Document Detail

Controlled delivery of naltrexone by an intraoral device: In vivo study on human subjects.
MedLine Citation:
PMID:  23644347     Owner:  NLM     Status:  Publisher    
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 transbuccal 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 group 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 analyzed 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.
Carlo Paderni; Giuseppina Campisi; Axel Schumacher; Thorsten Göttsche; Libero Italo Giannola; Viviana De Caro; Andy Wolff
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-5-2
Journal Detail:
Title:  International journal of pharmaceutics     Volume:  -     ISSN:  1873-3476     ISO Abbreviation:  Int J Pharm     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-5-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7804127     Medline TA:  Int J Pharm     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013. Published by Elsevier B.V.
Dept of Surgical and Oncologic Disciplines, University of Palermo, Italy.
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