At PCCA Science, we continuously build and grow scientific support for compounding and the technologies our members use in their practices. We test our bases using various methods before, during and after the release of a new product. We regularly submit results of these studies for publication in peer-reviewed journals and make them available to our members, who in turn can share them with prescribers, physicians and patients.

In Vitro Evaluation of the Percutaneous Absorption of Progesterone in Anhydrous Permeation-Enhancing Base Using the Franz Skin Finite Dose Model and Mass Spectrometry

What does the study say?

This study, published in the Archives of Dermatological Research, compares how well progesterone penetrates the skin in two topical formulations: one using Anhydrous VersaBase HRT and the second using a non-ionic cream. Results of the study showed that Anhydrous VersaBase HRT had a 3.2-fold increase in skin penetration over the non-ionic cream base, indicating it may be a good base to use in topical progesterone formulations.

Figure 1: The Anhydrous VersaBase HRT formulation offered a 3.2-fold increase in optical density (p = 0.029) for progesterone penetrating layers of skin compared to the non-ionic cream formulation.

What do the results of the study mean to prescribers and physicians?

Progesterone in a topical preparation using Anhydrous VersaBase HRT shows exceptional delivery of the hormone through the skin compared to the standard non-ionic cream base. It also indicates that the stability and potency of progesterone in the Anhydrous VersaBase HRT formulation was consistent for more than 180 days. Consistent hormone delivery is commonly recognized as achieving optimal prescriptive therapeutic outcomes for patients.

What do the results mean to patients?

The 180 beyond-use date (BUD) means patients will make fewer trips to the pharmacy for refills. Consistent hormone delivery may potentially help patients achieve a better therapeutic outcome.

What does anhydrous mean and why is that important?

Literally, anhydrous indicates a substance that contains no water. For compounded preparations, it means the water activity (Aw) — or the amount of available water in a substance — is less than 0.6 (<0.6). This is important because compounded preparations with Aw <0.6 do not support the growth of bacteria, yeast or molds.

Get a summary of study methods, images, graphs and more here.

*USP 795 establishes BUD limits by type of preparation in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information.

Progesterone: Size Matters

PCCA offers USP-grade Special Micronized Progesterone with an unparalleled particle size to promote better bioavailability:

• 100% <9 microns
• 99% <5 microns
• 90% <2 microns

Additional Benefits

• Consistently sourced from FDA-registered and GMP-compliant facilities
• Tested in PCCA formulations in a range of concentrations
• Above and beyond USP standards

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.