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Peptidni lijekovi i njihov široki terapijski potencijal postali su dostupniji općoj populaciji dolaskom generičkih peptidnih lijekova na tržište. Usprkos tome što ne postoje opće harmonizirane zakonske smjernice za proizvodnju i kontrolu kvalitete peptida, farmaceutska industrija pod pritiskom je plasiranja generičkih peptidnih lijekova na tržište kako bi se zadovoljile potrebe liječenja populacije. Kako bi generički lijek dobio odobrenje za stavljanje na tržište, potrebno je dokazati njegovu istovjetnost s originalnim lijekom, često proizvedenim različitim proizvodnim procesom. U svrhu ispitivanja istovjetnosti generičkih i originalnih peptidnih lijekova provode se brojne usporedne analize korištenjem širokog spektra analitičkih tehnika. Potrebno je provesti identifikaciju tvari, analizirati različite razine strukturnog uređenja peptidnih molekula, ispitati njihova fizikalno-kemijska i biološka svojstva te utjecaj na organizam u smislu imunogenosti te biološke aktivnosti i potentnosti. Posebnu pažnju treba posvetiti ispitivanju prisutnih i mogućih onečišćenja u djelatnoj tvari te u završnoj formulaciji. U radu je prikazana karakterizacija dekapeptida ikatibanta upotrebom novijih osjetljivih analitičkih tehnika. Peptide drugs and their wide therapeutic potential have become more available for patients around the world when generic peptide drugs entered to drug market. Although there are still no general guidelines for manufacturing and quality control of peptide drugs, pharmaceutical industry is working under pressure in order to place generic peptides to the market so they could accomplish their purpose in medical treatment. Pharmaceutical companies that are seeking approval for putting generic peptide drugs on the market need to demonstrate sameness between original and generic peptide drug. This is often challenging due to the fact that manufacturing processess of original and generic drug could be different. Wide range of analytical techniques are used in order to establish sameness and justify equivalence between original and generic peptide drugs. Some of many comparative tests that have to be done are identification of active pharmaceutical substance, molecule structure characterization, examination of physicochemical and biological properties such as biological activity and immunogenicity. Particular attention should be given to impurities that could be present in the active substance material or final formulation of the drug. In this Bachelor's Thesis, characterization of decapeptide icatibant using novel sensitive analytical techniques has also been presented. |
