For anhydrous formulations used in female hormone replacement therapy (HRT).
VersaBase Anhydrous 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.
VersaBase Anhydrous 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 VersaBase Anhydrous 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 VersaBase Anhydrous 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 VersaBase Anhydrous HRT replace VersaBase Cream?
While this base does not replace VersaBase Cream, it is an anhydrous option
to consider. VersaBase Anhydrous 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. VersaBase Anhydrous 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, VersaBase Anhydrous 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 VersaBase Anhydrous 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 VersaBase Anhydrous 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 VersaBase
Anhydrous 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.