ANHYDROUS LIPODERM® (30-4283)


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The standard in treatment just got even better. Water is no longer a problem for this permeation-enhancing vehicle.

Using similar technology to the well-studied and popular base, Lipoderm, PCCA has created an anhydrous version that is designed for active pharmaceutical ingredients (APIs) that are unstable in water. Like Lipoderm, Anhydrous Lipoderm has been intensively studied in order to validate its ability to transport drugs into and through human skin.

When Do You Need Anhydrous Lipoderm?

  • When an active ingredient is unstable in water
  • If aqueous stability is uncertain
  • When you don’t want the hassle of preparing an anhydrous pluronic lecithin organogel (PLO)

Characteristics

  • Low water activity (Aw < 0.6) to help accommodate unstable APIs
  • Validated to deliver ketoprofen through human skin better than PLO
  • Formulated without soy
  • High in natural ingredients, such as berry wax, Plukenetia volubilis seed oil (from Peru), cupuaçu butter (from the Amazon) and vitamin E
  • High in unsaturated fatty acids (Plukenetia volubilis seed oil is the richest source of unsaturated fatty acids, which can reach 94% of its composition, with 50% of them omega-3
  • Rich, silky feel
  • Formulated without parabens

Validation

PCCA teamed up with the highly regarded dermatological laboratory PRACS Institute – Cetero Research to conduct this study. It was designed to evaluate the percutaneous-absorption pharmacokinetics of PCCA’s Special Micronized Ketoprofen in Anhydrous Lipoderm versus PLO. Absorption was measured in human ex vivo skin, in vitro, using the finite dose technique and Franz diffusion cells. The data indicate that PCCA’s Special Micronized Ketoprofen penetrated into and through human skin, in vitro, from the test formulations provided. The absorption profiles indicate a rapid penetration to a peak flux occurring at approximately seven to eight hours after dose application followed by a steady decline thereafter. Anhydrous Lipoderm performed better than PLO at delivering PCCA’s Special Micronized Ketoprofen through human skin.

  • Not a DOT controlled material (United States). This material is not classified dangerous good according to international transportation regulations (ADR/RID-IMDG-ICAO/IATA).

Caution: *PROTECT FROM LIGHT* *MIX WELL PRIOR TO USE* - FOR USE AS AN EXCIPIENT

Test Specification
DESCRIPTION BEIGE TO TAN THICK CREAM; SEMI-SOLID; SHOULD NOT BE GRITTY OR GRAINY; SHOULD BE A CREAMY SUBSTANCE; CHARACTERISTIC ODOR
MELTING POINT 28-32 °C
SOLUBILITY INSOLUBLE IN WATER AND ALCOHOL
SPECIFIC GRAVITY 0.8-1.1