3. Umbruch 4.4..2005 - Online Pot

The development of Sativex ® – a natural cannabis-based medicine 243
Characterization, control and specification of BDS
The ranges for the principal cannabinoids and other cannabinoids are defined
in the BDS specification, as are the levels of non-cannabinoid compounds. The
minor cannabinoids and non-cannabinoids are considered to be adjuvants to
the principal cannabinoid rather than impurities. The non-cannabinoid fraction
may be regarded as a diluent, rather than an impurity, making up the difference
between assayed percentage of cannabinoids and 100% of the extract.
For regulatory approval, tight control of the content of the BRM, BDS and
BDP is essential. Even though the pharmaceutical product is a botanical product,
rather than a new chemical entity, characterization of more than 90% of
the composition of the whole extract is required. GW has achieved this.
Stability
Stability studies are ongoing to assess the stability of Tetranabinex ® ,
Nabidiolex ® and the finished product Sativex ® in order to establish a suitable
shelf-life for the product. Such studies include temperature cycling and photostability,
in compliance with international regulatory (International
Conference on Harmonisation) conditions. Additionally, studies are being performed
to investigate forced degradation.
Profile of a BDS
Typically, a GW Pharmaceuticals BDS contains the following.
• Principal cannabinoids
∆ 9 -THC (>90% of the cannabinoid fraction in THC BDS)
CBD (>85% of the cannabinoid fraction in CBD BDS)
• Minor cannabinoids
Cannabichromene (CBC)
Cannabigerol (CBG)
Cannabinol (CBN)
Tetrahydrocannabivarin (THC-V)
Cannabidivarin (CBD-V)
Tetrahydrocannabinolic acid (THCA)
Cannabidiolic acid (CBDA)
Cannabicyclol (CBL)
Cannabitriol (CBO)
Cannabielsoin (CBE)
Cannabichromivarin (CBC-V)
• Terpenes
Monoterpenes: myrcene, limonene, linalool, α-pinene
Sequiterpenoids: trans-caryophyllene, α-caryophyllene, caryophyllene