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21415064
Electronic nicotine delivery systems: a research agenda.

Beschreibung:

Electronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans. The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health. Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives.

Veröffentlicht in: Tobacco control

Veröffentlicht im: Apr 2011

21683116
Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs.

Beschreibung:

Aerosolized propylene glycol (PG) was generated as log-normally distributed particulate clouds in different concentrations using a novel capillary aerosol generator (CAG) and evaluated in a battery of non-clinical studies intended to assess its potential inhalation and systemic toxicity in 2 species before ICH-compliant "first-time-in-man" studies. Exposures were nose-only in rats, and via face mask with oropharyngeal tube in dogs. The CAG-generated PG aerosol had a mass median aerodynamic diameter (MMAD) of 2.29µm, with a 1.56 geometric standard deviation (GSD) in the rat studies, and a MMAD of 1.34µm (1.45 GSD) in the dog studies, consistent with expected particle size exposures in man. International Congress on Harmonization (ICH) Guidelines were followed, which recommend preliminary non-clinical safety studies using the vehicle and device (CAG-PG) prior to the first human exposure including safety pharmacology, pharmacokinetic (PK) studies, single dose toxicity studies, and repeated dose toxicity studies in two species. In the rat, the only biologically relevant findings included clinical signs of ocular and nasal irritation indicated by minor bleeding around the eyes and nose, and minimal laryngeal squamous metaplasia. This finding is commonly observed in inhalation studies in the rat, and likely related to the unique sensitivity of the tissue, as well as the circuitous airflow pathway through the larynx which increases particle deposition. In the female Beagle dog, treatment-related decreases in hemoglobin, red blood cells and hematocrit were observed in the two highest exposure groups, equivalent to approximately 18 and 60mg/kg/day. In male dogs from the high dose group, similar small decreases, albeit, non-statistically significant decreases were observed in these hematological markers as well. PK studies in rats and dogs showed that the absorption of PG following pulmonary inhalation exposure occurs rapidly, and equilibrium between lung tissue and plasma is achieved quickly. With daily inhalations of PG aerosols, there is evidence of minor tissue accumulation of PG in each species. Inhalation exposure to CAG-generated PG aerosols achieved PG concentrations in the systemic circulation that were similar to those attained via the oral route. Systemic elimination of PG appears to be saturable, presumably via hepatic metabolism. PG elimination in the high dose groups for both species showed terminal plasma and lung concentration-time profiles suggesting a zero-order elimination process. There was no apparent tissue toxicity of the lung, liver and kidney in these studies. Under the conditions of these studies, the NOEL for the rat was determined to be 20mg/kg/day for the 28-day study. In the Beagle dog, the NOEL was approximately 6.05mg/kg/day for the 28-day study. Overall, these studies allowed us to conclude that PG aerosol generated with the capillary aerosol generator could be administered safely in man, with an adequate margin of safety needed to conduct "first-time-in-man" human exposure studies.

Veröffentlicht in: Toxicology

Veröffentlicht im: Aug 2011

21571692
Interviews with "vapers": implications for future research with electronic cigarettes.

Beschreibung:

Awareness and use of electronic cigarettes (e-cigs) has increased dramatically. Electronic Nicotine Delivery Devices deliver an aerosol comprised usually of water, propylene glycol and/or glycerin, nicotine, and flavorings. Scant research exists to evaluate the efficacy and safety of such devices, and only one quantitative survey of European users (N = 81) has been published. This qualitative study explores e-cig users' ("vapers") experiences.

Veröffentlicht in: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

Veröffentlicht im: Aug 2011

21801287
Electronic cigarettes (e-cigs): views of aficionados and clinical/public health perspectives.

Beschreibung:

Electronic cigarettes (e-cigs) have experienced a rapid growth in popularity but little is known about how they are used.

Veröffentlicht in: International journal of clinical practice

Veröffentlicht im: Sep 2011

22045788
Saliva cotinine levels in users of electronic cigarettes.

Veröffentlicht in: The European respiratory journal

Veröffentlicht im: Oct 2011


   


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