In general conducting Inhalation studies using powder / liquid products are easy by generating the aerosol or fine dust using nose only exposure inhalation systems.
Palamur received the herbal cigarettes from its client for conducting acute and sub acute inhalation studies. We estimated successful how much cigarette smoke was generated by each puff by smokers and also how much puffs will be maximum for individual cigarettes.
Palamur found 35 ml of smoke was occupied in each puff to the smoker’s buccal cavity and maximum 7 pups are used for one stick of cigarette. Based on the above information, we have developed the cigarette smoking machine and successfully generated the required smoke for conducting the inhalation studies.
The product was an Anticancer drug fromulation and the challenge was to find a suitable vehicle for oral gavage Pharmacokinetic study in beagle dogs.
Palamar undertakes Pharmacokinetic studies along with the leading R&D Pharma companies in India and recently conducted one of the client anticancer formulations to study kinetic profile in Beagle Dog. All the dogs were vomited immediately within 5 minutes after the oral gavage the study was repeated with less concentration twice and resulted the same situation. Palamur identified that drug is not creating a problem; need to change the acceptable vehicle to Dogs.
Based on the properties of the drug we developed a unique formulation which was acceptable to the dog. A day of dosing was undertaken in multiple dogs to ensure that the formulation was well received. This ensured smooth conduct of the study with no challenge, with respect to the development of formulation or emesis in the dogs.