Long-acting injectable donepezil microspheres: Formulation development and evaluation
Journal of Controlled Release, ISSN: 0168-3659, Vol: 340, Page: 72-86
2021
- 15Citations
- 33Captures
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations15
- Citation Indexes15
- 15
- CrossRef7
- Captures33
- Readers33
- 33
Article Description
Novel formulations of donepezil (DNP)-loaded microspheres based on a bio-degradable polymer of poly(lactic- co -glycolic acid) (PLGA) with a one-month duration of effect were developed, aimed at reducing dosing frequency and adverse effects and improving patient adherence. The spherical and monodispersed DNP-loaded microspheres were precisely fabricated by the Inventage Lab Precision Particle Fabrication method (IVL-PPFM®) based on micro-electromechanical systems (MEMS) and microfluidic technology. The types of polymers and end-groups, the drug/polymer ratio (DPR), and the routes of administration for DNP were studied to ensure an effective concentration and desired duration. Laser-light particle size analysis and scanning electron microscopy were used to characterization. Also, non-clinical animal models of beagle dogs are used to optimize DNP formulations and evaluate their pharmacokinetic properties. The PK results showed that the DPR was a critical factor in determining the exposure level and duration of DNR release. Furthermore, the lactide ratio, which varied depending upon the type of polymer, determined the hydrophobic interaction and was also an important factor affecting the desired DNP release. Since DNP shows a large inter-species variation between dogs and humans, PK modeling and simulation of the reference drug (i.e., Aricept®) and DNP-loaded microspheres were used for formulation development to overcome and interpret these variations. In addition, the developed PK model was extrapolated to humans using the estimated PK parameter and published clinical pharmacology data for DNP. The predicted PK profile of the DNP-loaded microsphere in humans showed that the formulation with PLGA 7525A and the DPR of 1/9 could maintain drug concentration for a month and could control initial burst release. The data obtained from the study could be used as scientific evidence for decision-making in future formulation development.
Bibliographic Details
http://www.sciencedirect.com/science/article/pii/S0168365921005514; http://dx.doi.org/10.1016/j.jconrel.2021.10.022; http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85118492463&origin=inward; http://www.ncbi.nlm.nih.gov/pubmed/34715262; https://linkinghub.elsevier.com/retrieve/pii/S0168365921005514; https://dx.doi.org/10.1016/j.jconrel.2021.10.022
Elsevier BV
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