Bioavailability & Solubility
Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been….
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Simon Edwards, President, CDMO Sales & Marketing at Cambrex, discusses the biggest trends in the small molecule outsourcing market.
FORMULATION FORUM – Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.
FORMULATION FORUM – Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway
Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.
EXCLUSIVE ONLINE CONTENT
One of the most critical early steps in the development of novel drug delivery systems is to demonstrate convincing proof-of-concept. The dilemma is that while pharma companies can be interested in….
SeraNovo B.V. recently announced it has signed a second License Agreement with Carna Biosciences, Inc., a company engaged in the drug development of….
Ashland recently announced the launch of three new pharmaceutical solutions, Plasdone S630 Ultra, Benecel XR and XRF, and Viatel bioresorbable polymers. Ashland is expanding its portfolio to meet formulators’ growing needs….
ABITEC Corporation, a global manufacturer of functional lipid excipients continues to pursue new technologies that solve various formulation challenges in the pharmaceutical market.
TxCell SA and Lonza Pharma & Biotech recently announced entering into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.