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  • 1 Department of Applied Chemistry, National ChiaYi University, ChiaYi, Taiwan, Republic of China
  • | 2 Department of Biotechnology, Yuanpei University, Yuanpei Street, Hsin Chu, Taiwan, Republic of China
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Abstract

The purpose of this study was to investigate the thermal-induced solid-state characterization of metoclopramide hydrochloride monohydrate (MCP H2O) by using a combination of differential scanning calorimetry (DSC) and Fourier-transform infrared (simultaneous DSC-FTIR) microspectroscopy. The DSC and thermogravimetric (TG) analyses were also carried out. The result indicates that a continuous process of dehydration, amorphization and recrystallization for MCP H2O in the solid state was easily evidenced via the thermal responsive IR spectral changes by using this simultaneous DSC-FTIR microspectroscopy. In the heating course, one mole of water was first dehydrated from the MCP H2O sample beyond 77 °C, was then quickly transformed to an amorphous form due to the appearance of weak broad IR bands, and continuously recrystallized from 148 °C by showing the sharp IR bands. This one-step novel simultaneous DSC-FTIR microspectroscopy might be available for studying the changes in the progressive processes of the thermal-dependent solid-state characterizations of drugs.

  • 1. Vippagunta, SR, Brittain, HG, Grant, DJW 2001 Crystalline solids. Adv Drug Deliv Rev 48:326 .

  • 2. Rodríguez-Spong, B, Price, CP, Jayasankar, A, Matzger, AJ, Rodríguez-Hornedo, N 2004 General principles of pharmaceutical solid polymorphism: a supramolecular perspective. Adv Drug Deliv Rev 56:241274 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3. Storey, R, Royall, P 2008 Solid state characterization of pharmaceuticals 3 Wiley Chichester, England.

  • 4. Byrn, SR, Xu, W, Newman, AW 2001 Chemical reactivity in solid-state pharmaceuticals: formulation implications. Adv Drug Deliv Rev 48:115136 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 5. Brittain, H 1995 Physical characterization of pharmaceutical solids Marcel Dekker, Inc. New York, USA.

  • 6. Byrn, SR, Pfeiffer, RR, Stowell, JG 1999 Solid state chemistry of drugs 2 SSCI, Inc. West Lafayette, IN, USA.

  • 7. Gibson, M 2001 Pharmaceutical preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form Informa Healthcare, Interpharm/CRC Washington, DC, USA.

    • Search Google Scholar
    • Export Citation
  • 8. Desmond, PV, Watson, KJ 1986 Metoclopramide—a review. Med J Aust 144:366369.

  • 9. MacGregor, EA 2001 Anti-emetics. Curr Med Res Opin 17 Suppl 1 s22s25 .

  • 10. Stosik, AG, Junginger, HE, Kopp, S, Midha, KK, Shah, VP, Stavchansky, S, Dressman, JB, Barends, DM 2008 Biowaiver monographs for immediate release solid oral dosage forms: metoclopramide hydrochloride. J Pharm Sci 97:37003708 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11. Pabón, CV, Frutos, P, Lastres, JL, Frutos, G 1996 Application of differential scanning calorimetry and X-ray power diffraction to the solid-state study of metoclopramide. J Pharm Biomed Anal 15:131138 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 12. Qiu, Z, Stowell, JG, Cao, W, Morris, KR, Byrn, SR, Carvajal, MT 2005 Effect of milling and compression on the solid-state Millard reaction. J Pharm Sci 94:25682580 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 13. Maquille, A, Slegers, C, Habib, JL, Tilquin, B 2006 Electron beam and gamma radiolysis of solid-state metoclopramide. Pharm Res 23:13431349 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 14. Mitchell, AG 1985 Polymorphism in metoclopramide hydrochloride and metoclopramide. J Pharm Pharmacol 37:601604.

  • 15. Chetana, PR, Siddaramaiah, X, Ramappa, PG 2005 TGA studies of metoclopramide complexes of cobalt (II) in the solid state. Thermochim Acta 425:1321 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 16. Cheng, YD, Lin, SY 2000 Isothermal FT-IR microspectroscopic studies on the stability kinetics of solid-state intramolecular cyclization of aspartame sweetener. J Agric Food Chem 48:631635 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 17. Lin, SY, Cheng, WT, Wang, SL 2006 Thermodynamic and kinetic characterization of polymorphic transformation of famotidine during grinding. Int J Pharm 318:8691 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 18. Wang, SL, Lin, SY, Hsieh, TF, Chan, SA 2007 Thermal behavior and thermal decarboxylation of 10-hydroxycamptothecin in the solid sate. J Pharm Biomed Anal 43:457463 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 19. Lin, SY, Wang, SL, Chen, TF, Hu, TC 2002 Intramolecular cyclization of diketopiperazine formation in solid-state enalapril maleate studied by thermal FT-IR microscopic system. Eur J Pharm Biopharm 54:249254 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 20. Wang, SL, Lin, SY, Chen, TF, Chuang, CH 2001 Solid-state trans–cis isomerization of captopril determined by thermal Fourier transform infrared (FT-IR) microspectroscopy. J Pharm Sci 90:10341039 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 21. Hsu, CH, Lin, SY 2009 Simultaneous DSC-FTIR combined technique used to quickly examine the kinetic processes of intramolecular lactamization of gabapentin and evaporation of gabapentin-lactam. Thermochim Acta 486:510 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 22. Hsu, CH, Ke, WT, Lin, SY 2009 Progressive steps of polymorphic transformation of gabapentin polymorphs studied by hot-stage FTIR microspectroscopy. J Pharm Pharm Sci 13:6777.

    • Search Google Scholar
    • Export Citation
  • 23. Lin, SY, Chien, JL 2003 In vitro simulation of solid–solid dehydration, rehydration and solidification of trehalose dihydrate using thermal and vibrational spectroscopic techniques. Pharm Res 20:19261931 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 24. Gao, GY, Lin, SY 2010 Thermodynamic investigations of nitroxoline sublimation by simultaneous DSC-FTIR method and isothermal TG analysis. J Pharm Sci 99:255261 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 25. Jójárt-Laczkovich O , Szabó-Révész P. Amorphization of a crystalline active pharmaceutical ingredient and thermoanalytical measurements on this glassy form. J Therm Anal Calorim. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26. Lappalainen M , Karppinen M. Techniques of differential scanning calorimetry for quantification of low contents of amorphous phases. J Therm Anal Calorim. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 27. Giron, D, Mutz, M, Garnier, S 2004 Solid-state of pharmaceutical compounds: impact of the ICH Q6 guideline on industrial development. J Therm Anal Calorim 77:709747 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 28. Mahore, JG, Wadher, KJ, Umekar, MJ 2009 Taste abatement of metoclopramide hydrochloride using ion exchange resins. Der Pharm Lett 1:164171.

    • Search Google Scholar
    • Export Citation
  • 29. Patel, CM, Patel, MM 2009 Compressed matrix dual-component vaginal drug delivery system containing metoclopramide hydrochloride. Acta Pharm 59:273288 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 30. Gupta, P, Bansal, AK 2005 Devitrification of amorphous celecoxib. AAPS PharmSciTech 6:E223E230 (Article 32).

  • 31. Chan, KLA, Fleming, OS, Kazarian, SG, Vassou, D, Chryssikos, GD, Gionis, V 2004 Polymorphism and devitrification of nifedipine under controlled humidity: a combined FT-Raman, IR and Raman microscopic investigation. J Raman Spectrosc 35:353359 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 32. Qi, S, Weuts, I De Cort, S Stokbroekx, S, Leemans, R, Reading, M, Belton, P, Craig, DQ 2010 An investigation into the crystallisation behaviour of an amorphous cryomilled pharmaceutical material above and below the glass transition temperature. J Pharm Sci 99:196208 .

    • Crossref
    • Search Google Scholar
    • Export Citation

Manuscript Submission: HERE

  • Impact Factor (2019): 2.731
  • Scimago Journal Rank (2019): 0.415
  • SJR Hirsch-Index (2019): 87
  • SJR Quartile Score (2019): Q3 Condensed Matter Physics
  • SJR Quartile Score (2019): Q3 Physical and Theoretical Chemistry
  • Impact Factor (2018): 2.471
  • Scimago Journal Rank (2018): 0.634
  • SJR Hirsch-Index (2018): 78
  • SJR Quartile Score (2018): Q2 Condensed Matter Physics
  • SJR Quartile Score (2018): Q2 Physical and Theoretical Chemistry

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation
1969
Volumes
per Year
4
Issues
per Year
24
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)