donepezil sustained release / Generic mfg. - LARVOL DELTA

Establishment of Level a In Vitro-In Vivo Correlation (IVIVC) via Extended DoE-IVIVC Model: A Donepezil Case Study. (PubMed, Pharmaceutics) - "The in vitro dissolution patterns of donepezil SR tablets were described by Michaelis-Menten kinetics...The present extended DoE-IVIVC model may provide a valuable tool to predict the effect of formulation changes on in vivo pharmacokinetic behavior, leading to the more efficient development of SR formulations. The application of the present modeling approaches to develop other forms of drug formulation may be of interest for future studies."

Journal • Preclinical

Pharmacokinetic Evaluation of a Novel Donepezil-Loaded Dissolving Microneedle Patch in Rats. (PubMed, Pharmaceutics) - "The DMN arrays also effectively increased drug permeation and demonstrated sustained release and absorption of donepezil from DMN patches. These patches allow extended dosing intervals, reduced gastrointestinal adverse effects, and convenient self-administration to mitigate poor drug compliance, making them beneficial for the treatment of elderly patients with Alzheimer's disease."

Journal • PK/PD data • Preclinical • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Gastrointestinal Disorder

Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer's disease. (PubMed, NPJ Digit Med) - P3 | "The target trial (i.e., NCT00478205) is a Phase III double-blind, parallel-group trial that compared the 23 mg donepezil sustained release with the 10 mg donepezil immediate release formulation in patients with moderate to severe AD. Trial simulation using RWD could be a valuable tool for post-market comparative effectiveness studies and for informing future trials' design. Nevertheless, such an approach may be limited, for example, by the availability of RWD that matches the target trials of interest, and further investigations are warranted."

Clinical data • Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders