Proučevanje prepustnosti oblikovnih folij za plastične pretisne omote : [magistrski študij industrijska farmacija]

Kulovec, Primož (avtor), Kerč, Janez (mentor)

Pretisni omoti so najpogostejša oblika pakiranja trdnih farmacevtskih oblik v Evropi, so pa tako kot vsa druga ovojnina in procesi pakiranja podvrženi čedalje strožjim zahtevam regulatornih organov. Na trgu je vedno večja izbira folij za pretisne omote, ki pa se od proizvajalca do proizvajalca razlikujejo v sestavi ter prepustnosti za kisik in vlago, kar je tudi najpomembnejše za stabilnost farmacevtskih izdelkov. Sam PVC ima zelo visoko prepustnost za vlago. Folije, ki jih sedaj uporabljamo za pakiranje trdnih farmacevtskih izdelkov, imajo za osnovo PVC material, na to osnovo pa so nanešene plasti snovi, kot sta PVDC ali Aclar®, ki močno znižata prepustnost vlage skozi folijo. Večino bariernih karakteristik folije zagotavlja dodatna plast polimera, nanešena na PVC. Od nedavnega je na trgu folija s tanjšo plastjo PVC (z 250 μm na 200 μm), plast PVDC pa je ostala nespremenjena 60 g/m2. Ker je 200 μm PVC/PVDC folija veliko cenejša zaradi manjše količine porabljenega PVC materiala pri proizvodnji folij in hkrati bolj prijazna okolju, smo preučevali, ali ima folija z zmanjšano plastjo PVC primerljive barierne lastnosti v smislu prepustnosti za vlago, da nadomesti doslej uporabljeno 250 μm PVC/PVDC folijo. Prepustnosti folij enakih karakteristik (200 μm PVC/60 g/m2 PVDC) različnih proizvajalcev se po oblikovanju razlikujejo. Ugotovili smo, da je razlika v prepustnosti folij PVC/PVDC proizvajalcev Gallazzi in Klöckner pentaplast 5,06 %, ko primerjamo transparentne folije. Za podoben odstotek v prepustnosti ima vpliv dodatek barvila foliji in sicer ta poveča prepustnost za 6,6 %. Če primerjamo foliji z zmanjšano plastjo PVC z običajno 250 μm PVC/60 g/m2 PVDC, ki se sedaj v Leku uporablja za pakiranje na vlago srednje občutljivih izdelkov, lahko rečemo, da je folija z zmanjšano plastjo PVC proizvajalca Klöckner pentaplast bolj primerljiva v prepustnosti s folijo PVC/PVDC 250 μm/60 g/m2, saj je razlika med njima 8,2 %, medtem ko je razlika 13,7 %, če primerjamo folijo Gallazzi. V primerjavi z navadno PVC folijo, 60 g/m2 PVDC plast v laminatni PVC/PVDC foliji poveča barierno zaščito folij za več kot 50 %. Prav tako smo ugotovili, da ima folija PVC/AquaBa160 kar za 28,5 % manjšo prepustnost po oblikovanju v pretisni omot od primerljive folije PVC/Aclar®. Pri termičnem oblikovanju se debeline folij pretisnih omotov zmanjšujejo z naraščajočo temperaturo oblikovanja. Debeline kavitet pretisnih omotov iz vseh uporabljenih materialov se porazdeljujejo v obliki črke U, kar pomeni, da je ob pokrivni foliji oblikovna folija najdebelejša in se tanjša proti dnu kavitete.

• Jezik: Slovenski jezik
• Ključne besede: pretisni omoti ovojnine farmacevtska tehnologija prepustnost folij metode dela
• Vrsta gradiva: Magistrsko delo/naloga
• Tipologija: 2.09 - Magistrsko delo
• Organizacija: FFA - Fakulteta za farmacijo
• Kraj izida: Ljubljana
• Založnik: [P. Kulovec]
• Leto izida: 2012
• Št. strani: 84 f.
• PID: 20.500.12556/RUL-121146
• UDK: 542+661.12(043.3)
• COBISS.SI-ID: 3211889
• Datum objave v RUL: 30.09.2020

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Permeability investigation of a thermoformable plastic foils for blister packages

Izvleček

Blister packages are the most common form of packaging for solid pharmaceutical dosage forms in Europe and are as other packages and packaging processes subject to strict regulations. There is a growing offer of foils on the market, which differ from one manufacturer to another regarding composition and permeability of oxygen and water vapour, which is the most important for the stability of pharmaceutical products. PVC alone has very high permeability of water vapour. Foils that are currently used for packaging solid dosage forms have a PVC base and an additional layer of a material like PVDC and Aclar® that lowers the foil permeability. Most of the barrier characteristics can be ensured by an additional polymer layer over the PVC. The market offers a new foil with less PVC (reduced from 250 μm to 200 μm), with the PVDC foil unchanged at 60 g/m2. Because the 200 μm PVC/PVDC foil is much cheaper (less PVC is used in foil production) and more environmentally friendly, we have studied, if the foil with the thinner PVC layer has similar barrier characteristics regarding permeability of water vapour, so it could replace the currently used 250 μm PVC/PVDC foil. Permeability of foils with the same characteristics (200 μm PVC/60 g/m2 PVDC) from different manufacturers varies after the forming procedure. We found a 5.06% deviation between the manufacturers Gallazzi and Klöckner pentaplast, when comparing transparent foils. A similar percentage in permeability difference has been determined for coloured foils: pigment added increases permeability by 6.62%. If we compare foils with less PVC to regular 250 μm PVC/60 g/m2 PVDC foils, which is now being used by the company Lek for packaging medium moisture sensitive drug products, we can say that, compared to the PVC/PVDC 250 μm/60 g/m2 foil, the more appropriate foil with less PVC is the one by the manufacturer Klöckner (8.2% difference) than the one by Gallazzi (13.7% difference). The 60 g/m2 PVDC layer in PVC/PVDC foil increases the barrier protection of the foil by 50% compared to the monolayer PVC foil. We also found that the PVC/AquaBa160 foil has a 28.5% lower permeability after the cavity forming procedure than the comparable PVC/Aclar® foil. Foil thickness in blister packages gets thinner with higher temperature used for forming cavities. Cavity thickness in blisters, made from all materials that were used, gets distributed into a U-form, which means that the forming foil is thickest at the covering foil and thinnest at the bottom of the cavity.