Long-acting HIV pre-exposure prophylaxis (PrEP) approaches: recent advances, emerging technologies, and development challenges

V Agrahari, SM Anderson, MM Peet… - Expert opinion on …, 2022 - Taylor & Francis
Introduction Poor or inconsistent adherence to daily oral pre-exposure prophylaxis (PrEP)
has emerged as a key barrier to effective HIV prevention. The advent of potent long-acting …

[HTML][HTML] Hydrogel-forming microarray patches with cyclodextrin drug reservoirs for long-acting delivery of poorly soluble cabotegravir sodium for HIV Pre-Exposure …

F Volpe-Zanutto, LK Vora, IA Tekko… - Journal of Controlled …, 2022 - Elsevier
Hydrogel-forming microarray patches (HF-MAPs) offer minimally invasive, pain-free and
prolonged drug delivery. These devices are designed to be self-administered and self …

[HTML][HTML] Role of modeling and simulation in preclinical and clinical long-acting injectable drug development

M Siemons, B Schroyen, N Darville, N Goyal - The AAPS Journal, 2023 - Springer
Innovations in the field of long-acting injectable drug development are increasingly being
reported. More advanced in vitro and in vivo characterization can improve our …

CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide …

TN Gengiah, QA Karim, I Harkoo, L Mansoor… - BMJ open, 2022 - bmjopen.bmj.com
Introduction Young African women bear a disproportionately high risk for HIV acquisition.
HIV technologies that empower women to protect themselves are needed. Safe, potent …

[HTML][HTML] Physiological based pharmacokinetic and biopharmaceutics modelling of subcutaneously administered compounds–An overview of in silico models

IR Dubbelboer, E Sjögren - International Journal of Pharmaceutics, 2022 - Elsevier
Subcutaneous injection is a commonly used route of drug administration for both small
molecules and biologics. To facilitate the development of new subcutaneously administered …

Revisiting the in-vitro and in-vivo considerations for in-silico modelling of complex injectable drug products

A Dabke, S Ghosh, P Dabke, K Sawant… - Journal of Controlled …, 2023 - Elsevier
Complex injectable drug products (CIDPs) have often been developed to modulate the
pharmacokinetics along with efficacy for therapeutic agents used for remediation of chronic …

The LEAP process: streamlining the development of long-acting products and formulations for infectious diseases

C Flexner, M Siccardi, F Bunglawala… - Clinical Infectious …, 2022 - academic.oup.com
Developing long-acting products and formulations for infectious diseases is a nontrivial
undertaking that is frequently classified as high risk and low reward by the pharmaceutical …

[HTML][HTML] Preclinical considerations for long-acting delivery of tenofovir alafenamide from subdermal implants for HIV pre-exposure prophylaxis

M Gunawardana, M Remedios-Chan, D Sanchez… - Pharmaceutical …, 2023 - Springer
Purpose Long-acting formulations of the potent antiretroviral prodrug tenofovir alafenamide
(TAF) hold potential as biomedical HIV prevention modalities. Here, we present a rigorous …

A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables

CD Corpstein, T Li - Pharmaceutical Research, 2023 - Springer
Subcutaneously administered drugs are growing in popularity for both large and small
molecule drugs. However, development of these systems–particularly generics–is slowed …

Evaluation of Pharmacokinetics of a BCS Class III Drug with Two Different Study Designs: Tenofovir Alafenamide Monofumarate Film-coated Tablet

M Arısoy, M Saydam, YE Dolaksız, Ö Demirbaş… - AAPS …, 2024 - Springer
Tenofovir alafenamide (TAF) is a BCS Class III compound and an oral pro-drug of Tenofovir
(TFV) with limited oral bioavailability. The bioavailability of the oral intake increases with …