Development and formulation of a 0.2% oral solution of midazolam containing γ-cyclodextrin

International Journal of Pharmaceutics

Volumn 379, Issue 2, 2009, Pages 244-250

  Marçon, Frédéric ^a   Mathiron, David ^b   Pilard, Serge ^b   Lemaire Hurtel, Anne Sophie ^a   Dubaele, Jean Marc ^a   Djedaini Pilard, Florence ^b  

^a AMIENS UNIVERSITY HOSPITAL   (France)

^b UNIVERSITÉ DE PICARDIE JULES VERNE   (France)

Author keywords

Cyclodextrin midazolam inclusion complex; HPLC quantification; LC HRMS; NMR; Oral solution; Pre anesthesia

Indexed keywords

CITRIC ACID; GAMMA CYCLODEXTRIN; MIDAZOLAM; SUCRALOSE;

AQUEOUS SOLUTION; AROMA; ARTICLE; ASEPSIS; CONTROLLED STUDY; DRUG DETERMINATION; DRUG FORMULATION; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROPHOBICITY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PRIORITY JOURNAL; STOICHIOMETRY;

ADMINISTRATION, ORAL; CHEMISTRY, PHARMACEUTICAL; GAMMA-CYCLODEXTRINS; MIDAZOLAM; PHARMACEUTICAL SOLUTIONS; SUCROSE;

EID: 68949211075     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.05.029     Document Type: Article

References (29)

1. AFSSaPS, 2007. Bonnes Pratiques de Fabrication. Direction des Journaux Officiels, Paris.
2. Ali S.M., and Upadhyay S.K. Complexation study of midazolam hydrochloride with β-cyclodextrin: NMR spectroscopic study in solution. Magn. Reson. Chem. 46 (2008) 676-679
3. Amato M.E., Djedaïni-Pilard F., Perly B., and Scarlata G. High field NMR and molecular modelling study of the inclusion complexes of the nootropic drug tenilsetam in cyclodextrins. J. Chem. Soc. Perkin Trans. II (1992) 2065-2069
4. Amorim C.G., Araújo A.N., Montenegro M.C.B.S.M., and Silva V.L. Cyclodextrin-based potentiometric sensors for midazolam and diazepam. J. Pharm. Biomed. Anal. 48 (2008) 1064-1069
5. Armijo J.A., Herranz J.L., Pena Pardo M.A., and Adín J. Intranasal and buccal midazolam in the treatment of acute seizures. Rev. Neurol. 38 (2004) 458-468
6. Bar R., and Ulitzur S. Bacterial toxicity of cyclodextrins: luminuous Escherichia coli as a model. Appl. Microbiol. Biotechnol. 41 (1994) 574-577
7. Benesi H.A., and Hildebrand J.H. A spectrophotometric investigation of the interaction of iodine with aromatic hydrocarbons. J. Am. Chem. Soc. 71 (1949) 2703-2707
8. Davies F.C., and Waters M. Oral midazolam for conscious sedation of children during minor procedures. J. Accid. Emerg. Med. 15 (1998) 244-248
9. de Vries E.J.C., and Caira M.R. A structural and thermal investigation of the inclusion of parabens in heptakis(2,6-di-O-methyl)cyclomaltoheptaose. Carbohydr. Res. 343 (2008) 2433-2438
10. Decock G., Fourmentin S., Surpateanu G.G., Landy D., Decock P., and Surpateanu G. Experimental and theoretical study on the inclusion compounds of aroma components with β-cyclodextrins. Supramol. Chem. 18 (2006) 477-482
11. Djedaini-Pilard F., Lin S.Z., Perly B., and Wouessidjewe D. High field NMR techniques for the investigation of a beta-cyclodextrin-indomethacin inclusion complex. J. Pharm. Sci. 79 (1990) 643-646
12. Dodziuk H. Cyclodextrins and their Complexes: Chemistry, Analytical Methods, Applications (2006), Wiley-VCH, London
13. Echezarreta-Lopez M.M., Perdomo-Lopez I., Estrada E., Vila-Jato J.L., and Torres-Labandeira J.J. Utility of nuclear magnetic resonance spectroscopy to characterize the structure of dexamethasone sodium phosphate inclusion complexes with cyclodextrins in solution and to analyze potential competitive effects. J. Pharm. Sci. 91 (2002) 1536-1547
14. European Pharmacopoeia, 2007. 6th ed., Council of Europe, Strasbourg, pp. 567-583.
15. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., and Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal-part II. J. Pharm. Biomed. Anal. 45 (2007) 70-81
16. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., and Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal-part III. J. Pharm. Biomed. Anal. 45 (2007) 82-96
17. Higuchi T., and Connors K. Phase solubility techniques. In: Reilly C. (Ed). Advances in Analytical Chemistry and Instrumentation (1965), Wiley Intersciences, New York 117-212
18. Job P. Spectrographic study of the formation of complexes in aqueous solution. Compt. Rend. 180 (1925) 928-930
19. Ko Y.P., Huang C.J., Hung Y.C., Su N.Y., Tsai P.S., Chen C.C., and Cheng C.R. Premedication with low-dose oral midazolam reduces the incidence and severity of emergence agitation in pediatric patients following sevoflurane anesthesia. Acta Anaesthesiol. Sin. 39 (2001) 169-177
20. Lee M.J., Monté S., Sanderson J., and Haskins N.J. A preliminary study using fast liquid chromatogaphy coupled to a quadrupole orthogonal time-of-flight mass spectrometer. Rapid Commun. Mass Spectrom. 13 (1999) 216-221
21. Loftsson T., and Duchêne D. Cyclodextrins and their pharmaceutical applications. Int. J. Pharm. 329 (2007) 1-11
22. Loftsson T., Gudmundsdóttir H., Sigurjónsdóttir J.F., Sigurdsson H.H., Sigfússon S.D., Másson M., and Stefánsson E. Cyclodextrin solubilization of benzodiazepines: formulation of midazolam nasal spray. Int. J. Pharm. 212 (2001) 29-40
23. Loftsson T., Vogensen S.B., Brewster M.E., and Konrádsdóttir F. Effects of cyclodextrins on drug delivery through biological membranes. J. Pharm. Sci. 96 (2007) 2532-2546
24. McGraw T., and Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr. Anaesth. 8 (1998) 117-121
25. Orive M.M., Gallo B., Alonso R.M., Vicente F., Viré J.C., and Patriarche G.J. Spectrophotometric study of the acid-base equilibria of an imidazobenzodiazepine, midazolam, and its determination in pharmaceutical formulations. Microchim. Acta 97 (1989) 181-190
26. Péan C., Creminon C., Djedaïni-Pilard F., Pradelles P., and Perly B. NMR investigation of the inclusion of thyroxine and derivatives in natural and chemically modified cyclodextrins. J. Inclusion Phenom. 33 (1999) 307-319
27. Qian L., Guan Y., and Xiao H. Preparation and characterization of inclusion complexes of a cationic β-cyclodextrin polymer with butylparaben or triclosan. Int. J. Pharm. 357 (2008) 244-251
28. R Development Core Team, 2008. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna.
29. Szejtli J. The properties and potential uses of cyclodextrin derivatives. J. Inclusion Phenom. Macrocyclic Chem. 14 (1992) 25-36