The value of in Vitro dissolution in drug development: A position paper from the AAPS in Vitro release and dissolution focus group

Pharmaceutical Technology

Volumn 33, Issue 4, 2009, Pages 52-64

  Tong, Cheng ^a   Lozano, Ruben ^b   Mao, Yun ^c   Mirza, Tahseen ^d   Ldbenberg, Raimar ^e   Nickerson, Beverly ^a   Gray, Vivian ^f   Wang, Qingxi ^c  

^a PFIZER INC   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c Merck Co   (United States)

^d Novartis ^*  (Switzerland)

^e UNIVERSITY OF ALBERTA   (Canada)

^f VA Gray Consulting

Author keywords

[No Author keywords available]

Indexed keywords

BIOPHARMACEUTICS; CLASSIFICATION SYSTEMS; DISSOLUTION TESTING; DISSOLUTION TESTS; DRUG DEVELOPMENT; FOCUS GROUPS; IN-VITRO; IN-VITRO DISSOLUTIONS; IN-VIVO; PATIENT SAFETIES; POSITION PAPERS; PRODUCT QUALITIES; QUALITY BY DESIGNS;

DRUG PRODUCTS; DRUG PRODUCTS PLANTS; QUALITY CONTROL;

DISSOLUTION;

EXCIPIENT;

ARTICLE; CLASSIFICATION; CONTROLLED DRUG RELEASE; CORRELATION ANALYSIS; DRUG FORMULATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG RELEASE; DRUG SOLUBILITY; IN VITRO STUDY; PARTICLE SIZE; PATIENT SAFETY; PHYSICAL CHEMISTRY; PROCESS DEVELOPMENT; QUALITY CONTROL; REPRODUCIBILITY; TECHNOLOGY;

EID: 65349123573     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. E. Galia et al., "Evaluation of Various Dissolution Media for Predicting In Vivo Performance of Class I and II Drugs," Pharm. Res. 15 (5), 698-705(1998).
2. A. Avdeef, "Solubility of Sparingly Soluble Ionizable Drugs," Adv. Drug Deliv. Rev. 59 (7), 568-590 (2007).
3. G.L. Amidon et al., "A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability," Pharm. Res. 12 (3), 413-420 (1995).
4. N. Donauer and R. Lobenberg, "A Mini Review of Scientific and Phar- macopeial Requirements for the Disintegration Test," Int. J. Pharm. 345 (1-2), 2-8 (2007).
5. E.S. Kostewicz et aL, "Predicting the Precipitation of Poorly Soluble Weak Bases Upon Entry in the Small Intestine," J. Pharm. Pharmacol. 56 (1), 43-51 (2004).
6. J. Emami, "In Vitro-In Vivo Correlation: From Theory to Applications," J. Pharm. Sci. 9 (2), 31-51 (2006).
7. R. Lobenberg et al., "Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Dissolution Behavior of Glibenclamide," Pharm. Res. 17 (4), 439-444 (2000).
8. H. Wei et al., "Physiochemical Characterization of Five Glyburide Powders A BCS Based Approach to Predict Oral Absorption," Eur. J. Pharm. Sci. (2008), in press.
9. FDA, Guidance for Industry. SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bio- equivalence Documentation (Rockville, MD, 1997).
10. FDA, Guidance for Industry: Immediate-Release Solid Oral Dosage Forms. Scale-up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Rockville, MD, 1995).
11. S. Azarmi, W. Roa, and R. Lobenberg, "Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms," Int. J. Pharm. 328(1), 12-21(2007).
12. WE.BowenetaL, "A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies," in Biopharmaceutics Applications in Drug Development (Springer US, 2008) pp. 290-316.
13. C. Tong et al., "Commentary on AAPS Workshop: Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," Pharm. Res. 24 (9), 1603-1607 (2007).
14. FDA, Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Rockville, MD, 2000).
15. WHO, "Proposal to Waive In Vivo Bioequivalence Requirements for the WHO Model List of Essential Medicines Immediate Release, Solid Oral Dosage Forms," working document QAS/04.109/Rev.l, 2005.
16. EMEA, "Note for Guidance on the Investigation of Bioavailability and Bioequivalence. European Agency for Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products," (London, England) 2001.
17. E. Rinaki et al., "Identification of Biowaivers Among Class II Drugs: Theoretical Justification and Practical Examples," Pharm. Res. 21 (9), 1567-1572(2004).
18. M. Yazdanian et al., "The "High Solubility' Definition of the Current FDA Guidance on Biopharmaceutical Classification System May Be Too Strict for Acidic Drugs," Pharm. Res. 21 (2), 293-299 (2004).
19. FDA, Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered DrugProducts-General Considerations (Rock-ville, MD, 2003). PT