Using the test “Dissolution” for the study of reproducibility of drugs on the example of a combined preparation “Parakod ІС”

  • N.Ya. Golovenko -
  • I.Yu. Borisyuk -
  • Z.A. Giher -
  • A.V. Egorova -
  • A.V. Anelchik -

Abstract

A study of reproducibility of Parakod ІС® - the combined analgesic on the basis of paracetamol and codeine, is made, according to the principles of the biopharmaceutical classification system. The obtained results confirm the identity of the dissolution profiles of the Paracetamol and Codeine Caplets (The Boots Company PLS, UK) to Parakod IC® (TDV INTERCHEM). The release of more than 85% of paracetamol and codeine phosphate hemihydrate in 15 minutes in all tested series indicates the identity of dissolution profiles and requires no calculation of similarity factor f2.

References

1. Geher ZO, Yegorova AV, Anelchik GV, Golovenko M.Ya., Borisyuk I.Yu. // Pharmacology and drug toxicology. - 2010. - № 1-2 (14-15). - P. 21-28.

2. Golovenko M.Ya., Baula OP, Borisyuk I.Yu. Biopharmaceutical classification system. - K. - 2010. - 299 p.

3. Golovenko N.Ya. Physico-chemical pharmacology. - Odessa: Astroprint. - 2004. - 720 p.

4. Golovenko N.Ya., Borisyuk I.Yu. // Pharmacom. - 2007. - № 3. - P. 27-37.

5. Blume H.H., Schug B.S. // Eur. J. Pharm. Sci. - 1999. - № 9. - P 117-121.

6. Chowhan Z., Amaro A. // J. Pharm. Sci. - 1977 / - 66 (9). P. 1249-1253.

7. Raplan S., Cotler S., J. Pharm. Sci. - 1972. - 61 (9). P. 1361-1365.

8. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on biopharmaceutics classification system (2000) U.S. Department of Health and Human Services Food and Drug Administration's Center for Drug Evaluation and Research (CDER). August 2000.

9. WHO 2005. WHO Model List of Essential Medicines, 14th ed. World Health Organization, http://whqlibdoc.who.int/hq/2005/a87017_eng.pdf.
Published
2019-07-01
How to Cite
Golovenko, N., Borisyuk, I., Giher, Z., Egorova, A., & Anelchik, A. (2019). Using the test “Dissolution” for the study of reproducibility of drugs on the example of a combined preparation “Parakod ІС”. Farmatsevtychnyi Zhurnal, (4), 24-30. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/627
Section
Biopharmaceutical classification system