Glyceryl trinitrate dissolution too slow
July 29, 2016
FOLLOWING the Therapeutic
Goods Administration’s (TGA’s)
02 Jun Safety Advisory regarding
Anginine and Lycinate (glyceryl
trinitrate - GTN) tabs being slower
than expected in their rate of
dissolving under the tongue, as
well as being hard to break in half,
TGA tests have confirmed that the
round tablets do have a problem.
To address this issue, Arrow
Pharmaceuticals is working to
reformulate the product but this
will take some time, the TGA said.
With no other supplier of GTN
in Australia, the TGA is working
with industry to source alternative
supply, but recognises that the
current product is preferable to no
supply in terms of patient health.
In addition, the packaging is being
redesigned to clarify that the drug
is to be taken sublingually.
An older formulation of the drug
is presented in a square tablet and
does dissolve within the required
five minutes but consumers will
need to be advised to check that
their stock is still in date.
If clinically appropriate, the
TGA recommends healthcare
professionals consider switching
patients who use GTN tablets to the
GTN spray, Nitrolingual Pump Spray,
noting that the spray delivers a
different dose (400 micrograms) to
the tablets (600 micrograms).
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