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eye on excipients 50 September 2020 Tablets & Capsules This edition of Eye on Excipients describes a study conducted to evaluate the suitability of a novel co-processed excipient for use in orally disintegrating tablets and direct compression tableting. The characteristics evaluated included disintegrability, compactability, stabil- ity, and content uniformity. Improving medication adherence is an important aspect of patient- focused pharmaceutical development. Typical approaches for improving adherence include changing the route of administration from intrave- nous to oral and reducing the dos- ing frequency. Orally disintegrating tablets (ODTs) are one of the most popular dosage forms for improving medication adherence. ODTs dis- integrate in saliva in the oral cavity without requiring water. This allows patients with dysphagia, as well as geriatric and pediatric populations, to easily swallow the medication. Traditionally, manufacturing ODTs required special processes, such as lyophilization and mold- ing. However, since the early 2000s, manufacturers have been using an altern ative, d irect-co m p ressio n process, as it enables the produc- tion of ODTs using conventional tableting and packaging equip- ment. Currently, several co-pro- cessed excipients for ODTs have been launched to produce ODTs more easily using direct compres- sion [1]. Co-processed excipients provide not only good performance as ODTs, but also applicability for the direct-compression process. The following study evaluated a novel co-processed excipient for ODTs (HiSORAD) from the viewpoints of suitability as an ODT and applica- bility for direct compression. Ingredients and particle characteristics The co-processed excipient is composed of three excipients listed in the US, European, and Japanese pharmacopoeias: mannitol, micro- crystalline cellulose, and croscarmel- lose sodium. These three ingredients Yukiko Suganuma Daicel Figure 1 SEM image of HiSORAD co-processed excipient particles Figure 2 Disintegration and compactability of placebo ODTs containing co-processed excipient (99.0%) and sodium stearyl fumarate (1.0%) (Rotary tablet press, 200 mg, 8 mm diameter, flat beveled-edge shape) a. Disintegration time versus tablet hardness in vivo Pharmacopoeia b. Tablet hardness and friability versus compression force Disintegration time (seconds) 40 30 20 10 0 40 60 80 100 120 140 Tablet hardness (newtons) Tablet hardness (newtons) Compression force (kilonewtons) 2 4 6 8 140 120 100 80 60 40 0.5 0.4 0.3 0.2 0.1 0.0 Friability (%) Tablet hardness Friability

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