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26 April 2018 Tablets & Capsules taste masking and release. These systems enjoy wide regulatory acceptance, ease of use, stability, and minimal risk of bio-performance issues. pH-dependent systems include reverse enteric polymers. These polymer systems are soluble under acidic conditions, with ideally little or no release under neutral to alkaline conditions. This provides protection in th e p atien t' s m o u th , wh ere th e p H is h igh er. pH-dependent taste-masking approaches require careful consideration to mitigate possible variation in release performance depending, for example, on food types used for delivering the product to pediatric patients. Another key consideration when using this approach is the potential impact on bio-performance. Formulation strategies Formulators generally consider well-known and widely accepted ingredients, polymers (or coatings), and manufacturing methods when determining the right taste-masking strategy. Taste-masking polymers can be broadly categorized into two categories, pH-independent and pH-dependent. For pH-independent release coatings, both water- insoluble and water-soluble (hydrophilic) polymers are available, including ethylcellulose, cellulose acetate, hypromellose, and hydroxypropyl cellulose. For these systems, taste masking and API release is based on time- dependent diffusion, where polymer combinations are empirically determined to provide the desired degree of Figure 2 Release profiles for multiparticulates coated with combination water-insoluble and water-soluble polymer coatings a. 80 percent insoluble, 20 percent soluble b. 85 percent insoluble, 15 percent soluble c. 90 percent insoluble, 10 percent soluble Percent dissolved Percent dissolved Percent dissolved Percent dissolved Percent dissolved Percent dissolved 0 10 20 30 40 50 0 10 20 30 40 50 0 10 20 30 40 50 0 2 4 6 8 10 12 14 0 2 4 6 8 10 0 2 4 6 8 10 Time (minutes) Time (minutes) Time (minutes) Time (minutes) Time (minutes) Time (minutes) 100 80 60 40 20 0 100 80 60 40 20 0 100 80 60 40 20 0 50 40 30 20 10 0 20 15 10 5 0 20 15 10 5 0 Percent WG 20 25 30 35 40 Percent WG 20 25 30 35 40 Percent WG 20 25 30 35 40 Percent WG 20 25 30 35 40 Percent WG 20 25 30 35 Percent WG 20 25 30 35