Associate Director Bristol-Myers Squibb Company Summit, New Jersey
Palatability of oral dosage forms is important for their acceptability in the pediatric population. This study proposes a coating platform approach to effectively masking the aversive taste of drugs in micro-tablets, a preferred pediatric solid dosage form. Micro-tablets (1.2 mm diameter) containing quinine sulfate (a model bitter drug) were coated with reverse enteric (Eudragit® EPO and Kollicoat Smartseal® 30D), barrier (Surelease® with HPMC), and traditional aesthetic (PVA-based Opadry II) coating systems. An in-vitro dissolution tool, mimicking salivary and gastric pH conditions, predicted that 15% and 25% Smartseal 30D, and 25% and 35% Surelease:HPMC (80:20) would prevent quinine release in the mouth and ensure complete release in the stomach. A human sensory panel study, subsequently, confirmed the taste masking effectiveness of these coating systems. As a platform coating approach, 25% Kollicoat SmartSeal® 30 D and 35% Surelease®: HPMC (80:20) were proposed to taste mask bitter drugs in micro-tablets.
Learning Objectives:
Development strategies of pediatric micro-tablets.
Optimization coating systems in achieving robust taste masking of bitter drugs in micro-tablets.
Effective use of two-stage dissolution as an effective tool in optimizing coating systems.
Application of human sensory panel study as a confirmatory study.