By PCCA

We debuted our innovative compounding base Ellage Anhydrous Vaginal at the virtual International Seminar 2020. This proprietary PCCA base is the first anhydrous vehicle in the pharmacy compounding industry that was developed specifically for vaginal use. Ellage was designed to be gentle on vaginal tissue, release drugs and keep them in contact with the mucosal surface — all while providing a pleasant experience for patients with various health challenges who need compounded vaginal medication.

Ellage Anhydrous Vaginal is made of pharmaceutical-grade ingredients, all of which are used in FDA-approved drug products, and it has several characteristics that make it a promising new tool that compounding pharmacies can use to meet the needs of patients. Here are our top four reasons why you should try it in your pharmacy:

1. Ellage has significant potential to minimize the leakage of vaginal medication.

A common complaint for vaginal creams and gels is that they are messy and tend to leak. That’s why our Research and Development (R&D) team set out to create a compounding base that would provide customized medications without this drawback. The PCCA Science team, which is part of our R&D department, also assessed this product to see how well it would perform in that regard. In an in vitro leakage test , they applied two Ellage formulations to agar plates tilted at a high angle to see if the preparations would run down the plates — neither one did, even when diluted with synthetic vaginal fluid. This test shows that Ellage Anhydrous Vaginal is likely to adhere to vaginal tissue for a long period of time without leakage or messiness, despite vaginal secretions. Therefore, it may provide a much better medication experience for patients.

2. Ellage is nonirritating and doesn’t affect vaginal pH.

Our R&D team developed Ellage to be very gentle on vaginal tissue, and PCCA Science has conducted two in vitro tests to prove it’s just that. One irritation test assessed how Ellage affected a membrane within a hen’s egg, which is considered more sensitive than human vaginal tissue. Another irritation test evaluated its effect on EpiVaginal^™ tissue, which mimics vaginal mucosal tissue. These tests revealed that Ellage is nonirritating and that it is as mild as two over-the-counter vaginal lubricant products.

The PCCA Science team also assessed how the base affected the pH of a synthetic vaginal fluid. The results of this in vitro test show that Ellage does not affect vaginal pH. However, please note that ingredients incorporated into Ellage may affect the pH.

3. You can use Ellage with a wide variety of active pharmaceutical ingredients (APIs).

PCCA’s R&D team developed Ellage to be versatile so that it could allow compounders to make better customized vaginal medication for each and every woman. That’s why Ellage can accommodate a wide variety of APIs, including hormones, antimicrobials, antifungals, anti-inflammatories, anesthetics and vasodilators. In fact, our Formulation Development team has already created and tested over 50 formulas that use Ellage and a broad range of APIs. PCCA members with Clinical Services support can access this growing list in our formula database .

4. Ellage can save your compounding pharmacy thousands of dollars in stability testing.

Stability-indicating testing methods that are required to extend beyond-use dates (BUDs) can cost tens of thousands of dollars for each formulation, depending on the type and number of APIs involved. But because it is anhydrous — with water activity below 0.6 (Aw <0.6) — Ellage allows pharmacy compounders to assign longer BUDs by default without having to send their formulations to analytical labs for stability testing. Aside from the convenience that these longer BUDs provide for patients (because they don’t have to refill their prescription as often), they also allow compounding pharmacies to increase their operational efficiency when making anticipatory batches of compounded medications.

Taken together, these characteristics and benefits make Ellage ideal in formulations for patients with a wide variety of vaginal conditions, which will help compounding pharmacies to meet their patients’ and prescribers’ needs. For more information about this unique compounding base, including specifications and links to more studies, visit our online product catalog .

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 references cited did not necessarily evaluate PCCA products or formulas included in these statements. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.