After shoeing, the
ugg boots
from all of the formulations had a good appearance. None of the tablets
exhibited any signs of defects either during or after the shoeing
trials. Tablets from all the batches passed the acid phase of
dissolution testing with no release of ASA after 2 hours in 0.1 N HCL.
During the buffer phase of testing (pH=6.80, as with the unshoeed tablet
dissolution results, only the tablets containing just MCC and ASA
failed to meet the USP specification of not less than 80% ASA released
in 90 min. In fact, the other five formulations attained 80% ASA release
in less than 20 min.
After 3 months of storage at 40 degrees
uggs boots,
some of the tablets containing CCS or SSG exhibited softening of the
film shoeing and sticking of the tablets to one another within the HDPE
bottles. This occurred in the samples that were packaged both with and
without desiccant packs. Any tablets exhibiting signs of defects at this
point were considered stability failures.
The free salicylic acid results for the shoeed tablets were very similar
to those results obtained for the unshoeed tablets. The north face
denalilimit for the free salicylic acid in shoeed ASA tablets, 3.0%, is
higher than the unshoeed tablet specification. After 3 months in
accelerated conditions, the tablets containing just MCC as the excipient
exhibited higher, but acceptable, free salicylic acid levels.
Par
golfs le mardi 26 juillet 2011
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