Unit:
Κατεύθυνση Φαρμακευτική Ανάλυση - Έλεγχος ποιότηταςLibrary of the School of Science
Author:
Margaritis Georgios
Supervisors info:
Μιχαήλ Κουππάρης, Καθηγητής, Τμήμα Χημείας, ΕΚΠΑ
Original Title:
Ανάπτυξη και επικύρωση αναλυτικής μεθόδου για τη μελέτη της κινητικής αποικοδόμησης των συμπλόκων σακχαρούχου σιδήρου
Translated title:
Development and validation of an analytical method for the kinetic study of iron sucrose complex degradation
Summary:
Iron sucrose is a complex of polynuclear iron (III) hydroxide in sucrose. Iron sucrose consists of complex molecules of iron hydroxide nuclei with a carbohydrate shell. Iron sucrose does not have a specific structural formula. Therefore, it is an aggregate of molecules with similar chemical structures. The chemical structure and physicochemical properties of iron sucrose complexes that are critical for pharmacological action and pharmacokinetic properties, depend greatly on the production process, which must be strictly defined and controlled. The complexity of this pharmaceutical product requires the development of analytical methods suitable for quality control.
This dissertation aims to the development and validation of an analytical method for monitoring the iron sucrose degradation kinetics in the presence of an acidic solution of hydrochloric acid. The main applications of this analytical method are the following. Firstly, it is intended for the quality control of iron sucrose formulations. Secondly, for assessing the equivalence between two different formulations iron sucrose, a reference formulation and a test formulation, based on the degradation kinetics of the complexes. This provides an initial indication of the existence or not of bioequivalence (biosimilarity) between the two formulations. Moreover, with the use of experimental design, the robustness of the analytical method and the effects and interactions of various factors on the analytical result are examined.
Main subject category:
Science
Other subject categories:
Pharmacy
Keywords:
method development, method validation, iron sucrose, kinetic study, design of experiments
