The Galantamine extraction process is quite involved as you can see reading the info below we received from our supplier.
1. There are roughly 30,000 varieties of daffodils and only a handful of those varieties have the right genetics to produce Galantamine.
2. However, those daffodils do not naturally produce much Galantamine, therefore they have to be grown in the right location to stimulate them to produce Galantamine.
3. These “right locations” are not the normal place to grow daffodils, instead we’ve found they’ve got to be grown at the top of the mountains.
4. Therefore we have had to develop a completely new set of planting and harvesting equipment designed specifically for these challenging conditions.
5. Once we’ve harvested the daffodils, we then need to extract the Galantamine from the harvested biomass.
6. This ‘extraction’ is quite challenging as the biomass contains all manner of sugars, lipids and proteins as well as a real cocktail of bio-active alkaloids.
7. In addition, even after being grown in the right location the proportion of alkaloids to other material is very small in fact the biggest single fraction is water.
8. This process starts with quite a lot of filtration and concentration to get to a reasonably clean fraction to start extraction. This process involves a ‘disk-stack’ centrifuge and a clarifier centrifuge, followed by a vacuum filter press (with filter aid) and then finally a concentration step using a reverse osmosis membrane filtration.
9. The crude extraction above takes us to a ‘rich cocktail’ of daffodil bio-active alkaloids.
10. From there we need to ‘isolate’ the Galantamine from all the others.
11. So this lab process again starts with filtration step.
12. From there we use a counter current chromatography technique to get to reasonably clear first cut or each of the alkaloid fractions
13. This gives us a mother liquor to start a crystallization process. Obviously once the crystals have formed we need to drain off the mother liquor, wash off the crystals and dry them
14. We then re-dissolve the crystals and repeat the crystallization process above.
15. Again we dry the crystals in a vacuum oven at a low temperature.
16. The various crystal aliquots are all analyzed against standards (indeed we are doing analyses routinely at every step, so we can monitor the mass-transfer to the Galantamine between steps)
17. Each aliquot that passes the QC checks at this stage are then passed for blending and packing.