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JACQUES MICHAUD
Cerestar
Application Centre Pharma & Chemical
Vilvoorde, Belgium
Pharmaceutical
confectionery
24
SEPTEMBER 2002
PHARMACEUTICALS
SEPTEMBER 2002
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SEPTEMBER 2002
gastrointestinal
tract either
Active ingredient
dissolved or
suspended in
Benzalkonium
saliva and are
thus present in a
Cinnamic acid
readily bioCodeine phosphate
available form.
Camphor
The formulation
Camphorated opium lind
of a chewing gum is
Acetic acid
always based on the
Guaicol
gum base, see typical
Guaiphesin
formulation of a
Fluorinated chewing
Halogenated phenols
gum in Table VI.
Ipecacuanha liquid extract
Other added
Papaverine hydrochloride
components typically
Terpineol
include sweetening
agents, flavour and
aromas. The gum
base can consist of a complex mixture of
elastomers either natural or synthetic such
as polyisobutylene or styrene-butadiene,
PHARMACEUTICALS
REFERENCES
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Although it is quite
medicated chewing
Table V - Flowability of sorbitol
difficult to design
gum. A reduction of
according to particle size distribution
clinical trials for
the particle size of
chewing gum
the drug before its
Fine
Medium Coarse
formulated drugs, it
addition to the gum
Carr Index 20.6
20
15
has been reported
base can be used to
that a minimum
retard the release.
chewing time of 30
Finer particles can be
minutes should be used to be able to
more tightly embedded into the gum base
extrapolate the ordinary use of chewing
and their contact with saliva can therefore
gum. The rate at which a patient chews
be delayed. Another sustained release
the gum also affects the release of the
formulation possibility is the binding of a
drug. The average chewing rate is
drug to an ion exchange resin to decrease
normally about one chew every second,
the release. This is the well known example
although, it has been shown that slower
of Nicorette for which nicotine is
chewing rates give significantly lower
complexed to a methacrylic acid polymer.
drug release. The release of water
Different coating agents such as
soluble drugs (at least 100 g/l) is
polyvinylpyrrolidone and cellulose
generally about 75% or more during the
derivatives have also been used to obtain
first 5 minutes of chewing. When the
prolonged release. Embedding a drug in a
water solubility of a drug is lower, the
hydrophobic matrix consisting of lecithin
release of this drug decreases accordingly
and synthetic waxes is also reported.
(Figure 3) and not more that 5% release
Although pharmaceutical confectionery
can be expected for a drug
products are
that exhibit solubility lower Table VI - Composition
manufactured according
than 3 g/l.
to processed resembling
of a commercially available
The rapid release of
those of food products,
medicated chewing gum
drugs with high water
they must be strictly
solubility from a
complying with
Ingredients
Percentage
conventional chewing gum
pharmaceutical rules both
Gum base
52.6
might become a drawback
for ethical or OTC
Paraffin oil
3.4
when a sustained release
products. Full
Sorbitol
40.8
of the active ingredient is
documentation and
Mannitol
0.9
targeted. Only few
validation are required to
Saccharin
0.1
methods have been
obtain a product licence
Aromas
2.1
reported up to now to
from the national
Sodium fluoride
0.1
slow down the release of
authorities when any
the drug from the
medical claim is made. In
PHARMACEUTICALS
SEPTEMBER 2002
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