Tablets & Capsules


Issue link:

Contents of this Issue


Page 20 of 51

Tablets & Capsules July/August 2021 19 In dissolution tests, 100 percent of very soluble ascor- bic acid in fixed-dose combination tablets made with Reta M had been released after 13 hours, as shown in Figure 2, while sparingly soluble caffeine (16 mg/ml) showed a sus- tained release of 16 hours, as shown in Figure 3. Regulatory compliance Coprocessed excipients have gained popularity in recent years, which has resulted in increased regulatory scrutiny. To establish a clear understanding of copro- cessed excipients for excipient manufacturers, excipient users, and regulatory bodies, the International Pharmaceu- tical Excipients Council (IPEC) Americas and European chapters jointly published The International Pharmaceutical Council Co-processed Excipient Guide for Pharmaceutical Excipients (2). As an IPEC member, Meggle complies with this guide and manufactures Reta M using pharmaceutical-quality mannitol and hypromellose to ensure compliance with regulators' quality standards. T&C References 1. J. Siepmann, Y. Karrout, M. Gehrke, F. K. Penz, and F. Siepmann. "Predicting drug release from HPMC/ lactose tablets." International Journal of Pharmaceutics. 2013. Vol. 441, Nos. 1–2, pages 826–834. https://doi. org/10.1016/j.ijpharm.2012.12.009 2. Available at Dr. Christian Nowak is application manager at Meggle Excipients & Technology (, +49 8071 73 623). Figure 3 Caffeine release (pH 5.8 USP-NF) of 400-milligram tablets Drug release (percentage) Time (minutes) 100 50 0 0 500 1,000 1,500 Caffeine 50% (200 mg) Reta M 48.5%

Articles in this issue

Links on this page

Archives of this issue

view archives of Tablets & Capsules - TC0721