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ANDRODERM (testosterone transdermal system) is designed to deliver testosterone continuously for 24 hours following application to intact, non-scrotal skin (e.g., back, abdomen, thighs, upper arms).

Four strengths of ANDRODERM are available that deliver approximately 2 mg, 2.5 mg, 4 mg, or 5 mg of testosterone per day.

ANDRODERM has a central drug delivery reservoir surrounded by a peripheral adhesive area. The ANDRODERM 2 mg/day system has a total contact surface area of 32 cm² with a 6.0 cm² central drug delivery reservoir containing 9.7 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 2.5 mg/day 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 4 mg/day system has a total contact surface area of 39 cm² with a 12.0 cm² central drug delivery reservoir containing 19.5 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 5 mg/day 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 17β-hydroxyandrost-4-en-3-one.

Testosterone C₁₉H₂₈O₂
mw 288.42

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 (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.

Figure 1: System Schematic

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

Last reviewed on RxList: 11/3/2011
This monograph has been modified to include the generic and brand name in many instances.