In Vitro–In Vivo Correlation in Dosage Form Development: Case Studies
In vitro and in vivo correlation (IVIVC) refers to a predictive relationship of the in vitro properties of drug substances or dosage forms with their in vivo performance. For orally administered drug products, it is usually a correlation between the extent or rate of dissolution of a dosage form and its pharmacokinetic parameters, such as rate, duration, and extent of drug absorption. The physicochemical properties of dosage forms influence their in vivo performance in many different ways (Li et al., 2005). Through the establishment of a definitive relationship between certain physicochemical properties of a dosage form with the in vivo appearance of its active component, one can establish in vitro testing criteria which will predict, its in vivo performance.
KeywordsDosage Form Dissolution Method Life Cycle Management Metoprolol Tartrate Tartrate Salt
Unable to display preview. Download preview PDF.
- Center for Drug Evaluation and Research (CDER) (1997). Guidance for Industry: Extended release oral dosage forms: development, evaluation, and application of in-vitro/in-vivo correlation. Rockville, MD. US Department of Health and Human Services, Food and Drug Administration.Google Scholar
- Center for Drug Evaluation and Research (CDER) (2000). Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Food and Drug Administration.Google Scholar
- Li, S., Mueller-Zsigmondy, M., and Yin, H. (2007). The role of IVIVC in product develop-ment and life cycle management in pharmaceutical product development: In vitro-in vivo correlation. In: Chilukuri, D., Sunkara, G., Young, D. (eds.), Pharmaceutical Product Development (Drugs and the Pharmaceutical Sciences), Marcel Dekker Inc., New York.Google Scholar
- Pudipeddi, M., Serajuddin, A.T.M., and Mufson, D. (2006). Integrated drug product devel-opment - from lead candidate selection to life-cycle management. In: Smith, C.G. and O’Donnell, J.T. (eds.), The Process of New Drug Discovery and Development, 2nd ed. Informa Healthcare USA, Inc., New York, pp. 15-51.Google Scholar
- Turner, S., Federici, C., Hite, M., and Fassihi, R. (2004). Formulation development and human in vitro-in vivo correlation for a novel, monolithic controlled-release matrix sys-tem of high load and highly water-soluble drug niacin. Drug Dev. Ind. Pharm. 30(8):797-807.Google Scholar
- United States Pharmacopeial Convention, Inc. (1988). In vitro-in vivo correlation for extended release oral dosage forms. Pharmacopeial Forum Stimuli Article 4160-4161.Google Scholar