In vitro-in vivo correlation: perspectives on model development.
In vitro-in vivo correlation (IVIVC) allows prediction of the in vivo performance of a drug based on the in vitro drug release profiles. To develop an effective IVIVC, the physicochemical and biopharmaceutical properties of the drug as well as the physiological environment in the body must be taken into consideration. Key factors include drug solubility, pK(a), drug permeability, octanol-water partition coefficient and pH of environment. In general, construction of an IVIVC involves three stages of mathematical manipulation: construct a functional relationship between input (in vitro dissolution) and output (in vivo dissolution); establish a structural relationship using data collected; parameterize the unknowns in the structural model. Some key mathematical relationships used in IVIVC development are presented. The establishment of an effective IVIVC has important implications in quality control and regulatory compliance.
Department of Pharmaceutics, Purdue University, West Lafayette, IN 47907, USA.
Ying
Y
Lu
Sungwon
S
Kim
Kinam
K
Park
D016503:Drug Delivery Systems; D006863:Hydrogen-Ion Concentration; D008433:Mathematics; D008962:Models, Theoretical; D010539:Permeability; D012995:Solubility
J Pharm Sci. 2010 Oct;99(10):4427-36
20737642
J Pharm Sci. 2005 Jul;94(7):1396-417
15920764
Adv Exp Med Biol. 1997;423:269-88
9269503
J Am Pharm Assoc Am Pharm Assoc. 1957 Oct;46(10):607-14
13491466
Circulation. 2003 Feb 11;107(5):777-84
12578884
Adv Exp Med Biol. 1997;423:207-15
9269497
J Pharm Sci. 2001 Aug;90(8):1176-85
11536222
J Pharmacol Exp Ther. 1957 Mar;119(3):361-9
13417090
J Pharmacokinet Biopharm. 1977 Feb;5(1):53-94
15094
Pharm Res. 2006 Feb;23(2):256-61
16421665
Biopharm Drug Dispos. 2002 Jan;23(1):1-8
11891668
J Control Release. 2002 Dec 5;84(3):161-70
12468219
Am J Hosp Pharm. 1983 Aug;40(8):1334-6
6310994
Pharm Res. 1998 Mar;15(3):466-73
9563079
Pharm Sci Technol Today. 1999 Sep;2(9):373-380
10470025
Adv Exp Med Biol. 1997;423:199-206
9269496
Eur J Pharm Biopharm. 2003 Jan;55(1):77-84
12551707
Pharm Res. 2010 Aug;27(8):1730-7
20422263
J Pharm Sci. 1996 Jul;85(7):753-60
8819002
J Am Coll Cardiol. 1997 Mar 15;29(4):808-16
9091528
J Pharm Sci. 1985 Feb;74(2):142-7
3989682
J Pharm Pharmacol. 2003 Apr;55(4):495-504
12803771
J Pharm Sci. 1985 May;74(5):588-9
4020642
Pharm Res. 1996 Dec;13(12):1795-8
8987073
Eur J Pharm Biopharm. 2010 Jun;75(2):232-7
20159037