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Rheological evaluation of the isothermal cure characteristics of medical grade silicone elastomers
Author(s) -
McConville Christopher,
Andrews Gavin P.,
Laverty Thomas P.,
Woolfson A. David,
Malcolm R. Karl
Publication year - 2010
Publication title -
journal of applied polymer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.575
H-Index - 166
eISSN - 1097-4628
pISSN - 0021-8995
DOI - 10.1002/app.31682
Subject(s) - elastomer , silicone , materials science , rheology , composite material , isothermal process , silicone elastomers , thermodynamics , physics
Silicone elastomer systems have been shown to offer potential for the fabrication of medical devices and sustained release drug delivery devices comprising low molecular weight drugs and protein therapeutics. For drug delivery systems in particular, there is often no clear rationale for selection of the silicone elastomer grade, particularly in respect of optimizing the manufacturing conditions to ensure thermal stability of the active agent and short cycle times. In this study, the cure characteristics of a range of addition‐cure and condensation‐cure, low‐consistency, implant‐grade silicone elastomers, either as supplied or loaded with the model protein bovine serum albumin (BSA) and the model hydrophilic excipient glycine, were investigated using oscillatory rheology with a view to better understanding the isothermal cure characteristics. The results demonstrate the influence of elastomer type, cure temperature, protein loading, and glycine loading on isothermal cure properties. By measuring the cure time required to achieve tan delta values representative of early and late‐stage cure conditions, a ratio t 1 / t 2 was defined that allowed the cure characteristics of the various systems to be compared. Sustained in vitro release of BSA from glycine‐loaded silicone elastomer covered rod devices was also demonstrated over 14 days. © 2010 Wiley Periodicals, Inc. J Appl Polym Sci, 2010