Androderm (testosterone transdermal system) provides continuous delivery of testosterone (the primary endogenous androgen) for 24 hours following application to intact, non-scrotal skin (e.g., back, abdomen, thighs, upper arms).

Two strengths of Androderm are available which deliver in vivo 2.5 mg or 5 mg of testosterone per day across skin of average permeability.

Androderm has a central drug delivery reservoir surrounded by a peripheral adhesive area. The Androderm 2.5 mg system has a total contact surface area of 37 cm² with a 7.5 cm² central drug delivery reservoir containing 12.2 mg testosterone USP, dissolved in an alcohol-based gel. The Androderm 5 mg system has a total contact surface area of 44 cm² with a 15 cm² central drug delivery reservoir containing 24.3 mg testosterone USP, dissolved in an alcohol-based gel. Testosterone USP is a white, or creamy white crystalline powder or crystals chemically described as 17b-hydroxyandrost-4-en-3-one.

Testosterone
C₁₉H₂₈O₂    mw 288.43

The Androderm systems have six components as shown in Figure 1. Proceeding from the top toward the surface attached to the skin, the. system is composed of (1) metallized polyester/Surlyn^Ò* (ethylene-methacrylic acid copolymer)/ethylene vinyl acetate backing film with alcohol resistant ink, (2) a drug reservoir of testosterone USP, alcohol USP, glycerin USP, glycerol monooleate, methyl laurate, sodium hydroxide NF, to adjust pH, and purified water USP, gelled with carbomer copolymer Type B NF, (3) a permeable polyethylene microporous membrane, and (4) a peripheral layer of acrylic adhesive surrounding the central, active drug delivery area of the system. Prior to opening of the system and application to the skin, the central delivery surface of the system is sealed with a peelable laminate disc (5) composed of a five-layer laminate containing polyester/polyesterurethane adhesive/aluminum foil/polyester-urethane adhesive/polyethylene. The disc is attached to and removed with the release liner (6), a silicone-coated polyester film, which is removed before the system can be used.

*Surlyn is a registered trademark of E.I. DuPont de Nemours & Company.

Figure 1: System Schematic

The active ingredient in the system is testosterone. The remaining components of the system are pharmacologically inactive.

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