I· 1'·· I ,.. . ~· ; I · · : :t:: ······:~i· : i:'' ··· :'·'' ·;:'' ." ,·.$'~au:u I~ :~ lil·?c: i : ii 'I · r ··~ · -· B ·~~ ·) ,· ·C:' - ;i · ~~:I. ,~:~~;~;;"~E~~'~·a~E~~I~"P~L~t"Yc";"l ~i] P ,,, I'~.~iPt~62~E~~~&RPe~"~E d 91 ri· c 1C ": .. ·;~ L1·7 r- C~ 3 ·:i I1~ICi~'~(rm~P~RM3~T~~~\~E~Y~WIIPI~JT~Pt~aae~8~~ ~· cT'' i' ·,. ,, ,~ib~i~E~iCdYAil~B~~iC~1~RI~R~t~wG~ulY~u-- r - "':x· ~·-· ··i· ··;,: ;I ii: ~9; ~· i "'Y 1~'15"ilb~ :'~b4; XWUII 31~-I~E IY~I~HI~I ~h~l6~~I~All~mEII?! i 4 L~u~~i~l'bYIEII~ I~Ylt IY*W I~~n~l~R~I~II~·YICI~IrK~i ··. '7S.C~4 21:e :I·.1·r I· .r: CI ,, O Il·l\d~w,J; I "·'· li~:ln,.,.j: i '~:~r~· · n.'·: F·tCf~ .I·~i~ I:. I J' ''I ·~·'·~tY·~ *' TV i... ., Cn u I~ BATCo document for Legal Services : Health Canada 19 May 1999 Technical Memorandum rL~b~ai* BUaFu LI~UIYLllellTRE ml~r~ol rRu~o No~ a 86,06,001 A CJMPARATIYE EYALUATION OF SMOKIYC BEHAIIDUA (PUFF·BY·PUFF) OATA CIR, PIINTER Authors fb OR, D~P. ROBIHSON R,P, RRRrS Ci~ula~on Date 6TH J~NE, 1986 File caE Key H'ords Sm)KIHO BEHRYIOUR PUFF OUPLICAiION CDHFIOE~IA1- NCT ~ BE COPIED OR SHOWN TO UNAUIHORISED PERSONS u BATCo document for Legal Senkls : Health Canada 18 Ya1l99) Author: C,R, Painter 6th June, 1986 Ref: CRPIL1/46E TM 86.06,001 A CCMPARATIYE EYALUA'TION OF SMOKING BEHAVIOUR ~PUFT-BY-'SUF~~ DATA BACKGROUND Human smoking data records supplied by Imperial Tobacco, Montreal an a puff·by·puff duplication basis have been examined within the Behavioural Testing unit of B~ UKbE, Research and Development Centti!, This further investigation was designed:o clarify certain aspects of the data which were apparently contrary to UK smoking research experience, these areas of potential anoma'y being: 1~ The shape of puff ~rofile, which was determined to be a hybrid of a square and a sine wave form. Such a profile has not beea previously observed in human snaking data. 2. A trend in the puff·by-puff profile to reducing volurnes, dropping a3proximiteiy one third across the nine puffs taken, 3, A TPM yield of 0,15 mg far the final puff where the penultimate puff is recorded as yielding 1,07 mg with a volume 10X higher. It was decided to use the UK pu~f·by-puff duplicator to duplicate the Canadian data record using the referred cigarette, Players Extra Light KS, and an in·ha~se reference cigarette, P161, which is highly similar to the Players product in design and delivery terms, PROCEDURE The Canadian human smoking record was recreated using a program designed to generate Apple data language~ This allowed an exact copy of the Canadian data to be used to drive the UK Apple based puff-by-puff duplicator, Upon duplication, parallel measurements of TPM, nicotine and water could be derived. Figure 1 shows the results derived from averages for 20 cigarettes smoked of Dcth Players Extra Mild and P161l The Figure compares profiles for Players EM and P161 as duplicated in the UK with the Canadian duplication profile, It can be observed that the UK duplicaticns indicate profiles of Players ~M and P161 to be, as expected, highly similar while the Canadian data difers~ Such is the magnitude of this difference, the Canadian final puff TPM is one-tenth tha; of the P equivalent UK dup'icated result, ICostinued ~~~ L, BATCo document for Legal Services : Health Canada 19 May 1999 These cigarettes were also smoked to standard machine smoking regime, and having produced an Apple based file it was possible to assess puf·by-puff deliveries of such. Results of this exercise are shown as Figure 2~ It is interesting to note from these results that the tenth 3j mi puff of 2 seconds duration with an interval of 58 seconds was taken in almost exactly the same place on the cigarette as the ninth human puf. However, this smaller volume produced nearly seven times as much TPM as the Canadian duplication result shows for human puff sine. CONCLUSION Assessment of the data in Figurer 1 and 2 suggests that an artefactua\ contribution may be leading to anomalies in Canadian duplication results. It is possible only to speculate on possible sources of artefact: 1~ A malfunction of the recording system, producing unusual individual puff profiles, 2. A duplicator malfunction resulting in an unusual spread of TPM data~ r nconsi stenci es i n the Cambri dge ~ad wei ghi ng data, In view of these anomalies, the indication from earlier ITL behavioural research that human smoking profiles show evidence of compensation for the tait·end delivery increase phenPnenan should be revisited~ C~R, PAINTER BAtCo document for Legal Services : Health Canada 19 May 1999 FiG, 1 U,K, PVFFxPU~F [ANxCAN.(AVERAGE BU~'T 391mml --- U.K. PUFFxPUFF P16lx[AH. (AVERAGE BUTT 34,2mm) -·- CANADIAN OUPLI[A~ION RESULTS 2.8 ii 16 Ij 21 t , i ;n r:' II 1.B \ \ i j 1,6 I 1,1 1 I/ II i~i · \i to o,s o,l j, o,z o h, 2 3 4, 5 6 1 8 jl w leer BATCo document for Legal Services : Health Canada 19 May 1999 FIG. 2 CANADIAN BUTT LENGTH AVERAGE 38,8mm P161 BU~T LENGTH AVERAGE 291mm --IP161 iD STO, 35ml PUAS SOsrl INT, ZseL OURAtlOH [A~l, · (AVERAGE FIGURES FOR 10 [IEARETT~S) 1,0 ,··' 0,9 ·1 o,B // TPH 1 ,) 0.6 0.5 0.i, 1 o,l Nl[OfHE ,,.cr~S 2 3 4 5 6 1 B 9 10 PUFFS BAfCo document for Legal Services : Health Canada 19 May 1999 B.xT ICli.and Export] limited R~SE~ReH L DEVELOPMENT CENTRE GUTHA#n:\ iNtl~NO TO Or. R~ Ginns FRON~ Mr. A.L, Heard O.p. Robinson I]r. R.R. Baker REF OPR/AIWI111 / SwE 16 February loei If Report 181 · 'OELIYER .~.~~ A CANADIAN PERSPECliYE' In a recent ITL report (No~lE1I an 'ev;tuatian' of the cigarette design model, DELIVER, has been publ~shed~ ihis evaluation was based on comparisons between Canad~ an measurements of nainstream deliveries and their prediction of these de!(veries using the DELIVER model. Such experiment v. prediction coRSatirons, if conducted carefully anC objectively, are the best and, some would argue, the only way to assess the val i di ty and range of aapl i cation of any model. Furthenore, such rigorous assessments are necessary before the model can be used with confidence, Indeed, with this approach in mind, we ourselves have conducted a wide ranoe of comparative evaluations in the past year, There assessments ha;e incl(ided machine and human smoking regimes and a variety of cigarettes, including reference cigarettes, Australian brands and Canadian brandsl Whils: not being exhaustive is their testing of the model, the results have been very enc6uraging. Having now spoken collectively uith a number of people in the Southampton R~OC and Stewart ~assey and Cathy McSride, I believe that the data presented in the Iii reprt pose some fundamental questions reoarding out present understanding cf faziors affecting cigarette deliveries Naturally, implicit in questioning our general understanding of cigarette behaviour, the basis of the DELIVER model is being challenged. The model simply reflects the understanding we have developed throughout the industry over many years through measurements of cigarette deliveries and smoking behaviour and supporting theories as influenced by a wide range of parameters. Uhilst I have a number of specific points to make regarding the inappropriate use of the model Sy IT~ under standard smoking conditions, the questions of fltnCamental understanding arise in the human smoking behaviour studies~ The points to note relate to Tables 13, 15 and Figure 13 which have been appended here for ease of reference, The smoking profile, Table r3, was purposely chosen because of the lack of variability from one puff to the nextl However, the duplicated measured deliveries show dramatic puff·by-puff delivery variations which are clearly not reflected by the DELIIIER model, Figure 13~ The question arises as to what human behavia~~ can possibly bring about such a dcliverj characteristic. unfortunately, the ITL report merely gives a ~·5 'shoppi ng' ii st of i tems to accommodate in the DELIVER model. ihe o report fails to address itself to the measured puff-by·puff variations. Typically, pufi te puff c~an3es in delirery which question our iv understanding are: BATCo document for legal Services : Health Canada 19 May 1999 Puff 2 - Puff 3 · 1~~ reduction in puff volume j4~ increase in delivery Pljii 4 · Puf 5 psfi volircs within 3", 6764 increase in delivery Puff 6 - Puff 7 puff volumes within 4 ~ · 36~ reduction in delivery Puff 8 · Puff 9 6"p increase in puff volumes 14", reducf;;on in delivery Unfortunately, even with a very vivid imagination, I and many of my colleagues in Southamptcn have failed to come up wi:h any plaus~b\e explanation, indeed, for completeness, I have plotted, in Figure I, the measured nicotine concentration per unit volume of each puff, The variations are astonishing especially when set against the predicted data from DELIVER, in the latter case, the ~onotonic trend simply reflects the increasing delivery resulting from reduced filtration by the shortening tobacco rod, Ii we accept the ITL Cats (many people don't, but I aa assured by IT1 that this is data of their highest quality), a long list of questions arises: do cigarettes have memory effects which result in one puff influencing the next in a dramatic way? Can designs enhance or moderate these effects? do smokers control/compensate for deliveries in a defined manner in order to achieve wile variations? how do sensory evaluations relate to duplicated deliveries? etc,, etc, In nrl own area, I doubt if I or anybody else could develop an understanding which would allow us to modify our models, even if it war thought appropriate, I would value any comments you might have, especially if you can come up with any plausible ex3lanations for this remarkable behaviour, in the meantime, I will write to ITL encouraging them to investigate the effects observed, Enc, cc: Mr, RIP. Fetrir O Mr, D,E, CreightPn Mr, U,D,E, Irwir, N Mr, P,K, Sandhu Mr, J,1, Beven C~ Mrs, U,C, Raines Mr, C~R, Painter - BATCo document for legal Services : Health Canada 19 May 1999 FIGURE 1 A comparison bet~eec measured and predicted nicotine deliveries for Ou Maurier light KS 450 ~ DELIVER O MEhSUIIED J00 r~ 350 S 330 /i' O O 250 o o ~50 O 100 O 50 100 150 200 250 300 350 " TIME A1IC3iT · seconds . N BAT~Co document for Legal Services : Health Canada 19 May 4999 9~sas Suc~~yb ~4JI 03q -16· r-8079-1 Program for UDoradl?g the Recordln~/Dn~llc3tlns System for Human Smoking Oblectlue: To ensure that all aspects of human smoking are accurately and properly monitored, Status: This is an ongoing activity to upgrade the recording and duplicating system for monitoring hcnn smoking behaviour, The strategy is to replace the current ISC microprocessor used for dupllca:lon with an Apple iIeltsaac system. This will result In a fully Integrated :ecordlngldupllcatlng syr:em, io date, paare 1 of the initial proposal has been achieved, ihls phase consisted 31 writing and tertlng control procedures for the Isaai'i data acfulil:tcn and control of the puffing process. Phase 2 Is underway and will be finished by February 15, 1986, This phase consists of using simulated puffs to test the software for control of the stepping motors and switches, Tests on a prototype (wlth 1 piston) are also underway. The final phase IS the validation procedure. This Includes tests with real data which should be completed by the beginning of March 1986. The new smoke duplicator will then be E~tenslvely evaluated In terms of accuracy and reprodu~lbl:lty. Consideration is also being given to the feasibility of Interfacing the apple Iie with the mainframe computer, This will allow us to transfer data directly O frn~ the Apple to :~e malnira~e lo that SAS Itatlstlcal packager oay be ;ncre readily accessed, ·~ii"~;"l i ~~ """" B~Co document for Legal Services : Health Canada 19 May 1999 -17- ;-80f9-2 Alternative Methods for Ou0l1catlon Objective: To review the presently available methods, both within and external to the BAi group, for measuring mouth level smoke constituents with the aim of assessing the feasibility of adapting andlor developing a method to be used alternatively or In condunctlon with duplication, Status: Two methods were designated for assessment: 1) the BAi (UX h E] A &1 computer program DELIVER. 2) the determination of puff by puff TPM by IR refleetance. A,prellmlnary tnves:lgatlon of the applicability of DELIVER to ITI has been completed, The results of this investigation indicated tnat DELIVER was able ~3 predict total deliveries of tar and nicotine as determined by standard smoking conditions to within 1.00X and 1.25X of the experimental values respe[tlvely. However, this could only be achieved If some of the input parameters were significantly altered from the original values, Furthermore there appeared to be serious discrepancies between predicted (OE1IVER) and experimental values or a puff by puff basis. Differences ranged from 134100X higher for the first puffs and 4416X lower for the last puffs. This :nvertigatlon is presented ~n do Internal repar: (Novem~er 30, 1P85, 5, Keleman). The results have also Seen comnunlcated to BAT (UK b E) R b O so " that further refinement of the model may continue. Bared on current information It Is not teconrmendec that DELIVER, In Its present form, be ~ ineo,porated Into the Human Smoking Behaviour methodology. However should the model be iufilclently refined In the future, serious consideration should be given to i:; inclusion as a i~urnan Smoking Behaviour prc:edure, a ··· "~°~·~:; ;F~·: ':'~PPd:~Csssll~FPIIT·l·-"~llr~· BATCo document for legal Services : Health Canada 19 May 1999 -18- The feartblllty of In~orporatlng the determination of puff by puff TPH by IR refie[tance into the recording e~ulpment for Human Smoking is presently being aririr(d. Baied dn :i~ nr!hod oi doni~nr ant 6dill an initial apparatus was developed by BAT UK Fr E A b O during 1983-81. Before any significant Investigation Is Initiated, the work of BdT UK 6 E A b O In this area will be reviewed, If these results seem promising, the apparatus could be developed during 1985. T-8079-3 Assessment of the ~easlbll!~ of Hearurlng Inhalatton Patterns and Human Retent!n of Claarette Smoke Obleetive: To lavestlgate the ur2fjiness and feasibility of measuring human Inhaiatlon patterns and retention of smoke for possible inclusion Into human smoking behavlour~stadles, Status: The project was initiated In Octsber 1985, To date a report concerning this subject has been completed, This report II a review of methods developed both within and external to the BIZT Stoup for the measurement of human Inhalatlon and retention of cigarette smoke. Behaviour Research Methods, Instr, 6 Computers, 1981, 16(3), 263-211. "An Instrumental Cigarette Smoke Monitor Designed for the Olrect Measurement of Smoke Partlculate Matter Generated In Human Smoking S~ud~er", FC;h~3F·-·~'·-·~-.---·I IX~1~L~~ ::CP 11··;:4. 1~!1~1~1 ~ .~ :ZP." BA~TCo document for Legal Services : Heath Canada 19 May 1999 -19· It is made up of three parts: Smoking patterns (~nhalatlonlExhalatloni and puff parameters. b) Human retention of cigarette smoke (nlcotlne and tar), c) Human retention of carbon monoxlde from cigarette smaktng, The conclusions and recommendations are iurrvnartzed as follows: Of all the methods reviewed In this project, only the chest rerptratory Inductive pletnysmograph combined with a modified cigarette holder or a cheek plethysmograph appears to be feasible for use in Human Smoking studies. This method Would a~tow the measurement of both Inhalatlon and puffing parameters, The results obtained appear to he relatively accurate, reliable and non-obtrusive, Although quite expenslve,:hls method permits measurements In a "natural" environment, However, the decision to Include such a method In Human Saoklng Research will also be based on the relative value of the new Iniormatlon which would be added by the method, #any methods have been developed for measuring smoke reteotlon, Experimental procedures are similar throughout all research groups and implementation appears to be relatively simple, The lame ptovlios mentioned above for lohaiatlon also apply to the adoption of a method for retention, 7-8077-17 Investigation of the Effects of Nicotine Enhancement on Human Smoking behaviour Obfectlve: To assess the changes, if any, occurring In Human Smoking Behaviour as a a result of cigarettes vlth enhanced levels of nicotir,e, O c.lr w·.a .:r - BATCo document for Legal Services : Health Canada 19 May 1999 Status: As a result of the pilot study conducted In April 1985, the appropriate levels of nicotine enhancement were determined to be 15 and 30~ for mid to high delivery products and 30 and 45% for low delivery produc:s~ These levels ate sufficiently nlg~ that changes In smoking behaviour and human delivery can be 'attrlbuted to increases In available nicotine and not to variability In the apparatus, Ou Haurler K,S~ and ~a:ln~e E~H. K,S, (IS and 4 mg tar delivery reSpectlvely) were selected as the brands for study. Cigarettes were Injected with the appropriate ouantltles of nicotine citrate solution to achieve Increases In smoke nicotine content of 15 and 30X for du Maurler K,S, and 30 and 45% for Hatliiee E,M, X,S~ The du Haurler K,S, samples had to be rejected since a distinct off-taste was noticed during subJective evaluation. Panelists had difficulty In differentiating between the control natlnCe E,M, g,S; and the nicotine enhanced sampler, The leaf and smoke analyses were conducted concurrently with the subjective evaluatton. leaf analysis Indicated the appropriate Increases In blend nicotine. However, rmo~e analysis showed a poor transfer of Injected nicotine from tobacco to smoke, This may have been due to an uneven distribution of nicotine along the tobacco rod when the sampler were Injected with nicotine citrate. It may have also contributed to the aff.tarte found for du Maurier K,S. in light of the.above, small puantltles of Hatlnee E~n~ K,S,, du Haurter K,S, and du Maurler Light K.S, tobaccos were sprayed with sufficient nicotine citrate to Increase the smoke level of nicotine by 15, 30 and 15X, Smoke analysis ~es~ltr Indicated that the smoke alcotlne of t~ele ewperlmeata' cigarettes was appropriately Increased, "'' "' "' BA~Co document for legal Services : Health Canada ~S May 1994 ·21- Suhjec:lve evaluation of the Matinee E.H, samples Indicated a small but definite difference between the control and enhanced nicotine ctgarettes~ the nicotine enhanced cigarettes were perceived to have more Impact and to be slightly more irritating than the controls, but no off-taste was detected. du Haurler K.S, cigarettes with 30X more nicotine were also tested iubjecttvely~ These results showed do naurler K.S. with added nicotine to have an equal pr sllgi~tlg greater taste level, more impact and to he Slightly more Irritating than the control, Subjective evaluation of the du naurler Light K.S~ clearly showed an increase In taste, impact and Irritation of the product with an increase in nicotine level, Of the three brands tested du Haurier light K,5~ appeared to be the most acceptable and will therefore be the product used for further study. The human smoking study is expected to start In April 1986, T-809241 bopllcation of Oelta for Product Screenlpq and Evaluation a)'Pt_alect Om_eqa Oblec:lve: To determine the relative positions of MatlnCe K,S, and Regular In the market, Status: Hatlnee, In both king size and regular lengths, was evaluated by the Delta panel relative to the major competitors, For both lengths, subjective evaluation indicated that Hatlnee was milder than its competitors, having less irritation, taste and after-effects. For the king Ilte brands, Craven A IRotnmans) appeared to be most similar to HatlnCe, while for the regular length brands, Belvedere E~n~ (B h H) was the closer: match to Hatlnee~ BATCo document for Legal Services : Health Canada 19 May 1999 -22- b) Project Swirl Oblectlve: To further evaluate the subjective characteristics of two novel filters designed to Improve the smoke ~uallty of low delivery cigarettes by changing the smoke pattern, Status: Due to differences In filtration efficiencies and ventilation, direct comparison of swirl filters and regular cellulose acetate filters on the subjective smoke ouailtles of Medallion was not possible, Far this :erron the contribution of swirl to subjective Improvement was assessed by comparing 1 s;ilrl fllteri both ulth and vlthout d picstle sleeve (whlch dtrrupts sul:l), In the previous progress report (May 19851 It was noted that the sleeve Itself caused a rublectlve change, The sleeve has now been redesigned and using the nen sleeve it has been shown that twirl doer Improve the subjec:lve response to Medallion, which delivers nominally 1 mg of tar, The next phase will c3nrlst of measuring the deliveries of these products under both standard and human smoking conditions, T-80B2·3 investloatlon of the Effect of Brand Imaper_v_p? Suble:tlve Evaiua:~on O_blectlvc: To study the Influence of brand identification and pack imagery on subjective e~a:ua:lon, ·-- -- BATCo document for Legal Services : Health Canada 19 Wlay 1999 -23- StatlJs: The initial study war reported In the previous progress report and details are given In an Internal report (dune 1985, C, Bols3oly), A second study was designed to: 1) control for product famtllarlty by using foreign products, 2) Isolate the pack effect from the brand name effect by evaluating empty packager and subsequently masked products In different packages, Panells:r were asked to evaluate: empty packager In terms of product expectations, 2j masked products alone, 3) masked products presented In their own packages, 41 masked products In different packages. 5) unmasked products atone, At this point the first four stager have been completed, Each evaluation war repeated twice with an inter-evaluation Interval of two Weeks. In any of the evaluations 85-90u of the variation has been explained and the Inter-tt~al correlation has exceeded 0,80, The fifth and final phase Is presently underway and will be completed by the end of nay, -- -- ----· ----· ---. --.~I,,----- BATCo document for Legal Services : Health Canada 19 May 1999 -24. T-8082-4 Inve rt~ qltlon of Prad uct Oua Iltr Attrl butes Ob_lec:lve: To determine the threshold level a: which subjects start to perceive a difference In the flrmness of cigarettes, States: Since the initial study tnvertlgatln~ cigarettes differing in weight by ~ 50 mg, a new study was initiated Investigating cigarettes with weight differences of ~ 25 sg. Results Indicate that, on average, subjects were still able to differentiate the flrenerr between the cigarettes, despite the fact that dppr~x:~ately 252 of the respondents claimed their answers were guesses and ail found the test very difficult, It appears, therefore, although the group results Indicate that subjects can perceive tactile differences, a smoker Would probably no; spontaneously recognize this difference as he picks a clgare:te out of patk~ Therefore It Is suggested to further study the imbac: of t~ese flrmnesr changes on the sensory evaluation of the product. BATCo document for Legal Services : Health Canada 19 May 1999 cc~usLe, -8- 2,1 siasoAR o SMOK i NG nHn I iI GHS The measured deliveries and tae appropriate predicted deliveries for each brand are given in Tabler 4-9 and illustrated In Figurer 1-6, Acceptable per puff deliveries are indicated by an asterisk, Hone of the measured deliveries exceeded the fol~o~lng ranger: 1) IPM: ~ 0,79 mg I puff ,2,81 mg I cigarette 2) Tar: ,0.50 mg I puff t 2.03 mg I clgaret~e 3) Nicotine: ,,0.04 mg I puff ,0.14 mg I clgaret~e 4) Water: ,0,75 mg I puff ~ 2,00 mg I clgaretre For the purposes of this study, total cigarette delivery II considered to be the sum of the individual puff deliveries. I: can he seen from Tables 4-9 that the total cigarette deliveries as determined In this way ate less than either declared target deliveries or total deliveries as measured by conven:lonal procedures l.e. 5 cigarettes rooked to a specific butt length on a single Eam~rldge filter, :he discrepancy between measured and target deliveries can be attributed to the experimental error associated with the determination of puff by puff deli verier, especially water, Houever,:nll discrepancy II less tnport~n::n this study ;~an It would be In:he r0utlne use of OELIYil, since :ce purpose of the former war to arrerr tnp dlfferencel betveer, measurpe and p;el:l:ed d~liv~rler O vl:n identical design pdrameterr. i i~ "B" " Ldd~"~kd ~W ~ a ai~~g· X BAf~Co document for Legal Services : Health Canada 19 May 1999 ·rc~ -26- Tal:e j SUMMARY OF THF COMPARISONS BETWEEN P9EOtCiE? A~O #EASUREO ~ELI~Ea~ES ) OPera'ins Mode I Reference Predl[t:on I Pure Ptedlcilon Si~o~lng Cond'n. I j _ Cllaret~e Delivery 1 Clodret.:e Oellverv Sr~sice Cornconent i Hl~h Hld__ Low I High Mid Low ~acblne Conditions 1 Total TPR 1 G,A. G,A, G,A, I G,A.· . G.A, ~'N,A. TAR j G,A. G.A. t,A. N.A.O G.A,, II.A. NIt. I G.A, G,A, G,A, N.A~ ~N,A,~ ~N.A. Water G,A, N,A, A,A, I N,A. N.A, N.A, Puff by Puff TPM I A,I. G,A. C,A, I R,A, A,A, TAR G,A. G.A, G,A, G,A G,A, '1S~II) Ntc. I A.d. G.A, G,A, .R:O r.A.9 sr,: C.A, .A. ,A. i,A, Hunan~ ondltl on_I Total Ntt, I G,A,' Puff by Puff Nlc. j e.A; ~ aC ~JI i~.j G.A, · good agreement Leak; ~e~wl I~ I A.~..dcce~table agreement .ne agreement good agreement with considerable manlpufatlon oi the design criteria, ed 4' ·S1O$~A BATCo document for Legal Services : Health Canada 119 May 1999 __ __I _~ ___ -31- TABLE 15: COMPRRISON OF IEISIREO ANO PREOICIED NICOTINE OELIYEa~ES (RE:ERENCE PREDICTION HO_OE) FOR OU HAUAIER IIGHT K.S~ HUMAN SMOKING CONGITIONS I NICOTINE OEIIVERY !mg) ~ _[ PUFF I MEASUREO I PREOICTEO (mg) I I HUMBER_ I X I RANGE I i I h. / I O.11 / O. OS-0~2 ~~a4/ 0.12~~~s I 2 O.11 3.1Z olS jJ 3 0.17 1 ~16·0.17 ~4~ 0.13 o.rllJ 1 0.12 / 0.10-0.13 / 0.13 iJ j 1 0.20 0,18 - 0.21 0.14 (X I i 0.21 1 0.20 - 0,22 1 0,16 1~ 1 i 0.;3 i 0.11-0.14 i 0.16 0.16 jJ I 0.12 1 0.10 - 0.13 1 0.11 IX I To~al 1 1,31 1,32 I I I_ I I BATCo document for legal Services : Heath Canada 19 May 1999 ti· B~T · ~~EPndEqo~~i~d RESEARCH d DEVELOPME~f CEHTRE R~I~~ P~k Rol~ SP~~amp~n 509 lPf EnS!lnd ~~:~o~ : Sc~hlm~on ~10~ 1B2l11 ~HI~::;269 Fix 7803?2 Ou: Ref: DPR/11/11Q 28th May, 1986 Mr, j,!, Wilson, W06HO Wills (Australia) Ltd,, R&O Department, Private Bag No. 1, Haroubra, NSW 2035, AUSTRALIA. Dear Tasmdn, Further to my telex dat2d 15th May. 1986 please find attached some details of our measured and predicted puff-by-puff deliveries on ESCORT Extra Mild. The specification of the cigarette, as required by DE1IYER, is detailed in Table i. Note that this data is sl ightly different to the data you would specify on the version of OELIVER available to you. The version used as part of this study is DELrVER (VE~SiON 3,0), The supporting docunentation for this version will be issued shortly, Additional data which needs to be specified is primarily concerned with filtration ef:iciencies for the filter. The data as defined are based largely on measurements carried out in our analytical laboratories so I would be interested to hear of any discrepancies you identify bet~een these data and your own. A major enhancement to the new version of OEL!~ER is the provision of a Irererence mode' of operation, This enables the user to scaie predictions of the model to measured deliveries and puff number of a known reference ciga:ette, As a consequence if there are differences between Australian cigarettes and t~e ciga:eiies on which the model is essentially based, for whatever reason, then the reference prediction will eliminate these differences, To illustrate the use of the model, in both pure prediction and reference modes of operation, measo:ement~ and predictions of puff·by- puff deliveries have been made far standard machine smoking and an exaggerated human smoking record. (ai Standard Malhine Smo~ing The predicted deliveries are given in OUTPUI i following tabulation of ihe cigarette and smoking specification. The predicted TPM and nicotine deliveries are alsa ~eccrdfd in Tables 2 and 3 Elon9 with the measlred O ~aif·by-puff delivarier, I: Is cledr from figu:es 1 and 2 that the /Continued ,,, ~ uarba 91 b~ a ~ i ~L6mn GrJup Ae3d OMa P 0 BoI:9: ~nlm~~e ~~~c:u~~~n4 Londo~ ~~;~ ~t ~r~p~~rd in londoa ~o 1!9762 BATCo document for Legal Services : Health Canada 19 May 1999 Mr. T,I, WilZon 28th May, 1986 predicted puff·)y·pu:f trend is largely in agreement with that measured. However, the nicotine deliveries are somewhat over-predicted. This discrepancy has been observed in previous studies and has been identified as an artefact of the experimental method, The reason being that the pragrarunab~e smoking engine leaves:he Cambridge pads exposed during the sequential smoking of the cigarettes. As a consequence there is a significant loss of nicotine ovP· the period of smoking. Fortunately, with the reference mode of operation, we can acco~nodate this experimental limitation. The subsequent reference predictions, OUTPUi 2, are displayed in Figure 3 and clearly show good agreement with the measured deliveries. (b) Human Smoking An exaggerated human smoking record, shown in Table 4, has been sjecified in DELIVER and the programmable smoking engine. Note tne very large puff volumes, u? to 165 cm3(!)1 short durations, down to 0,8s, and snort inter~uff periods. down to as low as 5.4s, The DELIVER prediction for the pure predicti6e mode, OUTPUT 3, is tabulated in Tables 5 and 6 along with tne measu:ec data for TPM and nicotine respectively, from figure 4 it is clear that the DELIVER model is an extremely accurate representation of the measured cigarette behaviour. For nicotine, shown in Figure 5, the pad loss shown in the machine smoking is again apparent. Hawever ne are now in a position to utilise the reference moce, ~~seB on the machine smoking previously described, to predict the 'true' nicotine delivery, OUTPUT 4. This is shown in Figure 6 along with measured data. The agreement now, to say the least, is very encouraging. This early test of the capability of the DELIVER model under exaggerated human smoaing conditions is part of a broader study investigating the validity and range of application of the model. Whilst the human record used is extreme in the sense that high volumes, low duration and short interpoff periods are imposed this one run cannot be regarded as a definitive test of the model. We are at present conducting a systematic investigation into a range of volumes, durations and interpuff periods which miaht or might not highlight the need for some improvements to the model, iho ujtieate test will be to construct a 'human' record ~Ynich mixes ail three characteristics in a random manner. I will keep you informed of the availability of the new model and its documentation and of further validation and application tests as they are car;iec out, All the best, Yours sincerely, D,P, ADB1NSON, VI Encs, CC: O:, R,~, Bake: Cn 41- / BATCo document for Legal Senrices : Health Canada 19 May 1999 TABLE 2 IPM PUFF·BY·PUFF DELIVERIES FOR ~i2ACHI~E Sh~iclNG · ESCORT EM Measured Puff No, DELIVER 1 0,79 1 0,42 0,086 2 0,84 0,82 0,057 3 0.95 1,03 0,052 4 1,08 1,21 0,091 5 1,23 1,43 0,065 6 1,41 1,45 0,059 7 1,65 1,51 0,067 Overaii iii TABLE 3 NICOTINE PUFF·BY·PUFF DELIVERIES FOR MACHINE SillKING; ESCORT EM Measured Puff No, DELIVER ,,, i.,. 1 0,10 0,048 0,032 2 0,11 0,08 0,007 3 0,13 0,098 0,008 4 0,15 0,11 O,OOT 5 0,17 0,133 0,013 6 0,20 0,135 0.005 7 0,23 0,155 0,011 Overall 1.09 0,759 O 'Me?o of fou: sets of datd each on five cigarettes ;J BATCo document for Legal Services : Health Canada 19 May 1999 n 3 :I elf cu ii n r L -I I-I 'r~~~~' H*5 C1 ~t' St' 3 (3 nUu t~i I-Ill jiEe~LL C*~ (C K.tL *hTL xmEr My rrw ruu c~l 1:i rr~ Is E E U ~j ~I 1I1 3~- u u ri uuz 3' r ;j u 13 b 9 ii" :~~30h7 030 1) In~h cnon dnor h3 03CZ 3n0 5~1 I·I I(·I I·I 1· ·I II t I(( II I· II (Ily I I· I II Irio 5;:~pPk CC3 nt nhP* ~con ncgp nO ·3~- r*a 3ul! 131 : u cr i s~uu ~~Y~ h~~p nn 3 7 n lil : 1 1,I ,· I I Ir I I !u 31 1U I 1 I~ ;I I I I- 3~ 1 I Ic o 1~1 Iln II :I r-- tZ,' lil : ~1 r I~ I1I u r, r~J~ Zilyly I~LU ~CJZ ~~i c ii I~I- cl* ,3 3L~C 31* ;t lrIi ~~,-1~0 s*r ;i ,O~~ LJ~U LO~U LI ~~;- ZCC ;*IL rp 11I 1: ca 1 13 Ur I I ii I· I I I~ I I IP UJ I i II YI LI ni 1P rP cb I I ~u I I i, I I ,- ,, I I 1 1 ,n I I ~· 3~ 1 · · In I . 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JE i··I 1;1 ;J~ -, * s 'Y I I I 1 r 1 s :; ~J I 1 i ~u II ' I~ i I* ~* I I c ~* c t c c r ii:: 1- I: I I ,r u :1 y 1 ? le 11173 :- ~ LrI :; i 'L u * Jj L··~IZ r * ~·: I C ~I I i H c~ ',: 3 11 iu 7e ~· lq ~· c, ~D I~ ij I c Q - C rY Ir L :L ~e ~L C cC ', *IL -;-ru~ r~( ~~ Y 3J ~ L~ Jl -J ~ ~rli 3I: lli I- Jc~ ~~ Y. ii. ~. ;e i 1:Z-; Y~ L1 ~ Iv. ~-,su~< ·~. i- 3 ea ; L1 3 Ya -C C, I I~r I~ rl ~Yr flI' u~ ~Z cc cr u r* ii iC~s LiII' ic ;- ,~L >Ce ~~I~ -I 2: rlc: Ire: s~c: ~~ UL-; I: ::'-C;- ci; ~: r3~~ C~3~ cL3U cY C~f- i~y nill O I J ., _3.-1 ~U3 1~ *, ;3 **I C+V -: +ui~ ~u~~ 4u~~ 2r r-T; Lil :$I~ N ~~l~~,v~3 u BATCo dacumont for Legll Senicor : Hsalth Clnlda 19 May 1919 TABLE 4 HUMAN SMOKING RECORD Puff No. Yalocl~mi/ Ollrdipn(i) In[~ruallri 1 ; 164,70 2,4 25,2 Z 77,90 0,9 1 17,2 3 92,50 1,5 1 10,0 4 j 90,90 1,3 7,4 5 88,60 1,2 14,2 6 83,20 1,1 14,8 7 1 83,!0 1,1 t1,0 8 81,30 1,2 5,4 9 87,80 1,3 10,6 10 84,40 1,1 8,9 11 77,90 i 1,0 16,1 12 79,20 1,0 20,9 13 i 78,00 1,0 18,9 14 1 68,50 0.8 17.7 15 84,98 1,2 BATCo document for Legal Services : Health Canada 19 lay 1999 TABLE 5 iPM PUFF-BY-PUFF DELIVERIES FOR HUMAN SI~O~I~;ESCDRT EM i I Measured Puff No, I DELI\rER Nlan' ) S.D. 3,85 2.935 0,206 2 1,99 1,97 0,067. 3 i 2,43 2,595 0,096 $ 2,56 2,665 0,255 5 2,65 2,815 0,285 6 2.64 2.44 0.260 1 2,78 2.86 0,348 8 2,84 3,18 0,084 9 3,26 3,735 0,243 10 3.43 3,855 0,408 11 3,38 3,72 0,702 TABLE 6 NICOTINE PUFF-BY-PUFF DELIVERIES FDR HUMAN SMOKING ;~E~~OR1~ EM Measured Puff Nb, DELIVER Mean" S,O, 1 0,56 0,14 0,039 2 0,29 0,183 0,015 ' 3 0,34 0,235 0,015 4 0,36 0,215 0,011 5 0.36 0.22 0,018 6 0,35 0,22 1 0,022 7 0.37 0,26 0,037 8 0,37 1 0,28 0,012 9 0,42 0,295 0,026 10 0,41 0,31 0,049 11 0,40 0,29 0.041( hi tMe?n of four sets of data each on five cigarettes Co BATCo document for Legal Services : Health Canada 19 May 1999 i I "1~ a 1\ i I 1 I i ~I ,· i , c :: I I~ it z d PH HO rr ~Z 5:H wr 10 Q m to a rj ~I~HJ,W~:- ,~O" i 1 C O BATCo document for Legal Services : Health Canada II May 1941 b ~I d w I M o I i IH Ci~ M HPI ~] I ;r= ~H i ~I :lij #~r U1 O CI O ~1 Q CI O ~1 rl O ~, rl ~. ~I rl (1 rl O Ei % ~JH~(~M.-,TU;' E O N U BATCo doeumsnt for Lsg~l Sentlt : Ho~lL Canldl 19 Yy ~999 ia ia 1 . j Ij I\ I :?' ~I ~I W ~I I u H I / k~ r H i i =I~ z a IH I ·· e ~O ~f I r i;. 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