RESTRICTED Reference No. G3.07 Research Conference, Canada - August, 1982 GR&DC Research Programme, 1982 1984 PROPOSED REVISIONS FOR 1983 1985 Work Area 07 Hi-An Smoking/Smoke Aerosol Research General rhe major objectives of the Human Smoker Studies Programme are unchanged, although more clearly identif ied and reinforced by the need to instigate fundamental studies and develop techniques capable of assessing smoke/ smoker interaction in both sensory and pharmacological terms. ,ro make significant progress in understanding and attempt to manipulate in a benef icial way the complete smoking event there is a need for a fully integrated, multidisciplinary approach to the problems in this work area; this is planned. Programme Changes - Key Achievements 1. Kex factors controlling human smoke retention It has been clearly demonstrated in model systems that smoke particles are capable of considerable growth under the conditions experienced within the respiratory tract (01(f)). The effect of smoke aerosol concentration, physical composition and subsequent inhalation pattern on particulate retention is unknown. The implementation of a non- invasive respiratory pattern recording facility, in combination with recently acquired particle size/distribution equipment, will facilitate the study of particle growth under human smoking conditions (01 (e) ) . To complement these studies, work will be initiated in 1983 to investi- qate, puff by puff, the physical characteristics of smoke aerosols genera- ted under human smoking conditions using the puff duplicator. The findings will be used to assess the potential for developing a strategy in late 1984/early 1985 for designing products with reduced or 'controlled' growth potential. 3t is envisaged that a significant input will be required in this assess- ment by a physical chemist to characterise the structure of the smoke aerosol. In addition to the effect of growth potential on particulate retention, changes in respiratory airway 'function' can significantly influence deposition. Studies will be initiated in 1983 to study airway response to smoke and/or componentsl the findings will be integrated CYN into the smoke retention programme. Recent studies involving the evaluation of added particulate phase markers, although not fully evaluated, would suggest that this technique cf little advantage over more conventional spectrophotometric methods. BATCo document for Province of British Columbia 19 April 1999 2 Additional work (involving CKS) will be required to develop alternative techniques for assessing particulate retention by chemical means. The expertise within the smoke aerosol section will be used during 1983 and 1984 in two additional work areas: M characterisation of the particulate phase of sidestream in relation to its subjective visual and irritant assessment; (ii) identification of the role of filter/cigarette design in influencing particle size distribution, which may be of potential importance in enhancing the 'mouth" characteristics of low delivery products. 2. Evaluation of low-tar products Although originally planned for 1982, the reduction and replacement of external smoking behaviour studies with essentially internally generated work will now be complete by the end of 1983. During 1983, information will be available for the first time on long- torm switching to lower delivery cigarettes (02 (a) ) . Information on a range of smoking behaviour studies will be made available by aid-1983 through a central computer facility and will provide the basis of a group wide data base. Software facilities for analysing smoking behaviour data will be developed in collaboration w;.th other Operating Companies. The smoking behaviour section will continue to provide fundamental information on the effective dose of smoke to the smoker in relation to the cigarette design specification and to assess consumer and panel response to product modification and innovation. In addition and especially for low-tar products it is important to understand how the effective dose was attained by the smoker. Work will be programmed in this area commencing 1983 and will include the development of objective methods for measuring cigarette parameters which can be used to predict r@l how the effective dose will be obtained. Preliminary studies will be initiated in 1983 to test the potential of both combustion and filtration models to predict done (total and puff by puff) using human smoking behaviour patterns. 3. Smoke/smoker interaction and product acceptability A programme of study will be initiated in early 1983 to study the relation between mouth level intake and inhalation pattern as an inter- active mechanism for controlling an individual's smoke requirement. This specialised area of study will incorporate an input from all areas of the human studies group, including an additional contribution from a newly appointed pharmacologist. The studies programed to start in C=) 1983 will incorporate and extend existing elements of the programme (01(c,d a e)). The work will initially be carried out ip programme w.th Psychology Group (work Area 08) to allow objective measurements Cr% Lrl to be made in combination with subjective assessments. This work, BATCo document for Province of British Columbia 19 April 1999 3 together with the development of novel techniques during late 1983 and 1984, designed to investigate the fundamental nature of human sensory assessment within the respiratory tract and the development of an increased understanding of nicotine pharmacokinetics and CHS activity, will be used to develop a strategy in 19SS for developing acceptable low and ultra-low delivery products. BATCo document for Province of British Columbia 19 April 1999