Studying dissolution with a model integrating solid-liquid interface kinetics and diffusion kinetics

Analytical Chemistry

Volumn 84, Issue 24, 2012, Pages 10671-10678

  Gao, Jeff Y ^a  

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIFFUSION KINETICS; DISSOLUTION MODEL; DISSOLUTION PROFILES; GENERAL SOLUTIONS; INTERFACIAL CONCENTRATIONS; INTERFACIAL KINETIC; IONIZATION EQUILIBRIUM; SOLID-LIQUID INTERFACES; TRANSPORT KINETIC;

DISSOLUTION; SUPERSATURATION;

KINETICS;

ARTICLE; CHEMICAL MODEL; DIFFUSION; KINETICS; SOLUBILITY; SOLUTION AND SOLUBILITY;

DIFFUSION; KINETICS; MODELS, CHEMICAL; SOLUBILITY; SOLUTIONS;

EID: 84871279455     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/ac302297a     Document Type: Article

References (53)

1. Noyes, A. A.; Whitney, W. R. The Rate of Solution of Solid Substances in Their Own Solutions J. Am. Chem. Soc. 1897, 19, 930-934
2. Brunner, E. Z. Phys. Chem. 1904, 47, 56-102
3. Nernst, W. Z. Phys. Chem. 1904, 47, 52-110
4. Higuchi, W. I.; Parrott, E. L.; Wurster, D. E.; Higuchi, T Investigation of drug release from solids II. Theoretical and experimental study of influences of bases and buffers on rates of dissolution of acidic solids J. Am. Pharm. Assoc. 1958, 47 (5) 376-383
5. Higuchi, W. I.; Nelson, E; Wagner, J. G. Solubility and dissolution rates in reactive media J. Pharm. Sci. 1964, 53 (3) 333-335
6. Krause, P. D.; Kildsig, D. O. Mechanism of Dissolution III: Relationship between Solid-Liquid Interfacial Energies and Dissolution Rates in Organic Solvents J. Pharm. Sci. 1972, 61 (9) 1478-1480
7. Nelson, K. G.; Shah, A. C. Convective diffusion model for a transport-controlled dissolution rate process J. Pharm. Sci. 1975, 64 (4) 610-614
8. Shah, A. C.; Nelson, K. G. Evaluation of a convective diffusion drug dissolution rate model J. Pharm. Sci. 1975, 64 (9) 1518-1520
9. Nicklasson, M.; Brodin, A.; Sundelof, L.-O. On the determination of true dissolution rate parameters from rotating disc experiments Int. J. Pharm. 1983, 15, 87-95
10. Lu, A. T. K.; Frisella, M. E.; Johnson, K. C. Dissolution Modeling: Factors Affecting the Dissolution Rates of Polydisperse Powders Pharm. Res. 1993, 10 (9) 1308-1314
11. Alway, B.; Sangchantra, R.; Stewart, P. J. Modelling the dissolution of diazepam in lactose interactive mixtures Int. J. Pharm. 1996, 130, 213-224
12. Wang, J.; Flanagan, D. R. General Solution for Diffusion-Controlled Dissolution of Spherical Particles. 1. Theory J. Pharm. Sci. 1999, 88 (7) 731-738
13. Tinke, A. P.; Vanhoutte, K.; De Maesschalck, R.; Verheyen, S.; De Winter, H. A new approach in the prediction of the dissolution behavior of suspended particles by means of their particle size distribution J. Pharm. Biomed. Anal. 2005, 39 (5) 900-907
14. McNamara, D. P.; Amidon, G. L. Dissolution of acidic and basic compounds from the rotating disk: Influence of convective diffusion and reaction J. Pharm. Sci. 1986, 75 (9) 858-868
15. Levich, V. G. Physiochemical Hydrodynamics; Prentice-Hall: Englewood Cliffs, NJ, 1962.
16. Hamlin, W. E.; Northam, J. I.; Wagner, J. G. Relationship between in vitro dissolution rates and solubilities of numerous compounds representative of various chemical species J. Pharm. Sci. 1965, 54 (11) 1651-1653
17. Nicklasson, M; Brodin, A. The relationship between intrinsic dissolution rates and solubilities in the water-ethanol binary solvent system Int. J. Pharm. 1984, 18, 149-156
18. Bisrat, M.; Anderberg, E. K.; Barnett, M. I.; Nystrom, C. Physicochemical aspect of drug release. XV. Investigation of diffusional transport in dissolution of suspended, sparingly soluble drugs Int. J. Pharm. 1992, 80, 191-201
19. Yamamoto, K; Nakano, M.; Arita, T.; Takayama, Y.; Nakai, Y. Dissolution behavior and bioavailability of phenytoin from a ground mixture with microcrystalline cellulose J. Pharm. Sci. 1976, 65 (10) 1484-1488
20. Suzuki, H; Sunada, H.Influence of Water-Soluble Polymers on the Dissolution of Nifedipine Solid Dispersions with Combined Carriers Chem. Pharm. Bull. 1998, 46 (3) 482-487
21. Anderson, J. R.; Pitman, I. H. Solubility and dissolution rate studies of ergotamine tartrate J. Pharm. Sci. 1980, 69 (7) 832-835
22. Nyström, C.; Mazur, J.; Barnett, M. I.; Glazer, M. Dissolution rate measurements of sparingly soluble compounds with the Coulter Counter model TAII J. Pharm. Pharmacol. 1985, 37 (4) 217-221
23. Wurster, D. E.; Kildsig, D. O. Effect of complex formation on dissolution kinetics of m-aminobenzoic acid J. Pharm. Sci. 1965, 54 (10) 1491-1494
24. Gibaldi, M.; Feldman, S.; Wynn, R.; Weiner, N. D. Dissolution rates in surfactant solutions under stirred and static conditions J. Pharm. Sci. 1968, 57 (5) 787-791
25. Gibaldi, M; Feldman, S.; Weiner, N. D. Hydrodynamic and diffusional considerations in assessing the effects of surface active agents on the dissolution rate of drugs Chem. Pharm. Bull. 1970, 18 (4) 715-723
26. Higuchi, W. I.; Surpuriya, V.; Prakongpan, S.; Young, F. Participation of micelle at crystal-solution interface in rate-determining step for cholesterol gallstone dissolution in unsaturated bile media J. Pharm. Sci. 1973, 62 (4) 695-696
27. Stella, V. J.; Martodihardjo, S; Terada, K.; Rao, V. M. Some relationships between the physical properties of various 3-acyloxymethyl prodrugs of phenytoin to structure: Potential in vivo performance implications J. Pharm. Sci. 1998, 87 (10) 1235-1241
28. Amidon, G. L.; Lennernäs, H.; Shah, V. P.; Crison, J. R. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of Vitro Drug Product Dissolution and Vivo Bioavailability Pharm. Res. 1995, 12 (3) 413-420
29. Wurster, D. E.; Taylor, P. W. Dissolution rates J. Pharm. Sci. 1965, 54 (2) 169-175
30. Berthoud, A.Formation of Crystal Faces J. Chim. Phys. Phys.-Chim. Biol. 1913, 10, 624-635
31. Nedich, R. L.; Kildsig, D. O. Mechanism of dissolution I: Mathematical interpretation of concentration gradients developed during dissolution of a solid J. Pharm. Sci. 1972, 61 (2) 214-218
32. Higuchi, W. I.; Prakongpan, S.; Surpuriya, V.; Young, F. Cholesterol Dissolution Rate in Micellar Bile Acid Solutions: Retarding Effect of Added Lecithin Science 1972, 178, 633-634
33. Ho, N. F. H.; Gupta, S. L.; Higuchi, W. I. Theoretical treatment of cholesterol monohydrate dissolution in Renex-690/ionic surfactant systems based on a physical model approach J. Colloid Interface Sci. 1984, 101 (2) 544-553
34. Brendan, J. C. The kinetics of solubilization of nonpolar oils by nonionic surfactant solutions J. Colloid Interface Sci. 1981, 79 (1) 126-135
35. Higuchi, W. I. Diffusional Models Useful in Biopharmaceutics Drug Release Rate Processes J. Pharm. Sci. 1967, 56 (3) 315-324
36. Wood, J. H.; Syarto, J. E.; Letterman, H. Improved holder for intrinsic dissolution rate studies J. Pharm. Sci. 1965, 54 (7) 1068-1068
37. Viegas, T. X.; Curatella, R. U.; VanWinkle, L. L.; Brinker, G. Intrinsic drug dissolution testing using the stationary disk system Dissolution Technol. 2001, 8 (3) 1-4
38. Jashnani, R. N.; Byron, P. R.; Dalby, R. N. Validation of an improved Wood's rotating disk dissolution apparatus J. Pharm. Sci. 1993, 82 (6) 670-671
39. Nicklasson, M; Brodin, A; Nyqvist, H.Studies on the relationship between solubility and intrinsic rate of dissolution as a function of pH Acta Pharm. Suec. 1981, 18, 119-128
40. Jinno, J; Oh, D.-M; Crison, J. R.; Amidon, G. L. Dissolution of Ionizable Water-Insoluble Drugs: The Combined Effect of pH and Surfactant J. Pharm. Sci. 2000, 89 (2) 268-274
41. Sheng, J. J.; Kasim, N. A.; Chandrasekharan, R; Amidon, G. L. Solubilization and dissolution of insoluble weak acid, ketoprofen: effects of pH combined with surfactant Eur. J. Pharm. Sci. 2006, 29 (3-4) 306-314
42. Mooney, K. G.; Mintun, M. A.; Himmelstein, K. J.; Stella, V. J. Dissolution kinetics of carboxylic acids I: Effect of pH under unbuffered conditions J. Pharm. Sci. 1981, 70 (1) 13-22
43. Mooney, K. G.; Mintun, M. A.; Himmelstein, K. J.; Stella, V. J. Dissolution kinetics of carboxylic acids II: Effect of buffers J. Pharm. Sci. 1981, 70 (1) 22-32
44. McNamara, D. P.; Amidon, G. L. Reaction plane approach for estimating the effects of buffers on the dissolution rate of acidic drugs J. Pharm. Sci. 1988, 77 (6) 511-517
45. Southard, M. Z.; Green, D. W.; Stella, V. J.; Himmelstein, K. J. Dissolution of lonizable Drugs into Unbuffered Solution: A Comprehensive Model for Mass Transport and Reaction in the Rotating Disk Geometry Pharm. Res. 1992, 9 (1) 58-69
46. Hamlin, W. E.; Higuchi, W. I. Dissolution rate-solubility behavior of 3-(1-methyl-2-pyrrolidinyl)-indole as a function of hydrogen-ion concentration J. Pharm. Sci. 1966, 55 (2) 205-207
47. Tsinman, K; Avdeef, A.; Tsinman, O.; Voloboy, D.Powder dissolution method for estimating rotating disk intrinsic dissolution rates of low solubility drugs Pharm. Res. 2009, 26 (9) 2093-2100
48. Mooney, K. G.; Rodriguez-gaxiola, M.; Mintun, M.; Himmelstein, K. J.; Stella, V. J. Dissolution kinetics of phenylbutazone J. Pharm. Sci. 1981, 70 (12) 1358-1365
49. Serajuddin, A. T. M.; Jarowski, C. I. Effect of diffusion layer pH and solubility on the dissolution rate of pharmaceutical bases and their hydrochloride salts I: Phenazopyridine J. Pharm. Sci. 1985, 74 (2) 142-147
50. Serajuddin, A. T. M.; Jarowski, C. I. Effect of diffusion layer pH and solubility on the dissolution rate of pharmaceutical acids and their sodium salts II: Salicylic acid, theophylline, and benzoic acid J. Pharm. Sci. 1985, 74 (2) 148-154
51. Avdeef, A.; Tsinman, O. Miniaturized rotating disk intrinsic dissolution rate measurement: effects of buffer capacity in comparisons to traditional wood's apparatus Pharm. Res. 2008, 25 (11) 2613-2627
52. Sugano, K. Theoretical comparison of hydrodynamic diffusion layer models used for dissolution simulation in drug discovery and development Int. J. Pharm. 2008, 363 (1-2) 73-77
53. Kitamura, M. Strategy for control of crystallization of polymorphs CrystEngComm 2009, 11 (6) 949-964