Thesis
The Effect of CMC-Na Types Towards the Filtration Process and Stability of CMC-Na 0.5% Eye Drops
Dry eye disease (DED) is a common ocular disorder with multiple underlying causes.
Carboxymethylcellulose sodium (CMC-Na) is frequently used in artificial tear formulations to alleviate
DED symptoms. Different CMC-Na types from various brands can exhibit varying degrees of
substitution (DS) and viscosity, leading to variations in filtration process performance and stability in
formulations. This study aimed to evaluate the filtration process and stability of 0.5% CMC-Na eye
drops prepared using different CMC-Na types. Compatibility and stability tests during the
pre-formulation stage confirmed that all ingredients were compatible and stable. The findings
revealed that the combination of ultra-turrax mixing and steam sterilization yielded the most
favorable filtration outcomes, with the highest throughput and average flux. Among the different
CMC-Na types, type D from brand X was identified as the preferred choice, maintaining stable
physical properties, including viscosity, pH, osmolality, and density under stress conditions. Statistical
analysis indicated a significant impact of CMC-Na type and stress conditions on the filtration process
and stability, but there was no significant interaction between these factors. Future research should
include extensive stability testing under real-time storage conditions, investigating the impact of
mixing and steam sterilization, minimizing holding time, and undertaking additional chemical
analyses.
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