Study on the impact of SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) on the bioavailability of ibandronate (IBN) in postmenopausal women

This study was conducted to investigate whether the excipient SNAC (sodium N-[8-(2-hydroxybenzoyl)amino] caprylate) needs to be co-formulated or just co-dosed in order to increase the oral bioavailability of ibandronate (IBN). This was a single-dose, open-label, crossover study in 52 healthy postmenopausal women. Subjects were randomized to four of the following five treatments: A: 20 mg IBN plus 100 mg SNAC administered at the same time point (separate formulations), B: 20 mg IBN plus 100 mg SNAC administered as co-formulation, C: 100 mg SNAC administered 15 minutes prior to 20 mg IBN, D: 100 mg SNAC administered 30 minutes prior to 20 mg IBN and E: 20 mg IBN. Compared to IBN alone, SNAC co-formulated with IBN resulted in a 17- and 11-fold increase in Cmax and AUC0-last, respectively. When co-dosed but not co-formulated and when given 15 or 30 minutes prior to IBN, SNAC did not markedly affect the exposure to IBN. All treatments were well tolerated.