A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Androderm Online, Description, Chemistry, Ingredients - Testosterone Transdermal System- RxList Monographs
Androderm Online, Description, Chemistry, Ingredients - Testosterone Transdermal System- RxList Monographs
Androderm (testosterone transdermal system) provides continuous delivery
of testosterone (the
primary endogenous
androgen) for 24 hours following application to intact, nonscrotal 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-hydroxyandrostd-en-3-one.
The Androderm systems have six components. Proceeding from the top toward
the surface attached to the
skin, the system
is composed of
- Metallized polyester/SurlynÒ
(ethylene-meth-acrylic acid
copolymer)/ethyl vinyl acetate
backing film.
- A drug reservoir
of testosterone USP,
alcohol USP, glycerin
USP, glycerol monooleate, and methyl
laurate gelled with an acrylic acid
copolymer.
- A permeable polyethylene
microporous membrane.
- 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.
- Composed of a five-layer laminate containing polyester/polyesterurethane
adhesive/aluminum foillpolyesterurethane adhesive/polyethylene. The
disc is attached to and removed with the release
liner.
- A silicone-coated polyester film, which is removed before the system
can be used.
The active ingredient
in the system is testosterone.
The remaining components of the system
are pharmacologically inactive.
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