Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium “Long-Acting Injectables” Working Group
Authors (first, second and last of 21)
Collection
Long-acting Formulations
Long acting formulations are recently attracting increased attention to improve patient adherence to medications. For example, in the HIV field, several scientists are currently actively pursuing development of long acting injectable suspensions and implants. However long acting delivery is not confided only to the injectable space. Even for oral medications, there are now efforts to extend the behaviour of modified release system to multi-day release. Along with the increased formulation development complexity, long acting formulations bring new challenges in physicochemical and preclinical characterization and prediction of in vivo pharmacokinetics. The special issue hosts manuscripts that address contemporary challenges to the development of long acting products covering topics from basic design of formulation and evaluation of novel excipients to the preclinical and clinical in vivo evaluation.
Editors
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Stephanie E. Barrett
Dr. Barrett is a Senior Principal Scientist at Merck & Co., Inc., Rahway, NJ and is one of Merck’s leading experts in polymer and bioconjugate chemistry for enabled delivery of small molecule and macromolecular drugs, having made influential contributions to the discovery of novel polymer conjugates for siRNA therapeutics, polymer excipients for oral dosage forms, and polymer-based long-acting injectables and implantables. She is currently leading the team responsible for the design of Merck’s next generation of long-acting implant and injectable products—with potential applications in Neuroscience, HIV and other infectious diseases.
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Filippos Kesisoglou
Filippos Kesisoglou, PhD, is a Distinguished Scientist at Merck & Co., Inc., Rahway, NJ and had been leading the translational biopharmaceutics efforts across the small and large molecule portfolio in the Pharmaceutical Sciences department. He has more than 15 years of experience in the fields of biopharmaceutics and formulation development, PBPK and IVIVC modeling as related to clinical, drug product development and CMC regulatory applications. He has contributed to numerous new drug applications along therapeutic areas.
Articles (6 in this collection)
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A Retrospective Analysis of Preclinical and Clinical Pharmacokinetics from Administration of Long-Acting Aqueous Suspensions
Authors (first, second and last of 8)
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Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis
Authors (first, second and last of 14)
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Development and Evaluation of Dissolving Microarray Patches for Co-administered and Repeated Intradermal Delivery of Long-acting Rilpivirine and Cabotegravir Nanosuspensions for Paediatric HIV Antiretroviral Therapy
Authors (first, second and last of 11)
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Modulating Drug Release from Short Poly(ethylene glycol) Block Initiated Poly(L-lactide) Di-block Copolymers
Authors (first, second and last of 5)
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Osmolality of Excipients for Parenteral Formulation Measured by Freezing Point Depression and Vapor Pressure – A Comparative Analysis
Authors (first, second and last of 7)
