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Compounding

Your Compounding Questions Answered

Martin A. Erickson III, RPh
Published Online: Monday, April 18, 2011   [ Request Print ]

Q: Is dehydroepiandrosterone (DHEA) synthesized or plant-derived?

A: The starting material of DHEA is from plants, as phytosterols are extracted from the plant. Plant sterols are not recognized by human metabolic pathways. The plant sterols are modified (reacted or combined with other moieties, if you will) to provide a basic steroid structure useful in human metabolism onto which desired groups can be attached. So, in the end, the produced material can be said to have been synthesized from plant sterols; however, for simplicity, the usual communication to patients is that the various hormones are “plant-derived,” a more general description.

As pharmacists and chemists, we know not all that is “synthesized” is put together from, for example, formaldehyde or petroleum or some other ingredient(s) and a few stray elements, but rather “synthesis” applies to many kinds of reactions and processes. This is a bit complex to explain to the average layperson/patient in a busy health care setting, not that we should avoid the discussion. I would not advocate that course of action—let your professional judgment determine what you will say in a particular situation.

So here we are in a dilemma: synthesis does not mean taking 2 or 3 or more simple chemicals and combining them to make an active drug, although that is also synthesis. Here it refers to derivation, modification, and addition (or maybe subtraction) of some moieties (radicals), etc, to a basic structure.

As far as FDA regulations are concerned, and probably as far as we know, at this point, no plant allergens are transmitted through the process. Will we discover otherwise in the future? Maybe, but for now the material is so labeled because it meets assay requirements. PT


 Mr. Erickson is director of professional affairs at Gallipot Inc. 





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