Articles in this Issue
Bethanne M. Warrack, Angela K. Goodenough, Ph.D., Guodong Chen, Ph.D.
One of the most important considerations in the drug discovery process is safety, not only of the drug itself, but also impurities and degradation products. Impurities present in the active pharmaceutical ingredient (API) have to be identified to make sure no mutagenic or toxic substances will be administered to patients.
Dr. Chris Moreton, Ph.D.
This installment of the column is a little different. I hope to address some of the issues with new excipients. In general, it appears in recent years that small molecule drug candidates have become more sophisticated and chemically complex.
Ravi Kalyanaraman, Ph.D., George Dobler, Michael Ribick
Pharmaceutical counterfeiting has become a major issue in the recent decade in developing countries [1]. It has also placed a significant pressure on the assurance of supply chain integrity in developed countries due to increasing international trade and sales via the internet [2]. It is believed that this criminal business could reach $75 billion dollar this year worldwide, a 92 % increase from 2005 [3].
Jan Möschwitzer, Ph.D.
In the last 30 years, particle size reduction technologies turned from an exploratory approach into a mature commercial drug delivery platform. Nanonization technologies have gained a special importance due to a steadily increasing number of development compounds showing poor aqueous solubility. Many drug delivery companies and academic research groups have contributed to the currently existing large variety of different technologies to produce drug nanoparticles.
David Kilburn, Arn Malliett, Russell Wong, Ph.D.
Single use systems have become an integral part of biopharmaceutical drug manufacturing. The low capital investment and the flexibility of storage capacity appeals to manufacturers because costs are incurred when a product is being produced.
Michael J. Miller, Ph.D.
Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs).
Joanny Salvas, Jean-Sebastien Simard, Nicolas Abatzoglou, Ph.D.
Defining Process Analytical Technologies (PAT) is not straightforward, as their use is widespread and wide-ranged. Bakeev defines a PAT as an “analysis of the process…for the improvement of process development and control”.
B.A. Howell, P. Chhetri, A. Dumitrascu
Thermogravimetry has the potential to provide valuable information for the characterization of organoplatinum antitumor agents. For well-behaved systems, characteristic mass losses may suggest the identity of ligands present and the residue from thermal degradation will reflect the platinum content of the compound [1,2].
B. Gururajan, P. Cote, M. Bouty, E. Razzano, A.C. Bentham
Roller compaction is the densification of dry powders into a solid mass (compact). This densification process is achieved by controlled feeding of powder through a set of directly opposed, counter-rotating rollers with a controllable aperture (roller gap) between the rollers.
Otilia Koo, Ph.D.
Fixed-dose combination (FDC) drug products contain more than one active component in a single dosage form. In recent years, there is increasing interest in the pharmaceutical industry to develop FDC drug products. FDCs are developed to extend product life cycle and improve patient compliance by reducing pill burden.
Norbert Rasenack, Ph.D.
Pulmonary dosage forms containing particulate drug substance in micronized form, such as suspension based pMDIs (Metered Dose Inhaler) or DPIs (Dry Powder Inhalation Formulation) are widely used for locally pulmonary therapy (like asthma or COPD), but also developed for systemic therapy.
Sheng Qi, Duncan Q.M. Craig
Lipid based delivery systems continue to attract considerable interest within the pharmaceutical arena, not only because of their ability to improve bioavailability via their interaction with the components of the gastrointestinal tract [1-5] but also because they may be used to manipulate release rates in vitro and in vivo [6-10].