Towards a universal dissolution medium for carbamazepine

Drug Development and Industrial Pharmacy

Volumn 32, Issue 7, 2006, Pages 893-905

  El Massik, M A ^a   Abdallah, O Y ^a   Galal, S ^a   Daabis, N A ^a  

^a Alexandria University Faculty of Pharmacy   (Egypt)

Author keywords

Carbamazepine; Dissolution medium; Dissolution solubility; Methyl cellulose; Polymorphic transformation; Sodium lauryl sulphate

Indexed keywords

CARBAMAZEPINE; DODECYL SULFATE SODIUM; METHYLCELLULOSE; POVIDONE;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG SOLUBILITY; INFRARED SPECTROSCOPY; MICROSCOPY; PH; TABLET FORMULATION;

CARBAMAZEPINE; CHEMISTRY, PHARMACEUTICAL; HYDROGEN-ION CONCENTRATION; METHYLCELLULOSE; POVIDONE; POWDERS; SODIUM DODECYL SULFATE; SOLUBILITY; TABLETS;

EID: 33747616406     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040600762677     Document Type: Article

References (40)

1. Amidon, G. L., Lennernas, H., Shah, V. P., & Crison, J.R. (1995). A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12, 413-420.
2. Baxter, J. L., Kukura, J., & Muzzio, F. J. (2005). Hydrodynamics-induced variability in the USP II dissolution test. Int. J. Pharm., 292, 17-28.
3. Crowley, K. J., & Zografi, G. (2003). The effect of low concentrations of molecularly dispersed polyvinylpyrrolidone on indomethacin crystallization from the amorphous state. Pharm. Res., 20, 1417-1422.
4. Davidson, A. G. (1995). A multinational survey of the quality of carbamazepine tablets. Drug. Dev. Ind. Pharm., 21, 2167-2186.
5. Di Martino, P., Barthelemy, C., Palmieri, G. F., & Martelli, S. (2001). Physical characterization of naproxen sodium hydrate and anhydrate forms. Eur. J. Pharm. Sci., 14, 293-300.
6. Dodge, A., & Gould, P. I. (1987). Dissolution of chlorpropamide tablets in methanol-water binary solvent system. Drug. Dev. Ind. Pharm., 13, 1817-1826.
7. Ebian, A. R., Moustafa, M. A., Khalil, S. A., & Motawi, A. M. (1975). Succinyl sulfathiazole crystal forms I: I Effect of additives on kinetics of interconversion. J. Pharm. Sci., 64, 1481-1484.
8. Galal, S., El Massik, M. A., Abdallah, O. Y., & Daabis, N. A. (2004). Study of in-vitro release characteristics of carbamazepine extended release semisolid matrix filled capsules based on gelucires. Drug Dev. Ind. Pharm., 30, 817-829.
9. Galia, E., Nicolaides, E., Horter, D., Lobenberg, R., Reppas, C., & Dressman, J. B. (1998). Evaluation of various dissolution media for predicting in-vitro performance of class I and II drugs. Pharm. Res., 15, 698-705.
10. Grzesiak, A. L., Lang, M., Kim, K., & Matzger, A. J. (2003). Comparison of the four anhydrous polymorphs of carbamazepine and the crystal structure of form I. J. Pharm. Sci. 92, 2260-2271.
11. Jung, M., Milan, R. C., Girard, M. E., Leon, F., & Montaga, M. A. (1997). Bioequivalence study of carbamazepine tablets, in vitro/in vivo correlation. Int. J. Pharm. 152, 37-44.
12. Kahela, P., Aaltonen, R., Lewing, E., Anttila, M., & Kristoffersson, E. (1983). Pharmacokinetics and dissolution of two crystalline forms of carbamazepine. Int. J. Pharm. 14, 103-112.
13. Kobayashi, Y., Ito, S., Itai, S., & Yamamoto, K. (2000). Physicochemical properties and bioavailability of carbamazepine polymorphs and dihydrate. Int. J. Pharm. 193, 137-146.
14. Kukura, J., Baxter, J. L., & Muzzio F. J. (2004). Shear distribution and variability in the USP apparatus 2 under turbulent conditions. Int. J. Pharm., 26, 9-17.
15. Laine, E., Tuominen, V., Ilvessalo, P., & Kahela, P. (1984). Formation of dihydrate from carbamazepine anhydrate in aqueous conditions. Int. J. Pharm., 20, 307-314.
16. Lake, O. A., Olling, M., & Barends, D. M. (1999). In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers. Eur. J. Pharm. Biopharm., 48, 13-9.
17. Lobenberg, R., Kramer, J., Shah, V. P., Amidon, G. L., & Dressman, J. B. (2000). Dissolution testing as a prognostic tool for oral drug absorption: Dissolution behavior of glibenclamide. Pharm. Res. 17, 439-444.
18. Luhtala, S. (1992a). Effect of sodium lauryl sulphate and polysorbate 80 on crystal growth and aqueous solubility of carbamazepine. Acta. Pharm. Nord., 4, 85-90.
19. Luhtala, S. (1992b). Effect of poloxamer 184 on crystal growth and aqueous solubility of carbamazepine. Acta. Pharm. Nord., 4, 271-276.
20. McMahon, L. E., Timmins, P., Williams, A. C., & York, P. (1996). Characterization of dihydrates prepared from carbamazepine polymorphs. J. Pharm. Sci., 85, 1064-1069.
21. Matsuda, Y., Akazawa, R., Teraoka, R., & Otsuka, M. (1994). Pharmaceutical evaluation of carbamazepine modifications: comparative study for photostability of carbamazepine polymorphs by using Fourier-transformed reflection-absorption-infrared spectroscopy and colorimetric measurement. J. Pharm. Pharmacol., 46, 162-167.
22. McCarthy, L. G., Bradley, G., Sexton, J. C., Corrigan, O. I., & Healy, A. M. (2004). Computational fluid dynamics modeling of the paddle dissolution apparatus: agitation rate, mixing patterns, and fluid velocities. AAPS PharmSciTech., 5, 1-10.
23. Miyazaki, T., Yoshioka, S., Aso, Y., & Kojima, S. (2004). Ability of polyvinylpyrrolidone and polyacrylic acid to inhibit the crystallization of amorphous acetaminophen. J. Pharm. Sci., 93, 2710-2717.
24. Meyer, M. C., Straughn, A. B., Jarvi, E. J., Wood, G. C., Pelsor, F. R., & Shah, V. P. (1992). The bioequivalence of carbamazepine tablets with a history of clinical failures. Pharm. Res. 9, 1612-1616.
25. Meyer, M. C., Mhatre, S. R. M., Shah, V. P., Williams, R. L., & Lesko, L. J. (1998). The relative bioavailability and in vivo-in vitro correlations for four marketed carbamazepine tablets. Pharm. Res., 15, 1987-1991.
26. Motawi, A. M., Mortoda, S. A. M., El-Khawas, F., & El-khodairy, K. A. (1982). Crystal growth studies of sulfathiazole aqueous suspensions. Acta. Pharma. Technol., 28, 211-215.
27. Murphy, D., Rodriguez-Cintron, F., Langevin, B., Kelly, R. C., & Rodriguez-Hornedo, N. (2002). Solution-mediated phase transformation of anhydrous to dihydrate carbamazepine and the effect of lattice disorder. Int. J. Pharm., 246, 121-134.
28. O'Connor, K. M., & Corrigan, O. I. (2001). Comparison of the physicochemical properties of the N-(2-hydroxyethyl) pyrrolidine, diethylamine and sodium salt forms of diclofenac. Int. J. Pharm., 222, 281-293.
29. Otsuka, M., Ishii, M., & Matsuda, Y. (2003). Effect of surface modification on hydration kinetics of carbamazepine anhydrate using isothermal microcalorimetry. AAPS PharmSciTech., 4(1): E5.
30. Qureshi, S. A. (2004). Choice of Rotation Speed (rpm) for Bio-relevant Drug Dissolution Testing Using a Crescent-shape Spindle. Eur. J. Pharm. Sci., 23, 271-275.
31. Qureshi, S. A., & Shabnam, J. (2001). Cause of high variability in drug dissolution testing and its impact on setting tolerance. Eur. J. Pharm. Sci., 12, 271-276.
32. Raghavan, S. L., Trividic, A., Davis, A. F., & Hadgraft, J. (2001). Crystallization of hydrocortisone acetate: influence of polymers. Int. J. Pharm., 212, 213-221.
33. Rinaki, E., Valsami, G., & Macheras, P. (2003). Quantitative biopharmaceutics classification system: the central role of dose/solubility ratio. Pharm Res., 20, 1917-1925.
34. Rodriguez-Hornedo, N., & Murphy, D. (2004). Surfactant-facilitated crystallization of dihydrate carbamazepine during dissolution of anhydrous polymorph. J. Pharm. Sci., 93, 449-460.
35. Schmidt, A. G., Wartewig, S., & Picker, K. M. (2003). Potential of carrageenans to protect drugs from polymorphic transformation. Eur. J. Pharm. Biopharm., 56, 101-110.
36. Shah, V. P., Konecy, J. J., Everett, R. L., Mc Cullough, B., Noorizadeh, A. C., & Skelly, J. P. (1989). In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Pharm. Res., 6, 612-618.
37. Shefter, E., & Higuchi, T. (1963). Dissolution behavior of crystalline solvated and non solvated forms of some pharmaceuticals. J. Pharm. Sci., 52, 781-791.
38. Young, W. W. L., & Suryanarayanan, R. (1991). Kinetics of transition of anhydrous carbamazepine to carbamazepine dehydrate in aqueous suspension. J. Pharm. Sci., 80, 496-500.
39. Ziller, K. H., & Rupprecht, H. H. (1988). Control of crystal growth in drug suspensions. Part 1 Design of a control unit and application to acetaminophen suspension. Drug. Dev. Ind. Pharm., 14, 2341-2370.
40. Ziller, K. H., & Rupprecht, H. H. (1990). Control of crystal growth in drug suspensions. Part 2. Influence of polymers on dissolution and crystallization during temperature cycling. Pharm. Ind., 52, 1017-1022.