March 12th 2025
Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.
February 17th 2025
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply
August 1st 2008To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.
Microdosing in Phase O: A Q&A with J. Scott Tarrant, Xceleron
August 1st 2008J. Scott Tarrant, executive vice-president of Xceleron, explains the role of microdosing in drug development. He describes how microdose data can be used to predict pharmacological dose absorption, distribution, metabolism, and excretion/pharmacokinetic outcomes using accelerator mass spectrometry.
Solid Microstructured Transdermal Delivery Highlighted at Controlled Release Society's Meeting
July 17th 20083M Drug Delivery Systems has successfully designed a proof of concept device using a solid microstructured transdermal system for the systemic delivery of high-potency pharmaceuticals. The technology was showcased at a poster session at the annual meeting of the Controlled Release Society held this week in New York City.
European Pharmacopeia Defines Policy for Potentially Genotoxic Impurities
July 10th 2008The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.
Nanoscale Technique Measures Surface Physical Properties of APIs
July 3rd 2008Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.
Enhancing the in vitro assessment of nasal sprays
July 1st 2008Nasal 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.
Study Tests Antibody-Coated Nanotubes and NIR Light to Kill Cancer Cells
June 26th 2008Biomedical researchers at UT Southwestern Medical Center and nanotechnology scientists at UT Dallas are collaborating on a study that seeks to selectively kill cancer cells using monoclonal antibodies to coat carbon nanotubes that heat up when exposed to near-infrared (NIR) light.
HHS Targets FDA's Generic Drug Reviews
June 19th 2008With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.
FDA Urges Early Switch to HFA-Propelled Albuterol Inhalers
June 5th 2008The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.