背景:尽管全球范围内医用大麻(MC)的使用呈上升趋势,关于植物材料中植物大麻素在不同储存条件下的长期稳定性的数据不足。具体来说,关于储存条件对汽化大麻中(-)-Δ9-反式-四氢大麻酚(THC)可用性的影响的数据不足.Syqe吸入器通过吸入提供计量剂量的植物大麻素,并利用包装在防篡改墨盒中的精确数量的研磨大麻花序。我们旨在评估在Syqe墨盒中包装之前和之后的地面大麻中植物大麻素的稳定性,以及雾化剂量中THC递送的可重复性。
方法:在不同的温度和湿度条件下储存地面MC花序,包装在Syqe墨盒中之前或之后。在不同时间点使用超高效液相色谱(U-HPLC)分析其中的主要植物大麻素的浓度。使用在25°C下储存长达2年的药筒评估通过Syqe吸入器雾化的THC剂量。每个蒸气芯片包含13.5±0.9mg的研磨MC粉末。
结果:在聚丙烯容器中批量储存3个月后,在5°C下密封在铝箔袋中,未观察到磨碎的大麻花序中植物大麻素浓度的显着变化。相比之下,当将地面花序在25°C的墨盒中存储2年时,发现植物大麻素浓度发生了显着变化。具体来说,CBGA,THCA,总THC浓度从基线时的0.097±0.023、2.7±0.3和2.80±0.16mg/片下降至0.044±0.007(下降55%),1.50±0.27(减少44%),2年后为2.20±0.083(下降21%)毫克/片,分别,而CBN和THC浓度从基线时的0.005±0.005和0.44±0.11mg/片增加到2年后的0.14±0.006(2700%增加)和0.88±0.22mg/片,分别。在30°C下储存显示在更短的时间内植物大麻素浓度的更陡的变化。尽管盒内的相对大麻素成分发生了显着变化,气雾剂中存在的THC的实际剂量在此期间保持相对稳定,并且在药物级吸入器所需的500mcg±25%的剂量范围内.
结论:Syqe药筒中的MC粉末可以在生产后在室温下储存至少2年,而不会影响输送给患者的雾化THC剂量超过±25%。未来的研究应该分析大麻花序中的其他植物大麻素和萜烯,并评估在Syqe药筒中储存后不同大麻品种的稳定性。
BACKGROUND: Although the worldwide use of medical cannabis (MC) is on the rise, there is insufficient data regarding the long-term stability of
phytocannabinoids in the plant material under different storage conditions. Specifically, there is insufficient data on the effect of storage conditions on the availability of (-)-∆9-trans-tetrahydrocannabinol (THC) in vaporized cannabis. The Syqe inhaler delivers metered doses of
phytocannabinoids by inhalation and utilizes accurate quantities of ground cannabis inflorescence packaged in tamper-proof cartridges. We aimed to assess the stability of
phytocannabinoids in ground cannabis before and after packaging in Syqe cartridges as well as the reproducibility of THC delivery in the aerosolized dose.
METHODS: Ground MC inflorescence was stored under different temperature and humidity conditions, before or after being packaged in Syqe cartridges. Concentrations of the major
phytocannabinoids therein were analyzed at different time points using ultra-high performance liquid chromatography (U-HPLC). THC doses aerosolized via the Syqe inhaler were evaluated using cartridges stored for up to 2 years at 25°C. Every vapor chip contains 13.5±0.9 mg of ground MC powder.
RESULTS: No significant changes were observed in phytocannabinoid concentrations in ground cannabis inflorescence after 3 months of bulk storage in a polypropylene container and sealed in an aluminum foil pouch at 5°C. In contrast, significant changes in phytocannabinoid concentrations were found when ground inflorescence was stored in the cartridges at 25°C for 2 years. Specifically, CBGA, THCA, and total THC concentrations decreased from 0.097±0.023, 2.7±0.3, and 2.80±0.16 mg/chip at baseline to 0.044±0.007 (55% decrease), 1.50±0.27 (44% decrease), and 2.20±0.083 (21% decrease) mg/chip following 2 years, respectively, while CBN and THC concentrations increased from 0.005±0.005 and 0.44±0.11 mg/chip at baseline to 0.14±0.006 (2700% increase) and 0.88±0.22 (100% increase) mg/chip following 2 years, respectively. Storage at 30°C revealed a steeper change in phytocannabinoid concentrations within an even shorter period. Despite the significant change of relative cannabinoid composition within the cartridge, the actual THC dose present in the aerosol remained relatively stable throughout this period and within the dosage range of 500mcg±25% required for pharmaceutical-grade inhalers.
CONCLUSIONS: MC powder in Syqe cartridges may be stored at room temperature for at least 2 years after production without affecting the aerosolized THC dose delivered to patients by more than ±25%. Future studies should analyze additional
phytocannabinoids and terpenes in the cannabis inflorescence and assess the stability of different cannabis cultivars following storage in Syqe cartridges.