Predicting the effect of fed-state intestinal contents on drug dissolution

Pharmaceutical Research

Volumn 27, Issue 12, 2010, Pages 2646-2656

  Carrier, Rebecca Lyn ^a   Gamsiz, Ece Dilber ^a,d   Ashtikar, Mukul ^b,e   Crison, John ^c,f   Woltosz, Walt ^c   Bolger, Michael B ^c  

^a Northeastern University   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

^c Simulations Plus Inc   (United States)

^d BROWN UNIVERSITY   (United States)

^e FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

^f BRISTOL MYERS SQUIBB   (United States)

Author keywords

Biorelevant media; Dissolution; Food effect; Mathematical modeling

Indexed keywords

2 NAPHTHOL; 4 AMINOBENZOIC ACID; ATROPINE; CLOFAZIMINE; DIPYRIDAMOLE; FLUORENE; GLYCEROL OLEATE; GRISEOFULVIN; HALOPERIDOL; INDOPROFEN; IOPANOIC ACID; OLEATE SODIUM; PHENYLBUTAZONE; PHENYTOIN; PHOSPHATIDYLCHOLINE; SOLUBILIZER; SPIRONOLACTONE; THYMINE; TRIAMCINOLONE;

ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG SOLUBILITY; FOOD DRUG INTERACTION; HYDROPHOBICITY; INTESTINE ABSORPTION; MICELLE; MOLECULAR WEIGHT; PHARMACOKINETICS; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; SIMULATION; STATISTICAL MODEL; TREND STUDY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FOOD; GASTROINTESTINAL CONTENTS; INTESTINES; MICELLES; MODELS, BIOLOGICAL; PARTICLE SIZE; PHARMACOKINETICS; SOLUBILITY;

EID: 78651282634     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-010-0264-x     Document Type: Article

References (22)

1. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev. 2001;46(1-3):3-26. (Pubitemid 33653411)
2. Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms. Pharm Res. 1998;15(1):11-22.
3. Porter CJH, Trevaskis NL, Charman WN. Lipids and lipid-based formulations: Optimizing the oral delivery of lipophilic drugs. Nat Rev Drug Discov. 2007;6(3):231-48.
4. Lentz KA. Current methods for predicting human food effect. AAPS J. 2008;10(2):282-8.
5. Agoram B, Woltosz WS, Bolger MB. Predicting the impact of physiological and biochemical processes on drug bioavailability. Adv Drug Deliv Rev. 2001;(50)S41-S67.
6. Oh DM, Curl RL, Amidon GL. Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans: A mathematical model. Pharm Res. 1993;10(2):264-70.
7. Sinko PJ, Leesman GD, Amidon GL. Predicting fraction dose absorbed in humans using a macroscopic mass balance approach. Pharm Res. 1991;8(8):979-88.
8. Takano R, Sugano K, Higashida A, hayashi Y, Machida M, Aso Y, et al. Oral absorption of poorly soluble water-soluble drugs: Computer simulation of fraction absorbed in humans from a miniscale dissolution test. Pharm Res. 2006;23(6):1144-56.
9. Yu LX, Lipka E, Crison JR, Amidon GL. Transport approaches to the biopharmaceutical design of oral drug delivery systems: Prediction of intestinal absorption. Adv Drug Deliv Rev. 1996;19 (3):359-76.
10. Willmann S, Solodenko J, Sevestre M, Lippert J, Schmitt W. A pharmacodynamic extension for the physiology-based pharmacokinetic whole-body model PK-Sim((R)). Eur J Pharm Sci. 2004;23: S75-5.
11. Jamei M, Marciniak S, Feng KR, Barnett A, Tucker G, Rostami- Hodjegan A. The simcyp (R) population-based ADME simulator. Expert Opin Drug Metab Toxicol. 2009;5(2):211-23.
12. www.simulations-plus.com, 2009.
13. Higuchi WI. Effects of interacting colloids on transport rates. J Pharm Sci. 1964;53:532-5.
14. Gamsiz ED, Miller L, Thombre AG, Ahmed I, Carrier RL. Modeling the influence of cyclodextrins on oral absorption of lowsolubility drugs: I. Model development. Biotechnol Bioeng. 2010;105(2):409-20.
15. Jantratid E, Janssen N, Reppas C, Dressman JB. Dissolution media simulating conditions in the proximal human gastrointestinal tract: An update. Pharm Res. 2008;25(7):1663-76.
16. Amidon GE, Higuchi WI, Ho NF. Theoretical and experimental studies of transport of micelle-solubilized solutes. J Pharm Sci. 1982;71(1):77-84.
17. Crison JR, Shah VP, Skelly JP, Amidon GL. Drug dissolution into micellar solutions: Development of a convective diffusion model and comparison to the film equilibrium model with application to surfactant-facilitated dissolution of carbamazepine. J Pharm Sci. 1996;85(9):1005-11.
18. Okazaki A, Mano T, Sugano K. Theoretical dissolution model of poly-disperse drug particles in biorelevant media. J Pharm Sci. 2008;97(5):1843-52.
19. Swarbrick J. Encyclopedia of pharmaceutical technology. New York: Informa Healthcare, Inc; 2003.
20. Li J, Carr PW. Accuracy of emprical correlations for estimating diffusion coefficients in aqueous organic mixtures. Anal Chem. 1997;69(13):2530-6.
21. Besler HT. Proteins in food processing. In: Yada R, editor. 2005.
22. Persson EM, Gustafsson A-S, Carlsson AS, Nilsson RG, Knutson L, Forsell P, et al. The effects of food on the dissolution of poorly soluble drugs in human and in model small intestinal fluids. Pharm Res. 2005;22(12):2141-51.