Study of Stability and Drug-Excipient Compatibility of Estriol

Abstract

Abstract: Estriol, is a major urinary estrogen hormone.  Differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR) were used to assess the compatibility between estriol and drug excipients (1:1; w/w). In this study, thermodynamic and spectroscopic data obtained from pure estriol and mixtures of pure estriol with pharmaceutical excipients were compared. Preliminary studies using thermal and spectroscopic technique implied the compatibility of mannitol, calcium phosphate dibasic, sucrose, butylated hydroxyanisole, cellulose, lactose, magnesium stearate, talc and sodium carboxymethyl cellulose with the drug estriol. As a result of the experimental study, there is incompatibility of estriol-mannitol, estriol-sucrose, estriol-lactose and estriol-magnesium stearate. Keywords Estriol, Stability Compatibility,  DSC,  FTIR

Keywords

• DSC,, Compatibility,Stability,, FTIR

References

1. Bozdağ-Pehlivan, S., Subaşı, B., Vural, I., Ünlü, N., Capan, Y. 2011. Evaluation of drug-excipient interaction in the formulation of celecoxib tablets. Acta Poloniae Pharmaceutica - Drug Research, 68(3), 423-33. Retrieved from http://www.ptfarm.pl/pub/File/Acta_Poloniae/2011/3/423.pdf.
2. Brown, M.E., Antunes, E.M., Glass, B.D., Lebete, M., Walker, R.B. 1999. DSC Screening of potential prochlorperazine-excipient interactions in preformulation studies. Journal of Thermal Analysis and Calorimetry, 56, 1317–1322. Bruni, G., Amici, L., Berbenni, V., Marini, A., Orlandi, A. 2002. Drug-Excipient Compatibility Studies. Search of interaction indicators. Journal of Thermal Analysis and Calorimetry, 68, 561–573.
3. Cunha-Filho M.S.S., Martínez-Pacheco, R., Landín, M. 2007. Compatibility of the antitumoral b-lapachone with different solid dosage from excipients. Journal of Pharmaceutical and Biomedical Analysis, 45, 590–598. https://doi.org/10.1016/j.jpba.2007.08.016.
4. Falah, N., Torday, J., Quinney, S.K., Haas, D.M. 2015. Estriol review: Clinical applications and potential biomedical importance. Clinical Research and Trials, 1(2), 29-33. https://doi.org/ 10.15761/CRT.1000109.
5. Fioravanti, V., Brandhoff, L., van den Driesche, S., Breiteneder, H., Kitzwögerer, M., Hafner, C., Vellekoop, M.J. 2016. An Infrared absorbance sensor for the detection of melanoma in skin biopsies. Sensors 16 (1659), 1-12. https://doi.org/10.3390/s16101659.Giordano, F., Bettinelli, G.P. 1988. An experimental and theoretical approach to the analysis of pharmaceutical binary systems. Journal of Pharmaceutical and Biomedical Analysis, 6, 951–955. https://doi.org/10.1016/0731-7085(88)80115-8.
6. Joshi, B.V., Patil, V.B., Pokharkar, VB. 2002. Compatibility studies between carbamazepine and tablet excipients using thermal and nonthermal methods. Drug Development and Industrial Pharmacy, 28, 687–694. https://doi.org/10.1081/DDC-120003860.
7. Minaeva, V.A., Minaev, B.F., Hovorun, D.M. 2008. Vibrational spectra of the steroid hormones, estradiol and estriol, calculated by density functional theory. The role of low-frequency vibrations. Ukrains’kyi Biokhimichnyi Zhurnal, 80(4), 82-95.
8. Monajjemzadeh, F., Hassanzadeh, D., Valizadeh, H., Siahi-Shadbad, M.R., Mojarrad, J.S., Robertson, T.A., Roberts, MS. 2009. Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets. The European Journal of Pharmaceutics and Biopharmaceutic, 73, 404–413. https://doi.org/10.1016/j.ejpb.2009.06.012 .

9. Mura, P., Manderioli, A., Bramanti, G., Furlanetto, S., Pinzauti, S. 1995. Utilization of differential scanning calorimetry as a screening technique to determine the compatibility of ketoprofen with excipients. International Journal of Pharmaceutics, 119, 71–79. https://doi.org/10.1016/0378-5173(94)00374-E.
10. Oliveira, P.R., Stulzer, H.K., Bernardi, L.S., Borgmann, S.H.M, Cardoso, S.G., Silva, M.A.S. 2010. Sibutramine hydrochloride monohydrate thermal behavior, decomposition kinetics and compatibility studies. Journal of Thermal Analysis and Calorimetry, 100, 277–282. https://doi.org/10.1007/s10973-009-0200-7.
11. Pani, N.R., Nath, L.K., Acharya, S. 2011. Compatibility studies of nateglinide with excipients in immediate release tablets. Acta Pharmaceutica, 61, 237–247. https://doi.org/10.2478/v10007-011-0016-4 .
12. Pyramides, G., Robinson, J.W., Zito, S.W. The combined use of DSC and TGA for the thermal analysis of atenolol tablets. 1995. Journal of Pharmaceutical and Biomedical Analysis, 13, 103–110. https://doi.org/10.1016/0731-7085(94)00112-F.
13. Soares, M.F.R., Soares-Sobrinho, J.L., Silva, K.E.R, Alves, L.D.S, Lopes, P.Q., Correia, L.P., Souza, F.S., Macedo, R.O., Rolim-Neto, P.J. 2011. Thermal characterization of antimicrobial drug ornidazole and its compatibility in a solid pharmaceutical product. Journal of Thermal Analysis and Calorimetry, 104, 307–313. https://doi.org/10.1007/s10973-010-1185-y.
14. Soares-Sobrinho, J.L., Soares, M.F.R., Lopes, P.Q., Correia, L.P., Souza, F.S., Macedo, R.O., Rolim-Neto, P.J.A. 2010. Preformulation study of a new medicine for chagas treatment: physico-chemical characterization, thermal stability and compatibility of benznidazole. The American Association of Pharmaceutical Scientists, 11(3), 1391–1396. https://doi.org/10.1208/s12249-010-9495-8.
15. Swathi, R., Sunitha Reddy, M. 2017. UV-Visible spectrometric method and validation, compatibility studies of nevirapine cubosome formulation. World Journal of Pharmacy and Pharmaceutical Sciences, 6(01), 111-1121.
16. Tita, B., Fulias, A., Bandur, G., Marian, E., Tita, D. 2011. Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms. Journal of Pharmaceutical and Biomedical Analysis, 56, 221–227. https://doi.org/10.1016/j.jpba.2011.05.017.
17. Verma, R.K., Garg, S. 2005. Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility testing. Journal of Pharmaceutical and Biomedical Analysis, 38, 633–644. https://doi.org/10.1016/j.jpba.2005.02.026.
18. Viana, O.S., Arauijo, A.A.S., Simoes, R.A., Matos, C.R.S, GrangeiroJúnior, S., Lima, C.M., Rolim-Neto P.J. 2008. Kinetic analysis of the thermal decomposition of efavirenz and compatibility studies with selected excipients. Latin American Journal of Pharmacy, 27(2), 211–216.
19. Wakasawa, T., Sano, K., Hirakura, Y., Toyooka, T., Kitamura, S. 2008. Solid-state compatibility studies using a high-throughput and automated forced degradation system. International Journal of Pharmaceutics, 355, 164–173. https://doi.org/10.1016/j.ijpharm.2007.12.002.
20. Wesolowski, M. 1992. Analysis of drug formulations by thermal decomposition. Thermochimica Acta 209, 223–251. https://doi.org/10.1016/0040-6031(92)80201-7.