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Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes [...]

In the complex and multi-dimensional environment of modern manufacturing operations, it is a challenge to identify the best manufacturing approach for a specific product, taking into account financial, product and [...]

In the complex and multi-dimensional environment of modern manufacturing operations, it is a challenge to identify the best manufacturing approach for a specific product, taking into account financial, product, and [...]

The global pharmaceutical industry loses an estimated $564 billion annually due to medication non-adherence (1). The development of innovative products, custom-made for specific patient populations and indications, is the first [...]

This article describes a new process analytical technology based on impedance spectroscopy and its potential application for characterising product attributes during the freeze-drying process, including drying rates, end points and [...]

Common controlled-release product designs include the manufacture of polymer-coated multiparticulates. A crucial aspect to the success of this method is to create drug-containing multiparticulates (i.e., drug pellets) that are spherical, [...]

Extractables and leachables evaluation of packaging components and components of bioprocessing systems is a crucial regulatory requirement. Solvents used for evaluation of process components may include surfactants that can interfere [...]

PharmTech spoke with Tim Freeman of Freeman Technology; David Beach, technology advisor and consultant to Accu-Break Pharmaceuticals; and Thierry Menard, lab manager, and Bruno Villa, president, both at Medelpharm, about [...]

Micronized APIs help to improve solubility and are appropriate in low-dose formulations. Wet or dry granulation is typically used instead of direct compression (DC) in solid-dosage formulations to achieve homogenity [...]

High-potency manufacturing is a niche, but specialized area that requires proper facility design equipment selection, production processes, and operator knowledge to safely handle and produce highly potent APIs (HPAPls) and [...]

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be [...]

An approach for applying dry powder coatings (guest particles) onto the surface of cohesive pharmaceutical powders (host particles) was investigated using a resonant acoustic mixer (RAM). Processed powders were characterized [...]

Multiunit particulate systems (MUPS) have received a great deal of consideration in recent years as a controlled drug-delivery method. The current review describes the role and selection of excipients, pellet [...]

Catalysis plays a crucial role in small-molecule synthesis, whether it is in making an intermediate or the final active pharmaceutical ingredient (API). The effective development and application of a catalyst [...]

The US Food and Drug Administration's draft process-validation guidance changes regulatory expectations by requiring manufacturers to validate their processes by performing enough tests to achieve statistical significance. The author describes [...]

Orally dissolving films have emerged as an alternative to orally disintegrating tablets, These films possess advantages of pleasant mouthfeel, rapid disintegration in the mouth, and quick dissolution, initially launched as [...]

Melt extrusion has saved time and resources for decades in the plastics and engineering industries. The authors provide a review of its evolution and applications in the pharmaceutical industry. Specifically [...]

Small-angle X-ray scattering (SAXS) offers various ways to characterize drug-delivery systems and large molecules. Understanding the structure of drug-delivery systems and large molecules at a molecular level is a crucial [...]

Chromatography often is used for downstream purification steps, and buffered mobile-phase properties such as ionic strength and pH are often critical process parameters. An in-line buffer-dilution (IBD) system that uses [...]

Novel reactor concepts with modular microstructured plate arrangements allow continuous-flow chemistry to be performed in a laboratory environment. The technology enables the development of robust processes for the fine-chemical and [...]

In Part I of this article, which appeared in the November 2009 issue of Pharmaceutical Technology, the authors explained a process for moisture-activated dry granulation (MADG) in detail and provided [...]

Buffers used to formulate proteins should not serve as substrates or inhibitors. They should exhibit little or no change in pH with temperature, show insignificant penetration through biological membranes, and [...]

Statistical metrics were used to allocate and quantify sources of variation during tablet manufacture and to identify operations that needed improvement. Variance component analysis of blend and tablet data was [...]

Historically, it has been virtually impossible to get same-day microbiological identification results. The efficiency of phenotypic identification systems using differential media and staining techniques depends on operator skill. The use [...]

Electrical resistance, low-temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of [...]

The quality of a solid pharmaceutical preparation is influenced by primary micromeritic characteristics such as the shape and size of drug crystals, especially when large amounts of poorly soluble drugs [...]

The Tableting Science Anti-Stick Research (TSAR) program conducted by tablet-compression tooling manufacturer I Holland in collaboration with the University of Nottingham in the UK aims to investigate the common tablet-manufacturing [...]

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing. To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, Pharmaceutical [...]

Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are designed, optimized, and controlled using advanced, model-predictive systems. These [...]

Solid dispersions represent a promising formulation approach for overcoming today's major challenge in pharmaceutical formulation development: poorly soluble and poorly permeable active pharmaceutical ingredients (APIs). Solid dispersions can be obtained [...]

Continuous manufacturing is gradually advancing through select projects of pharmaceutical companies and researchers in academia. Granulation is one processing step moving to a continuous mode. The article examines some recent [...]

Strategies to improve drug solubility are of crucial importance to the pharmaceutical industry. Advancement of high-throughput screening techniques for lead identification in drug discovery has had the benefit of generating [...]

Adjuvants are becoming more common in vaccine and other drug formulations to increase therapeutic response. Some of these substances, however, are close enough in size to bacteria that they are [...]

Catalysts play an important role in chemical reactions, but they are particularly important in producing fine chemicals or pharmaceutical compounds to meet desired yields, purity, and stereoselectivity. Elucidating how a [...]

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high-performance liquid chromatography without having to prepare standards, The authors [...]

The majority of highly potent APIs (HPAPIs) to date have been developed for the treatment of cancer (cytotoxics and cytostatics), particularly tyrosine kinase inhibitors and derivatives. There are, however, other [...]

Using model-predictive design to define, predict, and control a process is well-established in many industries, and is beginning to take hold in pharmaceutical process development and manufacturing. Modeling software helps [...]

Spray drying is a key process for manufacturing amorphous dispersions because of its breadth of applicability. The wide range of potential atomization techniques and controllable drying kinetics enables amorphous spray-dried [...]

Tastemasking of solid dosage forms and liquid drugs is a challenge for pharmaceutical manufacturers. Most APIs are unpleasant or harsh tasting, which can lead to patient noncompliance. This challenge affects [...]

Process chemists face the challenge of developing cost-effective and efficient commercial manufacturing routes for APIs. They encounter the challenges of increasing product yield, achieving greater stereoselectivity and regioselectivity, and improving [...]

Q. Excipients add important functionality to a formulation. With respect to solubility improvement specifically, how can excipients be used to improve solubility and therefore bioavailability? Can you provide examples in [...]

Txtbooks and journal articles treat common cause variation as if it is an inevitable fact of nature and beyond our control: 'In any production process, regardless of how well-designed or [...]

With ever increasing titers, column chromatography has become a bottleneck in the downstream processing of monoclonal antibodies (mAbs) and a major barrier in the development of a truly disposable single-use [...]