Tablets & Capsules

TC0720

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Tablets & Capsules July 2020 17 shows, there was very little variation in the tablet thick- ness and hardness. Table 9 shows the initial and composite sample friabil- ity and disintegration time for the pilot batch. All the parameters were within specifications, indicating that, by adding talc to the formulation, the scientists were able to successfully scale up the process from proof-of-concept to a pilot scale of 130,000 tablets. T&C Smruti P. Chaudhari, PhD, is developmental scientist I and Yogesh Sadhale, PhD, is associate director, pharmaceutical development at Metrics Contract Services, Greenville, NC (252 752 3800, www.metricscontractservices.com). Metrics is a full-service global contract development and manufacturing organization specializing in oral dosage forms. Table 9 Pilot batch tablet friability and disintegration time Friability (percentage) Disintegration time (seconds) Initial sample 0.055 35 Composite sample 0.009 33 Table 8 Pilot batch tablet thickness and hardness data Time (HH:MM) Thickness (millimeters) Hardness (kilopascals) 00:00 3.41 3.9 00:15 3.31 4.3 00:30 3.28 4.4 00:45 3.27 4.4 01:00 3.18 4.3 01:15 3.33 3.9 01:30 3.17 4.3 01:45 3.30 4.2 02:00 3.31 4.5 02:10 3.27 4.4

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