Abstract
Thermal analysis is an essential, analytic tool used in preliminary studies and preparation of new pharmaceutical formulations. This study was performed to investigate the possible interactions between trandolapril and three commonly used natural excipients, namely α-lactose monohydrate, microcrystalline cellulose, and pregelatinized starch. The compatibility studies were carried out using thermoanalytic along with other complementary techniques. Differential scanning calorimetry and thermogravimetric analysis have proved that trandolapril is fully compatible with all the studied excipients until 100 °C. The complementary techniques used in this study were X-ray powder diffraction, Fourier transform-infrared spectroscopy, and scanning electron microscopy which confirmed the findings of thermal analysis.
Similar content being viewed by others
References
Guay DRP. Trandolapril: a newer angiotensin-converting enzyme inhibitor. Clin Ther. 2003;25:713–75.
Jaweed M., Merwade A., Ansari S., Saiyad A. Novel crystalline polymorph of trandolapril and a process for preparation thereof. Patent. WO/2007/026372. 2007.
Makai Z, Bajdik J, Eros I, Pintyehodi K. Evaluation of the effects of lactose on the surface properties of alginate coated trandolapril particles prepared by a spray-drying method. Carbohydr Polym. 2008;74:712–6.
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.
Jackson K. Drug–excipient interactions and their affect on absorption. Pharm Sci Technol Today. 2000;3:336–45.
Moura EA, Correia LP, Pinto MF, Procópio JVV, Souza 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. 2009;100:289–93.
Picciochi R, Diogo HP, Minas da Piedade ME. Thermochemistry of paracetamol. J Therm Anal Calorim. 2010;100:391–401.
Huang L-F, Tong W-Q. Impact of solid state properties on developability assessment of drug candidates. Adv Drug Delivery Rev. 2004;56:321–34.
Bruni G, Amici L, Berbenni V, Marini A, Orlandi A. Drug-excipient compatibility studies. Search of interaction indicators. J Therm Anal. 2002;68:561–73.
Schmitt E. Rapid, practical and predictive excipient compatibility screening using isothermal microcalorimetry. Thermochim Acta. 2001;380:175–84.
Van Dooren AA. Design for drug-excipient interaction studies. Drug Dev Ind Pharm. 1983;9:43–55.
Waltersson JO. Factorial designs in pharmaceutical preformulation studies. I. Evaluation of the application of factorial designs to a stability study of drugs in suspension form. Acta Pharm Suec. 1986;23:129–38.
Dürig T, Fassihi AR. Identification of stabilizing and destabilizing effects of excipient-drug interactions in solid dosage form design. Int J Pharm. 2003;97:161–70.
Jacobson H, Reier G. Application of differential thermal analysis to compatibility and stability problems in penicillin-stearic acid mixtures. J Pharm Sci. 1969;58:631–3.
Cunha-Filho MSS, Martínez-Pacheco R, Landín M. Compatibility of the antitumoral beta-lapachone with different solid dosage forms excipients. J Pharm Biomed Anal. 2007;45:590–8.
Mura P, Faucci MT, Manderioli A, Bramanti G, Ceccarelli L. Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy. J Pharm Biomed Anal. 1998;18:151–63.
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.
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. 2010;105:517–27.
Kiss D, Zelkó R, Novák C, Éhen Z. Application of DSC and NIRS to study the compatibility of metronidazole with different pharmaceutical excipients. J Therm Anal Calorim. 2006;84:447–51.
Bernardi L, Oliveira P, Murakami F, Silva M, Borgmann S, Cardoso S. Characterization of venlafaxine hydrochloride and compatibility studies with pharmaceutical excipients. J Therm Anal Calorim. 2009;97:729–33.
Botha SA, Lötter AP. Compatibility study between naproxen and tablet excipients using differential scanning calorimetry. Drug Dev Ind Pharm. 1990;16:673–83.
Byrn S, Pfeiffer R, Ganey M, Hoiberg C, Poochikian G. Pharmaceutical solids: a strategic approach to regulatory considerations. Pharm Res. 1995;12:945–54.
Bettinetti G, Mura P. Dissolution properties of naproxen in combinations with polyvinylpyrrolidone. Drug Dev Ind Pharm. 1994;20:1353–66.
Bettinetti GP, Mura P, Liguori A, Bramanti G, Giordano F. Solubilization and interaction of naproxen with polyvinylpyrrolidone in aqueous solution and in the solid state. Farmaco Ed Prat. 1988;43:331–43.
Karavas E., Koutris E., Kotzagiorgis E., Bikiaris D., Improved pharmaceutical composition containing ace inhibitor and method for the preparation thereof, Patent. WO/2000/044353A. 2008.
Corvi Mora P, Cirri M, Mura P. Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations. J Pharm Biomed Anal. 2006;42:3–10.
Roumeli E, Tsiapranta A, Kachrimanis K, Bikiaris D, Chrissafis K. Physicochemical characterization and decomposition kinetics of trandolapril. Thermochimica Acta. 2012;. doi:10.1016/j.tca.2012.04.009.
Giron D. Applications of thermal analysis in the pharmaceutical industry. J Pharm Biomed Anal. 1986;4:755–70.
Gombás A, Antal I, Szabó-Révész P, Marton S, Erõs I. Quantitative determination of crystallinity of alpha-lactose monohydrate by near infrared spectroscopy (NIRS). Int J Pharm. 2003;256:25–32.
Verma RK, Garg S. Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations. J Pharm Biomed Anal. 2004;35:449–58.
Peres-Filho MJ, Gaeti MPN, Oliveira SR, Marreto RN, Lima EM. Thermoanalytical investigation of olanzapine compatibility with excipients used in solid oral dosage forms. J Therm Anal Calorim. 2010;104:255–60.
Smith BC. Infrared spectral interpretation: a systematic approach. 1st ed. Boca Raton: CRC Press; 1998.
Bruni G, Berbenni V, Milanese C, Girella A, Marini A. Drug-excipient compatibility studies in binary and ternary mixtures by physico-chemical techniques. J Therm Anal Calorim. 2009;102:193–201.
Author information
Authors and Affiliations
Corresponding author
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Roumeli, E., Tsiapranta, A., Pavlidou, E. et al. Compatibility study between trandolapril and natural excipients used in solid dosage forms. J Therm Anal Calorim 111, 2109–2115 (2013). https://doi.org/10.1007/s10973-012-2476-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10973-012-2476-2