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 www.ipecamericas.org.
Dr. Christian Nowak is application manager at Meggle
Excipients & Technology (christian.nowak@meggle.com,
+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%
