In vitro-in vivo correlation (ivivc) and determining drug concentrations in blood from dissolution testing - a simple and practical approach

Open Drug Delivery Journal

Volumn 4, Issue SPEC. ISSUE 1, 2010, Pages 38-47

  Qureshi, Saeed A ^a  

^a HEALTH CANADA   (Canada)

Author keywords

Comparative release characterisation; Convolution method; Drug dissolution; Ivivc; Method development; Product independent procedures

Indexed keywords

DILTIAZEM;

ARTICLE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG ELIMINATION; DRUG HALF LIFE; DRUG QUALITY; DRUG SAFETY; DRUG SOLUBILITY; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; PREDICTION; PRIORITY JOURNAL; SUSTAINED RELEASE FORMULATION; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRAVIOLET SPECTROPHOTOMETRY;

EID: 78249285625     PISSN: None     EISSN: 18741266     Source Type: Journal    
DOI: 10.2174/1874126601004020038     Document Type: Article

References (10)

1. USP General Chapter on Dissolution <711>. United States Pharmacopeia and National Formulary; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2008. pp. 267-274.
2. Meyer, M.C.; Straughn, A.B.; Mhatre, R.M.; Shah, V.P.; Williams, R.L. Lack of in vitro/in vivo correlations of 50 mg and 250 mg primidone tablets. Pharm. Res., 1998, 15, 1085-1089.
3. Food and Drug Administration. 1997. Guidance for industry: extended release oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula toryInformation/Guidances/UCM070239.pdf [Accessed October 21, 2009].
4. th ed. McGraw-Hill/Appleton & Lange: Columbus OH, 1998.
5. Gaynor, C.; Dunne, A.; Davis, J. A comparison of the prediction accuracy of two IVIVC modelling techniques. J. Pharm. Sci., 2008, 97, 3422-3432.
6. th ed. MacMillan Publishing Co.: New York, 1985.
7. Food and Drug Administration. 2003. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Available at: http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm070124.pdf [Accessed October 21, 2009].
8. Qureshi, SA. Choice of rotation speed (rpm) for bio-relevant drug dissolution testing using a crescent-shape spindle. Eur. J. Pharm Sci., 2004, 23, 271-275.
9. USP. Diltiazem Tablets and Extended-Release Capsules monogrphs. USP 28 - The United States Pharmacopeial Convention, Inc. Rockville, MD., 2005, pp. 655-658.
10. Bendas E.R. Two different approaches for the prediction of in vivo plasma concentration-time profile from in vitro release data of once daily formulation of diltiazem hydrochloride. Arch. Pharm. Res., 2009, 32, 1317-1329.