Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama

undergraduate thesis

• Title (english): Application of accelerated stability testing method on pharmaceutical active substances
• Author: Valnea Sindičić
• Mentor: Šime Ukić (mentor)
• Committee member: Šime Ukić (predsjednik povjerenstva)
• Committee member: Danijela Ašperger (član povjerenstva)
• Committee member: Marijana Kraljić Roković (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2017-09-18, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry; Analytic Chemistry

Abstract

Ovaj rad izrađen je u PLIVA d.o.o., Hrvatska te zbog poslovne tajnosti nije moguće iznositi točna imena uzoraka i aktivnih farmaceutskih supstanci kao ni njihove karakteristike. Tijekom razvoja aktivnih farmaceutskih supstanci (API-ja) potrebno je provesti nekoliko dugoročnih stabilitetnih testiranja. Rok trajanja, koji se treba odrediti, temelji se na vremenu u kojem API ostaje unutar svojih granica specifikacije tijekom nastanka produkata razgradnje. Osiguravanje stabilnog proizvoda od iznimne je važnosti za zdravlje bolesnika. Primjena programa ubrzane procjene stabilnosti (ASAP) omogućuje predviđanje roka trajanja API-ja u svega dva tjedna koristeći kontrolirane komore za stabilnost u minijaturi i statističke protokole. ASAP se znanstveno bazira na korigiranoj Arrheniusovoj jednadžbi koja se koristi za procjenu učinaka temperature i vlage na stupanj degradacije API-ja. U ovom radu primijenjena je ova kratkotrajna metoda ispitivanja na dvokomponentnom API-ju za testiranje međusobnih utjecaja kemijske stabilnosti. Produkti degradacije određeni su pomoću UHPLC-a s DAD detektorom i C18 separacijskom kolonom. Razvijena je kromatografska metoda za odvajanje svih produkata razgradnje i dva API-ja. Rezultati su pokazali aditivni učinak u stabilnosti dvokomponentnog sustava u dvotjednom razdoblju testiranja.

Abstract (english)

This bachelor thesis was made in PLIVA d.o.o., Croatia and due to the company confidentiality policy it's not possible to disclose exact names of samples and active pharmaceutical ingredients as well as theirs characteristics. During the development of an active pharmaceutical ingredients (APIs), certain number of the long-term stability testings are required. Shelf-life, which has to be determined, is based on the period in which API stays within the limits of it's specification during the formation of the degradation products. Ensuring the stability of product is of exceptional importance for patients' health. The application of The Accelerated Stability Assessment Program (ASAP) enables APIs shelf-life prediction in just two weeks by using controlled miniature stability chambers and the statistical protocols. ASAP is scientifically based on corrected Arrhenius equation which is used for estimation of the effects of temperature and humidity on the degradation rate of APIs. In this thesis, explained short-term testing method was applied on a two-component API for testing of mutual effects in chemical stability. Degradation products were determined by UHPLC with a DAD detector and C18 separation column. Chromatographic method was developed for separation of all degradation products and two APIs. Results have shown additive effect in stability of two-component system during the two-week testing period.

• Keywords: ASAP; API; stabilitetna testiranja; UHPLC; korigirana Arrheniusova jednadžba
• Keywords (english): ASAP; API; stability testing; UHPLC; humidity-corrected Arrhenius equation
• Language: croatian
• URN:NBN: urn:nbn:hr:149:520398
• Study programme: Title: Applied Chemistry - Undergraduate study; specializations in: Environmental chemistry and green technologies, Advanced materials and technologies, Applied organic chemistry; Course: Applied organic chemistry; Study programme type: university; Study level: undergraduate; Academic / professional title: sveučilišni/a prvostupnik/prvostupnica (baccalaureus/baccalaurea) primijenjene kemije (sveučilišni/a prvostupnik/prvostupnica (baccalaureus/baccalaurea) primijenjene kemije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2021-03-12 12:37:35