Pharmaceutical Research

Mechanism of pH-sensitive Amphiphilic Endosomal Escape of Ionizable Lipid Nanoparticles for Cytosolic Nucleic Acid Delivery

Continuing the highly cited review published in 2023 titled "Structure and Function of Cationic and Ionizable Lipids for Nucleic Acid Delivery," which can be accessed via https://link.springer.com/article/10.1007/s11095-022-03460-2, Prof. Zheng-Rong Lu and his co-authors have written a sequel. This new Review aims to provide further insights into the cellular uptake mechanisms of lipid nanoparticles (LNPs) used for gene delivery. The article focuses on discussing a new strategy of utilizing ionizable lipids to formulate LNPs that achieve pH-sensitive amphiphilic membrane disruption and endosomal escape of delivered nucleic acids. This critical Review is highly recommended for anyone conducting drug delivery research.

If your manuscript has been declined, and you are planning to submit your article to another of the four AAPS journals (AAPS Open, The AAPS Journal, AAPSPharmSciTech, or Pharmaceutical Research), we can help make the peer review process faster and smoother by extending the use of previous peer reviewer comments! Portable Peer Review, an opt-into service available for any author of these journals, allows us to share, between the portfolio, previous peer review comments and reviewer names, subject to approval of all parties. This can help speed up the assessment process, should the editor choose to make a decision on the basis of the comments and revision. Interested?  Email us with the name of the journal to which you are going to submit. Note: Portable peer review is opt-in only, available at the authors’ preference, and the reviewer identities and comments will only be shared between offices, not to the author.

The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology

In this article, the authors propose several strategic changes based on the finite absorption time (F.A.T.) concept for drug and generic development, including enhancing Phase I studies with absolute bioavailability, applying physiologically based finite time pharmacokinetic (PBFTPK) models in Phase II and III studies, and modifying generic development approaches. By offering more accurate estimates of absorption duration (τ) and drug input rates, this approach may significantly facilitate model-informed drug development (MIDD).