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
[Display omitted] 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 sy...
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Veröffentlicht in: | International journal of pharmaceutics 2024-07, Vol.660, p.124286, Article 124286 |
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Sprache: | eng |
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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. |
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ISSN: | 0378-5173 1873-3476 1873-3476 |
DOI: | 10.1016/j.ijpharm.2024.124286 |