ANHYDROUS VERSABASE® HRT (30-5056)

For anhydrous formulations used in female hormone replacement therapy (HRT).

Anhydrous VersaBase HRT is the pharmacy compounding industry’s first proprietary anhydrous base developed specifically to deliver female bioidentical hormones through the skin. It is also the latest addition to the VersaBase family of compounding bases that has provided patients with much-needed customized medication options for over a decade. It uses a unique, patent-pending delivery system designed to improve the solubility of lipophilic molecules, such as hormones, and is proven to increase the permeation of those molecules into and through the skin. Despite this base being an anhydrous system, these lipophilic hormones are able to partition (release) from it and into the skin.

This new base also addresses changes in the pharmacy compounding industry. Recent shifts in guidelines and standards have led to a focus on the role of water activity in establishing beyond-use dates (BUDs) for compounded medications. This, combined with the need of compounding pharmacies to maximize efficiency and control costs, is leading compounders to look for anhydrous bases to meet the needs of their patients while providing longer BUDs by default.

Anhydrous VersaBase HRT fulfills these needs. It has water activity below 0.6 (Aw < 0.6), which classifies it as an anhydrous base and allows for longer default BUDs according to the latest standards in pharmacy compounding. It performs exceptionally well in delivering female hormones through the skin, such as estriol, estradiol and progesterone. It is also pleasing to the touch, offering patients elegant medications customized to their unique hormone replacement needs.

Benefits for Compounders

• Proven performance : In vitro testing proves that Anhydrous VersaBase HRT delivers estriol, estradiol and progesterone into and through human skin tissue at a rate and extent that is better than, yet comparable to, VersaBase Cream
• Increased profitability : It allows for longer default BUDs, which can save compounders thousands of dollars when compounding unique medications for individual patients
• Increased efficiency: Due to this base’s solubilizing properties, most preparations made with it will not require milling, thus saving compounding and cleanup time

Benefits for Patients

• Convenience : It’s anhydrous, which allows for longer default BUDs and less-frequent prescription refills even if the medication hasn’t undergone formal stability testing
• Pleasant application : It’s smooth and creamy, and it rubs into the skin easily, offering a refined cosmetic feel to customized medications without a greasy or tacky residue

Related Specialties

• Family practice
• Internal medicine
• Integrative medicine
• Endocrinology

Formulated Without

• Water
• Preservatives
• Petrolatum/mineral oil
• Soy
• Nuts
• Gluten

The Proof

The results of in vitro testing show that Anhydrous VersaBase HRT delivered progesterone as well as the estrogens estriol and estradiol through human skin tissue at a higher rate and extent than, yet comparably to, VersaBase Cream, the industry standard for women’s topical HRT compounds.

Frequently Asked Questions

Does Anhydrous VersaBase HRT replace VersaBase Cream?

While this base does not replace VersaBase Cream, it is an anhydrous option to consider. Anhydrous VersaBase HRT is a great option when starting a new patient on an HRT preparation in light of the delivery data and low water activity properties.

Should I transition my patients who are using other topical bases for hormone replacement to this base?

It depends on the situation. Anhydrous VersaBase HRT is a great drug delivery option when starting a new patient on an HRT formulation. Also, if a patient is experiencing symptoms with her current HRT medication, changing the base instead of the dose may be a good option, in which case this base is a consideration. However, changing a woman’s hormone formulation may affect her hormone levels, thus affecting symptom control. Therefore, if a patient is currently stable on an HRT compound, and she and her prescriber are pleased with it, we recommend not changing that compound.

When transitioning a patient to this base from another topical base, should I use the same concentration of hormones?

Based on preliminary testing, Anhydrous VersaBase HRT delivers hormones at a rate and extent comparable to VersaBase Cream, so compounders may use an equivalent concentration when transitioning a patient from that base. However, since each patient is unique, the compounder may need to adjust the compound to suit the patient’s needs based on the patient’s response and consultation with the prescriber. When transitioning a patient from a topical base other than VersaBase Cream, the compounder should use their clinical judgement and consult the prescriber and available literature to determine dosing.

When transitioning a patient from another dosage form to a topical compound using this base, what adjustments should I make to the medication strength?

We do not recommend attempting to convert dosage strengths from one dosage form to another. Instead, it would be best to consider them separately. We recommend that the compounder use their clinical experience and consult the prescriber and available literature to determine an optimal starting dose for each patient.

Is Anhydrous VersaBase HRT recommended for vaginal use?

This base contains silicones that are not recommended for use on internal mucosal membranes (intra-vaginally or intra-rectally). Therefore, we recommend it for topical use only.

Which formulas using Anhydrous VersaBase HRT require the use of an ointment mill?

The majority of formulas we have tested and provided in the PCCA formulations database do not require milling, which greatly reduces total compounding time and cleanup. However, formulas with a high bulk powder load may still require milling. For such cases, please refer to PCCA formulas or do an initial small batch test of the preparation.

Which dispensing devices should I use with this base?

Topi-Click^® metered topical applicators or EMP jars and oral/topical amber syringes are options as dispensing devices to achieve the most accurate and reliable dosage with this base.

Due to the unique physical attributes (viscosity and rheology) of Anhydrous VersaBase HRT, we have found that MegaPumps^® do not provide accurate and uniform dosing with it. Therefore, we do not recommend using them as dispensing devices in this case.

Always make sure you have checked the PCCA Formula Database and are following the most up-to-date version of a formula, as changes are continually made to existing formulations to provide the highest quality. The formulas and/or statements listed are provided for educational purposes only. They are compounding ideas that have commonly been requested by physicians, and have not been evaluated by the Food and Drug Administration. Formulas and/or material listed 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. Every patient is unique, and formulas should be adjusted to meet their individual needs.