Comparison of methods for predicting dissolution and the theoretical implications of particle-size-dependent solubility

Journal of Pharmaceutical Sciences

Volumn 101, Issue 2, 2012, Pages 681-689

  Johnson, Kevin C ^a  

^a Intellipharm   (United States)

Author keywords

Diffusion layer thickness; Dissolution; Dynamic simulation; Mathematical model; Nanoparticles; Ostwald ripening; Ostwald Freundlich equation; Particle size; Solubility

Indexed keywords

CILOSTAZOL; HYDROCORTISONE; NANOPARTICLE;

ARTICLE; COMPARATIVE EFFECTIVENESS; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG SOLUBILITY; INTERMETHOD COMPARISON; MATHEMATICAL MODEL; MOLECULAR DYNAMICS; NONHUMAN; PARTICLE SIZE; THEORY VALIDATION;

EID: 84455205712     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22778     Document Type: Article

References (21)

1. Wang J, Flanagan DR. 1999. General solution for diffusion-controlled dissolution of spherical particles. 1. Theory. J Pharm Sci 88:731-738.
2. Wang J, Flanagan DR. 2002. General solution for diffusion-controlled dissolution of spherical particles. 2. Evaluation of experimental data. J Pharm Sci 91:534-542.
3. Hintz RJ, Johnson KC. 1989. The effect of particle size distribution on dissolution rate and oral absorption. Int J Pharm 51:9-17.
4. Lu ATK, Frisella ME, Johnson KC. 1993. Dissolution modeling: Factors affecting the dissolution rates of polydisperse powders. Pharm Res 10:1308-1314.
5. Johnson KC, Swindell AC. 1996. Guidance in the setting of drug particle size specifications to minimize variability in absorption. Pharm Res 13:1795-1798.
6. Johnson KC. 2003. Dissolution and absorption modeling: Model expansion to simulate the effects of precipitation, water absorption, longitudinally changing intestinal permeability, and controlled release on drug absorption. Drug Dev Ind Pharm 29:833-842.
7. Kesisoglou F, Panmai S, Wu Y. 2007. Nanosizing-Oral formulation development and biopharmaceutical evaluation. Adv Drug Deliv Rev 59:631-644.
8. Kesisoglou F, Wu Y. 2008. Understanding the effect of API properties on bioavailability through absorption modeling. AAPS J 10:516-525.
9. Jinno J, Kamada N, Miyake M, Yamada K, Mukai T, Odomi M, Toguchi H, Liversidge GG, Higaki K, Kimura T. 2006. Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs. J Control Release 111:56-64.
10. Xia D, Cui F, Piao H, Cun D, Piao H, Jiang Y, Ouyang M, Quan P. 2010. Effect of crystal size on the in vitro dissolution and oral absorption of nitrendipine in rats. Pharm Res 27:1965-1976.
11. Müller RH, Jacobs C, Kayser O. 2001. Nanosuspensions as particulate drug formulations in therapy rationale for development and what we can expect for the future. Adv Drug Deliv Rev 47:3-19.
12. Sheng JJ, Sirois PJ, Dressman JB, Amidon GL. 2008. Particle diffusional layer thickness in a USP dissolution apparatus II: A combined function of particle size and paddle speed. J Pharm Sci 97:4815-4829.
13. Sugano K. 2008. Theoretical comparison of hydrodynamic diffusion layer models used for dissolution simulation in drug discovery and development. Int J Pharm 363:73-77.
14. Ranz WE, Marshall WR. 1952. Evaporation from drops. I. Chem Eng Prog 48:141-146.
15. Cussler EL. 1984. Diffusion, mass transfer in fluid systems. Cambridge: Cambridge University Press.
16. Harriott P. 1962. Mass transfer to particles: Part 1. Suspended in agitated tanks. AIChE J 8:93-101.
17. Galli C. 2006. Experimental determination of the diffusion boundary layer width of micron and submicron particles. Int J Pharm 313:114-122.
18. de Villiers MM. 1996. Influence of agglomeration of cohesive particles on the dissolution behaviour of furosemide powder. Int J Pharm 136:175-179.
19. Bisrat M, Anderberg EK, Barnett MI, Nyström C. 1992. Physicochemical aspects of drug release. XV. Investigation of diffusional transport in dissolution of suspended, sparingly soluble drugs. Int J Pharm 80:191-201.
20. De Almeida LP, Simões S, Brito P, Portugal A, Figueiredo M. 1997. Modeling dissolution of sparingly soluble multisized powders. J Pharm Sci 86:726-732.
21. Van Eerdenbrugh B, Vermant J, Martens JA, Froyen L, Van Humbeeck J, Van den Mooter G, Augustijns P. 2010. Solubility increases associated with crystalline drug nanoparticles: Methodologies and significance. Mol Pharm 7:1858-1870.