A New Choice in Customized Medication for Pain Management

This article was updated 10/19/2020

At our International Seminar in 2018, we were excited to debut PermE8^® Anhydrous Gel, a compounding base that holds a lot of potential for compounding pharmacies and their patients.

PermE8 is an anhydrous gel that can hold multiple active pharmaceutical ingredients and deliver them through the skin comparably to Lipoderm ^®, the industry standard for permeation-enhancing bases. PermE8 is ideal for compounded medication related to pain management, sports medicine, oncology and many other specialties.

We developed PermE8 because we wanted to help compounders to extend default beyond-use dates (BUDs) for their penetration-enhancing topical preparations without having to spend thousands of dollars on stability testing. This makes customized medications more efficient for compounders and more convenient for their patients.

At the same time, we wanted to improve on older anhydrous bases to invent something that delivers active pharmaceutical ingredients very well, has a silky texture that isn’t greasy and spreads easily on the skin.

Below is some additional information about this base. We have developed and tested over 45 formulas with PermE8 that PCCA members with Clinical Services access can find in our formula database, and we will continue to create more.

Benefits for Compounders

• Lower Operating Costs
  PermE8 is anhydrous, allowing for prolonged default BUDs without having to spend thousands of dollars on stability testing, and increasing operational efficiency for compounders making anticipatory batches
• Higher Performance
  In vitro testing shows that PermE8 significantly outperformed Anhydrous Lipoderm in delivering ketoprofen through human skin tissue (Figures 1 and 2)
• Broader Application
  It is a stable base that can accommodate multiple drugs in one preparation, including those in salt forms and those not stable in aqueous environments

Benefits for Patients

• Convenience
  It is anhydrous, which allows for longer BUDs and less-frequent prescription refills
• Pleasant Application
  PermE8 isn’t tacky or oily, and spreads on the skin more easily than some other anhydrous bases, such as Anhydrous Lipoderm

Delivery Performance

We tested PermE8 to compare it to two of our other transdermal bases: the industry-leading Lipoderm, as well as Anhydrous Lipoderm, our first-generation anhydrous base for permeation-enhancing topical compounds.

The in vitro testing showed that PermE8 performed comparably to Lipoderm and significantly outperformed Anhydrous Lipoderm. (Figures 1 and 2.)

Figure 1: Amount of Ketoprofen Special Micronized USP 10% (μg) Delivered into and through ex Vivo Human Abdomen Skin over 40 Hours from a Single Application

Figure 2: Mean Flux (μg/cm2/hr) Results: Percutaneous Absorption of Ketoprofen Special Micronized USP 10%  through ex Vivo Human Abdomen Skin over 40 Hours from a Single Application

Note

We still recommend that compounders use Lipoderm for their permeation-enhancing topical compounds, and we have numerous Lipoderm-based formulas with extended BUDs that have been studied using stability-indicating methods. But for compounders who need prolonged BUDs for formulas that do not have stability studies behind them, we recommend using PermE8.

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.