QUALITY OF PARENTERAL ANTIBIOTICS

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DOI: https://doi.org/None
Issue: 
4
Year: 
2015

Professor N.F. Farashchuk, MD; Yu.P. Koryakina, PhD Smolensk State Medical Academy; 28, Krupskaya St., Smolensk 214019

A substantial proportion of antibiotics are manufactured as parenteral dosage forms. Their bioavailability is not being investigated in this situation. Quality is most relevant for generic drugs, particularly when there is no certainty that the good manufacturing practice (GMP) standards are followed during their producton. Comparative investigations of original and generic antibiotics have revealed that the latter frequently contain foreign impurities as insoluble particles and degradation products of the active ingredient and that there are differences in its content, and other violations. To take economic advantage of the generics, there is a need for an effective system for their quality control, as well as the introduction of GMP standards from a manufacturing process to ready-made products. It is shown that it is necessary to develop own manufacture of substances, to set up a uniform database that is accessible to physicians on original and generic antibiotics and their biological and therapeutic equivalence.
Keywords: 
antibiotics
generics
quality
efficacy
equivalence
References: 
  1. Zyryanov S.K., Belousov Yu.B. Problema kachestva dzhenerikov i ocenka ih sootvetstviya original`nym preparatam. KMAH, 2010; 12. (4): 314–320.
  2. Maev I.V., Samsonov A.A., Golubev N.N. Klaritromicin kak neot``emlemyy komponent antihelikobakternoy terapii. Farmateka, 2009; 6: 22–29.
  3. Nedogoda S.V., Marchenko I.V., Chalyabi T.A. Sravnitel`naya antigipertenzivnaya e`ffektivnost` dzhenerikov angiotenzinprevrashhayushhego fermenta e`nalaprila (Reniteka, E`napa, E`dnita, Invorila, E`nvasa i E`nama) i stoimost` lecheniya bol`nyh gipertonicheskoy bolezn`yu. Arterial`naya gipertoniya, 2000; 1: 52–55.
  4. Nikulin A.A., Cyuman Yu.P., Martinovich A.A., E`ydel`shteyn M.V., Kozlov R.S. K voprosu o vzaimozamenyaemosti vnutrivennyh form original`nyh i dzhenericheskih preparatov: nuzhny li sravnitel`nye issledovaniya? KMAH, 2010; 12: 31–40.
  5. Panyushin R. Original`nye i dzhenerikovye preparaty: edinstvo ili bor`ba protivopolozhnostey? Farmacevticheskiy vestnik, 2003; 16: 23.
  6. Stepanova I. Lechit` i ne kalechit`. Osnovnoy prioritet – kachestvo lekarstvennyh preparatov. Medicinskaya gazeta, 2014; 42: 12
  7. Tarlovskaya E.I. Dzheneriki i original`nye preparaty: vzglyad prakticheskogo vracha. Rus. med. zhurnal, 2008; 16. (5): 333–337.
  8. Tel`nova E.A. O sisteme kontrolya kachestva lekarstvennyh sredstv. Vestnik Roszdravnadzora, 2010; 4: 10–16.
  9. Truhan D.I. Originaly i dzheneriki: perezagruzka v svete e`konomicheskogo krizisa. Spravochn. poliklinich. Vracha, 2012; 5: 4–8.
  10. Hoseva E.N., Morozova T.E. E`konomicheskie preimushhestva i slabye storony dzhenerikov v sisteme lekarstvennogo obespecheniya naseleniya v Rossii i za rubezhom. Kachestven. klin. praktika, 2013; 2: 63–68.
  11. Bikhazi A.B., Shiatis J.A., Haddad A.F. Quantitative estimation of particulate matter in pharmaceutical preparations intended for intravenous administration. J. Pharm. Sci., 1977; 2 (66): 181–186.
  12. Kilarski D.J., Visconti J.A., Frank S.G. Particulate matter in four reconstituted cephalosporin injections. Am. J. Hosp. Pharm., 1983; 4 (40): 619–623.
  13. Lambert P.A., Conway B.R. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocefin. J. Chemother., 2003; (15): 357–368.
  14. Nightingale C.H. A survey of the quality of generic clarithromycin products from 18 countries. Clin. Drug Investig., 2005; 25: 135–152.
  15. Parkins D.A., Taylor A.J. Particulate-matter content of 11 cephalosporin injections: conformance with USP limits. Am. J. Hosp. Pharm., 1987; 5 (44): 1111–1118.