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
Damiana Scuteri,
Roberta Cassano,
Sonia Trombino,
Rossella Russo,
Hirokazu Mizoguchi,
Chizuko Watanabe,
Kengo Hamamura,
Soh Katsuyama,
Takaaki Komatsu,
Luigi Antonio Morrone,
Laura Rombolà,
Annagrazia Adornetto,
Annarita S. Laganà,
Maria Tiziana Corasaniti,
Paolo Tonin,
Shinobu Sakurada,
Tsukasa Sakurada,
Pierluigi Nicotera,
Giacinto Bagetta
Affiliations
Damiana Scuteri
Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Roberta Cassano
Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Sonia Trombino
Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Rossella Russo
Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Hirokazu Mizoguchi
Department of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan
Chizuko Watanabe
Department of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan
Kengo Hamamura
Department of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan
Soh Katsuyama
Department of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan
Takaaki Komatsu
Department of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan
Luigi Antonio Morrone
Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Laura Rombolà
Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Annagrazia Adornetto
Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Annarita S. Laganà
Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
Maria Tiziana Corasaniti
Department of Health Sciences, University “Magna Graecia” of Catanzaro, 88100 Catanzaro, Italy
Paolo Tonin
Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy
Shinobu Sakurada
Department of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan
Tsukasa Sakurada
Department of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan
Pierluigi Nicotera
German Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, Germany
Giacinto Bagetta
Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy
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.
