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26 July 2017 Tablets & Capsules During that process, tablet samples were taken every 5 minutes and tested for content uniformity. To analyze the results and see whether the different MCCs showed any difference in segregation of the levothyroxine, it was first necessary to determine whether to base the results on weight variance or on con- tent uniformity. For this we relied on USP General Chapter <905>, which states that tablets containing less than 25 percent API should use an acceptance value based on content uniformity. The acceptance value was calculated as shown in Equation 1: |M-X|+ks (1) where M is the reference value X is the mean of individual contents k is the acceptability constant, and s is the sample standard deviation. In this case, the maximum allowable acceptance value was 15 percent. Figure 6 presents the results. After the 120-minute blending process, the acceptance values were 12.7 percent for the PH-102 and 7.3 percent for the novel MCC, both within the 15 percent thresh- old. Results from multiple tests of the tablet samples con- taining PH-102 MCC—taken at 5-minute intervals— showed the acceptance values were 18.9 percent, 13.8 percent, and 16.9 percent. This shows that the PH-102 did not adequately limit levothyroxine segregation after the blend was transferred to the hopper and passed through the tablet press. In contrast, tests on tablet sam- ples that included the novel MCC and taken at the same intervals showed acceptance values of 13.0 percent, 14.1 percent, and 14.0 percent. These results indicate that using the novel MCC can limit the potential segregation in formulations containing a low dose of levothyroxine. T&C Reference 1. Ceolus UF-702 from Asahi Kasei, Tokyo, Japan. Yosuke Honda is chief engineer and Syozo Kaneyama is an engi- neer in the Ceolus R&D department, Functional Additives Divi- sion, of Asahi Kasei, Tokyo, Japan. Stephen Turner is US sales manager, Functional Additives Division, of Asahi Kasei America, 800 Third Avenue, 30th Floor, New York, NY 10022. Tel. 212 371 9900, ext. 221. Website: www.ak-america.com. Figure 6 Acceptance values of powder blends and tablets containing different MCCs Novel MCC [1]: 80% PH-102 : 80% Acceptance value (%) 30 25 20 15 10 5 0 After mixing Tabletting start 5 min tabletting 10 min tabletting Further reading Find more information about how to prevent or miti- gate segregation of direct-to-press blends in the article "Identifying and controlling segregation in tablet press feed systems," by Kerry Johanson. It appeared in the May 2017 issue. Another Johanson article, "Relating flow properties to process behavior in tablet presses and capsule filling machines," appeared in the May 2014 issue. Find more information in Tablets & Capsules' article index in the November 2016 issue and at T&C's website, www.tabletscapsules.com. You missed it! You'll find valuable information you can't find elsewhere, including: • Industry experts answering your questions • Preview of upcoming articles • Supplier Directory Solid Dose Digest is T&C's twice-monthly e-newsletter Sign up now by emailing kmyers@cscpub.com your name, company, and email address. To see a sample, please visit our website www.tabletscapsules.com.