrospray Ion-Mobility Time-of-Flight Mass Spectrometry Coupled with Ion–Molecule ReactionsThe authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.
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The BRIC Countries: Opportunities for Regulated Market PlayersThe author outlines the opportunities and challenges for manufacturers aiming to enter the BRIC-country markets.
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A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquidsThe 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.
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Improving the Integrity Test Assurance of Multiround Housings AssessmentsThe authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.
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Creating PVA copolymer capsulesWhen 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.
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Formulation effects on the thermomechanical properties and permeability of free films and coating filmsUnderstanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
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Solid Dispersions by Hot-Melt ExtrusionThe advantages and disadvantages of hot-melt extrusion in solid dispersion formulations.
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Enhanced brain drug delivery and targetingThe 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..
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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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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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Achieving Aseptic Drying With Spray Drying TechnologiesHenrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.
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The recovery mission – coping with validation failuresPractical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.
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Successful strategies for product optimization...an uninformed decision based on commercial requirements alone may, ultimately, have disastrous consequences on the efficacy of the target recombinants.
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20th Anniversary Special Feature: The impact of regulationsDuring 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.
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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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Dessicants for Pharmaceutical ApplicationsThis article examines the different types of dessicants avaliable to the pharmaceutical industry. It provides information on choosing the right type, and how and when it should be used.
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The counterfeit detectiveAs 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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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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Where have we reached with REACH?The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007.
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Peer-Reviewed Technical Note: Quality by Design in Freeze-DryingCycle design and robustness testing using advanced process analytical technology.
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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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Information-Technology Criteria in CMO Selection and ManagementA sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.
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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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Handling difficult samples in bio-analytical chemical analysisThere 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...
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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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Improving liposome integrity and easing bottlenecks to productionThe importance of liposomes as an effective drug delivery system is well accepted in the pharmaceutical industry, but their handling remains a challenge.
