Bioavailability & Solubility
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
FORMULATION FORUM – Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
EXCLUSIVE ONLINE CONTENT
Emisphere Technologies, Inc. recently announced it has entered into a definitive agreement with Novo Nordisk, whereby Novo Nordisk will acquire Emisphere, on a cash-free, debt-free basis, for….
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.