FORMULATION FORUM – Parenteral Sustained Delivery of ASD-005 Liposomal Formulation: A Case Study in Applications of Lipid-Based Nanoparticle Carriers
Jim Huang, PhD, presents an investigation aimed at studying the administration of a liposomal form of a third-generation β-blocker, ASD-005, by injectable route of administration to efficiently manage emergency hypertension and congestive heart failure.
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES – Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
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.
CUSTOM DEVICE SOLUTIONS – Device Design Will Act as Competitive Distinguisher in a Post-Patent Expiry Biosimilar Market
George I’ons dissects the different factors that will determine biosimilars’ adoption and pace of advancement against their original counterparts, namely clinical confidence in the biosimilar and patient confidence in the drug delivery device.
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
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.
DEVICE DEVELOPMENT – Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
EXCLUSIVE ONLINE CONTENT
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