Abstract
The compatibility of aceclofenac with various tableting excipients was investigated by means of differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR). The excipients applied in the direct pressing retard tablets were Carbopol 940, hydroxypropyl-methyl-cellulose, microcrystalline cellulose, Aerosil 200 and magnesium stearate. The ingredients alone and their 1:1 (w/w) binary mixtures were investigated before and after accelerated storage. An interaction was observed only between aceclofenac and magnesium stearate. The DSC and FT-IR examinations indicated formation of the magnesium salt of aceclofenac. For the other mixtures, there was no incompatibility between the components.
Similar content being viewed by others
References
Thumma S, Repka MA. Compatibility studies of promethazine hydrochloride with tablet excipients by means of thermal and non-thermal methods. Pharmazie. 2009;64:183–9.
Crowley P, Martini L. Drug-excipient interactions. Pharm Technol Eur. 2001;13:26–34.
McDaid FM, Barker SA, Fitzpatrick S, Petts CR, Craig DQM. Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug–excipient interactions. Int J Pharm. 2003;252:235–40.
Kiss D, Zelkó R, Novák Cs, Éhen Zs. Application of DSC and NIRs to study the compatibility of metronidazole with different pharmaceutical excipients. J Therm Anal Calorim. 2006;84:447–51.
Mura P, Manderioli A, Bramanti G, Furlanetto S, Pinzauti S. Utilization of differential scanning calorimetry as a screening technique to determine the compatibility of ketoprofen with excipients. Int J Pharm. 1995;119:71–9.
Rezende RLO, Santoro MIRM, Matos JR. Stability and compatibility study on enalapril maleate using thermoanalytical techniques. J Therm Anal Calorim. 2008;93:881–6.
Araújo AAS, Storpirtis S, Mercuri LP, Carvalho FMS, Filho MS, Matos JR. Thermal analysis of the antiretroviral zidovudine (AZT) and evaluation of the compatibility with excipients used in solid dosage forms. Int J Pharm. 2003;260:303–14.
Zaccaron CM, Oliveira RVB, Guiotoku M, Pires ATN, Soldi V. Blends of hydroxypropyl methylcellulose and poly(1-vinylpyrrolidone-co-vinyl acetate): miscibility and thermal satibility. Polym Degrad Stab. 2005;90:21–7.
Schmitt EA, Peck K, Sun Y, Geoffroy J-M. Rapid, practical and predictive excipient compatibility screening using isothermal microcalorimetry. Thermochim Acta. 2001;380:175–83.
Verma RK, Garg S. Selection of excipients for extended release formulations of glipizide through drug–excipient compatibility testing. J Pharm Biomed Anal. 2005;38:633–44.
Hasan NY, Abdel-Elkawy M, Elzeany BE, Wagieh NE. Stability indicating methods for the determination of aceclofenac. Il Farmaco. 2003;48:91–9.
Chopra D, Sinha VR, Singh M. Thermal and isothermal methods in development of sustained release dosage forms of ketorolac tromethamine. J Chem. 2008;5:316–22.
Mutalik S, Naha A, Usha AN, Ranjith AK, Musmade P, Manoj K, Anju P, Prasanna S. Preparation, in vitro, preclinical and clinical evaluations of once daily sustained release tablets of aceclofenac. Arch Pharm Res. 2007;30:222–34.
Parfitt K. Analgesics, anti-inflammatory and antipyretics. In: Reynolds JEF, editor. Martindale the complete drug reference. 32nd ed. London: Pharmaceutical Press; 1999. p. 2–12.
Burrull M, Madridejos R, Gregori A, Busquets E. Non-steroid anti-inflammatory agents and gastrointestinal protection: adequate prescription in primary care? Aten Primaria. 1996;18:507–10.
Mutalik S, Anju P, Manoj K, Usha AN. Enhancement of dissolution rate and bioavailability of aceclofenac: a chitosan-based solvent change approach. Int J Pharm. 2008;351:279–90.
Tran TT-D, Tran PH-L, Lee B-J. Dissolution–modulating mechanism of alkalizers and polymers in a nanoemulsifying solid dispersion containing ionizable and poorly water-soluble drug. Eur J Pharm Biopharm. 2009;72:83–90.
Patel AR, Joshi VY. Evaluation of SLS: APG mixed surfactant systems as carrier for solid dispersion. AAPS Pharmscitech. 2008;9:583–90.
Vadher AH, Parikh JR, Parikh RH, Solanki AB. Preparation and characterization of co-grinded mixtures of aceclofenac and Neusilin US2 for dissolution enhancement of aceclofenac. AAPS Pharmscitech. 2009;10:606–14.
Ceschel GC, Badiello R, Ronchi C, Maffei P. Degradation of components in drug formulations: a comparison between HPLC and DSC methods. J Pharm Biomed Anal. 2003;32:1067–72.
Acknowledgements
This work was supported by a TÁMOP research project: development of teranostics in cardiovascular, metabolics and inflammatory diseases (TÁMOP-4.2.2-08/1-2008-0013).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Aigner, Z., Heinrich, R., Sipos, E. et al. Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods. J Therm Anal Calorim 104, 265–271 (2011). https://doi.org/10.1007/s10973-010-1105-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10973-010-1105-1