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Compatibility study of the acetylsalicylic acid with different solid dosage forms excipients

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Abstract

This study is part of a research project aimed to find and optimize methods by which drug-excipient compatibility can be reliably and quickly assessed. The objective of the present study was to evaluate the compatibility of the acetylsalicylic acid (ASA), an non-steroidal anti-inflammatory drug, with pharmaceutical excipients of common use including diluents, binders, disintegrants, lubricants and solubilising agents. In order to investigate the possible interactions between ASA and eleven excipients differential scanning calorimetry (DSC) and thermogravimetry/derivative thermogravimetry analysis completed by Fourier transform infrared spectroscopy (FT-IR) and X-ray powder diffraction were used for compatibility study. The DSC has proven to be, among the selected analytical techniques, the most sensitive and specific in assessing the compatibility. The samples, as physical mixtures, were prepared by mixing the analyte and excipients in a proportion of 1:1 (w:w). On the basis of thermal results (especially DSC), confirmed by FT-IR and X-ray analysis, a possible chemical interaction was found between the ASA with polyvinylpyrrolidone K30 (PVP) and magnesium stearate, respectively a possible physical interaction with colloidal silicon dioxide and stearic acid (Ac. St.).

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References

  1. Teslyuk O, Bel’tyukova S, Yegorova A, Yagodkin B. Complex compounds of terbium(III) with some nonsteroidal anti-inflammatory drugs and their analytical applications. J Anal Chem. 2007;62:330–5.

    Article  CAS  Google Scholar 

  2. Kovala-Demertzi D. Recent advances on non-steroidal anti-inflammatory drugs, NSAIDs: organotin complexes of NSAIDs. J Organomet Chem. 2006;691:1767–74.

    Article  CAS  Google Scholar 

  3. Chang-Ying Y, Yi L, Jun-Cheng Z, Dan Z. Inhibitory effect of copper complex of indomethacin on bacteria studied by microcalorimetry. Biol Trace Elem Res. 2008;122:82–8.

    Article  Google Scholar 

  4. Chatterjee NR, Kulkarni AA, Ghulekar SP. Synthesis, pharmacological activity and hydrolytic behavior of ethylenediamine and benzathine conjugates of ibuprofen. Eur J Med Chem. 2008;43:2819–23.

    Article  CAS  Google Scholar 

  5. Kobelnik M, Ribeiro CA, dos Santos DiasD, Almeida S, Crespi MS, Capela JMV. Study of the thermal behavior of the transition phase of Co(II)–diclofenac compound by non-isothermal method. J Therm Anal Calorim. 2011;105:467–71.

    Article  CAS  Google Scholar 

  6. Galico DA, Holanda BB, Perpetuo GL, Schnitzler E, Treu-Filho O, Bannach G. Thermal and spectroscopic studies on solid Ketoprofen of lighter trivalent lanthanides. J Therm Anal Calorim. 2012;108:371–9.

    Article  CAS  Google Scholar 

  7. Patel MN, Pansuriya PB, Parmar PA, Gandhi DS. Synthesis, characterization, and thermal and biocidal aspects of drug-based metal complexes. Pharm Chem J. 2012;42:687–92.

    Article  Google Scholar 

  8. Dutta S, Padhye S, Mckee V. Structural characterization and SOD activity of copper–oxaprozinate. Inorg Chem Commun. 2004;7:1071–4.

    Article  CAS  Google Scholar 

  9. Tuorkey FAJM, Abdul-Aziz KK. A pioneer study on the anti-ulcer activities of copper nicotinate complex [CuCl(HNA)2] in experimental gastric ulcer induced by aspirin-pyloris ligation model (Shay model. Biomed Pharmacother. 2009;63:194–201.

    Article  CAS  Google Scholar 

  10. Rubner G, Bensdorf K, Wellner A, Bergemann S, Ott I, Gust R. [Cyclopentadienyl]metalcarbonyl complexes of acetylsalicylic acid as neo-anticancer agents. Eur J Med Chem. 2010;45:5157–63.

    Article  CAS  Google Scholar 

  11. Oliveira PR, Bernardi LS, Murakami FS, Mendes C, Silva MAS. Thermal characterization and compatibility studies of norfloxacin for development of extended release tablets. J Therm Anal Calorim. 2009;97:741–5.

    Article  CAS  Google Scholar 

  12. Lira AM, Araújo AAS, Basílio IDJ, Santos BLL, Santana DP, Macedo RO. Compatibility studies of lapachol with pharmaceutical excipients for the development of topical formulations. Thermochim Acta. 2007;457:1–6.

    Article  CAS  Google Scholar 

  13. Singh AV, Nath LK. Synthesis, characterization, and compatibility study of acetylated starch with lamivudine. J Therm Anal Calorim. 2012;108:307–13.

    Article  CAS  Google Scholar 

  14. Singh AV, Nath LK. Evaluation of compatibility of tablet excipients and novel synthesized polymer with lamivudine. J Therm Anal Calorim. 2012;108:263–7.

    Article  CAS  Google Scholar 

  15. Bruni G, Sartor F, Berbenni V, Milanese C, Maietta M, Franchi D, Marini A. Compatibility of paroxetine hydrochloride and GW597599B. A physico-chemical approach. J Therm Anal Calorim. 2012;108:381–8.

    Article  CAS  Google Scholar 

  16. Tomassetti M, Catalani A, Rossi V, Vecchio S. Thermal analysis study of the interactions between acetaminophen and excipients in solid dosage forms and in some binary mixtures. J Pharm Biomed Anal. 2005;37:949–55.

    Article  CAS  Google Scholar 

  17. Barboza F, Vecchia DD, Tagliari MP, Silva MAS, Stulzer HK. Differential scanning calorimetry as a screening technique in compatibility studies of acyclovir extended release formulations. Pharm Chem J. 2009;43:363–8.

    Article  CAS  Google Scholar 

  18. Pani NR, Nath LK, Acharya S, Bhuniya B. Application of DSC, IST, and FTIR study in the compatibility testing of nateglinide with different pharmaceutical excipients. J Therm Anal Calorim. 2012;108:219–26.

    Article  CAS  Google Scholar 

  19. Lavor EP, Duarte Freire F, Aragão CFS, Raffin FN, de Lima e Moura TFA. Application of thermal analysis to the study of anti-tuberculosis drug compatibility. Part 1. J Therm Anal Calorim. 2012;108:207–12.

    Article  CAS  Google Scholar 

  20. Tiţa D, Fuliaş A, Tiţa B. Thermal stability of ketoprofen—active substance and tablets. Part 1. Kinetic study of the active substance under non-isothermal conditions. J Therm Anal Calorim. 2011;105:501–8.

    Article  Google Scholar 

  21. Tiţa D, Fuliaş A, Tiţa B. Thermal stability of ketoprofen—active substance and tablets. Part 2. Kinetic study of the active substance under isothermal conditions. J Therm Anal Calorim. doi:10.1007/s10973-011-2147-8.

  22. Tiţa B, Fuliaş A, Bandur G, Marian E, Tiţa D. Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms. J Pharm Biomed Anal. 2011;56:221–7.

    Article  Google Scholar 

  23. Tiţa B, Fuliaş A, Szabadai Z, Rusu G, Bandur G, Tiţa D. Compatibility study between ibuprofen and excipients in their physical mixtures. J Therm Anal Calorim. 2011;105:517–27.

    Article  Google Scholar 

  24. Tiţa B, Fuliaş A, Bandur G, Rusu G, Tiţa D. Thermal stability of ibuprofen. Kinetic study under non-isothermal conditions. Rev Roum Chim. 2010;55:553–8.

    Google Scholar 

  25. Tiţa B, Fuliaş A, Ştefănescu M, Marian E, Tiţa D. Kinetic study of decomposition of ibuprofen under isothermal conditions. Rev Chim (Bucureşti). 2011;62:216–21.

    Google Scholar 

  26. Moyano MA, Broussalis AM, Segall AI. Thermal analysis of lipoic acid and evaluation of the compatibility with excipients. J Therm Anal Calorim. 2010;99:631–7.

    Article  CAS  Google Scholar 

  27. Tiţa B, Ştefănescu M, Tiţa D. Complex of anti-inflammatory non-steroidal drugs from carboxylic acids family. 1. Synthesis and characterization of Zn(II) complex with Ibuprofen. Rev Chim (Bucureşti). 2011;62:1060–4.

    Google Scholar 

  28. Tiţa B, Ştefănescu M, Tiţa D. Complex of anti-inflammatory non-steroidal drugs from oxicam family. 1. Synthesis and characterization of Zn(II) complex with Piroxicam. Rev Chim (Bucureşti). 2011;62:1002–7.

    Google Scholar 

  29. Bannach G, Cervini P, Gomes Cavalheiro T, Ionashiro M. Using thermal and spectroscopic data to investigate the thermal behavior of epinephrine. Thermochim Acta. 2010;499:123–7.

    Article  CAS  Google Scholar 

  30. El-Gamel AEN, Hawash FM, Fahmey AM. Structure characterization and spectroscopic investigation of ciprofloxacin drug. J Therm Anal Calorim. 2012;108:253–62.

    Article  CAS  Google Scholar 

  31. Tiţa B, Fuliaş A, Marian E, Tiţa D. Thermal behaviour of acetylsalicylic acid—active substance and tablets. Kinetic study under non-isothermal conditions. Rev Chim (Bucureşti). 2009;60:419–23.

    Google Scholar 

  32. Bertol CD, Cruz AP, Stulzer HK, Murakami FS, Silva MAS. Thermal decomposition kinetics and compatibility studies of primaquine under isothermal and non-isothermal conditions. J Therm Anal Calorim. 2010;102:187–92.

    Article  CAS  Google Scholar 

  33. Gombas A, Szabo-Revesz P, Kata M, Regdon G Jr, Eros I. Quantitative determination of crystallinity of α-lactose monohydrate by DSC. J Therm Anal Calorim. 2002;68:503–10.

    Article  CAS  Google Scholar 

  34. Desai SR, Shaikh MM, Dharwadkar SR. Preformulation compatibility studies of etamsylate and fluconazole drugs with lactose by DSC. J Therm Anal Calorim. 2003;71:651–8.

    Article  CAS  Google Scholar 

  35. Cides LCS, Araujo AAS, Santos-Filho M, Matos JR. Thermal behaviour, compatibility study and decomposition kinetics of glimepiride under isothermal and non-isothermal conditions. J Therm Anal Calorim. 2006;84:441–5.

    Article  CAS  Google Scholar 

  36. Marini A, Berbenni V, Pegoretti M, Bruni G, Cofrancesco P, Sinistri C, Villa M. Drug-excipient compatibility studies by physico-chemical techniques. The case of atenolol. J Therm Anal Calorim. 2003;73:547–61.

    Article  CAS  Google Scholar 

  37. Nunes RS, Semaan FS, Riga AT, Cavalheiro ETG. Thermal behaviour of verapamil hydrochloride and its association with excipients. J Therm Anal Calorim. 2009;97:349–53.

    Article  CAS  Google Scholar 

  38. Aigner Z, Heinrich R, Sipos E, Farkas G, Ciurba A, Berkesi O. Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods. J Therm Anal Calorim. 2011;104:265–71.

    Article  CAS  Google Scholar 

  39. Mura P, Furlanetto S, Cirri M, Marras MA, Pinzauti S. Optimization of glibenclamide tablet composition through the combined use of differential scanning calorimetry and D-optimal mixture experimental design. J Pharm Biomed Anal. 2005;37:65–71.

    Article  CAS  Google Scholar 

  40. Agatonovic-Kustrin S, Markovic N, Ginic-Marcovic M, Mangan M, Glass DB. Compatibility studies between mannitol and omeprazole sodium isomers. J Pharm Biomed Anal. 2008;48:356–60.

    Article  CAS  Google Scholar 

  41. Verma KR, Garg S. Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility testing. J Pharm Biomed Anal. 2005;38:633–44.

    Article  CAS  Google Scholar 

  42. Stulzer HK, Rodrigues PO, Cardoso TM, Matos JSR, Silva MAS. Compatibility studies between captopril and pharmaceutical excipients used in tablets formulations. J Therm Anal Calorim. 2008;91:323–8.

    Article  CAS  Google Scholar 

  43. Neto HS, Cs Novák, Matos JR. Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form. J Therm Anal Calorim. 2009;97:367–74.

    Article  Google Scholar 

  44. Freire FD, Aragao CFS, de Lima e Moura TFA, Raffin FN. Compatibility study between chlorpropamide and excipients in their physical mixtures. J Therm Anal Calorim. 2009;97:355–7.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Faculty of Pharmacy, University of Medicine and Pharmacy „Victor Babeş“, Eftimie Murgu Square 2, 300041, Timisoara, Romania

    Dumitru Tita, Adriana Fulias & Bogdan Tita

  2. Speciality of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, Nicolae Jiga Street, No. 29, Oradea, Romania

    Tunde Jurca & Eleonora Marian

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  1. Dumitru Tita
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  2. Tunde Jurca
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  3. Adriana Fulias
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  5. Bogdan Tita
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Correspondence to Bogdan Tita.

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Tita, D., Jurca, T., Fulias, A. et al. Compatibility study of the acetylsalicylic acid with different solid dosage forms excipients. J Therm Anal Calorim 112, 407–419 (2013). https://doi.org/10.1007/s10973-013-2937-2

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