Preparation and characterization of polymorphs of the glucocorticoid deflazacort

References

• Brittain HG. Polymorphism in pharmaceutical solids. 2nd ed. New York: Informa Healthcare; 2009
   Google Scholar
• U.S. Department of Health and Human Services. Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry ANDAs: Pharmaceutical Solid Polymorphism Chemistry, Manufacturing, and Controls Information; July 2007
   Google Scholar
• Hilfinger R. Polymorphism in the pharmaceutical industry. 1st ed. Weinheim: Wiley-VCH; 2006
   Google Scholar
• Aucamp M, Stieger N, Barnard N, Liebenberg W. Solution-mediated phase transformation of different roxithromycin solid-state forms: implications on dissolution and solubility. Int J Pharm 2013;449:18–27
   PubMed Web of Science ®Google Scholar
• Graeser KA, Strachan CJ, Patterson JE, et al. Physicochemical properties and stability of two differently prepared amorphous forms of Simvastatin. Cryst Growth Des 2008;8:128–135
   Web of Science ®Google Scholar
• Bernstein J. Polymorphism in molecular crystals. 1st ed. New York: Oxford University Press; 2002
   Google Scholar
• Bratu I, Borodi G, Kacsó I, et al. New solid form of norfloxacin: structural studies. Spectros Int J 2011;25:53–62
   Web of Science ®Google Scholar
• Näther C, Jess I. New news about an old drug: investigations on the polymorphism of triamcinolone acetonide. Angew Chem Int Ed Engl 2006;45:6381–6383
   PubMed Web of Science ®Google Scholar
• Suitchmezian V, Jeß I, Näther C. Investigations on the polymorphism and pseudopolymorphism of the glucocorticoid triamcinolone: new findings for a well-known drug. Cryst Growth Des 2007;7:69–74
   Web of Science ®Google Scholar
• Joshi N, Rajeshwari K. Deflazacort. J Postgrad Med 2009;55:296–300
   PubMed Web of Science ®Google Scholar
• Markham A, Bryson HM. Deflazacort – a review of its pharmacological properties and therapeutic efficacy. Drugs 1995;50:317–333
   PubMed Web of Science ®Google Scholar
• Budavari S, O’Neil MJ, Smith A, Heckelman PE, eds. The Merck Index. 11th ed. Rahway (NJ): Merck & Co. Inc.; 1989: 449
   Google Scholar
• Cooper MS. Sensitivity of bone to glucocorticoids. Clin Sci 2004;107:111–123
   PubMed Web of Science ®Google Scholar
• Grossmann C, Scholz T, Kochel M, et al. Transactivation via the human glucocorticoid and mineralocorticoid receptor by therapeutically used steroids in CV-1 cells: a comparison of their glucocorticoid and mineralocorticoid properties. Eur J Endocrinol 2004;151:397–408
   PubMed Web of Science ®Google Scholar
• Byrn SR, Pfeifer R, Stowell JF. Solid-state chemistry of drugs. 2nd ed. Indinana: West Lafayette; 1999:180–192
   Google Scholar
• Cuffini S, Ayala A, Mendes Filho J, et al. Physicochemical characterization of deflazacort: thermal analysis, crystallographic and spectroscopic study. Steroids 2007;72:61–69
   Web of Science ®Google Scholar
• Price CP, Grzesiak AL, Matzger AJ. Crystalline polymorph selection and diskovery with polymer heteronuclei. J Am Chem Soc 2005;127:5512–5517
   PubMed Web of Science ®Google Scholar
• Haleblian JK, Koda RT, Biles JA. Comparison of dissolution rates of different crystalline phases of fluprednisolone by in vitro and in vivo methods. J Pharm Sci 1971;60:1488–1491, and references therein
   PubMed Web of Science ®Google Scholar
• Aaltonen J, Allesø M, Mirza S, et al. Solid form screening – a review. Eur J Pharm Biopharm 2009;71:23–37
   PubMed Web of Science ®Google Scholar
• Sperandeo NR, Kassuha D. Development and validation of a dissolution test for 6 mg deflazacort tablets. Sci Pharm 2009;77:679–693
   Google Scholar
• USP 31. General Chapter, general information <1087> Intrinsic Dissolution; 2008:578–579
   Google Scholar
• Tenho M, Heinänen P, Tanninen VP, Lehto VP. Does the preferred orientation of crystallites in tablets affect the intrinsic dissolution? J Pharm Biomed Anal 2007;43:1315–1323
   PubMed Web of Science ®Google Scholar
• Yu LX, Carlin AS, Amidon GL, Husain AS. Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs. Int J Pharm 2004;270:221–227
   PubMed Web of Science ®Google Scholar
• Paulino AS, Rauber G, Campos CEM, et al. Dissolution enhancement of deflazacort using hollow crystals prepared by antisolvent crystallization process. Eur J Pharm Sci 2013;49:294–301
   PubMed Web of Science ®Google Scholar
• Yonemochi E, Kitahara S, Maeda S, et al. Physicochemical properties of amorphous clarithromycin obtained by grinding and spray drying. Eur J Pharm Sci 1999;7:331–338
   PubMed Web of Science ®Google Scholar
• Zimper U, Aaltonen J, Mc Goverin CM, et al. Quantification of process induced disorder in milled samples using different analytical techniques. Pharmaceutics 2010;2:30–49
   PubMedGoogle Scholar
• Clas SD, Cotton M, Morfina E, et al. Assessment of the physical stability of lyophilized MK-0591 by differential scanning calorimetry. Thermochim Acta 1996;288:83–96
   Web of Science ®Google Scholar
• Teagarden DL, Baker DS. Practical aspects of lyophilization using non-aqueous co-solvent systems. Eur J Pharm Sci 2002;15:115–133
   PubMed Web of Science ®Google Scholar
• Giron D. Thermal analysis and calorimetric methods in the characterization of polymorphs and solvates. Thermochim Acta 1995;248:1–59
   Web of Science ®Google Scholar
• Crowley KJ, Zografi G. Cryogenic grinding of indomethacin polymorphs and solvates: assessment of amorphous phase formation and amorphous phase physical stability. J Pharm Sci 2002;91:492–507
   PubMed Web of Science ®Google Scholar
• Trasi NS, Boerrigter SXM, Byrn SR. Investigation of the milling-induced thermal behavior of crystalline and amorphous Griseofulvin. Pharm Res 2010;27:1377–1389
   PubMed Web of Science ®Google Scholar
• Chieng N, Rades T, Saville D. Formation and physical stability of the amorphous phase of ranitidine hydrochloride polymorphs prepared by cryo-milling. Eur J Pharm Biopharm 2008;68:771–780
   PubMed Web of Science ®Google Scholar
• Craig DQM, Royal PG, Kett VL, Hopton ML. The relevance of the amorphous state to pharmaceutical dosage forms: glassy drugs and freeze dried systems. Int J Pharm 1999;179:179–207
   PubMed Web of Science ®Google Scholar
• Kaushal AM, Chakraborti AK, Bansal AK. FTIR studies on differential intermolecular association in crystalline and amorphous states of structurally related non-steroidal anti-inflammatory drugs. Mol Pharmaceutics 2008;5:937–945
   PubMed Web of Science ®Google Scholar
• Jinno J, Oh D, Crison JR, Amidon GL. Dissolution of ionizable water-insoluble drugs: the combined effect of pH and surfactant. J Pharm Sci 2000;89:268–274
   PubMed Web of Science ®Google Scholar
• Hancock BC, Parks M. What is the true solubility advantage for amorphous pharmaceuticals? Pharm Res 2000;17:397–404
   PubMed Web of Science ®Google Scholar
• Agrawal S, Ashokraj Y, Bharatam PV, et al. Solid-state characterization of rifampicin samples and its biopharmaceutic relevance. Eur J Pharm Sci 2004;22:127–144
   PubMed Web of Science ®Google Scholar