Dissolution testing for solid oral drug products: Theoretical considerations

American Pharmaceutical Review

Volumn 7, Issue 5, 2004, Pages 26-30

  Zhang, Hua ^a   Yu, Lawrence X ^b  

^a ASTRAZENECA   (United Kingdom)

^b Food/Drug Administration   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM PHOSPHATE DIBASIC; CARBAMAZEPINE; CIMETIDINE; DANAZOL; DODECYL SULFATE SODIUM; DRUG; EXCIPIENT; FLUTAMIDE; HYDROCHLORIC ACID; MEBENDAZOLE; MEDROXYPROGESTERONE ACETATE; METOPROLOL; PROPRANOLOL; RANITIDINE; SPIRONOLACTONE; SURFACTANT;

ARTICLE; BIOEQUIVALENCE; CHEMICAL COMPOSITION; CONTROLLED RELEASE FORMULATION; CORRELATION ANALYSIS; CULTURE MEDIUM; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG GRANULATION; DRUG MANUFACTURE; DRUG PENETRATION; DRUG QUALITY; DRUG RELEASE; DRUG RESEARCH; DRUG SOLUBILITY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MEDICAL LITERATURE; PH; PHYSICAL CHEMISTRY; PREDICTION; PROCESS CONTROL; PROCESS MONITORING; QUALITY CONTROL; ROTATION; SENSITIVITY ANALYSIS; STOMACH EMPTYING; SUSTAINED RELEASE FORMULATION; TABLET MANUFACTURE; TASK PERFORMANCE; TEMPERATURE; THEORY;

EID: 7944225198     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. Guidance for industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms. August 1997, CDER/FDA.
2. L.X. Yu, M.S. Furness, A. Raw, K.P. Woodland Outlaw, N.E. Nashed, E. Ramos, S.P.F. Miller, R.C. Adams, F. Fang, R.M. Patel, F.O. Holcombe, Jr., Y. Chiu, A.S. Hussain, Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications. Pharm. Rev. 20:531-536 (2003).
3. P. Gao, B. D. Rush, W. P. Pfund, T. Huang, J. M. Bauer W. Morozowich, M.-S. Kuo, and M. J. Hageman. Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability. J. Pharm. Sci. 92:2386-2398 (2003).
4. Guidance for industry, Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes. November 1995, CDER/FDA.
5. Guidance for industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. August 2000, CDER /FDA
6. Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In vitro/In vivo Correlations. September 1997, CDER/FDA.
7. E. Swanepoel, W. Liebenberg, and M. M. de Villiers. Quality evaluation of generic drugs by dissolution test: changing the USP dissolution medium to distinguish between active and non-active mebendazole polymorphs. Eur. J. Pharm. Biopharm. 55: 345-349 (2003).
8. G. S. Rekhi, N. D. Eddington, M. J. Fossler, P. Schwartz, L. J. Lesko, and L. L. Augsburger. Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations. Pharm. Dev. Technol. 2:11-24 (1997).
9. N. D. Eddington, M. Ashraf, L. L. Augsburger, J. L. Leslie, M. J. Fossler, L. J. Lesko, V. P. Shah, and G. S. Rekhi. Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets. Pharm. Dev. Technol. 3:535-547 (1998).
10. J. E. Polli, G. S. Rekhi, L. L. Augsburger, and V. P. Shah. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86:690-700 (1997).
11. J. M. Clarke, L. E. Ramsay, J. R. Shelton, M. J. Tidd, S. Murray, and R. F. Palmer. Factors influencing comparative bioavailability of spironolactone tablets. J. Pharm. Sci. 66:1429-32 (1977).
12. A. Scholz, E. Kostewicz, B. Abrahamsson, and J. B. Dressman. Can the USP paddle method be used to represent in-vivo hydrodynamics? J. Pharm. and Pharmacol. 55:443-451 (2003).
13. L. X. Yu, C. D. Ellison, A. S. Hussain. Predicting human oral bioavailability using in silico models. In R. Krishna (Ed). Applications of Pharmacokinetics Principles in Drug Development. Marcel Dekker, New York, 2004. Pp. 53-74.
14. L. X. Yu. An integrated absorption model for determining causes of poor oral drug absorption. Pharm. Res. 16:1883-1887 (1999).
15. E. S. Kostewicz, U. Brauns, R. Becker, J. B. Dressman. Forecasting the oral absorption behavior of poorly soluble weak bases using solubility and dissolution in biorelevant media. Pharm. Res. 19:345-349 (2002).