Orally Disintegrating Tablets: The Effect of Recent FDA Guidance on ODT Technologies and Applications - Pharmaceutical Technology

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Orally Disintegrating Tablets: The Effect of Recent FDA Guidance on ODT Technologies and Applications
The authors describe the various available technologies used in orally disintegrating tablets.

Pharmaceutical Technology


1. FDA, CDER data standards manual (C-DRG-00201 Version 008), http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071666.htm/, accessed Aug. 20, 2009.

2. FDA, Guidance for Industry: Orally Disintegrating Tablets (Rockville, MD, Dec. 2008), http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0365-gdl.pdf, accessed Aug. 20, 2009.

3. European Pharmacopeia, Version 6.5, 2009.

4. EMEA, Committee for Medicinal Products for Human Use (CHMP), Reflection Paper: Formulations of Choice for the Paediatric Population, Adoption by CHMP Sept. 21, 2006, http://www.emea.europa.eu/pdfs/human/paediatrics/19481005en.pdf, accessed Aug. 20, 2009.

5. S. Freedman et al., "Oral Ondansetron for Gastroenteritis in a Pedatric Emergency Department," New Eng. J. of Med. 354 (16), 1698-1705 (2006).

6. R. Bohnacker et al., "Bestimmung der Zerfallszeit von Schmelztabletten mit Hilfe der Texture Analyser-Methode," Pharm. Ind. 67 (3), 327–335, (2005).

7. D. Gole et al., "Pharmaceutical and Other Dosage Forms," US patent 5,648,093, 1997.


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