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Pharmaceutical Formulations and Analytical Methods of Donepezil
Vu Dang Hoang1, Hue Minh Thi Nguyen2, Tuan Anh Nguyen3,4,5
1Faculty of Analytical Chemistry and Drug Quality Control, Hanoi University of Pharmacy, 13-15 Le Thanh Tong, Hanoi, Vietnam. hoangvd@hup.edu.vn.
AAPS Pharmscitech
|November 11, 2025
Summary
This review explores advanced pharmaceutical formulations and analytical methods for donepezil, an Alzheimer's disease treatment. Innovations in drug delivery and quality control are crucial for improving patient outcomes and ensuring therapy effectiveness.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Neuroscience
Background:
- Donepezil is a key acetylcholinesterase inhibitor for Alzheimer's disease (AD).
- Evolving therapeutic needs necessitate advancements in drug quality, efficacy, safety, and patient compliance.
- Pharmaceutical formulation and analytical methodologies are critical for optimizing AD treatment.
Purpose of the Study:
- To review recent innovations in donepezil pharmaceutical formulations.
- To summarize advancements in analytical methodologies for donepezil characterization and quality control.
- To highlight the synergy between formulation and analytical science in enhancing donepezil therapy.
Main Methods:
- Literature review focusing on pharmaceutical formulations and analytical techniques for donepezil.
- Exploration of novel drug delivery systems (liposomes, nanoparticles, microneedles, nasal gels, depots).
- Review of analytical methods including RP-HPLC, LC-MS/MS, chiral separations, electrochemistry, and spectroscopy.
Main Results:
- Novel formulations aim to improve brain targeting, prolong release, and minimize side effects.
- Advanced analytical methods enable precise quantification and characterization in various matrices.
- Validated methods are essential for formulation performance evaluation, stability monitoring, and regulatory adherence.
Conclusions:
- Progress in pharmaceutical formulation is key to developing enhanced donepezil delivery systems.
- Advancements in analytical science are vital for ensuring the quality and efficacy of donepezil products.
- Integrated development of formulation and analytical strategies is crucial for optimizing donepezil-based Alzheimer's disease management.
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