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  • 1 Faculty of Pharmacy, University of Medicine and Pharmacy “Victor Babeş”, Eftimie Murgu Square 2, 300041, Timişoara, Romania
  • | 2 Industrial Chemistry and Environmental Engineering Faculty, Politehnica University of Timişoara, Victoriei Square 2, 300006, Timişoara, Romania
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Abstract

The thermal techniques of analysis were used to assess the compatibility between ibuprofen (IB) and some excipients used in the development of extended released formulations. This study is a part of a systematic study undertaken to find and optimizes a general method of detecting the drug–excipient interactions, with the aim of predicting rapidly and assuring the long-term stability of pharmaceutical product and speeding up its marketing. The thermal properties of IB and its physical association as binary mixtures with some common excipients were evaluated by thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry. FT-IR spectroscopy and X-ray powder diffraction (XRPD) were used as complementary techniques to adequately implement and assist in interpretation of the thermal results. Based on their frequent use in preformulations nine different excipients: starch; microcrystalline cellulose (PH 101 and PH 102); colloidal silicon dioxide; lactose (monohydrate and anhydre); polyvinylpyrrolidone; magnesium stearate and talc were blended with IB. The samples were prepared by mixing the analyte and excipients in a proportion of 1:1 (w:w). The TG/DSC curves of the IB have shown a single stage of mass loss between 175 and 290 °C, respectively, an endothermic peak at 78.5 °C, which corresponds to the melting (literature Tm = 75–78 °C).

  • 1. Kovala-Demertzi, D 2006 Recent advances on non-steroidal anti-inflammatory drugs, NSAIDs: Organotin complexes of NSAIDs. J Organomet Chem. 691:17671774 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2. Kafarska, K, Czakis-Sulikowska, D, Wolf, WM 2009 Novel Co(II) and Cd(II) complexes with non-steroidal anti-inflammatory drugs. Synthesis, properties and thermal investigation. J Therm Anal Calorim. 96:617621 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3. Teslyuk, OI, Beltyukova, SV, Yegorova, AV, Yagodkin, BN 2007 Complex compounds of terbium(III) with some nonsteroidal anti-inflammatory drugs and their analytical applications. J Anal Chem. 62:330335 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 4. Ying, YC, Yi, L, Cheng, ZJ, Dan, Z 2008 Inhibitory effect of copper complex of indomethacin on bacteria studied by microcalorimetry. Biol Trace Elem Res 122:8288 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 5. Fini, A, Fasio, G, Benetti, L, Ghedini, V 2007 Thermal analysis of some diclofenac salts with alkyl and alkylhydroxy amines. Thermochim Acta. 464:6574 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 6. Mora Corvi, P, Cirri, M, Mura, P 2006 Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations. J Pharm Biomed Anal. 42:310 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 7. Neto HS , Barros FAP, de Sousa Carvalho FM, Matos JR, Thermal analysis of prednicarbate and characterization of thermal decomposition product, J Therm Anal Calorim. 2010. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 8. Macêdo, RO, Aragão, CFS, do Nascimento, TG, Macêdo, AMC 1999 Application of thermogravimetry in the quality control of chloramphenicol tablets. J Therm Anal Calorim. 56:13231327 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 9. Moura EA , Correia LP, Pinto MF, Procopio JVV, de Sousa FS, Macedo RO. Thermal characterization of the solid state and raw material fluconazole by thermal analysis and pyrolysis coupled to GC/MS. J Therm Anal Calorim. 2010. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 10. Giordano, F, Rossi, A, Pasquali, I, Bettini, R, Frigo, E, Gazzaniga, A, Sangalli, ME, Miles, V, Catinella, S 2003 Thermal degradation and melting point determination of diclofenac. J Therm Anal Calorim. 73:509518 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11. Picciochi, R, Diogo, HP, da Piedade, MEM 2010 Thermochemistry of paracetamol. J Therm Anal Calorim. 99:391401 .

  • 12. Tiţa, B, Marian, E, Tiţa, D, Vlase, G, Doca, N, Vlase, T 2008 Comparative kinetic study of decomposition of some diazepine derivatives under isothermal and non-isothermal conditions. J Therm Anal Calorim. 94:447452 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 13. Tiţa, B, Fuliaş, A, Marian, E, Tiţa, D 2009 Thermal behaviour of acetylsalicylic acid—active substance and tablets. Kinetic study under non-isothermal conditions. Rev Chim (Bucureşti) 60:419423.

    • Search Google Scholar
    • Export Citation
  • 14. Tiţa, B, Fuliaş, A, Marian, E, Tiţa, D 2009 Thermal stability and decomposition kinetics under non-isothermal conditions of sodium diclofenac. Rev Chim (Bucureşti) 60:524528.

    • Search Google Scholar
    • Export Citation
  • 15. Fuliaş, A, Tiţa, B, Bandur, G, Tiţa, D 2009 Thermal decomposition of some benzodiazepines under non-isothermal conditions. Kinetic study. Rev Chim (Bucureşti) 60:10791083.

    • Search Google Scholar
    • Export Citation
  • 16. Tiţa, B, Fuliaş, A, Rusu, G, Tiţa, D 2009 Thermal behaviour of indomethacin—active substance and tablets kinetic study under non-isothermal conditions. Rev Chim (Bucureşti) 60:12101215.

    • Search Google Scholar
    • Export Citation
  • 17. Bernardi, LS, Oliveira, PR, Murakami, FS, Silva, MAS, Borgmann, SHM, Cardoso, SG 2009 Characterization of venlafoxine with pharmaceutical excipients. J Therm Anal Calorim. 97:729733 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 18. Moyano MA , Broussalis AM, Segall AI. Thermal analysis of lipoic acid and evaluation of the compatibility with excipients. J Therm Anal Calorim. 2010. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 19. Oliveira, PR, Bernardi, LS, Murakami, FS, Mendes, C, Silva, MAS 2009 Thermal characterization and compatibility studies of norfloxacin for development of extended release tablets. J Therm Anal Calorim. 97:741745 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 20. Lira, AM, Araújo, AAS, Basílio, IDJ, Santos, BLL, Santana, DP, Macedo, RO 2007 Compatibility studies of lapachol with pharmaceutical excipients for the development of topical formulations. Thermochim Acta. 457:16 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 21. Tomassetti, M, Catalani, A, Rossi, V, Vecchio, S 2005 Thermal analysis study of the interactions between acetaminophen and excipients in solid dosage forms and in some binary mixtures. J Pharm Biomed Anal. 37:949955 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 22. Barboza, F, Vecchia, DD, Tagliari, MP, Silva, MAS, Stulzer, HK 2009 Differential scanning calorimetry as a screening technique in compatibility studies of acyclovir extended release formulations. Pharm Chem J. 43:363368 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 23. Bannach G , Cervini P, Cavalheiro ETG, Ionashiro M. Using thermal and spectroscopic data to investigate the thermal behaviour of drugs and excipients by unique calculations. J Therm Anal Calorim. 2010. doi: .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 24. Iliescu, T, Baia, M, Miclăuş, V 2004 A Raman spectroscopic study of the diclofenac sodium-β-cyclodextrin interaction. Eur J Pharm Sci. 22:487495 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 25. Bannach, G, Cervini, P, Cavalheiro, ETG, Ionashiro, M 2010 Using thermal and spectroscopic data to investigate the thermal behaviour of drugs and excipients by unique calculations. Thermochim Acta. 499:123127 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26. Tiţa, B, Fuliaş, A, Bandur, G, Rusu, G, Tiţa, D 2010 Thermal stability of ibuprofen. Kinetic study under non-isothermal conditions. Rev Roum Chim. 55:553558.

    • Search Google Scholar
    • Export Citation
  • 27. Bertol, CD, Cruz, AP, Stulzer, HK, Murakami, FS, Silva, MAS 2010 Thermal decomposition kinetics and compatibility studies of primaquine under isothermal and non-isothermal conditions. J Therm Anal Calorim. 102:187192 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 28. Marini, A, Berbenni, V, Moioli, S, Bruni, G, Cofrancesco, P, Margheritis, C 2003 Drug–excipient compatibility studies by physico-chemical techniques. The case of indomethacin. J Therm Anal Calorim. 73:529545 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 29. Gombas, A, Szabo-Revesz, P, Kata, M G Regdon Jr Eros, I 2002 Quantitative determination of crystallinity of α-lactose monohydrate by DSC. J Therm Anal Calorim. 68:503510 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 30. Balestrieri, F, Magri, AD, Magri, AL, Marini, D, Sacchini, A 1996 Application of differential scanning calorimetry to the study of drug–excipient compatibility. Thermochim Acta. 285:337345 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 31. Desai, SR, Shaikh, MM, Dharwadkar, SR 2003 Preformulation compatibility studies of etamsylate and fluconazole drugs with lactose by DSC. J Therm Anal Calorim. 71:651658 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 32. Cides, LCS, Araújo, AAS, Santos-Filho, M, Matos, JR 2006 Thermal behaviour, compatibility study and decomposition kinetics of glimepiride under isothermal and non-isothermal conditions. J Therm Anal Calorim. 84:441445 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 33. Oliveira, GGG, Ferraz, HG, Matos, JSR 2005 Thermoanalytical study of glibenclamide and excipients. J Therm Anal Calorim. 79:267270 .

  • 34. Marini, A, Berbenni, V, Pegoretti, M, Bruni, G, Cofrancesco, P, Sinistri, C, Villa, M 2003 Drug–excipient compatibility studies by physico-chemical techniques. The case of atenolol. J Therm Anal Calorim. 73:547561 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 35. Bruni, G, Amici, L, Berbenni, V, Marini, A, Orlandi, A 2002 Drug–excipient compatibility studies. J Therm Anal Calorim. 68:561573 .

  • 36. Nunes, RS, Semaan, FS, Riga, AT, Cavalheiro, ÉTG 2009 Thermal behavior of verapamil hydrochloride and its association with excipients. J Therm Anal Calorim. 97:349353 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 37. Stulzer, HK, Tagliari, MP, Cruz, AP, Silva, MAS, Laranjeira, MCM 2008 Compatibility studies between piroxicam and pharmaceutical excipients used in solid dosage forms. Pharm Chem J. 42:215219 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 38. Stulzer, HK, Rodrigues, PO, Cardoso, TM, Matos, JSR, Silva, MAS 2008 Compatibility studies between captopril and pharmaceutical excipients used in tablets formulations. J Therm Anal Calorim. 91:323328 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 39. Neto, HS, Novák, Cs, Matos, JR 2009 Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form. J Therm Anal Calorim. 97:367374 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 40. Freire, FD, Aragao, CFS, e Moura, TFA, Raffin, FN 2009 Compatibility study between chlorpropamide and excipients in their physical mixtures. J Therm Anal Calorim. 97:355357 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 41. Abbas, D, Kaloustian, J, Orneto, C, Piccerelle, P, Portugal, H, Nicolay, A 2008 DSC and physico-chemical properties of a substituted pyridoquinoline and its interaction study with excipients. J Therm Anal Calorim. 93:353360 .

    • Crossref
    • Search Google Scholar
    • Export Citation

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  • 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)

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