Tablets & Capsules

TC0120

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32D January 2020 Tablets & Capsules References 1. P Desai, C Liew, P Heng; Review of Disintegrants and the Disintegration Phenomena, J Pharma Sci, 2016, 105, 2545. 2. Y Lan, A Joshi, J Shang, N Langley; Formulation of rapidly disintegrating tablets with high bitter drug load and high tensile strength, AAPS 2018, Washington DC. 3. F Bang, T Cech, V Geiselhart; Investigating the impact of crospovidone particle size on the characteris- tics of an orally disintegrating tablet, 4th Conference on Innovation in Drug Delivery, 2016, Antibes, France. Jiantao Zhang, Yidan Lan, and Ashish Joshi are technical ser- vice managers, and Nigel Langley is a director of technical service at BASF, Tarrytown, NY (800 526 1072, www.basf.com). that of the commercial ODT (0.4 percent). At 10 to 20 kilonewtons of compression force, the friability of refor- mulated ODTs was much lower than that of the commer- cial ODT, ranging from 0.13 percent to 0.03 percent (Figure 2). This low friability is a result of the strong bind- ing effect of Kollidon CL-SF, which generates a robust ODT that can withstand handling and transportation [3]. Finally, the ODTs' disintegration times were compared using water as a medium. As shown in Figure 3, the refor- mulated ODTs disintegrated in 10 to 40 seconds, depend- ing on the compression force, while the commercial ODT took 42 seconds to disintegrate. Kollidon CL-F can also be used as a disintegrant in this formulation at 15 percent, resulting in similar properties as Kollidon CL-SF at 15 percent; however, the super-fine particle size of Kollidon CL-SF offers an exceptionally creamy mouthfeel, which makes it ideal for use in ODT formulations. Panel in-vivo tests showed that the reformulated ODT had a smooth, pleasant, and creamy mouthfeel; dissolved quickly; and was easy to swallow. In comparison, the commercial ODT product had a sandy/gritty texture, and a scratchy feel on the tongue, mouth, and throat that per- sisted long after swallowing. Conclusion The reformulated CoQ10 ODTs were the same dos- age strength and of a similar size, weight, and shape as the commercial CoQ10 ODTs but demonstrated increased hardness, decreased friability, and faster disin- tegration. The addition of Kollidon CL-SF improved the disintegration time, mouthfeel, and uniform disper- sion of colored ingredients, preventing a speckled tablet surface. The improved organoleptic properties and physical appearance of the reformulated CoQ10 tablets may help to greatly improve patients' product experi- ence as well as compliance. T&C Figure 2 Friability of CoQ10 ODTs Friability (%) Compression force (kN) Commercial ODT 0.6 0.5 0.4 0.3 0.2 0.1 0 5 10 15 20 Figure 3 Disintegration time of CoQ10 ODTs Disintegration time (seconds) Compression force (kN) Kollidon CL-SF Kollidon CL-F 50 40 30 20 10 0 5 10 15 20 Commercial ODT FOLLOW US

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