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Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC)


Reference:

Bittner, B., McIntyre, C., Tian, H., Tang, K., Shah, N., Phuapradit, W., Ahmed, H., Chokshi, H., Infeld, M., Fotaki, N., Ma, H., Portron, A., Jordan, P. and Schmidt, J., 2012. Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC). Die Pharmazie - An International Journal of Pharmaceutical Sciences, 67 (3), pp. 233-241.

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Official URL:

http://dx.doi.org/10.1691/ph.2012.1648

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Abstract

The aim of this study was to select a novel oral formulation for ibandronate (IBN, CAS number: 13892619). In four cohorts of 28, 21, 19 and 29 healthy volunteers, the impact of the carrier molecule sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC, CAS number: 203787-91-1) on the bioavailability of IBN was investigated. Within each cohort different oral formulations with one dose of ibandronate (30 mg) and three different ratios of IBN:SNAC (1:5, 1:10 and 1:20) were compared to the approved oral IBN tablet formulations (150 and 50 mg IBN) in a 4-way cross-over design and a one week washout between the administrations. The highest mean IBN exposure was achieved with a capsule formulation containing drug-coated beadlets and an IBN:SNAC ratio of 1:5. AUClast and Cmax of IBN were approximately 1.3- and 2.2-fold higher compared to the reference treatment (150 mg IBN without SNAC). Increasing the post-dose fasting duration from 15 to 30 min resulted in a more than 2-fold increase in AUClast, while superimposable IBN serum concentration-time profiles were achieved after a 30 and 60 min fast. The tolerability of the IBN/SNAC treatments in all cohorts was similar to that in the IBN reference groups and most adverse events (AEs) were of mild to moderate intensity.

Details

Item Type Articles
CreatorsBittner, B., McIntyre, C., Tian, H., Tang, K., Shah, N., Phuapradit, W., Ahmed, H., Chokshi, H., Infeld, M., Fotaki, N., Ma, H., Portron, A., Jordan, P. and Schmidt, J.
DOI10.1691/ph.2012.1648
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URLURL Type
http://www.scopus.com/inward/record.url?scp=84861170949&partnerID=8YFLogxKUNSPECIFIED
DepartmentsFaculty of Science > Pharmacy & Pharmacology
RefereedYes
StatusPublished
ID Code32779

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