A comparative assessment of solubility advantage from glassy and crystalline forms of a water-insoluble drug

European Journal of Pharmaceutical Sciences

Volumn 32, Issue 1, 2007, Pages 45-57

  Chawla, Garima ^a   Bansal, Arvind K ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Amorphous form; Devitrification; Dissolution medium; Irbesartan; Solubility

Indexed keywords

HYDROCHLORIC ACID; IRBESARTAN;

ARTICLE; CRYSTAL STRUCTURE; DRUG SOLUBILITY; GLASS TRANSITION TEMPERATURE; LIPOPHILICITY; MELTING POINT; PH; PRIORITY JOURNAL;

ALGORITHMS; ANTIHYPERTENSIVE AGENTS; BIPHENYL COMPOUNDS; BUFFERS; CALORIMETRY, DIFFERENTIAL SCANNING; CRYSTALLIZATION; DRUG STABILITY; HYDROCHLORIC ACID; PHASE TRANSITION; SOLUBILITY; TETRAZOLES; THERMODYNAMICS; WATER;

EID: 34548672900     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2007.05.111     Document Type: Article

References (24)

1. Almarsson O., and Gardner C.R. Novel approaches to issues of developability. Curr. Drug Dis. 1 (2003) 21-26
2. Angell C.A. The old problems of glass and the glass transition, and the many new twists. Proc. Natl. Acad. Sci. 92 (1995) 6675-6682
3. Caron, A., Chantreox, D., Bouloumie, C., 1997. Process for the preparation of a tetrazole derivative in two crystalline forms and the novel crystalline form thereof. US 5,629,331.
4. Crowley K.J., and Zografi G. The use of thermal methods for predicting glass-former fragility. Thermochim. Acta 380 (2001) 79-93
5. Elamin A.A., Ahlneck C., Alderborn G., and Nystrom C. Increased metastable solubility of milled griseofulvin, depending on the formation of a disordered surface structure. Int. J. Pharm. 111 (1994) 159-170
6. Erk N. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by liquid chromatography. J. Chromatogr. B 784 (2003) 195-201
7. Fagegaltier N.B., Menegotto J., Lamure A., Duplaa H., Caron A., Lacabanne C., and Bauer M. Molecular mobility study of amorphous and crystalline phases of a pharmaceutical product by thermally stimulated current spectroscopy. J. Pharm. Sci. 91 (2002) 1548-1560
8. Galia E., Nicolaides E., Horter D., Lobenberg R., Reppas C., and Dressman J.B. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 15 (1998) 698-705
9. Gardner C.R., Walsh C.T., and Almarsson O. Drugs as materials: valuing physical form in drug discovery. Nature 3 (2004) 926-934
10. Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms (1997), US Food and Drug Administration, Rockville, MD, USA
11. Gupta P., Chawla G., and Bansal A.K. Physical stability and solubility advantage from amorphous celecoxib: the role of thermodynamic quantities and molecular mobility. Mol. Pharm. 1 (2004) 406-413
12. Gupta P., Kakumanu V.K., and Bansal A.K. Stability and solubility of celecoxib-PVP amorphous dispersions: a molecular perspective. Pharm. Res. 21 (2004) 1762-1769
13. Hancock B.C. Disordered drug delivery: destiny, dynamics and the Deborah number. J. Pharm. Pharmacol. 54 (2002) 737-746
14. Hancock B.C., and Parks M. What is the true solubility advantage for amorphous pharmaceuticals. Pharm. Res. 17 (2000) 397-404
15. Hara T.O., Dunne A., Butler J., and Devane J. A review of methods used to compare dissolution profile data. Pharm. Sci. Tech. Today 1 (1998) 214-233
16. Kakumanu V.K., and Bansal A.K. Enthalpy relaxation studies of celecoxib amorphous mixtures. Pharm. Res. 19 (2002) 1873-1878
17. Law B., Krill S.L., Schmitt E.A., Fort J.J., Qiu Y., Wang W., and Porter W.R. Physicochemical considerations in the preparation of amorphous ritonavir-poly(ethylene glycol) 8000 solid dispersions. J. Pharm. Sci. 90 (2001) 1015-1025
18. Lipinski C.A., Lombardo F., Dominy B.W., and Feeney P.J. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv. Drug Deliv. Rev. 23 (1997) 3-25
19. Mbah C.J. Kinetics of decomposition of irbesartan in aqueous solutions determined by high performance liquid chromatography. Pharmazie 59 (1994) 920-922
20. Shah V.P., Konecny J.J., Everett R.L., Mccullough B., Noorizadeh A.C., and Skelly J.P. In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Pharm. Res. 6 (1989) 612-618
21. The United States Pharmacopeia (USP 23), 1995. United States Pharmacopeial Convention, Inc., Rockville, MD.
22. Veesler S., Lafferrere L., Garcia E., and Hoff C. Phase transitions in supersaturated drug solution. Org. Process Res. Dev. 7 (2003) 983-989
23. Verheyen S., Blaton N., Kinget R., and Mooter G.V.D. Mechanism of increased dissolution of diazepam and temazepam from polyethylene glycol 6000 solid dispersions. Int. J. Pharm. 249 (2002) 45-58
24. Yu L.X. An integrated model for determining causes of poor oral drug absorption. Pharm. Res. 16 (1999) 1883-1887