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Razvoj metode ločevanja delcev praška za inhaliranje in testa njihovega raztapljanja
ID Žvokelj, Ana (Author), ID Janković, Biljana (Mentor) More about this mentor... This link opens in a new window, ID Huzjak, Tilen (Comentor)

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Abstract
Astma in kronična obstruktivna pljučna bolezen sodita med najpogostejše kronične respiratorne bolezni, ki predstavljajo globalen zdravstveni izziv. Eden izmed ključnih načinov zdravljenja teh bolezni so farmacevtske oblike za inhaliranje, kot so suhi praški za inhalacijo, ki omogočajo neposredno dostavo zdravilnih učinkovin v dihalne poti. V okviru magistrskega dela smo razvijali in vrednotili metode ločevanja delcev praška slabo topne zdravilne učinkovine za inhaliranje na podlagi njihove aerodinamične velikosti ter testirali njihovo raztapljanje. Cilj je bil razviti metodo, ki bi ustrezno razlikovala med preiskovanimi vzorci –profile raztapljanja smo primerjali s podatki in vivo ter vrednotili vpliv fizikalno-kemijskih lastnosti zdravilne učinkovine na lastnosti praška oz. aerosola in na uspešnost ločevanja in odlaganja delcev ter njihovega raztapljanja. Pri tem smo uporabili različne metode na stopenjskem trkalniku za ločevanje delcev aerosola v toku zraka (stopenjski trkalnik nove generacije in stopenjski trkalnik hitrega rešetanja) in prilagojeno metodo stopenjskega trkalnika nove generacije s skodelico z izvodilom. V okviru testov raztapljanja smo iskali ustrezno metodo, ki je hkrati enostavna za izvedbo, zagotavlja ponovljive ter reprezentativne rezultate in je diskriminatorna za preiskovane lastnosti vzorcev. Preizkusili smo metodo z majhnimi volumni in metodo v petrijevkah. Testa raztapljanja sta pokazala razlike med preiskovanimi vzorci, vendar korelacije in vitro-in vivo ni bilo možno vzpostaviti zaradi visoke variabilnosti rezultatov. Opravljeno eksperimentalno delo prispeva k boljšemu razumevanju lastnosti inhalacijskih formulacij ter odpira možnosti za nadaljnje izboljšave metod ločevanja, zbiranja in vrednotenja sproščanja zdravilne učinkovine.

Language:Slovenian
Keywords:suhi praški za inhalacijo, aerodinamična porazdelitev velikosti delcev, raztapljanje, stopenjski trkalnik nove generacije, bioekvivalenca
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FFA - Faculty of Pharmacy
Year:2025
PID:20.500.12556/RUL-175972 This link opens in a new window
COBISS.SI-ID:258215939 This link opens in a new window
Publication date in RUL:15.11.2025
Views:147
Downloads:0
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Secondary language

Language:English
Title:Development of particle size distribution separation method and their dissolution test for dry powder inhalers
Abstract:
Asthma and chronic obstructive pulmonary disease are among the most prevalent chronic respiratory diseases, representing a significant global health challenge. One of the key treatment strategies is the use of inhalation dosage forms, such as dry powder inhalers, which enable direct delivery of active pharmaceutical ingredients to the respiratory tract. The aim of this master's thesis was to develop and evaluate suitable methods for separating dry powder particles based on their aerodynamic size, and to assess their dissolution performance. The goal was to develop a method capable of discriminating between the investigated samples -by comparing in vitro dissolution profiles with in vivo data and to assess the influence of physicochemical properties of the active pharmaceutical ingredient on the powder and aerosol characteristics, as well as on the efficiency of particle separation, deposition, and dissolution. Different approaches using cascade impactor techniques were applied for the separation of aerosol, including the next generation impactor, the fast-screening impactor and modified next generation impactor with an exhaust cup. Within the dissolution studies, we aimed to identify a method that would be simple to perform; while providing reproducible, representative, and discriminatory results for the investigated samples. Two approaches were tested: the small volume dissolution method and petri dish method. Both dissolution tests revealed differences among the investigated samples, however, a clear in vitro-in vivo correlation could not be established due to the high variability of the results. The experimental work contributes to better understanding of the properties of inhalation formulations and provides a foundation for the further improvement of methods for particle separation, collection and evaluating of drug release performance.

Keywords:dry powder inhalers, aerodinamic particle size distribution, dissolution, next generation impactor, bioequivalence

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