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with respect to tablet hardness, API stability, low
levels of peroxide, and long-term stability. Aqueous
coating of ODT formulations containing the Parteck®
ODT excipient system is also possible with no impact
on disintegration time.
Given all of these attributes, the compatibility of
Parteck® ODT with most actives, and its simplicity,
this excipient system can help to accelerate both
formulation development and the regulatory
registration process, making it a viable, economical
option for ODT formulations.
References
1. Behnke, K., et al. " Mirtazapine orally disintegrating tablet
versus sertraline: a prospective onset of action study. " J. Clin.
Psychopharmacol. 23: 358-64 (2003).
2.
Jaccard, T. and J. Leyder. " Une nouvelle forme galenique le lyoc. "
Ann. Pharm. Fr. 43: 123-31 (1985).
3. Dollo, G., et al. " Bioavailability of phloroglucinol in man. " J. Pharm.
Belg. 54: 75-82 (1999).
4. Gafitanu, E., et al. " Formulations and bioavailability of
propyphenazone in lyophilized tablets. " Rev. Med. Chir. Soc. Med.
Nat. Iasi. 95: 127-128 (1991).
5. Parakh, S. and Gothoskar, A. V. " A review of mouth dissolving
tablet technologies. " Pharmaceutical Technology 27: 92-100
(2003).
6. Douroumis, D. " Orally disintegrating dosage forms and tastemasking
technologies. " Expert Opinion on Drug Delivery. 8:
665-675 (2011).
7. Bandari, S., et al. " Orodispersible tablets: An overview. " Asian
Journal of Pharmaceutics. 2(1) (2008).
8. Ohrem, H., et al. " ODT delivery platforms: A comparison of
dissolution times. " Tablets and Capsules Oct. 2010. Web.
9. FDA Guidance for Industry - Orally Disintegrating Tablets, U.S.
Food and Drug Administration. Dec. 2008.
10. Ohrem, L., et al. " ODT-Formulations: Fast dissolution not always
follows fast disintegration. " AAPS Annual Meeting and Exposition.
2010. Web.
11. Ohrem, L. and Ognibene, R. " Is another ODT excipient necessary? "
Pharmaceutical Technology Europe. Sep. 2009. Web.
12. Ohrem, L., et al. " Stability Issues Due to Peroxides in ODT
Formulations. " AAPS Annual Meeting and Exposition. 2013. Web.
13. Deutsches Arzneibuch Deutscher Apotheker Verlag, Stuttgart,
Govi-Verlag, Frankfurt a. M, 1996; p VII.1.3.2.
14. Ohrem, L. and. Ognibene, R. " ODT Formulations with Aqueous
Coatings? " AAPS Annual Meeting and Exposition. 2012. Web.
About the Authors
Hans-Leonhard Ohrem
Technical Product Manager of Formulation,
MilliporeSigma
Leo brings 20 years of experience as Marketing Manager
and expertise in solid dose excipients and formulation
technologies to his current role. His responsibilities include
coordination of customer projects, development of
production processes in functional particle engineering,
and regulatory support. Leo has five years' experience
leading the development group and pilot plant unit in
central process development, with a focus on preparative
chromatography and continuous reactor design. Leo
received master's degrees in chemical engineering from
RWTH Aachen and Cornell University and a Ph.D. in
biochemical engineering from RRTH Aachen.
Adela Kasselkus, Ph.D.
Technical Communication Manager Formulation,
MilliporeSigma
Global Technical Product Manager, Synthetic
Lipids, MilliporeSigma Adela Kasselkus is Technical
Communication Manager at Merck, Darmstadt. She
holds a doctorate in pharmaceutical technology from the
University of Duesseldorf and has a broad experience in
formulation development and bioavailability enhancing
technologies with a focus on solid dose formulation. In her
current role, she is supporting a wide range of activities for
solid, liquid and drug delivery applications.
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