СТУДИЈА НА СТАБИЛНОСТ НА СУВ ЦВЕТ ОД МЕДИЦИНСКИ КАНАБИС
STABILITY STUDY OF DRIED CANNABIS FLOWER

Summary/Abstract: Anytime someone is prescribed a medication, they expect to see details for use on the medicine’s label, including the shelf life and the recommended storage conditions. This should be no different when they receive their dry cannabis flower. Every pharmaceutical product on the market shall be constituted so that, if stored as it is directed, it will meet all applicable pharmacopoeia requirements and manufacturer’s specifications until its expiration date. More people than ever rely on medical cannabis to manage their health problems like chronic pain, epilepsy, multiple sclerosis, and more. The stability programme designed with the ICHQ1 Guidelines on Stability is required to establish the shelf life of a product and for receiving a marketing authorization. According to EU-GMP, the manufacturer must have an ongoing stability programme to support the shelf-life of the product. The specific requirements for stability testing on herbal drugs like Cannabis, which is a narcotic substance, are sometimes challenging. E.g., storage needs to be done in climate chambers in specifically designed and secured facilities. In addition, specific rules have to be followed concerning transport, sample and waste handling, and documentation. (GMP journal 04.2022). Stability testing for medical cannabis is a scientific process that evaluates how a product degrades over time under different environmental conditions, such as temperature, humidity, and light. Stability testing involves placing samples into environmental chambers to monitor how the product’s quality changes over time. Each condition simulates real-world scenarios to help predict how the product will behave throughout its shelf life. The purpose of a stability study of dry medical cannabis flower is to determine how long the product retains its quality, safety, and efficacy under different storage conditions. Such studies analyze physicochemical properties, including the content of active cannabinoids (THC and CBD), moisture, and microbiological purity. This stability study is performed on three batches of the same strength, and all batches are packed the same way. The difference between them is that they are set at different storage conditions. They are set at Long-term storage conditions (25°C ± 2°C // 60% RH ± 5% RH) and at Intermediate storage conditions (30°C ± 2°C // 65% RH ± 5% RH). Samples are tested every three months, including the starting test point at 0 months, when all testing parameters are performed. All testing parameters are performed at the 12-th month, and between these testing points at 3, 6, and 9 months, only stability indicative parameters are performed. The obtained results clearly show that this product remains with its Quality Specification requirements, and that there is no significant degradation at the active cannabinoids THC and CBD, which means that this product, packed in its original packaging, and stored under recommended conditions on the packaging it is stable for one year. This stability study can be prolonged for one more year, according to the ICH Guideline. Additionally, a stability study can be performed on different packaging, which can include the largest and the smallest packaging, and thereby apply the Bracketing stability model, or some other model according to EU-GMP.

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