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Compatibility of Ramipril and Lercanidipine Drug Substances in a Single Solid Dosage Form

  • DRUG SYNTHESIS METHODS AND MANUFACTURING TECHNOLOGY
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Pharmaceutical Chemistry Journal Aims and scope

The chemical properties of ramipril and lercanidipine drug substances were studied to select the conditions necessary for technology development of solid dosage forms. Mixtures containing two or three ingredients were formulated to study the chemical compatibility of the substances and their compatibility with the excipients and were placed into storage. Analyses of these mixtures showed that the substances could be compatible in a single dosage form. Samples of intermediates (mixtures, granulates, tableting masses, tablet cores) and finished products (film-coated tablets) were manufactured, placed into storage, and analyzed to find the optimum processing factors. It was proven that the tableting process and the coexistence of ramipril and lercanidipine in any kinds of intermediates had significant effects on the ingrowth of impurities. The need to use bilayer tablet technology was justified.

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References

  1. N. A. Vaulin, Consil. Medicum, No. 5, 74 – 80 (2011).

  2. Yu. Kuligina, Farm. Vestn., No. 10, 31 (2010).

  3. Tripartite Harmonized ICH Guideline Q8, Vialek Knowledge Book, (2011), pp. 10 – 12.

  4. V. Bolugoddu, S. R. Mamilla, et al., US Pat. Appl. No. 2007 / 0232680, IPC A61K31 / 403, C07D209 / 02, “Preparation of ramipril and stable pharmaceutical compositions,” Oct. 4, 2007.

  5. N. B. Dharmadhikari and V. V. Dhavse, US Pat. Appl. No. 2006 / 0045911, IPC A61K9 / 20, A61K31 / 403, “Stable pharmaceutical formulations,” Mar. 2, 2006.

  6. N. Parmara, S. Amina, N. Singlab, and K. Kohlia, Pharm. Dev. Technol., 17, 730 – 740 (2012).

    Article  Google Scholar 

  7. J. Fiori, R. Gotti, C. Bertucci, and V. Cavrini, J. Pharm. Biomed. Anal., 41(1), 176 – 181 (2006).

    Article  CAS  PubMed  Google Scholar 

  8. Guideline for Drug Review [in Russian], Vol. II, Grif i K, Moscow (2013).

  9. Proceedings of the IIIrd All-Russian Scientific-Practical Conference with International Participation “Innovation in National Health” [in Russian], Nov. 10 – 11, 2015, Izd. SPKhFA, St. Petersburg (2015), pp. 490 – 492.

  10. B. L. Moldaver, R. A. Sherstyuk, A. B. Serdyukova, and A. S. Pivovarova, Drug Incompatibilities [in Russian], SPKhFA, St. Petersburg (2003), p. 45.

    Google Scholar 

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Authors and Affiliations

  1. St. Petersburg State Chemical Pharmaceutical Academy, Ministry of Health of Russia, 14 Prof. Popov St., St. Petersburg, 197376, Russia

    A. A. Shadrin, E. V. Flisyuk & E. N. Kirillova

Authors
  1. A. A. Shadrin
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  2. E. V. Flisyuk
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  3. E. N. Kirillova
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Correspondence to A. A. Shadrin.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 12, pp. 24 – 29, December, 2017.

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Shadrin, A.A., Flisyuk, E.V. & Kirillova, E.N. Compatibility of Ramipril and Lercanidipine Drug Substances in a Single Solid Dosage Form. Pharm Chem J 51, 1096–1101 (2018). https://doi.org/10.1007/s11094-018-1747-z

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  • DOI: https://doi.org/10.1007/s11094-018-1747-z

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