Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials

Abstract

Glass is the favorite material for parenteral packaging because of its physico-chemical properties. Type I borosilicate glass is worldwide use at this scope, but it may have some issues related to breakage, corrosion and delamination that might compromise the drug quality, safety and efficacy. These issues can be mitigated and avoided starting from the appropriate selection of the most suitable raw material at the early stage of the glass container design. In this study, Type I borosilicate glass vials manufactured using two glass tubes having different chemical compositions, were studied and compared in terms of their resistance to corrosion. Testing design was applied with the aim to select the best practice approach comparing different storage simulation conditions: ageing treatment through autoclaving and stability testing (real-time and accelerated). Clear differences were found between the different glass types in terms of hydrolytic and corrosion resistance that highlighted the relation between chemical composition and glass chemical durability. Non-negligible differences were also observed using different storage conditions.

Insights on surface analysis techniques to study glass primary packaging

“…Indeed, two containers of different glass composition, obtained through a similar forming process, can show different chemical properties. 29 The slight increase in sodium, detected on the inner surface of vials, is partially due to volatile species generated from the bottom area during the forming process, which condense on the inner glass surface of the vial due to the lower temperature along the vial wall. The condensation process leads to an inhomogeneous coating of the inner walls with typical evaporation deposits like sodium borates.…”

“…Obviously, the mixed‐alkali effect may also influence properties of the final container. Indeed, two containers of different glass composition, obtained through a similar forming process, can show different chemical properties 29 . The slight increase in sodium, detected on the inner surface of vials, is partially due to volatile species generated from the bottom area during the forming process, which condense on the inner glass surface of the vial due to the lower temperature along the vial wall.…”

Avaliação da resistência à delaminação de frascos de vidro tipo I para produtos injetáveis disponíveis no mercado brasileiro

“…A durabilidade química é usualmente utilizada para se referir à resistência do vidro contra um ataque promovido por soluções aquosas ou por agentes atmosféricos (Panighello & Pinato, 2020). Soluções aquosas contendo ânions, em condições alcalinas (pH > 8), ou quando expostas a altas temperaturas, como nos casos de esterilização térmica, podem interagir com o vidro da embalagem (Ennis et al, 2001) Em um primeiro estágio desse ataque, parte dos íons de hidrogênio (H ) da água tende a se difundir no vidro, deslocando uma quantidade equivalente de sódio (Na ) do vidro para a água ou solução de contato, de acordo com a reação:…”

“…Segundo Iacocca (2011), a delaminação é um processo cinético que necessita de energia e tempo suficientes para remover a sílica da estrutura do vidro e a formação dos flakes, sendo que, o aumento das partículas de vidro visíveis na solução, decorrente do processo de corrosão, é linear com o decorrer do tempo (Panighello & Pinato, 2020). Iacocca & Allgeier (2007) De forma geral, os fatores capazes de influenciar a durabilidade química de frascos de vidro destinados ao mercado de produtos farmacêuticos podem ser concentrados em três grandes tópicos (Biavati et al, 2017;Ditter et al, 2018;Evaluation…, 2020;FDA, 2011;Pillai et al, 2016;Rupertus et al, 2014;Zhao et al, 2014):…”