A standardized mini paddle apparatus as an alternative to the standard paddle

AAPS PharmSciTech

Volumn 9, Issue 4, 2008, Pages 1179-1184

  Klein, Sandra ^a   Shah, Vinod P ^b  

^a GOETHE UNIVERSITY   (Germany)

^b NONE

Author keywords

Dissolution; Hydrodynamics; Mini paddle; Miniaturization; Paddle

Indexed keywords

ATENOLOL; DIAZEPAM; FUROSEMIDE; HCT BETA; HYDROCHLOROTHIAZIDE; IBUHEXAL; METOPROLOL; PIROXICAM; PREDNISOLONE; SANDOZ; STADA; TABLINEN; UNCLASSIFIED DRUG;

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CALIBRATION; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG MANUFACTURE; DRUG RELEASE; DRUG SOLUBILITY; MATHEMATICAL COMPUTING; MINI PADDLE APPARATUS; STANDARDIZATION; ULTRAVIOLET SPECTROSCOPY; BIOAVAILABILITY; CHEMISTRY; INSTRUMENTATION; SOLUBILITY; TABLET; ULTRAVIOLET SPECTROPHOTOMETRY;

BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; SOLUBILITY; SPECTROPHOTOMETRY, ULTRAVIOLET; TABLETS;

EID: 63649144572     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-008-9161-6     Document Type: Article

References (16)

1. Dissolution testing of immediate release solid oral dosage forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
2. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 2000.
3. A. Scholz, E. Kostewicz, B. Abrahamsson, and J.B. Dressman. Can the USP paddle method be used to represent in-vivo hydrodynamics. J. Pharm. Pharmacol. 55(4):443-451 (2003).
4. Y. Wu, D.O. Kildsig, and E.S. Ghaly. Effect of hydrodynamic environment on tablets dissolution rate. Pharm. Dev. Technol. 9(1):25-37 (2004).
5. S. Diebold. Physiological parameters relevant to dissolution testing: hydrodynamic considerations. In J.B. Dressman, and J. Kraemer (eds.), Pharmaceutical dissolution testing, Taylor & Francis, Boca Raton, FL, 2005, pp. 127-191.
6. M. Lindenberg, S. Kopp, and J.B. Dressman. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur. J. Pharm. Biopharm. 58(2):265-278 (2004).
7. N.A. Kasim, M. Whitehouse, C. Ramachandran, M. Bermejo, H. Lennernas, A.S. Hussain, H.E. Junginger, S.A. Stavchansky, K.K. Midha, V.P. Shah, and G. Amidon. Molecular properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification. Mol. Pharm. 1(1):85-96 (2004).
8. C.Y. Wu, and L.Z. Benet. Predicting drug disposition via application of BCS: Transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm. Res. 22(1):11-23 (2005).
9. S. Klein. The mini paddle apparatus - a useful tool in the early developmental stage? Experiences with immediate release dosage forms. Dissolution Technologies. 13(4):6-11 (2006).
10. J.W. Moore, and H.H. Flanner. Mathematical comparison of dissolution profiles. Pharm. Technol. 20:64-74 (1996).
11. V.P. Shah, Y. Tsong, P. Sathe, and R.L. Williams. Dissolution profile comparison using similarity factor, f2. Dissolution Technol. 6(3):15 (1999).
12. V.P. Shah, Y. Tsong, P. Sathe, and J.P. Liu. In vitro dissolution profile comparison - statistics and analysis of the similarity factor, f2. Pharm. Res. 15(6):889-896 (1998).
13. Extended release oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
14. SUPAC-MR: Modified release solid oral dosage forms. Scale-up and postapproval changes: Chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
15. Oral extended (controlled) release dosage forms in vivo bioequivalence and in vitro dissolution testing; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Office of Generic Drugs, U.S. Government Printing Office: Washington, DC, 1993.
16. T. Mirza, J. Yatindra, J.L. Qian, and R. Vivilecchia. Evaluation of dissolution hydrodynamics in the USP, Peak™ and Flat-Bottom Vessels using different solubility drugs. Dissolution Technol. 12(1):11-16 (2005).