Yes, we do need a new ODT excipient
In answer to the earlier question "Is there a need for another excipient system for direct compression and fast dissolution?",
we believe that the answer is "yes"; there is certainly a use for a new ODT formulation. The combination of two components
in Parteck ODT — one binder and a superdisintegrant — shows valuable characteristics for direct compression. Through its large
surface area, the formulator can achieve high tablet strength at low friability while still achieving fast disintegration
and a pleasant mouth feel. Tablets produced with Parteck ODT exhibit rapid disintegration within the oral cavity, as well
as fast release of the active. We believe that this excipient system speeds up the regulatory registration process and is
compatible with most actives, making it a good, economical option.
H. Leonhard Ohrem is Technical Manager at Merck KGaA (Germany). Hans-Leonhard.Ohrem@merck.de
Roberto Ognibene is Technical Support, Merck KGaA (Germany).
References
1. P. van Arnum, Pharm. Technol., 31(10), 66–76 (2007).
2. FDA Guidance for Industry — Orally Disintegrating Tablets, December 2008.
http://www.fda.gov/
3. European Pharmacopoeia 6.0, Orodospersible Tablets, July 2007.
4. R. Bohnacker et al., Pharm. Ind., 67(3), 327–335 (2005).
5. W. Camarco, D. Ray and A. Druffner, Pharm. Technol., 30(10), 27–37 (2006).
6. USP 24-NF 19.
7. M. Bertoni, F. Ferrari and C. Caramella, Pharm. Technol. Eur., 17(11), 17–24 (1995).
8. M.S. Gordon, B. Chatterjee and Z.T. Chowhan, J. Pharm. Sci., 79(1), 43–47 (1990).
9. C. Ferrero et al., Int. J. Pharm., 147, 11–21 (1997).
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