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Pan L, Qian Y, Cheng M, et al. Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs. Acta Pharm Sin B. 2015;5(1):74-8doi: 10.1016/j.apsb.2014.11.003.
Pan, L., Qian, Y., Cheng, M., Gu, P., He, Y., Xu, X., & Ding, L. (2015). Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs. Acta pharmaceutica Sinica. B, 5(1), 74-8. https://doi.org/10.1016/j.apsb.2014.11.003
Pan, Liping, et al. "Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs." Acta pharmaceutica Sinica. B vol. 5,1 (2015): 74-8. doi: https://doi.org/10.1016/j.apsb.2014.11.003
Pan L, Qian Y, Cheng M, Gu P, He Y, Xu X, Ding L. Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs. Acta Pharm Sin B. 2015 Jan;5(1):74-8. doi: 10.1016/j.apsb.2014.11.003. Epub 2015 Jan 07. PMID: 26579428; PMCID: PMC4629124.
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Acta Pharm Sin B. 2015 Jan;5(1):74-8. doi: 10.1016/j.apsb.2014.11.003. Epub 2015 Jan 07.

Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs.

Acta pharmaceutica Sinica. B

Liping Pan, Yafang Qian, Minlu Cheng, Pan Gu, Yanna He, Xiaowen Xu, Li Ding

Affiliations

  1. Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.

PMID: 26579428 PMCID: PMC4629124 DOI: 10.1016/j.apsb.2014.11.003

Abstract

This paper describes the development and validation of a liquid chromatography-mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hydrochloride sustained-release capsule (SR-test), as an instant-release tablet (IR-reference) and as the market leader sustained-release capsule (Rythmol, SR-reference) in male beagle dogs (n=8). In Study A comparing SR-test with IR-reference in a crossover design T max and t 1/2 of propafenone for SR-test were significantly higher than those for IR-reference while C max and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed C max and AUC of propafenone for SR-test (124.5±140.0 ng/mL and 612.0±699.2 ng·h/mL, respectively) were higher than for SR-reference (78.52±72.92 ng/mL and 423.6±431.6 ng·h/mL, respectively) although the differences were not significant. Overall, the new formulation has as good if not better sustained release characteristics to the market leader formulation.

Keywords: Beagle dog; Pharmacokinetics; Plasma; Propafenone; Sustained-release

References

  1. Am J Cardiol. 2002 Dec 15;90(12):1300-6 - PubMed
  2. Am J Cardiol. 2003 Oct 15;92(8):941-6 - PubMed
  3. Yao Xue Xue Bao. 2005 May;40(5):457-61 - PubMed
  4. Int J Pharm. 2008 Apr 2;353(1-2):124-30 - PubMed
  5. Clin Pharmacokinet. 1991 Jul;21(1):1-10 - PubMed
  6. N Engl J Med. 1990 Jun 21;322(25):1764-8 - PubMed
  7. Int J Cardiol. 2013 Dec 10;170(2):208-14 - PubMed
  8. Eur J Clin Pharmacol. 1986;30(6):665-71 - PubMed
  9. Am J Cardiol. 1984 Nov 14;54(9):9D-12D - PubMed
  10. Circulation. 1983 Sep;68(3):589-96 - PubMed
  11. Am J Cardiol. 1996 Sep 1;78(5):579-81 - PubMed
  12. Am J Cardiol. 1997 Feb 15;79(4):418-23 - PubMed
  13. J Clin Pharmacol. 1998 Jun;38(6):496-501 - PubMed
  14. Am J Cardiol. 1998 Oct 16;82(8A):66N-71N - PubMed

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