Dissolution testing for generic drugs: An FDA perspective

AAPS Journal

Volumn 13, Issue 3, 2011, Pages 328-335

  Anand, Om ^a   Yu, Lawrence X ^a   Conner, Dale P ^a   Davit, Barbara M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

bioequivalence; biopharmaceutics; generic drugs; in vitro dissolution; quality by design

Indexed keywords

GENERIC DRUG;

ALCOHOLIC BEVERAGE; BIOEQUIVALENCE; CONTROLLED DRUG RELEASE; DRUG ABSORPTION; DRUG ALCOHOL INTERACTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG EFFICACY; DRUG INDUSTRY; DRUG PENETRATION; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; FOOD DRUG INTERACTION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INTESTINE MUCOSA PERMEABILITY; MEDICAL DECISION MAKING; PH MEASUREMENT; PREDICTION; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUALITY CONTROL; REVIEW; TABLET FORMULATION; VALIDATION PROCESS;

CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUGS, GENERIC; SOLUBILITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80052592985     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9272-y     Document Type: Review

References (26)

1. M Siewert J Dressman CK Brown VP Shah 2003 FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms AAPS PharmSciTech 4 1 1 10.1208/pt040107
2. VP Shah NW Tymes JP Skelly 1989 In vitro release profile of clonidine transdermal therapeutic systems and scopolamine patches Pharm Res 6 346 351 2748524 10.1023/A:1015962911344 1:CAS:528:DyaL1MXitlOjsbc%3D (Pubitemid 19134615)
3. Food and Drug Administration. Guidance for industry: immediate release solid oral dosage forms: scale-up and post-approval changes. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; November 1995.
4. Food and Drug Administration. Guidance for industry: modified release solid oral dosage forms: scale-up and post-approval changes. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; October 1997.
5. Chapter 711: Dissolution. In: United States Pharmacopeia 31 (USP 31): National Formulary 26 (NF 26). 2008. p. 267-274. 2010.
6. Chapter 724: Drug release. In: United States Pharmacopeia 31 (USP 31): National Formulary 26 (NF 26). 2008. p. 275-278. 2010.
7. Chapter 1092: The dissolution procedure. Development and validation. In: United States Pharmacopeia 31 (USP 31): National Formulary 26 (NF 26). 2008. p. 573-678.
8. Food and Drug Administration. Guidance for industry: dissolution testing of Immediate Release Solid Oral Dosage Forms. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; August 1997.
9. Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; March 2003.
10. Anand O. Dissolution testing: an FDA perspective; AAPS workshop, physical pharmacy and biopharmaceutics. May 5-13, 2009. Baltimore, MD. In: http://mediaserver.aapspharmaceutica.com/meetings/09-PPB/Wed/Track-I/Om-Anand. pdf. Accessed 26 September 2010.
11. Food and Drug Administration. 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: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; August 2000.
12. GL Amidon H Lennernäs VP Shah JR Crison 1995 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 7617530 10.1023/A:1016212804288 1:CAS:528:DyaK2MXksVGqur8%3D
13. Individual Product Bioequivalence Recommendations: In: US FDA. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm075207.htm. Accessed 06 October 2010.
14. FDA Alert for Healthcare Professionals (July 2005): Hydromorphone Hydrochloride Extended-Release Capsules (marketed as Palladone™). 2005 July: http://www.fda.gov/cder/drug/InfoSheets/HCP/hydromorphoneHCP.pdf. Accessed 04 October 2010.
15. Chandaroy P, Jiang X, Lee C, Thompson C, Conner DP, Davit BM. In vitro alcohol-induced dose-dumping dissolution studies of generic modified-release oral drug products: American Association of Pharmaceutical Scientists 2008 annual meeting, Atlanta, November 2008: http://www.aapsj.org/abstracts/AM-2008/ AAPS2008-001832.PDF. Accessed 20 February 2011.
16. FDA/CDER to Osmotica Pharmaceutical Corp. - petition partial approval and denial. In: http://www.regulations.gov/search/Regs/home.html#docketDetail?R= FDA-2009-P-0403. Accessed 6 October 2010.
17. FDA/Associate Commissioner for Policy and Planning - petition approval. Docket ID:FDA-2005-P-0366. In: http://www.regulations.gov/search/Regs/home. html#documentDetail?R=090000648044af45. Accessed 07 October 2010.
18. Kefauver-Harris Amendments. Public Law (PL) 87-781, 87th Congress. 10-10-1962.
19. Drug Efficacy Study: a report to the commissioner of Food and Drugs, National Academy of Sciences, National Research Council, Washington, DC, 1969.
20. Conner DP, Davit BM. Bioequivalence and drug product assessment, in vivo. In: Shargel L, Kanfer I, editors. Generic drug product development, solid oral dosage forms. Marcel Dekker, Inc: 2005. p 227-55.
21. Orange book: In: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ ucm079068.htm#Therapeutic%20Equivalence-Related%20Terms. Accessed 06 October 2010.
22. Abdou HM. Dissolution. Remington: the science and practice of pharmacy. Nineteenth ed. Mack Publishing Company; 1995. p. 593-604.
23. S Azarmi W Roa R Lobenberg 2007 Current perspectives in dissolution testing of conventional and novel dosage forms Int J Pharm 328 12 21 17084051 10.1016/j.ijpharm.2006.10.001 1:CAS:528:DC%2BD28Xht1Kiu77L (Pubitemid 44827563)
24. Chewing gum, medicated, drug release. European Pharmacopoeia, Edition 4. Strasbourg, France: Directorate for the quality of medicines of the Council of Europe; 2002. p. 227-228.
25. Food and Drug Administration. Guidance for industry: nonsterile semisolid dosage forms: scale-up and post-approval changes. Rockville: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 1997.
26. H Zhang LX Yu 2004 Dissolution testing for solid oral drug products: theoretical considerations Am Pharm Rev 7 5 26 31 1:CAS:528:DC%2BD2cXhtVSlt7vE