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28 April 2018 Tablets & Capsules References 1. A. M. Peterson, L. Takiya, and R. Finley, "Meta- analysis of trials of interventions to improve medication adherence," American Journal of Health System Pharmacists, Vol. 60, pages 657-665, (2003). 2. Zelalem Ayenew, Vibha Puri, Lokesh Kumar, and Arvind K. Bansal, "Trends in pharmaceutical taste- masking technologies: A patent review," Recent Patents on Drug Delivery & Formulation, Vol. 3, pages 26-39, (2009). 3. Daniel To, Jason Teckoe, and Ali Rajabi-Siahboomi, "Investigation of taste-masking performance of an aqueous ethylcellulose dispersion (Surelease) on acetaminophen granules," Poster session presented at the American Association of Pharmaceutical Scientists Annual Meeting, November 2013, San Antonio, TX. 4. Raxit Y. Mehta, Charles R. Cunningham, and Ali R. Rajabi-Siahboomi, "Evaluation of acetaminophen particle size and crystal morphology on taste-masking performance from coated granules and chewable tablets," Poster session presented at the Controlled Release Society Annual Meeting, July 2015, Edinburgh, Scotland. 5. AMBERLITE is a trademark of the Dow Chemical Company. 6. Edward F. Bouchard, Ira J. Friedman, and Roy J. Taylor, "Vitamin B12 products and preparation thereof," US patent no. 2,830,933, (1958). 7. Tussionex is a trademark of the UCB group of companies. 8. Delsym is a trademark of Reckitt Benckiser. Charles Vesey is a formulation technology manager in the market development group at Colorcon (215 699 7733, www. colorcon.com) and a licensed pharmacist in the Commonwealth of Pennsylvania. Additionally, the small particle size of IER polymers produces a less gritty mouthfeel, improving the palatability of taste-masked formulations. For these reasons, IERs can achieve an effectiveness and duration of taste masking that's not possible with other methods, as demonstrated by the example in Figure 4. In this example, a BCS Class I API was combined with an IER (AMBERLITE [5]) at a 1:1 API-to-resin ratio (w/w). The resulting resinate achieved a taste-masking duration of 20 minutes and a taste-masking efficiency of 94 percent, which was calculated as the C max of the API-resin complex divided by the C max of the API and expressed as a percentage. IERs have a long history in pharmaceuticals dating back to the mid-1950s and their use enhancing the stability of vitamin B formulations [6]. One of the most well-known IER applications is for taste masking liquid antitussive and cough suppressant preparations, such as Tussionex [7] and Delsym [8]. IERs offer several advantages over other approaches to taste masking, including: • High taste-masking efficiency for extended periods of time; • Ease of scale-up from laboratory to production; • Applicability for liquids and suspensions; • Excellent palatability and less gritty mouthfeel; • Elimination of breakthrough taste. Summary Taste-masked formulations can be challenging to develop, and the best method is often dictated by the API's physicochemical properties and taste profile. Fortunately, effective methods, such as flavors and sweeteners, barrier membrane coatings, and IERs, are available for use individually or in combination, depending on the application. While the methods and polymers may vary, coating remains the preferred method for masking bitter APIs and improving patient experience. T&C The Solids Flow Experts If you have a Particle, We can Characterize it Dedicated to providing cost effec�ve engineered solu�ons based on measure- ment of key material flow proper�es. We can combine material flow property tes�ng with nearly 40 years consul�ng experience to solve any flow and han- dling problems facing today's producers of fine powders and granules. C u s t o m D e s ig n s Call us: +1-352-379-8879 Visit us: www.ma�lowsol.com