An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets - Pharmaceutical Technology

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An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.


Pharmaceutical Technology
Volume 32, Issue 8

References

1. Draft Guidance for Industry Orally Disintegrating Tablets (FDA, Rockville, MD), http://www.fda.gov/cder/guidance/index.htm, April 2007.

2. CDER Data Standards Manual, Dosage Forms, C-DRG-00201, version 008 (April, 1992).

3. W. Habib et al., "Fast-Dissolve Drug Delivery Systems," Critical Reviews in Therapeutic Drug Carriers Systems 17 (1), 61–72 (2000).

4. "Orally Disintegrating Tablet and Film Technologies: Technologies, Market Analysis, & Business Opportunities," in Market Study Reports, 4th ed. (Technology Catalysts International Corp. Falls Church, VA, 2006), pp. 5–6.

5. "‹701› Disintegration," in USP 29 (US Pharmacopieal Convention, Rockville, MD) pp. 2670–2672.

6. F. Fang et al., "Desktop Disintegration Test for Orally Disintegrating Tablets (ODTs): A Rapid and Simple Method for Observing the Disintegration Behavior for the Regulatory Review Scientist in the Evaluation of Drug Applications," presented at the 12th Annual FDA Science Forum, April 1, 2006.

7. J. Segado Ferran et al., "Orally Disintegrating Tablets and Process for Obtaining Them," WO 103629 (2003).

8. G. Abdelbary et al., "Determination of the In Vitro Disintegration Profile of Rapidly Disintegrating Tablets and Correlation With Oral Disintegration," Int. J. Pharm. 292 (1–2), 29–41 (2005).

9. S. el-Arini and S. Clas, "Evaluation of Disintegration Testing of Different Fast Dissolving Tablets Using the Texture Analyzer," Pharm Dev Technol. 7, 361–371 (2002).

10. M.Gohel et al, "Formulation Design and Optimization of Mouth Dissolve Tablets of Nimesulide Using Vacuum Drying Technique," AAPS Pharm. SciTech. 5 (3), 1–6 (2004).

11. J.M. Dor et al., "A New In Vitro Method to Measure the Disintegration Time of a Fast-Disintegration Tablet," Proc. Intl Control. Rel. Bioact. Mater. 26, 939–940 (1999).

12. M. Rawasqalaji et al., "Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration," US Patent 0059361 (2007).

13. J. Park and S. Wu, "Should Orally Disintegrating Tablets (ODTs) Have A Weight Limit?," poster presentation, AAPS Annual Meeting and Exposition, San Diego, CA, Nov. 19–23, 2007.

14. B. Li and J. Robinson, "Chapter 2: Preclinical Assessment of Oral Mucosal Drug Delivery Systems," in Drugs and Pharmaceutical Sciences, Vol. 145: Drug Delivery to the Oral Cavity, Molecules to Market (Taylor & Francis, Oxford, UK, 2005), p. 47.




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