Unit:
Κατεύθυνση Χημική Ανάλυση-Έλεγχος ΠοιότηταςLibrary of the School of Science
Author:
Skandalis Dimitrios-Argirios
Supervisors info:
Μιχάλης Κουππάρης, Καθηγητής, Τμήμα Χημείας, ΕΚΠΑ
Original Title:
Συγκριτική κινητική μελέτη ιονανταλλαγής νατρίου-καλίου με ρητίνη νατριούχο σουλφονικό πολυστυρένιο σε φαρμακευτικά σκευάσματα με ιοντική χρωματογραφία
Translated title:
Sodium potassium Ion exchange kinetic study with sodium polystyrene sulfonate in medicinal products
Summary:
In this MSc Thesis, the kinetic part of an in vitro biowaiver study was performed. Biowaiver study was justified since the API is not absorbed in the systemic circulation. The study was between a medicinal product under Market Authorization Application and an already marketed product, used as reference. Both medicines have same indication which is hyperkalemaea, where potassium level in the human body is above normal. The mechanism for both products is to attach the extra potassium in the body, particularly in the large intestine, so it can be removed from the body in the stool. The study was performed under a protocol which dictated that solutions, from both investigational and reference product, were to be prepared and the efficacy of potassium bonding was investigated in 2 concentration levels, of potassium solution, in 3 different pH and in 8 time points. The analytical technique used was Ion Chromatography.
Main subject category:
Science
Keywords:
Sodium polystyrene sulfonate, sodium-potassium exchange, kinetic study, bioequivalence, ion chromatography, hyperkalemaea
