Palatability Assessment of a New Amphetamine Extended-Release Tablet Formulation

Background

Palatability is a positive factor in adherence and persistence with prescribed medication regimens. We assessed palatability for a new amphetamine extended-release tablet (Dyanavel XR® Extended Release Tablet; AMPH ER TAB).

Methods

Single-dose AMPH ER TAB 20 mg was chewed under fasting (Treatment A) and fed (Treatment B) conditions. Subjects rated the palatability of AMPH ER TAB (Treatments A+B) through a 5-item questionnaire. The items were: 1. Assess mouth feel of the tablet 2. Assess taste 3. How strong is the taste? 4. Aftertaste of the product 5. How strong is the aftertaste? Subjects completed the questionnaire within 10 minutes from administration, which was then scored: Q1,2,4: (Palatability)- Very unpleasant (score of 1), Unpleasant (2), No mouthfeel (3), Pleasant (4), and Very pleasant (5) Q3,5 (Taste/aftertaste strength): Very strong (score of 1), Strong (2), Moderate (3), Mild (4), No aftertaste (5). Scores of 1-2 for both categories were Negative; 3 was Neutral, 4-5 were Positive.

Results

35 subjects participated. For Treatments A and B, most subjects rated the oral sensation/mouth feel (Question 1) and the taste (Question 2) as positive (pleasant to very pleasant) (70.1% and 83.6%, respectively). For taste strength (Question 3): 43.3% rated strength as positive (mild/no taste) and 43.3% of subjects rated strength as neutral (moderate taste). Also, 82.1% rated aftertaste (Question 4) as positive (pleasant/very pleasant) and 52.2% rated strength of the aftertaste as positive (mild/no taste).

Conclusion

AMPH ER TAB provided an overall pleasant taste and mouthfeel experience for the participants.