Abstract
BackgroundSubstantial advancements were achieved in the management of postoperative pain, however the need for further improvement remains. This study explores the pharmacokinetics and safety of the CannaHaler, a metered dose inhaler for plant material made by Kite-Systems situated in Tel-Aviv, Israel.MethodsThe study was conducted on 12 healthy adult volunteers divided into four arms (each arm/group holds 3 volunteers) with the evaporated plant material being Alaska strain provided by “Tikun Olam”. This strain is a hybrid of 70% Sativa and 30% Indika strains, consisting of 20–22% THC and 0% CBD. Each arm received a single dose and groups were divided in an ascending dose fashion: Group I-IV receiving 10, 15, 20, 25 mg of THC respectively. The volunteers inhaled a single dose of THC using the CannaHaler, device. Blood samples for Δ9 – Tetrahydrocannabinol (THC) and 9-THCCOOH were taken at base line and up to 30 min after dosing. Adverse events were monitored following the inhalation. Pharmacokinetics profile was obtained for each patient in all arms.ResultsAscending doses of THC produced a linear increase in the maximum concentration 10, 15, 20 and 25 mg of THC. (35.43 ± 5.97, 51.47 ± 13.79, 72.37 ± 15.93, 88.63 ± 14.75 respectively) with the same linear increase in the dimension of the AUC (441.59 ± 88.49, 624 ± 123.56, 698.35 ± 174.98, 971.36 ± 310.4 respectively) both with no change in the time needed to reach such concentration. No adverse events were recorded in all of study subjects. The CannaHaler achieved high Cmax (35.43–88.63 ng/mL) values and low coefficient of variations (16.64–26.79%) in comparison to both smoking and oral preparations, thus reaching the potential of a pharmaceutical grade device for inhaled substance.ConclusionsThe current study showed that the use of Kite-Systems CannaHaler as a smokeless medical cannabis inhalation device is feasible and efficient. The low coefficient of variation together with the high Cmax values, suggest the potential use of the CannaHaler device as a pharmaceutical cannabis dosing administrator.
Highlights
Each year millions of surgeries are performed; most surgical procedures are associated with some degree of postoperative pain
Pain related to activity will often remain moderate (VAS 4–6) for days or longer. (Brennan 2011; Moiniche et al 1997) Substantial advancements were achieved in the management of postoperative pain: pain is continuously evaluated and pain management protocols are the standard of care in every modern surgical department, the need for further improvement remains
During the current study 12 healthy volunteers were recruited for the experiment
Summary
Each year millions of surgeries are performed; most surgical procedures are associated with some degree of postoperative pain. Many of the commonly used drugs namely opiates and opiate derivates, paracetamol or non-steroidal antiinflammatory drugs, prove insufficient as a single agent and often are used in combination Often such combinations prove inadequate for lack of efficacy or multiple side effects. Tetrahydro -cannabinolo (THC) and cannabidiol mixtures offers a potentially distinctive role in postoperative pain management for its analgesic qualities, anti-inflammatory effects as well as relief of muscle spasm, reduction of nausea and vomiting, and appetite stimulation (Barden et al 2004). It may support postoperative recovery without adverse effects such as respiratory depression, renal failure, or gastrointestinal ulceration. This study explores the pharmacokinetics and safety of the CannaHaler, a metered dose inhaler for plant material made by Kite-Systems situated in Tel-Aviv, Israel
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