-T_S7_.iRCu ~ " OUAL:TY
s inc e ni 0 ' s -p-Rr7= c c 1 c g al Eup-- c - -:
~_n br e ak in a
snc..- ty = cSes oz :-ne tas beeri under
ng
d--'sc,-:ss i:::~ sn-_4 has lz-d :z zhe I -a - n
C' cf -0 of
nicc7ine
Niz=retze, Boehrincer Mann-ein)
2. N S a r s
n G e 1 n IT z 7. e -T S , C a G e g y - 'I ik o f
r a '10 r ,
Hefa-7r_=nc7, Ar2neini,:--el
O~har 7-7-pes :f plaster are '-e4ng tested or
have_
alreac, zeen regis:ered world ide (e.g.
'T4-c-clan, Zlan~
sold i:, '--,! War-ar-LamberzI.
in the,:- ::ar.-.acclogical effects both fcrms
(:,f appl-;caz'-cn
differ q.-i-E ~:Iaar_ly from nicotine intake via
smcking.
Nicot--ne in~~2_,re 4s slow and ccrtJnucus - w--th
chewing gur
7
7.--cctine over a perioc. of appr=x. 2C-30
-n:.n-_,tes
after in7:ake slcwlv ceases (I.) - plaster over a
period of 4-- until a plateau is reached (2). The
nico,::.ne ccncentra: ions neasured in the blood
fluctuate
an-_4 are somewhat lcwer z~ian those fcu7,--:
anong smckerz ~3,4).
in ccntrasz- :c :his, smcking induces -iery rapid
nicctine
inta',e wnic` reams that maximum ccncentraticns in
the
L-lood are acniz_,,ed wizhin 10 -nin--,,:es and
then subside
again (1).
Tte slow -_:.creas2 ---i nizc,:~_ne
concentrar-4-cm and t"9 longer
pericdl d-,~:-= it ramains high -nean ztar_ the
niccz"-ne
racapzcrs in 7-_ -zan-ral nervous syszem
Rda-pt/are blcckec.
in -eans -he stimularing effects acnievei
s:7c'-_4-7 ~:e achiaved it-, -hase produc--s f5) -
On the -h=_ ~tlmcsz constanzi, _~-;h nicot4ne
1 5 U,: 5 S S r a W a I s Y- -p 7 c 7- s
C7 r- I E e- 71 C 7 U:7 a S 1: e t
CC
13 ATCO document for Province of BritiSh Columbia
26 October 1999


Grad,_,al incraass and decrzase in n--cor-ine
::n:sitraicr.
during the day; during the night the nicor-i:.a
level
su-sidles. As i-_ is the remains
effective fr=r-. day to day.
!:) plasuer
Gradual '_ncrease and fcr-.at_4on of a olaceaL:
r==ains slmosz =5--anz. The nicszi::e leva_- t:es
not
su-side cvarnign-: (24-ouz plaster)
2. kdvantages
a ) G LI.T.
The smoka_r can organize inzake ':o suJ t '"J
~sz'f . Active
ccnzrol ~;ver inta,e and 7he condition it
pr::-.:~as.
b~ Plaszer
Sirple fc:7 of applicat'_=-.. '-ndependent of any
si':uaci=n, aria invisiole.
0 i s advanz age s
a) Gum
Pr-~~)Iams and chewing. Tn so7re :sSas nausea
and hEada--'es. The danger of' addiction.
~D) '01as':ar
In some cases skin 4rr`r=-,~cn, in I'solated
z=--=-=s nausea
and sweating. Thecretically -:he danger of
ni_-c,tine in:o1aranze -
1--7. Therapeu:icai eff=_c::
The effect :~f therapies tc break the smoking
using
plasters cr c .iewing gu:-. is disputed_ 7-
-.1 the sh:r: term (a
few wee-s) -far higher abscirence rates are
obser-,ed. After
.;.-2 years, hc-ever, these have adapted
themsel-.-es ro the
rates of place=o or ccntrcl groups which means
._'iac most
inveszigaricns do not establish success rates are
s i gr i f i c a n~ I y o e r- t =- r .
Tor this reascn. ar. -idd'_,:'_oraI behaviour
zherap, -s
recom=erided in almosr all appliCal:4,:,ns (2,7,8
7 h9 i~,rcduz': ~_s a oiasta_- whi:~ is
nan--faczured- ;sing an
innova,:ive :::7zination mem ora~ne/marrix ~_:r
-ne
ST--i"a subsz_mnce.
:~mpared c7ner pr~:-ducts this is 4. tanded
act4eve a
77 cre even r~_'ease rate _fcr :he acri-ze
substance w`izia is
:ass --zs WO CD
s -.-=n -~s '~un :'-L- cr~nz:.:'_a is sai--
s--bs':anc,~s z- cc
1 _7
BATCo document for Province of British Columbia 26
October 1999


;,s -:-= -:r-=:~ple cf n~co-:in= ip=-,4caz~on
~.Ioes not: differ
:,,f- other (Enc. 1), z:ie pharmacological
effe~:-: :ne pr,=--cz: izt all its advantages and
is eq-_ii-:alz_nz to that of the or-her nicotine
=rcduc-:s.
-he E:ne--_=z fas,:=-r absoz-ztion of nicotine
h--;c'- Stow~c
e:n;n_=si:es and !:"-,:s rhe 7ore raioid
achievement of a
clazaa.: snculd no: ze seen as a arcducr-
advantage compare,_~
with '_-ecause of :h2 generally differing
pha:-Trac---
dyna:7::3.
Ilse a ter'ad ~_f ony 'nours ~s also recs=,ended
~:r
the pr:~_uc7s of :~tnar cz-7petitors Ie.g. Fabi
Pharnazia)
The sensizivitv Rnd lower
proc.--:710n. ~::csr_s cannoz 6;? :cnclusirely
-appraised with e
curren- -.- available int~:-::nation.
Nicc::.7=_ a=clicati= in -,2 treat-nerit of
Alzheimer's and
Far~-in_==::'s diseasa is -inder discuss'-or,
worldwide and
~;ein,7 --lin-":ally tested in some cases (10).
As fa: as is known :oaay, success is only
pcssil~la if
deve_-:=:n9n: of nicc:ine inz:slerance is avoided.
nicor4ne `as :o be appl-ad shorz-zern i n
A
7
small ~_:ses e.g. innal_zricn, nasal sprays) (11).
The --ransder:7al applizarion of o~:,ter
pharmaceut4cal
prod.-:7S is dccumen,:en in several ca7ents and
'-; ?:he
o-"-jec-: :f -r.;:nerous research projects being
carri ed out
the -z:~ar:naceutical industry.
V.
The r=_;id, Leaking in:ake of nicotine which the
smoker
C"ear-__- -ants cannot be achieved with nicotine
applicat-J=
-a 7um or tlas-er ~Enc. 2)
Tc cv=_r==:ne this disadvantace other fcrrs of
nicocine
inta.ke are necessar-.-.
-or :-i_z reason inten s4ve word, is being carried
out on
deve_'=;Ing nasal sprays and inhalators (Favor
type) . Some
are --ndergcing clinical tests (6)
T~~e -~=`van:age of rapid nicotine intake similar
to that
-4 i::~ a cigars. 7a is seen in the danger of
-?eople
;:cssi,_-,_-, oec:,-7ning ~::epenaent on it.
Suc=esses in '_-reaxin,; the s7no?ing habit Rre
therefore seen
in a z:nzinaz-on of slo~~ and fasz-working
nicotine release
sysze:7s tailczed to needs.
Enc. _~ fr= 6) provides ~Ln overview of nicotine
suos7i:,_,:s sysrens ;nic" are already available
or are
N-)
Co
BATCo document for Province of British Columbia 26
October 1999


V:. :
BENOWIT-7 'I. 'Te~ j. Med. 319, 1318 (1988)
7 . RCSE j.-7. , in '-~:e Managemenz :-f Nicotine
DeDendenc?, ~-d. J.A. C~coras 13;-, Spriiger
publishing
:-,ouse (1991)
3. 2U30IS j. 7. sta'- . Find . ---xp. Clinic.
Ptarmacol .
Ii, is-, (il'-39)
4. BEITOWITZ M. aral ?har:7acol . Ther. 41, 467
(1987)
5. BEITOWITZ Bri-:. ,dd4-,=,:. 96, 495 (1991)
6. RT-ISS---'- 11. A. Brie: . Addic: . 36, 653
(1991)
7. Z-I-TCS k. Azal- Chas: 100(2(S~), 4S (1991)
3. *--JR- R. D. H. Mavo Ci~ ----- - rcc. 65, 152S
(1990)
9 . 5OLZ S71=1 'T-~AURA n The C I c a 1 Man
ageme.-It
:ependen:=, Ad. J.A. C3czres 181, Spr,-nger
1 h i n
10. NEWHOUSE P.A., HUGHES :.R., 7. Addict. 86, 521
(:991)
11. kDLK,'T-TR personal infor:7a,:i=
CD
r\-)
U-I
co
U
BATCo document for Province of British Columbia 26
October 1999


Appendix I
wo Sqffl7M
STG'~:C Product
PCTIGMIDOI85
4 b
3 a
2
I = release line-
2 = adhesive layer
3 = microporous memorane
4 a = Polveste, face
4 b = aluminised layer
5 = nicotine formulation
cc
U-7
BATCo document for Province of BritiSh Columbia 26
October 1999


' p 2 E
- n d i x
A
Construction of Nicotinell TTS
backino sheet
rr a tr i x ;aye r
fleece .,i -~
nicotine solution
mat-rix laver
(nembrane)
adhesive laver
release 14ner with
stri.o.pfr.q supoort
IN-)
00
U-I
,_-I
CIO
BATCo document for Province of British Columbia 26
October 1999


cc
W
t-
o p
cc
z
zw 0
116
0
0
In
0
z +.
z
U)
w
Y. ------------ I.,z7-
CL 0
U)
C'A
CM CM CM CM
OLU/61A) BfWn UUMVId
CD
r\)
U-I
a3
4 ~-
U-I
U.-I
I-4D
BATCo document for Province of British Columbia 26
October 1999


Anlace
RATE OF ABSORPTION SPECTRUM
TOBACCO PRODUCTS NEW DELIVERY SYSTEMS
RAPID ABSORPTIOAf
Premi .er c:garette
Inhaled smoke <-- Nicotine inhaler
Nasal snuff <- Nasal nicotine spray
Oral snuff
Chewing tobacco
Nicotine puffer
<- Nicotine lozenge
<- Nicotine chewing gum
Non-inhaled
pipe & cigar
<- N[cctine skin patch
SLOW ABSORPTION
Figure 1. znd re--- nicotine
d,!;z-:f-iys,,errs.:an be cost-rione-drou.-Idy on
a ipec.-rvnba;edonrhea:eqf
nicotine aclor,=on c&=nedfrom their ue.
00
_Z~:.
Lr_,
cr,
CD
BATCo document for Province of BritiSh Columbia 26
October 1999