Development and in vitro evaluation of an infant friendly self-nanoemulsifying drug delivery system (SNEDDS) loaded with an amphotericin B-monoacyl phosphatidylcholine complex for oral delivery
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Until relatively recently, the pediatric population has largely been ignored during the development of new drug products, which has led to a high level of “off-label” use of drugs in this particular population. In this study, an infant friendly self-nanoemulsifying drug delivery system (SNEDDS) was developed for oral delivery of a commonly used “off-label” drug – amphotericin B (AmB). AmB was complexed with monoacyl-phosphatidylcholine (MAPC) by lyophilization, transforming crystalline AmB into its amorphous state in the AmB-MAPC complex (APC). The APC-loaded SNEDDS (APC-SNEDDS) showed excellent self-emulsifying properties; after dispersion of the APC-SNEDDS in purified water, nanoscale emulsion droplets were formed within 1 min with a z-average size of 179 ± 1 nm. In vitro pediatric gastrointestinal (GI) digestion and dissolution results showed that the APC-SNEDDS significantly increased the amount of AmB solubilized in aqueous phase and that the precipitated AmB from the APC-SNEDDS re-dissolved faster, compared with crystalline AmB in SNEDDS (AmB-SNEDDS), the complex without the SNEDDS (APC), the physical mixture of AmB and MAPC (AmB/MAPC PM), and crystalline AmB alone (AmB). Overall, the present in vitro results suggest that integrating the APC into an infant friendly SNEDDS is a promising approach for oral delivery of AmB to young pediatric patients.
Originalsprog | Engelsk |
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Artikelnummer | 124286 |
Tidsskrift | International Journal of Pharmaceutics |
Vol/bind | 660 |
Antal sider | 8 |
ISSN | 0378-5173 |
DOI | |
Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:
Support from the University of Copenhagen, Denmark and the grant from China Scholarship Council, China (Fund No. 201706010335) for the research are kindly acknowledged. Disclosure. The authors report no conflicts of interest in this work.
Funding Information:
Support from the University of Copenhagen and the grant from China Scholarship Council (Fund No. 201706010335 ) for the research are kindly acknowledged.
Publisher Copyright:
© 2024 The Authors
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