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Updated: May 26, 2026

Fabrication and Operation of an Oxygen Insert for Adherent Cellular Cultures
Published on: January 6, 2010
A case study exploring the impact of an oxygen barrier coating on formulation stability, in-vitro dissolution and
James C Mann1, Amitava Mitra, Samuel R Pygall
1Analytical Sciences, MSD Ltd, Hoddesdon, Hertfordshire, UK.
Objectives:
The impact of a carmellose sodium (sodium carboxymethycellulose)-based coat (Opaglos 2) on the stability of an oxygen-sensitive compound A and in-vitro dissolution and bioperformance of compound B has been investigated.
Methods:
Tablets containing compounds A and B were coated with various weight gains of Opaglos 2 and a comparative elegance coating (poly(vinyl alcohol)-based Opadry II). Film-coated tablets were assessed for oxidative degradation under accelerated stability conditions (30°C/65% RH and 40°C/75% RH).
Key Findings:
An apparent rank order of restriction of oxygen (O(2) ) permeability afforded by the coatings was observed, with only higher Opaglos 2 coating weight gains (6 and 8% w/w) providing adequate oxidative degradation stability for up to 52 weeks. Improved stability at the higher coating weight gains was attributed to incomplete polymeric film formation at lower coating weight gains. The 6% and 8% w/w Opaglos 2 formulations showed dissolution retardation compared with elegance-coated formulations in USP dissolution apparatus II, predicting significant impact on formulation bioperformance. However, pharmacokinetic studies in Beagle dogs showed similar bioperformance for all formulations.
Conclusions:
The Opaglos 2 coating system evaluated in these studies afforded adequate protection from oxidative degradation with no negative impact on bioperformance as compared to elegance coating. However, further studies are needed using several compounds to assess the broader applicability of these coatings.
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