A New Anhydrous Base for Female Hormone Delivery

Fri, 11 Oct 2019 13:52:00 GMT

By PCCA

This morning at International Seminar 2019, attendees packed into the ballroom to hear our Chief Scientific Officer Gus Bassani, PharmD, deliver his PCCA Innovation presentation. This is where Gus reveals the much-anticipated new PCCA products every year. This time, he introduced the audience to VersaBase® Anhydrous HRT, the pharmacy compounding industry’s first proprietary anhydrous base developed specifically to deliver female bioidentical hormones through the skin, such as estriol, estradiol and progesterone.

PCCA Chief Scientific Officer Gus Bassani introduces
International Seminar attendees to VersaBase Anhydrous HRT.

This new base is the latest addition to the VersaBase family of vehicles, and it uses a patent-pending delivery system that improves both the solubility of hormones and their permeation into and through the skin. This is typically difficult to achieve with an anhydrous base, but our Director of Research and Development Daniel Banov, MS, RPh, and his team have spent their careers inventing products that surpass what most consider possible. This one is no exception. VersaBase Anhydrous HRT performed comparably to VersaBase Cream (the industry standard for women’s topical HRT) during in vitro testing that demonstrated it delivering our Special Micronized Progesterone into and through human skin tissue.

VersaBase Anhydrous HRT also complements our newer anhydrous bases that we first released in 2018 to address changing needs in the compounding industry. Like PermE8™ Anhydrous Gel and W06™ Anhydrous Topical Gel, this newest base has water activity lower than 0.6 (Aw < 0.6), which qualifies it as anhydrous according to the standards in the latest version of USP General Chapter <795>. Therefore, formulations in these bases have longer default beyond-use dates (BUDs), which the chapter allows for nonaqueous dosage forms. This can save compounders thousands of dollars per formulation because the medications do not have to be stability tested in order to have the longer BUD. It also makes compounds more convenient for patients, since they won’t have to return to the pharmacy as often for prescription refills. To increase efficiency further, most of the VersaBase Anhydrous HRT formulas that we have tested and published in the PCCA formula database do not require the use of an ointment mill, which reduces both compounding time and cleanup time.

Also on The PCCA Blog: Why Water Activity Matters in Pharmacy Compounding

PCCA members with Clinical Services access can visit our formula database to see the numerous VersaBase Anhydrous HRT formulas that we have already developed to help eet the needs of patients. If they have questions about compounding with this base, they can contact our clinical compounding pharmacists at 800.331.2498.

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.

Why VersaBase Cream Is Your Best Choice for Women’s HRT

Wed, 17 Apr 2019 18:08:16 GMT

VersaBase Cream is a stable, pharmaceutically elegant base that can accommodate a broad range of active ingredients for customized, patient-specific medications. Compounding pharmacies have been using it for many applications over the years, but where it stands out is in topical and vaginal hormone replacement therapy (HRT). Our Clinical Services, R&D and Formulation Development departments continually research, test and formulate with VersaBase Cream, and independent researchers have worked with it as well. This makes it one of the most studied bases in the pharmacy compounding industry with a substantial portfolio of supporting data and materials, giving compounders incredible support in using it to help their patients.

VersaBase by the Numbers

5 publications to support its use in compounded medications

230+ formulas, offering a plethora of potential treatment options

20 formulas with extended beyond-use dates (BUDs)

13 bracketed formulas with extended BUDs to expand the possibilities for pharmacy and patient

7 related marketing resources to help in discussions with prescribers]

It’s Been Studied
Both PCCA and independent researchers have been studying VersaBase Cream for over a decade, giving compounders support when they recommend it in compounded medications. It has been included in the Journal of Women’s Health Care, where a peer-reviewed, in vitro study showed that it delivered our Special Micronized Progesterone into and through human skin. An independent, peer-reviewed study published in Gynecologic and Obstetric Investigation evaluated the absorption of estriol, estradiol, progesterone, DHEA and testosterone in VersaBase Cream, among other experimental factors. The International Journal of Pharmaceutical Compounding recently published an independent case study showing transdermal delivery of testosterone in this base, and another study evaluating the chemical stability of a range of estriol concentrations in a VersaBase vaginal cream. U.S. Pharmacist has also published an independently developed compounding formulation of progesterone in this base.

It’s Backed by Numerous Formulas
Not only is VersaBase Cream well studied, but we have also supported it with numerous formulations as well, offering compounders, practitioners and patients a host of potential treatment options. We have developed over 230 formulas in total that use VersaBase Cream. Of those, 20 have gone through our FormulaPlus™ program, so they have extended BUDs supported by stability-indicating assays. This can save compounders thousands of dollars in stability testing, it makes compounds more convenient for patients because they won’t need to refill prescriptions as often. We provide the data behind each BUD study as well. Of those formulas, 13 are bracketed, meaning that they offer the compounder a range of active ingredient concentrations with the same extended BUD, substantially expanding their value for the pharmacy and the patient. PCCA members can easily access all of these under the formula tab of the VersaBase Cream page on the Members-Only Website.

It Has Marketing Support
We have also developed various marketing materials to help pharmacies that compound topical and vaginal HRT with VersaBase Cream. PCCA members have access to the product information sheet, customizable top formula cards, a customizable PowerPoint presentation and much more. They can find all of them on the Marketing Resources page of the Members-Only Website.

If PCCA members have questions about compounding with VersaBase Cream, they can contact our Clinical Services department at 800.331.2498.

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.

THE PCCA BLOG

A New Anhydrous Base for Female Hormone Delivery

Why VersaBase Cream Is Your Best Choice for Women’s HRT