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Volume 13
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Article

Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia

by
Damiana Scuteri
1,2,
Roberta Cassano
3,
Sonia Trombino
3,
Rossella Russo
4,
Hirokazu Mizoguchi
5,
Chizuko Watanabe
5,
Kengo Hamamura
6,
Soh Katsuyama
5,
Takaaki Komatsu
6,
Luigi Antonio Morrone
4,
Laura Rombolà
4,
Annagrazia Adornetto
4,
Annarita S. Laganà
3,
Maria Tiziana Corasaniti
7,
Paolo Tonin
2,
Shinobu Sakurada
5,
Tsukasa Sakurada
6,
Pierluigi Nicotera
8 and
Giacinto Bagetta
1,*
1
Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
2
Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy
3
Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
4
Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
5
Department of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan
6
Department of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan
7
Department of Health Sciences, University “Magna Graecia” of Catanzaro, 88100 Catanzaro, Italy
8
German Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, Germany
*
Author to whom correspondence should be addressed.
Pharmaceutics 2021, 13(3), 379; https://doi.org/10.3390/pharmaceutics13030379
Submission received: 16 February 2021 / Revised: 3 March 2021 / Accepted: 5 March 2021 / Published: 12 March 2021
(This article belongs to the Special Issue Lipid Nanoparticles in the Treatment of Neurological and Other Aging Related Disorders)
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Abstract

Dementia is one of the most common causes of disability worldwide characterized by memory loss, cognitive impairment, and behavioral and psychological symptoms (BPSD), including agitation. Treatment of the latter consists of the off-label use of harmful atypical antipsychotics, though a significant reduction is afforded by pain control. The use of an essential oil endowed with analgesic properties and devoid of toxicity would represent an important option for the management of agitation in dementia. Therefore, the aim of this study was to engineer a nanotechnology delivery system based on solid lipid nanoparticles loaded with bergamot essential oil (BEO) and devised in the pharmaceutical form of an odorless cream (NanoBEO) to confirm its analgesic efficacy for further development and application to control agitation in dementia. BEO has proven strong antinociceptive and anti-allodynic properties and, in its bergapten-free form, it is completely devoid of phototoxicity. NanoBEO has been studied in vivo confirming the previously reported analgesic activity of BEO to which is now added its anti-itching properties. Due to the nanotechnology delivery system, the stability of titrated BEO components is guaranteed. Finally, the latter invention, currently under patent consideration, is smell-devoid allowing efficacy and safety to be established in double-blind clinical trials; until now the latter studies have been impeded in aromatherapy by the strong odor of essential oils. A clinical trial NCT04321889 has been designed to provide information about the efficacy and safety of NanoBEO on agitation and pain in patients suffering from severe dementia.
Keywords: essential oil of bergamot; dementia; BPSD; agitation; pain; nanotechnology delivery system essential oil of bergamot; dementia; BPSD; agitation; pain; nanotechnology delivery system

Share and Cite

MDPI and ACS Style

Scuteri, D.; Cassano, R.; Trombino, S.; Russo, R.; Mizoguchi, H.; Watanabe, C.; Hamamura, K.; Katsuyama, S.; Komatsu, T.; Morrone, L.A.; et al. Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia. Pharmaceutics 2021, 13, 379. https://doi.org/10.3390/pharmaceutics13030379

AMA Style

Scuteri D, Cassano R, Trombino S, Russo R, Mizoguchi H, Watanabe C, Hamamura K, Katsuyama S, Komatsu T, Morrone LA, et al. Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia. Pharmaceutics. 2021; 13(3):379. https://doi.org/10.3390/pharmaceutics13030379

Chicago/Turabian Style

Scuteri, Damiana, Roberta Cassano, Sonia Trombino, Rossella Russo, Hirokazu Mizoguchi, Chizuko Watanabe, Kengo Hamamura, Soh Katsuyama, Takaaki Komatsu, Luigi Antonio Morrone, and et al. 2021. "Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia" Pharmaceutics 13, no. 3: 379. https://doi.org/10.3390/pharmaceutics13030379

APA Style

Scuteri, D., Cassano, R., Trombino, S., Russo, R., Mizoguchi, H., Watanabe, C., Hamamura, K., Katsuyama, S., Komatsu, T., Morrone, L. A., Rombolà, L., Adornetto, A., Laganà, A. S., Corasaniti, M. T., Tonin, P., Sakurada, S., Sakurada, T., Nicotera, P., & Bagetta, G. (2021). Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia. Pharmaceutics, 13(3), 379. https://doi.org/10.3390/pharmaceutics13030379

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