Fizikalno-kemijsko preskušanje plastičnih ovojnin za trdne farmacevtske oblike po USP 661.2. : univerzitetni študijski program Industrijska farmacija

Jazbec, Anja (author), Časar, Zdenko (mentor)

Glavni funkciji ovojnine sta fizična in kemična zaščita farmacevtske oblike. Ovojnina ščiti farmacevtsko obliko pred mehanskimi poškodbami med distribucijo in shranjevanjem, prav tako jo ščiti pred kisikom, toploto, vlago in svetlobo. Ti dejavniki lahko povzročijo kemijske reakcije v farmacevtski obliki in s tem vplivajo na kakovost in varnost farmacevtske oblike. Zagotavljanje kakovosti, varnosti in učinkovitosti končnih izdelkov v farmacevtski industriji je osnovni pogoj za varovanje zdravja bolnikov in uspešno poslovanje farmacevtskega podjetja, zato mora biti tudi plastična ovojnina primerno preskušana. V magistrskem delu smo v skladu s predpisi v monografiji USP 661.2 izvedli fizikalnokemijske preskuse na 10 plastičnih ovojninah, izdelanih iz polietilena z visoko gostoto, ki so se med seboj razlikovale glede na razmerje površine na volumen, proizvajalca, glede na tehnologijo izdelave, barvo in glede različne sestave ovojnin. Preskušane ovojnine se lahko uporabljajo za pakiranje trdnih farmacevtskih oblik. Najprej smo izvedli preliminarno preskušanje kislosti oz. bazičnosti, v sklopu katerega smo izvedli preskus občutljivosti raztopine indikatorja metil rdečega ter preliminarno preskušanje na prečiščeni vodi. Na podlagi preliminarnega preskušanja smo nato s primerjavo rezultatov vrednotili raztopine vzorcev iz 10 ovojnin na treh paralelkah. Po izvedenem preliminarnem testiranju smo izvedli fizikalno-kemijsko preskušanje plastičnih ovojnin, in sicer smo izvedli preskus izgleda raztopine vzorca iz ovojnine (barva in bistrost),izvedli smo meritve absorbance, preskus kislosti oz. bazičnosti, meritve celotnega organskega ogljika ter tudi preskus elementnih nečistot, ki trenutno ni del fizikalnokemijskega preskušanja po USP 661.2.Na podlagi rezultatov smo ugotovili, da so bile vse raztopine vzorcev iz ovojnin brezbarvne in bistre, da so imele vse raztopine vzorcev iz ovojnin vrednost absorbance nižjo od 0,2, da so rezultati kislosti oz. bazičnosti in rezultati meritev celotnega organskega ogljika ustrezali specifikacijskim predpisom v USP 661.2. Iz rezultatov preskusa elementnih nečistot lahko sklepamo, da se v raztopine vzorcev iz ovojnin niso izločile elementne nečistote.Na podlagi vseh izvedenih preskusov torej lahko zaključimo, da vse preskušane ovojnine ustrezajo specifikacijskim predpisom v USP 661.2 in so primerne za uporabo.

• Language: Slovenian
• Keywords: plastična ovojnina polietilen visoke gostote fizikalno-kemijsko preskušanje monografija USP 661.2 izvlečki elementne nečistote
• Work type: Master's thesis/paper
• Typology: 2.09 - Master's Thesis
• Organization: FFA - Faculty of Pharmacy
• Place of publishing: Ljubljana
• Publisher: [A. Jazbec]
• Year: 2018
• Number of pages: III, 50 f.
• PID: 20.500.12556/RUL-120254
• UDC: 661.12:615.45(043.3)
• COBISS.SI-ID: 4646257
• Publication date in RUL: 17.09.2020

Secondary language

• Language: English
• Title: Physicochemical testing of plastic packaging systems for solid dosage forms according to USP 661.2.

Abstract

The main functions of packaging system are the physical and chemical protection of the dosage form. The packaging system protects the dosage form from mechanical damage during distribution and storage, as well as against oxygen, heat, moisture and light. These factors can cause chemical reactions in the dosage form and thus affect the quality and safety of the dosage form. Ensuring the quality, safety and efficacy of finished products in the pharmaceutical industry is a prerequisite for protecting the health of patients and for the successful business performance of a pharmaceutical company, therefore the plastic packaging systems have to be tested properly. The aim of the master thesis was to perform physicochemical tests according to the USP 661.2 monograph on 10 plastic packaging systems made of high-density polyethylene, which were different in terms of size, manufacturer, production technology, colour and packaging composition. The tested packaging systems can be used for the packaging of solid dosage forms. First, we performed a preliminary acidity or alkalinity test, where the test for sensitivity of methyl red indicator and the preliminary test on purified water were performed. On the basis of the preliminary testing we evaluated samples of 10 packaging systems on three parallels by comparing the results. After the preliminary testing, we performed physicochemical testing of plastic packaging systems, we tested the appearance of samples (colour and clarity), we performed the measurements of absorbance, acidity or alkalinity tests, total organic carbon measurements, as well as the test of elemental impurities, which is not yet part of the USP 661.2 physicochemical tests. Based on the results, we concluded that all the samples of packaging system were colourless and clear, all the samples of packaging system had values of absorbance less than 0,2, the results of acidity or alkalinity and also the results of measurements of total organic carbon corresponded to the specifications in USP 661.2. Based on the results of the test for elemental impurities, we can conclude that elemental impurities were not extracted from the packaging systems to the samples. On the basis of all the tests performed, we can conclude that all the packaging systems tested meet the specification requirements of USP 661.2 and are suitable for use.

• Keywords: plastic packaging system high density polyethylene physicochemical testing according to USP 661.2 extractables elemental impurities.