TY - JOUR
T1 - Controlled delivery of naltrexone by an intraoral device:In vivo study on human subjects
AU - Giannola, Libero Italo
AU - Campisi, Giuseppina
AU - De Caro, Viviana
AU - Paderni, Carlo
AU - Goẗtsche, Thorsten
AU - Schumacher, Axel
AU - Campisi, Giuseppina
AU - Campisi, Giuseppina
AU - Giannola, Libero Italo
AU - Wolff, Andy
PY - 2013
Y1 - 2013
N2 - Naltrexone is widely used in the treatment of opiate addiction but its current peroral administration is characterized by low bioavailability with various side effects. The development of a long-acting trans-buccal delivery device(IntelliDrug) for NLX may be useful to improve patient compliance and the therapy effectiveness.The aims of the study are(a)to test basic safety and effectiveness of controlled transbuccal drug delivery on human subjects;(b)to compare NLX bioavailability following transbuccal delivery vs per os conventional delivery; and(c)to test the hypothesis that transbuccal delivery is more efficient than the conventional route.In this randomized cross-over pilot study,12 healthy subjects received in a different order 2 types of NLX administration,per os or transbuccal delivery, based on which grou they were randomized to. For per os administration 50mg NLX tablets were used, while for transbuccal administration, a NLX-loaded prototype of the IntelliDrug device was fixed on patients’ dental arch. Serial blood samples were drawn and analysed for the NLX concentration. The IntelliDrug prototype functioned properly and it did not exert any adverse side-effect.The transbuccal route resulted in administration efficiency 4–17 times higher than conventional per os route. Transbuccal delivery of NLX appears to be a more efficient drug administration route compared to peroral one. It allows to reach a given therapeutic blood level using a small drug dose.
AB - Naltrexone is widely used in the treatment of opiate addiction but its current peroral administration is characterized by low bioavailability with various side effects. The development of a long-acting trans-buccal delivery device(IntelliDrug) for NLX may be useful to improve patient compliance and the therapy effectiveness.The aims of the study are(a)to test basic safety and effectiveness of controlled transbuccal drug delivery on human subjects;(b)to compare NLX bioavailability following transbuccal delivery vs per os conventional delivery; and(c)to test the hypothesis that transbuccal delivery is more efficient than the conventional route.In this randomized cross-over pilot study,12 healthy subjects received in a different order 2 types of NLX administration,per os or transbuccal delivery, based on which grou they were randomized to. For per os administration 50mg NLX tablets were used, while for transbuccal administration, a NLX-loaded prototype of the IntelliDrug device was fixed on patients’ dental arch. Serial blood samples were drawn and analysed for the NLX concentration. The IntelliDrug prototype functioned properly and it did not exert any adverse side-effect.The transbuccal route resulted in administration efficiency 4–17 times higher than conventional per os route. Transbuccal delivery of NLX appears to be a more efficient drug administration route compared to peroral one. It allows to reach a given therapeutic blood level using a small drug dose.
UR - http://hdl.handle.net/10447/93476
M3 - Article
VL - 452
SP - 128
EP - 134
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
ER -