REDUCED STABILITY STUDY DESIGN FOR HERBAL PRODUCT „DRY CANNABIS FLOSS“

Abstract

Stability of the final product, independently whether it is an active substance or a drug of herbal, mineral
or other origin, according to the guide of the International Conference for Harmonization (ICH): "Stability testing of
new drug substances and products Q1A(R2)" is defined as the ability of the final product to keep the quality
(physical-chemical and microbiological) prescribed in the specification for quality within the expiry date if it is
stored in the proposed packaging. Stability testing enables the establishment of recommended storage conditions,
retesting period, or expiry date for the product. When it comes to determining the stability of a herbal product, the
procedure is more complex, taking into account the inhomogeneity of herbal preparations, which depends on many
factors. This is also the case with cannabis-based preparations, especially dried cannabis flowers, which can be very
heterogeneous depending on the variety. Therefore, it is necessary to test the stability of such products with a
precisely defined protocol, a properly selected series of flowers, properly selected parameters to be monitored and
the justification of the choice of parameters. In such cases, the guide provides accurate guidance for developing a
stability protocol using a reduced design that simultaneously provides more information about the quality of the
product packaged in several different packages, while significantly reducing the number of analyzes performed. In
this way, the manufacturer using this design has an advantage in terms of reduced financial burden, reduced time
constraints for obtaining data and rapid scientific expertise for decision making. In this direction, the aim of our
research was to develop a protocol for monitoring the stability of dried cannabis flowers in different sizes from the
same package using a reduced design, according to the guidelines of the International Council for Harmonization for
the preparation of this type of stability study. During creating the protocol, the following topics were taken into
account: specifications and certificates on the quality of the materials used for the final packaging of the herbal
product, technological files for each produced batch of flowers that are tested for stability, as well as procedures and
instructions for the process of growing and processing the flower . The stability study included batches of the final
plant product - dried cannabis flower, with the same potency, or uniform content of the active component with
proven therapeutic activity (tetrahydrocannabinol), so that the results would be comparable. The final product, dried
cannabis flower, was packaged in multi-layer aluminum packaging in three different sizes. A stability protocol was
developed in a way to includ different sampling frequencies from different packaging size, using bracketing and
matrix principles. When carrying out the reduced design of the stability study, it was considered that the deviation of
any parameter at any point of the test would mean a further extension of the test to obtain more relevant data to
support the proposed packaging in the appropriate shelf life.