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PERME8™ ANHYDROUS GEL (30-5038)

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PermE8™ Anhydrous Gel

A new base for transdermal delivery with prolonged BUDs

PermE8 Anhydrous Gel is a new base from PCCA that uses next-generation technology to provide compounders with a better option than previous anhydrous transdermal bases while giving patients a more pleasant and convenient medication experience.

Changes in the industry, along with the perennial need to maximize efficiency in the pharmacy, have lead compounders to look for vehicles that can extend beyond-use dates (BUDs) without having to spend thousands of dollars on stability testing. At the same time, they need bases that perform well and provide an elegant finished preparation for the patient.

PermE8 is the solution to these needs. It has water activity below 0.6 (aw < 0.6), classifying it as an anhydrous base. This allows extended default BUDs for preparations that do not have stability studies. Additionally, PermE8 can hold multiple drugs at once, including those in salt form.

Importantly, PermE8 delivers APIs exceptionally well. In independent testing, PermE8 delivered ketoprofen through human skin comparably to our industry-leading Lipoderm®, and it significantly outperformed Anhydrous Lipoderm.

Finally, it has a silky, smooth texture that provides better application for patients than other anhydrous transdermal bases, such as Anhydrous Lipoderm.

This base offers compounders an anhydrous transdermal gel that that can hold and deliver a broad range of drugs while lowering operating costs and increasing efficiency. It offers patients a convenient and potentially life-changing dosage form with a pleasant texture and a longer BUD.

Benefits for Compounders

  • Lower Operating Costs: PermE8 allows for prolonged default BUDs without having to spend thousands of dollars on stability testing, and it can increase operational efficiency for compounders making anticipatory batches
  • Higher performance: In independent testing, PermE8 significantly outperformed Anhydrous Lipoderm in delivering ketoprofen transdermally
  • Broader application: It is a stable base that can accommodate multiple APIs in one preparation, including those in salt forms and those not stable in aqueous environments

Benefits for Patients

  • Convenience: It’s anhydrous, which allows for a longer BUDs and less-frequent prescription refills
  • Pleasant application: PermE8 isn’t tacky or oily, and spreads on the skin more easily than other anhydrous transdermal vehicles, such as Anhydrous Lipoderm

 

The Proof

  • PermE8 delivered a comparable amount of ketoprofen through the skin to Lipoderm
  • PermE8 delivered four times as much ketoprofen through the skin as Anhydrous Lipoderm

 

Frequently Asked Questions

Does PermE8 replace Lipoderm?

No. Lipoderm is still the industry’s leading transdermal base. Through our FormulaPlus™ program, we have numerous Lipoderm (PCCA #30-3338) and Lipoderm ActiveMax® (PCCA #30-4482) formulas with extended beyond-use dates that are supported by stability-indicating assays. Some of these formulas have been studied in bracketed ranges, meaning that compounders can use a range of API strengths in those formulas and still assign the extended BUDs. These formulations are still our first recommendations. Please see PCCA Document #98004 for the full list of all FormulaPlus formulations.

Can I use PermE8 for transdermal veterinary medications?

Yes. PermE8 is safe for veterinary use.

sometimes I notice particles in the base. Will these affect the final preparation?

No. Due to the characteristics of a vegetable-butter ingredient, a slight appearance of particles may occur in PermE8. However, these particles melt when rubbing into the skin, or they can be eliminated by mixing the preparation in an electronic mortar and pestle or milling according to the procedure stated in the formula.

 
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 continuously 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.
  • Not applicable
Test Specification
Description WHITE TO OFF-WHITE CREAM-GEL

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