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Physico-chemical Characterization of Hydrated and Anhydrous Crystal Forms of Amlodipine Besylate

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Abstract

The antihypertensive drug substance amlodipine besylate crystallizes in two stable crystal forms, an anhydrate and a hitherto unknown monohydrate. Both forms have been characterized by thermal analysis, X-ray powder diffractometry, FTIR- and FT Raman spectroscopy. Moisture sorption- and desorption investigations reveal their unusual physical stability in a broad range of relative humidities. The monohydrate forms an isomorphic dehydrate upon dehydration, which was elucidated by variable temperature X-ray powder diffractometry. Physico-chemical properties as well as relative stabilities of the crystal forms are described and discussed based on a comprehensive analytical identification, and enable an estimation of practical relevance for manufacturing of amlodipine besylate solid dosage forms.

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References

  1. Martindale, The Extra Pharmacopoeia, Royal Pharmaceutical Society, 1999.

  2. RxList: The Top 200 Prescriptions for 2000 by Number of US Prescriptions Dispensed, http://www.rxlist.com (2001).

  3. A. Grunenberg, B. Keil and J.-O. Henck, Int. J. Pharm., 118 (1995) 11.

    Article  CAS  Google Scholar 

  4. A. Burger and K. T. Koller, Sci. Pharm., 64 (1996) 293.

    CAS  Google Scholar 

  5. A. Burger, J. M. Rollinger and P. Brüggeller, J. Pharm. Sci., 86 (1997) 674.

    Article  CAS  Google Scholar 

  6. F. Hirayama, M. Honjo, H. Honjo, H. Arima, K. Okimoto and K. Uekama, Eur. J. Pharm. Sci., 11 (2000) 81.

    Article  CAS  Google Scholar 

  7. J. M. Rollinger and A. Burger, J. Pharm. Sci., 90 (2001) 949.

    Article  CAS  Google Scholar 

  8. K. R. Morris, S. L. Nail, G. E. Peck, S. R. Byrn, U. J. Griesser, J. G. Stowell, S.-J. Hwang and K. Park, PSTT, 1 (1998) 235.

    CAS  Google Scholar 

  9. A. Burger and R. Ramberger, Mikrochim. Acta, 1979 II (1979) 259.

    Article  Google Scholar 

  10. S. Byrn, R. Pfeiffer, M. Ganey, C. Hoiberg and G. Poochikian, Pharm. Res., 12 (1995) 945.

    Article  CAS  Google Scholar 

  11. U. J. Griesser and A. Burger, Int. J. Pharm., 120 (1995) 83.

    Article  CAS  Google Scholar 

  12. G. A. Stephenson, E. D. Groleau, R. L. Kleemann, W. Xu and D. R. Rigsbee, J. Pharm. Sci., 87 (1998) 536.

    Article  CAS  Google Scholar 

  13. S. Petit and G. Coquerel, Chem. Mat., 8 (1996) 2247.

    Article  CAS  Google Scholar 

  14. C. Habare, S. Petit and G. Coquerel, PhandTA 4, Karlsruhe Workbook KC 5 (1999).

  15. A. I. Kitaigorodsky, Molecular Crystals and Molecules, Academic Press, New York, London 1973, p. 184.

    Google Scholar 

  16. E. Shefter and T. Higuchi, J. Pharm. Sci., 52 (1963) 781.

    CAS  Google Scholar 

  17. A. Burger and U. J. Grieβer, Eur. J. Pharm. Biopharm., 37 (1991) 118.

    CAS  Google Scholar 

Download references

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Authors and Affiliations

  1. Institute of Pharmacy/Pharmacognosy, University of Innsbruck, Innrain 52, Josef-Moeller-Haus, A-6020, Innsbruck, Austria

    J. M. Rollinger & A. Burger

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  1. J. M. Rollinger
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  2. A. Burger
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Correspondence to J. M. Rollinger.

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Rollinger, J.M., Burger, A. Physico-chemical Characterization of Hydrated and Anhydrous Crystal Forms of Amlodipine Besylate. Journal of Thermal Analysis and Calorimetry 68, 361–372 (2002). https://doi.org/10.1023/A:1016067130634

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  • DOI: https://doi.org/10.1023/A:1016067130634

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