4.3 Article

Palatability of Aripiprazole Gummies Prepared from Commercially Available Products: Pharmaceutical Formulation for Improving Patient Adherence

Journal

CHEMICAL & PHARMACEUTICAL BULLETIN
Volume 71, Issue 6, Pages 441-446

Publisher

PHARMACEUTICAL SOC JAPAN

Keywords

aripiprazole; gummy drug; adherence; pharmaceutical preparation; palatability

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Good adherence to medication is crucial for treating psychiatric disorders successfully. Tailor-made pharmaceutical formulations can offer individual patients a suitable dosage form to address poor adherence to industrially manufactured products. In this study, aripiprazole gummies with different flavors were prepared and their palatability was evaluated through gustatory sensation tests. The results showed that cocoa-flavored gummies containing aspartame, cocoa powder, and banana flavor, as well as grapefruit-flavored gummies, had the highest palatability scores. These tailor-made formulations could be acceptable for patients and serve as alternatives to enhance medication adherence.
Good adherence to medication is critical for successfully treating psychiatric disorders. Tailor-made pharmaceutical formulations can provide a suitable dosage form to meet the specific needs of individual patients who exhibit poor adherence to industrially manufactured products. Herein, we prepared aripiprazole (ARP) gummies (ARP-Gs) using a commercially available ARP formulation. We aimed to clarify the palatability of ARP-Gs by performing a gustatory sensation test in healthy volunteers. We performed two types of organoleptic masking of ARP-Gs, cocoa-and fruit-flavoured gummies (6.0 mg of ARP/3.5 g of gummy), and conducted two different gustatory sensation tests for each ARP-G. Ten young, healthy volunteers (mean +/- standard deviation, 23.7 +/- 1.2 years) were enrolled in each trial. The overall palatability of ARP-Gs was evaluated using the 100-mm visual analogue scale (VAS). Receiver operating characteristic (ROC) curve analysis was performed between VAS scores of total ARP-G palatability and acceptability assessed using a 5-point rating scale. Among cocoa-flavoured ARP-Gs, those combining aspartame, cocoa powder, and banana flavour (ABC-ARP-G) exhibited the highest VAS scores for total palatability. Similarly, the VAS scores of grapefruit-flavoured ARP-Gs (GF-ARP-G) showed the highest values considering all fruit-flavoured ARP-Gs. The VAS scores for ABC-ARP-G and GF-ARP-G greatly exceeded the cut-off values of acceptability calculated using the ROC curve. We developed two types of ARP-Gs with organoleptic masking as tailor-made pharmaceutical formulations. ABC-ARP-Gs and GF-ARP-Gs could be acceptable in patients. ARP-Gs could be an alternative to currently available pharmaceutical formulations to enhance their adherence and meet the specific needs of individual patients.

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