Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 477, Issue 1-2, Pages 390-398Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2014.10.039
Keywords
Insulin; SNEDDS; Hypoglycemia; Pharmacokinetic; Oral drug delivery; Enteric coating
Categories
Funding
- Drug Research Academy
- Danish Agency for Science Technology and Innovation
- NAnoMEChanical sensors and actuators, fundamentals and new directions(NAMEC)-aVillumKannRasmussen Centre of Excellence
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This study aims at evaluating the combination of self-nanoemulsifying drug delivery systems (SNEDDS) and enteric-coated capsules as a potential delivery strategy for oral delivery of insulin. The SNEDDS preconcentrates, loaded with insulin-phospholipid complex at different levels (0, 2.5 and 10% w/w), were readily dispersed in water to form nanoemulsions of 35 nm and vesicles of 300 nm. The association efficiency of non-complexed insulin in the dispersed SNEDDS was 18.6%, and was increased to 73.1% for insulin-phospholipid complex (at 10% loading level). The morphology of the dispersed SNEDDS changed from nanoemulsion droplets to vesicular structures with increasing complex loading levels. A pH-dependent insulin release profile was observed for SNEDDS filled into capsules coated with the enteric polymer, Eudragit (R) L100. Using a Caco-2 cell model, it was observed that the transport of insulin was enhanced by factors of 7.7-and 9.3-for SNEDDS loaded with 2.5 and 10% complex, respectively. In healthy fasted rats, administration of SNEDDS (10% complex) filled in enteric-coated capsules produced a 2.7-fold and 3.4-fold enhancement in the relative bioavailability and glucose reduction, respectively. This study shows the effectiveness of combining SNEDDS (loaded with insulin-phospholipid complex) with enteric-coated capsules for enhancing the oral absorption and efficacy of insulin. (C) 2014 Elsevier B.V. All rights reserved.
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