Compounding Hotline

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

If I want to buy progesterone micronized USP for compounding, what kind should I order: soy 5, soy 25, yam 5, yam 25, wettable??

The "5" and "25" refer to the approximate size of the majority of the particles, in microns. "Soy" refers to soy derivation (stigmasterol is extracted from soy and modified to hormones). "Yam" refers to wild yam derivation (diosgenin is extracted from wild yam and modified to hormones). The micronized forms (~5 and 25 micron) are used primarily for capsules—studies show improved bioavailability of micronized progesterone when Methocel E4M or an oil is used as an excipient in the capsule. The micronized form may also be used to compound topical preparations. It should not be used to compound molten, cooled, and hardened forms such as suppositories and troches—only the wettable form should be used for these, because the wettable particles are much larger and suspend better in the melt. For capsules, some compounders prefer 25 micron, claiming that 5 micron is too "flyaway" (ie, it picks up a static charge, resulting in particles repelling each other). Remedies include increasing the humidity in the room, using a beta-emitter, and others. Once a particle size is chosen, the compounder should specify the source and particle size in the formulation and always use that form. If another form is used (25 instead of 5, for example), the capsule formulation must be recalculated because of displacement differences. Wettable progesterone may be used to compound topical preparations.

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