THC chewing gum
ProPharma Group talk us through the process of creating a trial using chewing gum containing THC.
ProPharma Group has a global network of experts to support you in development of drug product, entering clinical studies and help you to get approval for a medical cannabis product in your country.
This article will provide an example of how we successfully supported a client with an idea of using chewing gums with THC for medicinal purposes.
The client is a virtual company lacking deep knowledge of developing a product towards clinical studies. They wanted to develop a formulation for oromucosal administration of THC or CBD or combination of both. A chewing gum formulation was chosen as the active substance would be administered in the buccal/oromucosal area thereby avoiding the oral route.
How did we approach this project?
Target product profile – We defined the following aspects for the chewing gum: – Project team
CMC – Quality assurance – Regulatory affairs – Clinical
This example shows that ProPharma Group has a good track record in supporting the complex activities needed to bring a product into clinical studies in the area of cannabinoids.
We set up a project team consisting of four different expertise areas, populated those with relevant SMEs and saw the project through to the initial stages of the clinical study. Now we look forward to the results of this first study in healthy volunteers, which will show us the way to further develop this product.
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