A Practical Guide to New Developments in Dispensing of Topical and Vaginal Hormone Preparations

The Compounding Pharmacy industry has certainly taken huge strides in providing devices that allow for easy and accurate delivery of creams, gels and ointments. This has been especially appreciated in the field of hormone replacement, where accurate dosing is critical. Over the years we have gone from jars and measuring spoons to syringes for hormone cream dispensing. Fortunately, now there are much better choices. Let’s take a look at some of the options out there and the benefits of each.

Volume of Hormone Cream – What is Appropriate?

When using topical or vaginal application of hormones, several factors concerning the volume of hormone cream need to be considered. 

Early studies with Androgel® showed that the larger the surface of application of the gel, the longer the serum level remained elevated. While serum testing does not reflect the amount of hormone in the tissues, this does demonstrate that the deposit effects in lipophilic tissues like adipose and skin cement (the lipophilic tissue between skin cells) are greater if a hormone is applied to a larger surface area. This factor would support using a large volume of cream, maybe 1 mL or greater.

However, the more a hormone cream is rubbed into the skin, the less chance of transference of the hormone to someone else that comes in contact with the site of application. My instructions to patients for rubbing a cream or gel in “well” require rubbing for at least 1 minute after the gel or cream disappears. It will take too much time and effort on the patient’s part to ensure good compliance if the volume of cream is too large. This requirement would support use of a smaller volume, maybe 0.1 mL or less.

I like to compromise and use 0.25 mL as my standard for hormone topical application. This small volume is not too difficult to rub in well. The dose can be increased to 0.5 mL without the immediate need for a new prescription and is still a reasonable amount for the patient to be able to rub in well.

Accuracy and Ease of Dosing for Topical Hormones

Precision of dosing is important with topical hormone preparations. For years the best method we had available was the use of an oral syringe. Years as a compounding pharmacist taught me that many patients often have difficulties obtaining accurate doses with syringes. Fortunately, there are now alternatives that allow the patient to easily obtain accurate dosing. Topi-CLICK® 140

One such device is the Topi-CLICK® dispenser. The two types of regular Topi-CLICK® dispensers look similar to a deodorant applicator bottle, but with a twist. The base of the dispenser is turned untilthere is an audible click. The volume dispensed in the center of the dome with each “click” is either 0.25 mL or 0.5 mL depending on the choice of dispensers. The domed top of the dispenser allows for direct application to the skin. I routinely use the dispenser that provides 0.25 mL per click for most topical hormone creams.

Recently the Topi-CLICK Micro® dispenser became available. With this dispenser, one click provides 0.05 mL of cream. Topi-CLICK Micro®This dispenser can be used for the smaller volumes required for vaginal application. I often use estriol or testosterone, or the combination of both, applied to the inner labia for vaginal dryness. I’ve always suggested using 0.1 mL of cream as this was the smallest amount that I felt a patient could measure accurately using a small oral syringe. Now I can use the Topi-CLICK Micro® and know that patients are getting an accurate dose. 

Since testosterone applied topically to the same area of skin can cause local hair growth, it may be easier to dose topical testosterone in a very small volume, so it is easier for the patient to rotate application sites and not overlap. This would be another scenario where the Topi-CLICK Micro®  dispenser would be appropriate.

Vaginal Administration of Creams

Topi-CLICK Pearl® vaginal kitLastly, if you wish to use a hormone cream intravaginally, the Topi-CLICK Perl® vaginal kit is a great way to go. The hormone cream is contained in a dispenser with a special port to which a vaginal applicator can be attached. The patient turns the base of the dispenser until it clicks, and the applicator is filled with the desired dose (0.25 mL per click). The applicator is reusable and dishwasher safe. This system allows accurate dosing and saves the patient the expense of pre-loaded individual vaginal syringes.

Knowing the correct amount of hormone to apply to the skin or vaginally is only half the battle. It’s also necessary to know which vehicle is appropriate to apply hormones to the site or application. Accuracy of dose is the other factor that determines consistent results with topical/vaginal hormone application.  Compounding pharmacists with their training and knowledge of available bases and the devices available to deliver the product can be a great benefit to anyone who is recommending or prescribing hormones.

If you are using hormone replacement therapy, it is important to test your hormone levels with reliable and convenient testing to ensure that you are obtaining physiologic levels. Order ZRT’s saliva test kit or blood spot test kit to measure your hormones to ensure you are properly monitoring topical dosing.

Related Resouces