Research Article
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Year 2019, Volume: 3 Issue: 2, 102 - 107, 30.09.2019
https://doi.org/10.30516/bilgesci.582054

Abstract

References

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Study of Stability and Drug-Excipient Compatibility of Estriol

Year 2019, Volume: 3 Issue: 2, 102 - 107, 30.09.2019
https://doi.org/10.30516/bilgesci.582054

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


References

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
There are 20 citations in total.

Details

Primary Language English
Journal Section Research Articles
Authors

Hale Seçilmiş Canbay This is me 0000-0002-3783-8064

Mümin Polat 0000-0001-8082-0735

Mahmut Doğantürk This is me 0000-0003-1133-6792

Publication Date September 30, 2019
Acceptance Date September 12, 2019
Published in Issue Year 2019 Volume: 3 Issue: 2

Cite

APA Seçilmiş Canbay, H., Polat, M., & Doğantürk, M. (2019). Study of Stability and Drug-Excipient Compatibility of Estriol. Bilge International Journal of Science and Technology Research, 3(2), 102-107. https://doi.org/10.30516/bilgesci.582054