Evaluation of palatability of cocoa-flavored gummi drug of aripiprazole developed from commercially available tablets

Abstract

Back ground: Patients with schizophrenia who often have poor medication adherence could easily take gummi drugs daily resulting in improvement of their therapy. Because gummi drugs are chewed, drugs with an unpleasant bitter taste in gummi formulations may result in poor adherence. In this study, we developed a cocoa-flavored gummi drug containing aripiprazole (ARP) from commercially available orally disintegrating tablets (ODTs) of ARP. We aimed to clarify the palatability of gummi drugs of ARP by performing gustatory sensation test in healthy volunteers. Methods: Four types of ARP gummi formulations (6.0 mg of ARP/3.5 g of gummi drug) were prepared as follows: formulation without organoleptic masking agents (ARP-G); with aspartame (A-ARP-G); with cocoa powder and flavor (CF-ARP-G); and with a combination of aspartame, cocoa powder, and flavor (ACF-ARP-G). A gustatory sensation test was performed in 10 healthy adult volunteers (mean age, 23.7 years). The volunteers chewed each gummi drug in their oral cavities, and then spat out the drug. We used the visual analog scale (VAS) to evaluate bitterness and the overall palatability of ARP-G, A-ARP-G, CF-ARP-G, and ACF-ARP-G while chewing and just after spitting out the drugs. VAS scores of 100 corresponding to bitterness and overall palatability meant "very bitter" and "good," respectively. Results: We developed a cocoa-flavored gummi drug of ARP from commercially available ARP-ODTs. In the gustatory sensation test, the VAS scores of bitterness while chewing the gummi drugs did not differ among the different formulations. The VAS scores of bitterness of A-ARP-G and ACF-ARP-G were significantly lower after spitting out the gummi drugs, while the VAS scores of sweetness were significantly higher than that of ARP-G. The VAS scores of overall palatability of ACF-ARP-G both during chewing and after spitting out were the highest among all gummi drugs tested and significantly higher than those of ARP-G. Conclusion: We were able to develop a cocoa-flavored gummi drug of ARP possessing good palatability from commercially available tablets. Therefore, ARP gummi drugs will be acceptable to patients and help improve their medication adherence.