Is another ODT excipient necessary? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Is another ODT excipient necessary?


Pharmaceutical Technology Europe
Volume 21, Issue 9

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).

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
9%
All of the above.
45%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology Europe,
Click here