Unit:
Τομέας ΦΑΡΜΑΚΕΥΤΙΚΗΣ ΧΗΜΕΙΑΣLibrary of the School of Science
Author:
Γαλανοπούλου Όλγα
Dissertation committee:
Αικατερίνη Αντωνιάδου –Βυζά Αναπλ. Καθηγήτρια (Επιβλέπουσα), Μιχαήλ Κουππάρης Καθηγητής , Εμμανουήλ Μικρός Καθηγητής
Original Title:
Εεπίδραση εκδόχων και άλλων παραγόντων στη σταθερότητα και φωτοσταθερότητα δραστικών ενώσεων σε διαλύματα και σε στερεές φαρμακευτικές μορφές
Translated title:
The effect of excipients and other factors on the stability and photostability of active drug substances both in solutions and in solid drug formulation
Summary:
The effect of excipients and of other parameters in both stability and safety
of drug product was investgated. During stability monitoring of Carvedilol
tablets, an unknown degradation product was reported and the interaction
between the active substance and polyvinylpyrrolidone (PVP) was studied. This
interaction was proved to be related to the mass ratio of the two substances,
Carvedilol and PVP, and to the water content of PVP. Alteration of blistering
materials provided a low humidity micro-environment and improved stability
performance of the drug product. The unknown products was isolated and
characterized as the oxime of Carvedilol.
Photodegradation of Carvedilol was studied using methanol as solvent and it was
attempted to reveal the connection between the initial concentration of
solution and the rate of photodegradation of Carvedilol. A linear equation of
the logarithmic values of the two parameters was revealed and it was used to
evaluate the effect of excipients co-existence.
The same study was attempted in aqueous solutions of Metronidazole. First-order
kinetics were found in solutions of low initial concentration, while in
solutions of high initial concentrations zero-order kinetics were observed.
Reproducible experimental process is prerequisite for photodegradation studies.
Keywords:
Photostability, Carvedilol, Metronidazole, Polyvinylpyrrolidone, Excipients
Number of references:
168
