A Pharmaceutical Approach
Medical cannabis is enlisted as a dangerous Schedule 1 drug prescribed by licensed physicians. As such, it should be manufactured under the constrains of the pharmaceutical industry and provided to patients in pharmacies.
- Formulation: Delivery of active pharmaceutical ingredients (API) requires combination of the drug with other molecules. This combination, the formulation of the medical product ensures the stability of the drug and its delivery to the active site at the correct dosage.
- Pharmaceutical production: Manufacturing of a drug requires the employment of pharmaceutical chemicals and solvents while avoiding toxic substances.
- Quality Control assessments: In process control assays, Final Release assay and Certificate of Analysis.
- Labeling: Quantitative information regarding the active ingredients, excipients and composition of the product; caution of use; date of manufacturing; expiry date, storage conditions.
- GMP regulations: Production under Good Manufacturing Protocols (GMP). These regulations are the guidelines for pharmaceutical production of medical products.
Standardization, Accuracy, Specificity and Reproducibility
Medicinal products are characterized by their standardized manufacturing protocol, ensuring their accuracy, specificity and reproducibility. In our medical cannabis lab we produce cannabis oil extracts following our standardized protocols. Furthermore, our team constantly develops standardized protocol for production for alternative cannabis based pharmaceutical products.
The Choice of Oil Products: Oral Administration versus Smoking
Repeatability, always know your medicine:
The amount of THC and other cannabinoids is depended on numerous variables. The variability is not only related to differences between strains but is also dependent on seasonal effects, quality of the crops and the location of the flower on the stem, storage conditions and more. Thus, with cannabis flowers, at best you roughly estimate the amount THC present in a cigarette. With standardized oils, you always know the amount of THC and other cannabinoids in your bottle!
The absorbance of THC after smoking is highly dependent on the patients smoking habits and may range from 5% to 56% . Variability in bioavailability following oral administration of oils is more moderate (10-20%) .
Following oral administration of oils THC is metabolized in the liver via first pass mechanism. 11-OH-THC is a key metabolite that demonstrates a spectrum of biological activity similar to that of THC. The potency of 11-OH-THC however, has been found to exceed that of THC. Consequently, the combined effect of THC and 11-OH-THC is greater following oral administration route versus smoke.
Peak plasma levels of THC are reached within minutes after smoking, followed by rapid elimination from the circulation. Consequently, the time interval between dosing is short. The pharmacokinetics of oral administration is different, although peak plasma levels are detected 1-2 hours post intake, THC is maintained in the circulation for longer periods and lasts 4-6 hours post administration.
Social and Public Considerations.
- Patient’s life habits are sustained.
- Patient’s privacy maintained.
- Less likely to be abused