Disintegration of highly soluble immediate release tablets: A surrogate for dissolution

AAPS PharmSciTech

Volumn 10, Issue 2, 2009, Pages 495-499

  Gupta, Abhay ^a   Hunt, Robert L ^a   Shah, Rakhi B ^a   Sayeed, Vilayat A ^a   Khan, Mansoor A ^a  

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

Author keywords

Disintegration test; Dissolution test; ICH Q6A; Specification

Indexed keywords

CALCIUM PHOSPHATE DIBASIC; CARBOXYMETHYLCELLULOSE; CELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; POVIDONE; TALC; VERAPAMIL;

ARTICLE; CONTROLLED STUDY; DRUG RELEASE; DRUG SOLUBILITY; IMMEDIATE DRUG RELEASE; TABLET COMPRESSION; TABLET DISINTEGRATION; TABLET FORMULATION; TABLET HARDNESS; CHEMISTRY; SOLUBILITY; TABLET;

CHEMISTRY, PHARMACEUTICAL; SOLUBILITY; TABLETS;

EID: 67549146878     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-009-9227-0     Document Type: Article

References (6)

1. United States Pharmacopeia 30/National Formulary 25. 2008. The U.S. Pharmacopeial Convention, Inc. Rockville, MD. (www.USP.org).
2. ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Available at www.ich.org. Accessed January 24, 2008.
3. Sayeed V. Disintegration test as a surrogate for dissolution: Some practical considerations. In: AAPS Workshop on the Role of Dissolution in QbD and Drug Product Life Cycle. Arlington, VA: AAPS Workshop, 2008.
4. Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Moller H, et al. Biowaiver monographs for immediate release solid oral dosage forms based on Biopharmaceutics Classification System (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol. J Pharm Sci 2004;93:1945-56.
5. Verapamil hydrochloride tablets monograph. United States Pharmacopeia 30/ National Formulary 25. 2008. The U.S. Pharmacopeial Convention, Inc. Rockville, MD. (www.USP.org).
6. Chen C. A FDA perspective on Quality by Design. Pharmtech, Dec 5, 2007. Available at http://pharmtech.findpharma.com/pharmtech/Article/ A-FDA-Perspective-on-Quality-by-Design/ArticleStandard/Article/detail/ 469915. Accessed May 15, 2008.