Structural and thermal characterization of zolpidem hemitartrate hemihydrate (Form E) and its decomposition products by laboratory x-ray powder diffraction

Journal of Pharmaceutical Sciences

Volumn 99, Issue 2, 2010, Pages 871-878

  Halasz, Ivan ^a   Dinnebier, Robert E ^a  

^a MAX PLANCK INSTITUT FÜR FESTKÖRPERFORSCHUNG   (Germany)

Author keywords

Crystallography; Dehydration; Imidazopyridines; Rietveld analysis; Solid state; Stability; Structure solution by powder diffraction; X ray powder diffractometry; Zolpidem

Indexed keywords

HYDROGEN; IMIDAZOPYRAZINE DERIVATIVE; UNCLASSIFIED DRUG; ZOLPIDEM; ZOLPIDEM HEMITARTRATE HEMIHYDRATE; ZOLPIDEM TARTRATE;

ARTICLE; CHEMICAL BOND; CRYSTAL STRUCTURE; CRYSTALLIZATION; DRUG DECOMPOSITION; DRUG STRUCTURE; DRUG SYNTHESIS; PROTON TRANSPORT; THERMOSTABILITY; WATER LOSS; X RAY POWDER DIFFRACTION;

EID: 74049151876     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21883     Document Type: Article

References (19)

1. Kaplan J-P, George P. 1983. Imidazo[1,2-A] pyridine derivatives and their application as pharmaceuticals. United States patent US4382938.
2. Priest RG, Terzano MG, Parrino L, Boyer P. 1997. Efficacy of zolpidem in insomnia. Eur Psychiatry 12:5-14.
3. Aronhime JR, Dolitzky B-ZPT, Kordova MKS, Leonov DR, Meszaros-Sos E, Schwartz AR, Szabo C, Zavurov SL. 2001. Zolpidem hemitartrate solvate. European Patent Application EP1541146A1.
4. Ettema GJB, Lemmens JM, Peters THA, Picha F. 2001. Zolpidem salt forms. United States Patent US6242460B1.
5. Leljak M, Miric S, Mestrovic E, Siljkovic Z. 2008. Pharmaceutical composition of zolpidem. International patent WO2008/071966A2.
6. Kumar Y, Mohan P, Asok N, Chandrashekar T, Santhakumar R, Ganguly S. 2006. Novel polymorph of zolpidem hemitartrate. International patent WO2006/008636A2.
7. Lawecka M, Kosmacinska B, Glice M, Korczak K. 2006. The influence of storage conditions on the polymorphic stability of zolpidem tartrate hydrate. J Therm Anal Calorim 83:583-585.
8. George P, Rossey G, Depoortere H, Mompon B, Allen J, Wick A. 1988. Zolpidem and related compounds: Synthesis, physical properties and structure-activity relationships. In: Sauvanet JP, Langer SZ, Morselli PL, editors. Imidazopyridines in sleep disorders. New York: Raven Press. pp. 11-23.
9. Huq A, Stephens PW. 2003. Subtleties in crystal structure solution from powder diffraction data using simulated annealing: Ranitidine hydrochloride. J Pharm Sci 92:244-249.
10. Sugimoto K, Dinnebier RE, Zakrzewski M. 2007. Structural characterization of anhydrous naloxoneand naltrexone hydrochloride by high resolution laboratory X-ray powder diffraction and thermal analysis. J Pharm Sci 96:3316-3323.
11. Cheng BK. 2001. Process for preparing zolpidem hemitartrate and tartrate polymorphs. International patent WO2007/040995A1.
12. Boultif A, Louër D. 2004. Powder pattern indexing with the dichotomy method. J Appl Crystallogr 7: 724-731.
13. Coelho AA. 2003. Indexing of powder diffraction patterns by iterative use of singular value decomposition. J Appl Crystallogr 36:86-95.
14. TOPAS, version 4.1, 2008. Bruker AXS.
15. Favre-Nicolin V, Černý R. 2002. FOX, 'free objects for crystallography': A modular approach to ab initio structure determination from powder diffraction. J Appl Crystallogr 35:734-743.
16. Dinnebier RE, Olbrich F, van Smaalen S, Stephens PW. 1997. Ab initio structure determination of two polymorphs of cyclopentadienylrubidium in a single powder pattern. Acta Crystallogr B53:153-158.
17. Larson AC, Von Dreele RB. 2000. Los Alamos National Laboratory Report LAUR. General Structure Analysis System (GSAS), edition. pp. 86-748.
18. Spek AL. 2003. Single-crystal structure validation with the program PLATON. J Appl Crystallogr 36: 7-13.
19. Dinnebier RE, Sieger P, Nar H, Shankland K, David WIF. 2000. Structural characterization of three crystalline modifications of telmisartan by single crystal and high-resolution X-ray powder diffraction. J Pharm Sci 89:1465-1479.