Full-text resources of PSJD and other databases are now available in the new Library of Science.
Visit https://bibliotekanauki.pl

PL EN


Preferences help
enabled [disable] Abstract
Number of results

Journal

2014 | 12 | 5 | 549-556

Article title

Development and validation of an intrinsic dissolution method for nimodipine polymorphs

Content

Title variants

Languages of publication

EN

Abstracts

EN
The polymorphs of nimodipine, Modification I (Mod I), the metastable racemate, and Modification II (Mod II), the stable conglomerate, were evaluated by means of the intrinsic dissolution procedure. For this purpose, a hydro alcoholic solution (ethanol:water, 50:50, v/v) was selected as the dissolution medium, maintained at 37±0.5°C. Different rotation speeds were tested (50, 75 and 100 rpm) and the lower one was chosen for the test validation. Although the sample initially characterized as polymorph Mod I presented higher intrinsic dissolution rates in all the conditions tested, no statistical differences were noticed between the two polymorphs. This result can be attributed to the partial solution-mediated phase transformation from Mod I to Mod II, detected through X-ray powder diffraction and differential scanning calorimetry. Also, reliable intrinsic dissolution rate data were acquired for the polymorph Mod II. The dissolution method was validated, being considered stable, specific, linear, sensible, accurate and precise.

Publisher

Journal

Year

Volume

12

Issue

5

Pages

549-556

Physical description

Dates

published
1 - 5 - 2014
online
21 - 2 - 2014

Contributors

  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of São Paulo
  • Federal University of Santa Catarina

References

  • [1] S. Agrawal, Y. Ashokraj, P.V. Bharatam, O. Pillai, R. Panchagnula, Eur. J. Pharm. Sci. 22, 127 (2004) http://dx.doi.org/10.1016/j.ejps.2004.02.011[Crossref]
  • [2] J.P. Carini, C. Pavei, A.P.C. Silva, G. Machado, A.S. Mexias, V.P. Pereira, S.L. Fialho, P. Mayorga, Int. J. Pharm. 372, 17 (2009) http://dx.doi.org/10.1016/j.ijpharm.2008.12.034[Crossref]
  • [3] N. Chieng, T. Rades, J. Aaltonen, J. Pharm. Biomed. Anal. 55, 618 (2011) http://dx.doi.org/10.1016/j.jpba.2010.12.020[Crossref]
  • [4] M. Sorrenti, G. Catenacci, B. Bruni, B. Luppi, F. Bigucci, G. Bettinetti, J. Pharm. Biomed. Anal. 63, 53 (2012) http://dx.doi.org/10.1016/j.jpba.2011.12.023[Crossref]
  • [5] L. Shargel, A.B.C. Yu, In: J. Swarbrick (Ed.), Encyclopedia of Pharmaceutical Technology, 3rd edition (Informa Healthcare USA, Inc., New York, 2007) 208
  • [6] P.B. Martínez, M.G. Navarro, In: J.L. Vila Jato (Ed.), Tecnologia farmacéutica: Aspectos fundamentales de los sistemas farmacéuticos y operaciones básicas (Síntesis, Madrid, 2001) 6 (in Spanish)
  • [7] C.K. Brown, H.P. Chokshi, B. Nickerson, R.A. Reed, R.B. Rohrs, A.P. Shars, Pharm. Technol. 28, 56 (2004)
  • [8] The United States Pharmacopoeia Monographs, 34th edition, National Formulary 29 (2011)
  • [9] G.E. Amidon, W.I. Higuchi, N.F. Ho, J. Pharm. Sci. 71, 77 (1982) http://dx.doi.org/10.1002/jps.2600710120[Crossref]
  • [10] L.X. Yu, G.L. Amidon, In: G.L. Amidon, P.I. Lee, E.M. Topp (Ed.), Transport Processes in Pharmaceutical Systems (Marcel Dekker, Inc., New York, 1999) 23
  • [11] L.X. Yu, A.S. Carlin, G.L. Amidon, A.S Hussain, Int. J. Pharm. 270, 221 (2004) http://dx.doi.org/10.1016/j.ijpharm.2003.10.016[Crossref]
  • [12] G. Kuminek, G.S. Rauber, M.K. Riekes, C.E.M. de Campos, G.A. Monti, A.J. Bortoluzzi, S.L. Cuffini, S.G. Cardoso, J. Pharm. Biomed. Anal. 78–79, 105 (2013) http://dx.doi.org/10.1016/j.jpba.2013.02.001[Crossref]
  • [13] P. Zakeri-Milani, M. Barzegar-Jalali, M. Azimi, H. Valizadeh, Eur. J. Pharm. Biopharm. 73, 102 (2009) http://dx.doi.org/10.1016/j.ejpb.2009.04.015[Crossref]
  • [14] K. Greco, D.P. Mcnamara, R. Bogner, J. Pharm. Sci. 100, 2755 (2011) http://dx.doi.org/10.1002/jps.22507[Crossref]
  • [15] M.M. Bueno, N. Rech, In: S. Storpirtis, J.E. Gonçalves, C. Chiann, M.N. Gai (Ed.), Ciências Farmacêuticas: Biofarmacotécnica (Guanabara Koogan, São Paulo, 2009) 12 (in Portuguese)
  • [16] S.R. Vippagunta, H.G. Brittain, D.J. Grant, Adv. Drug Deliv. Rev. 48, 3 (2001) http://dx.doi.org/10.1016/S0169-409X(01)00097-7[Crossref]
  • [17] J. Wells, In: M.E. Aulton (Ed.), Pharmaceutics: The science of dosage form design, 2nd edition (Churchill Livingstone Publishers, London, 2001) 113
  • [18] A.S. Raw, M.S. Furness, D.S. Gill, R.C. Adams, F.O. Holcombe, L.X. Yu, Adv. Drug Deliv. Rev. 56, 397 (2004) http://dx.doi.org/10.1016/j.addr.2003.10.011[Crossref]
  • [19] H. Nguyen, In: U. S. Food and Drug Administration, Bioequivalence reviews: ANDA 76 (2004)
  • [20] S.C. Sweetman, Martindale: The complete drug reference (Pharmaceutical Press, London, 2009) 1357
  • [21] British Pharmacopoeia Comission, British Pharmacopoeia, 7th edition (The British Pharmacopoeia Stationary Office, London, 2009)
  • [22] A. Grunenberg, B. Keil, J.-O. Henck, Int. J. Pharm. 118, 11 (1995) http://dx.doi.org/10.1016/0378-5173(94)00284-C[Crossref]
  • [23] A. Grunenberg, J.-O. Henck, H. W. Siesler, Int. J. Pharm. 129, 147 (1996) http://dx.doi.org/10.1016/0378-5173(95)04283-0[Crossref]
  • [24] T.M. Cardoso, P.O. Rodrigues, H.K. Stulzer, M.A.S. Silva, J.R. Matos, Drug Develop. Ind. Pharm. 31, 631 (2005) http://dx.doi.org/10.1080/03639040500216212[Crossref]
  • [25] M.K. Riekes, R.N. Pereira, G.S. Rauber, S.L. Cuffini, C.E.M. de Campos, M.A.S. Silva, H.K. Stulzer, J. Pharm. Biomed. Anal. 70, 188 (2012) http://dx.doi.org/10.1016/j.jpba.2012.06.029[Crossref]
  • [26] X.D. Liu, L. Xie, G.Q. Xu, J. Wang, Y.C. Zhou, G.Q. Liu, Chin. J. Pharmacol. Toxicol. 10, 25 (1996)
  • [27] ICH-Harmonised Tripartity Guideline, Validation of Analytical Procedures: Methodology Q2 (R1) (International Federation of Pharmaceutical Manufacturers & Associations, Geneva, 2005)
  • [28] Z. He, D. Zhong, X. Chen, X. Liu, X. Tang, L. Zhao, Eur. J. Pharm. Sci. 21, 487 (2004) http://dx.doi.org/10.1016/j.ejps.2003.11.009[Crossref]
  • [29] M. Skinner, I. Kanfer, Int. J. Pharm. 88, 151 (1992) http://dx.doi.org/10.1016/0378-5173(92)90311-O[Crossref]
  • [30] G.Z. Papageorgiou, D. Bikiaris, E. Karavas, S. Politis, A. Docoslis, Y. Park, A. Stergiou, E. Georgarakis, The AAPS J. 8, E623 (2006) [Crossref]
  • [31] A. Docoslis, K.L. Huszarik, G.Z. Papageorgiou, D. Bikiaris, A. Stergiou, E. Georgarakis, The AAPS J. 9, E361 (2007) http://dx.doi.org/10.1208/aapsj0903043[Crossref]
  • [32] X. Yung, W. Ke, P. Zi, F. Liu, L. Yu, J. Pharm. Sci. 97, 2702 (2008) http://dx.doi.org/10.1002/jps.21204[Crossref]
  • [33] Z. Guo, M. Ma, T. Wang, D. Chang, T. Jiang, S. Wang, AAPS PharmSciTech. 12, 610 (2011) http://dx.doi.org/10.1208/s12249-011-9628-8[Crossref]
  • [34] S. Sehic, G. Betz, S. Hadzidedic, S.K. El-Arini, H. Leuenberger, Int. J. Pharm. 386, 77 (2010) http://dx.doi.org/10.1016/j.ijpharm.2009.10.051[Crossref]
  • [35] K. Greco, R. Bogner, Mol. Pharm. 7, 1406 (2010) http://dx.doi.org/10.1021/mp1000197[Crossref]
  • [36] J. Aaltonen, P. Heinänen, L. Peltonen, H. Kortejärvi, V.P. Tanninen, L. Christiansen, J. Hirvonen, L. Yliruusi, J. Rantanen, J. Pharm. Sci. 95, 2730 (2006) http://dx.doi.org/10.1002/jps.20725[Crossref]
  • [37] G.W. Stowell, R.J. Behme, S.M. Denton, I. Pfeiffer, F.D. Sancilio, L.B. Whittall, R.R. White, J. Pharm. Sci. 91, 2481 (2002) http://dx.doi.org/10.1002/jps.10240[Crossref]
  • [38] K. Greco, R. Bogner, J. Pharm. Sci. 101, 2996 (2012) http://dx.doi.org/10.1002/jps.23025[Crossref]
  • [39] N. Qiao, K. Wang, W. Schlindwein, A. Davies, M. Li, Eur. J. Pharm. Biopharm. 83, 415 (2013) http://dx.doi.org/10.1016/j.ejpb.2012.10.005[Crossref]

Document Type

Publication order reference

Identifiers

YADDA identifier

bwmeta1.element.-psjd-doi-10_2478_s11532-014-0511-9
JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.