Testosterone 2.

5% in Isopropyl
Myristate 5% Topical Gel
Loyd V. Allen, Jr., PhD
Professor Emeritus
College of Pharmacy, University of Oklahoma
Oklahoma City

US Pharm. 2019;44(8):48-49.

Method of Preparation: Calculate the required quantity of each

ingredient for the total amount to be prepared. Accurately weigh and/or
measure each ingredient. Dissolve the testosterone in the ethyl alcohol
while mixing. Disperse the Carbopol 940 in the solution while mixing;
this may take up to 30 minutes. Add the isopropyl myristate and mix
well to form a thin gel. Bring the mixture to 90% of the total volume
with purified water and mix well. Dropwise, add trolamine while mixing
until the desired thickness of gel is achieved. Bring the mixture to final
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 volume with purified water and mix well. Package and label.

Use: Testosterone topical gels have been used in the treatment of low
testosterone concentrations in men and low libido in women.1

Packaging: Package in tight, light-resistant containers.

Labeling: Keep out of reach of children. Store in a cool place. Use only
as directed. For external use. Discard after ____ [time period].

Stability: A beyond-use date of 30 days may be used for this

preparation.1

Quality Control: Quality-control assessment can include theoretical

weight compared with actual weight, pH, specific gravity, active drug
assay, color, texture–surface, texture–spatula spread, appearance, feel,
rheologic properties, and physical observations.2

Discussion: Testosterone (Androderm, Androgel, C19H28O2, MW

288.42) occurs as white or slightly cream-colored crystals or
crystalline powder that is odorless and stable in air. Testosterone is
practically insoluble in water; it is soluble 1 g in 5 mL of ethanol, 2 mL of
chloroform, and 100 mL of ether, and it is soluble in vegetable oils.
Testosterone is not very bioavailable when given as an oral-swallow
preparation, but it is absorbed when it is administered buccally and
sublingually. Testosterone is indicated as androgen replacement for
delayed male puberty, postpartum breast pain and engorgement,
inoperable breast cancer, and male hypogonadism.3

Isopropyl myristate (C17H34O2, MW 270.51) is composed of esters of

propan-2-ol and saturated high-molecular-weight fatty acids,
principally myristic acid. It is used as an emollient, solvent, skin
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 penetrant, and oleaginous vehicle. Isopropyl myristate is a clear,
colorless, practically odorless, mobile liquid with a bland taste, and it
has a specific gravity of 0.846 to 0.854. Isopropyl myristate is miscible
with ethanol, ethyl acetate, fats, fatty alcohols, fixed oils, and waxes,
and it is practically insoluble in water.4

95% Alcohol (ethyl alcohol, ethanol, grain alcohol, C2H5OH, MW 46.07)

is a clear, colorless, mobile, and volatile liquid with a slight
characteristic odor and a burning taste. Its specific gravity is between
0.812 and 0.816, and its boiling point is 78.15°C. 95% Alcohol is
miscible with glycerin and water.5

Carbopol 940 is a synthetic high-molecular-weight polymer. It occurs

as white-colored, fluffy, acidic, hygroscopic powders with a slight
characteristic odor; in this preparation, it is used as a gelling agent.
Carbopol 940 is soluble in water and, after neutralization, in 95%
ethanol and in glycerin. Maximum viscosity can generally be obtained in
a pH range of 6 to 11.6

Trolamine (TEA, triethanolamine) is an alkalizing and emulsifying agent.

It occurs as a variable mixture of alkanolamines, and it is a clear,
colorless to pale yellow, viscous liquid with a slight ammoniacal odor. Its
specific gravity is approximately 1.120 to 1.128 g/mL, and it has a pH of
10.5 in a 0.1N aqueous solution. Trolamine is highly hygroscopic and is
miscible with water and 95% ethanol.7

REFERENCES

1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville,

MD: U.S. Pharmacopeial Convention, Inc; July 2019.
2. Allen LV Jr. Standard operating procedure for performing physical
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 quality assessment of ointments/creams/gels. IJPC. 1998;2:308-309.
3. Testosterone. In: Lund W, ed. The Pharmaceutical Codex. 12th ed.
London, England: Pharmaceutical Press; 1994:1135-1136.
4. Quinn ME. Isopropyl myristate. In: Sheskey PJ, Cook WG, Cable CG,
eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England:
Pharmaceutical Press; 2017:495-497.
5. Fenton ME. Ethanol. In: Sheskey PJ, Cook WG, Cable CG, eds.
Handbook of Pharmaceutical Excipients. 8th ed. London, England:
Pharmaceutical Press; 2017:356-359.
6. Draganoiu E, Rajabi-Siahboomi A, Tiwari S. Carbomer. In: Sheskey
PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients.
8th ed. London, England: Pharmaceutical Press; 2017:165-170.
7. Goskonda SR, Triethanolamine. In: Sheskey PJ, Cook WG, Cable CG,
eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England:
Pharmaceutical Press; 2017:994-996.

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