Development of dissolution tests on the basis of gastrointestinal physiology

Pharmaceutical Dissolution Testing

Volumn , Issue , 2005, Pages 193-227

  Klein, Sandra ^a   Wunderlich, Martin ^a   Dressman, Jennifer ^a   Stippler, Erika ^b  

^a GOETHE UNIVERSITY   (Germany)

^b PHAST GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056947501     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (18)

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2. Glomme A, März J, Dressman JB. Comparison of a miniaturized shake-flask solubility method with automated potentiometric acid/base titrations and calculated solubilities. J Pharm Sci 2005; 94(1):1-16.
3. Stippler E. Development of BCS-conform Dissolution Testing Methods. Dissertation thesis, University of Frankfurt, 2004.
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5. Avdeef A, Berger CM, Brownell C. pH-metric solubility. 2: correlation between the acid-base titration and the saturation shake-flask solubility-pH methods. Pharm Res 2000; 17:85-89.
6. Oberle R, Chen T-S, Lloyd C, Barnett J, Owyang C, Meyer J, Amidon G. The influence of the interdigestive migrating motility complex on the gastric emptying of liquids. Gastroenterology 1990; 99:1275-1282.
7. FDA. Guidance for Industry: SUPAC-IR Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence. Rockville MD, USA: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 1995.
8. FDA. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations (Revised) (I). Rockville MD, USA: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003.
9. World Health Organization. www.who.int.
10. Kalantzi L, Fürst T, Abrahamsson B, Goumas K, Kalioras V, Dressman J, Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability studies in the fasting and fed states. Proceedings of the AAPS Annual Meeting, Salt Lake City, UT, 2003.
11. Vertzoni M, Dressman J, Reppas C. Dissolution testing in media simulating the gastric composition in the fasted state. Proceedings of the AAPS Annual Meeting, Toronto, Canada, 2002.
12. Marques M. Dissolution Media Simulating Fasted and Fed States. Dissolution Technol 2004; 11:16.
13. Nicolaides E, Symillides M, Dressman JB, Reppas C. Biorelevant dissolution testing to predict the plasma profile of highly lipophilic drugs after oral administration. Pharm Res 2001; 18(3):380-388.
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15. Wunderlich M, Kostewicz E, Becker R, Brauns U, Dressman JB. Transfer model for the precipitation of weak bases in the gastrointestinal tract. J Pharm Pharmacol 2004; 56:43-51.
16. Charman W, Rogge M, Boddy A, Barr W, Berger B. Absorption of danazol after administration to different sites of the gastrointestinal tract and the relationship to single- and double-peak phenomena in the plasma profiles. J Clin Pharmacol 1994; 33:1207-1212.
17. United States Pharmacopeia. (USP 27). Rockville, MD: United States Pharmacopoeia Convention, Inc., 2004.
18. Klein S, Rudolph M, Dressman JB. Drug release characteristics of different mesalazine products using USP apparatus 3 to simulate passage through the GI tract. Dissolution Technol 2002; 9:6-12.