F O R M U L A T I O N S

Tetracycline Hydrochloride 2.2-mg/mL Topical Solution

administration. Tetracyclines are broad-spectrum antibiotics
and are active against many gram-negative, gram-positive,
and other bacteria; but they are ineffective against fungi
and viruses. 3

Rx
For 100 mL
Tetracycline hydrochloride
Sodium bisulte
Ethyl alcohol, 95%
Citric acid powder
Puried Water USP

qs

220
100
45
150
100

mg
mg
mL
mg
mL

METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the
total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Dissolve the sodium bisulte, citric acid and tetracycline
hydrochloride in 50 mL puried water.
4. Add the ethyl alcohol and mix well.
5. Add a sufficient quantity of puried water to bring to a
volume of 100 mL and mix well.
6. Package and label.

PACKAGING
Package in a tight, light-resistant glass container.

LABELING
Shake well. For external use only. Keep out of reach of children. Use only as directed.

Sodium bisulfite (NaHSO 3 , MW 104.07, sodium hydrogen sulte) occurs as a white crystalline powder. It is soluble 1 in 3.5
parts of water and in 70 parts of 95% alcohol. 4
Alcohol (C 2 H 5 OH, MW 46.07, ethyl alcohol, ethanol, grain alcohol) is a clear, colorless, mobile, volatile liquid with a slight
characteristic odor and a burning taste. It is miscible with
chloroform, with glycerin, and with water; and its solutions
may be sterilized by autoclaving or ltration. 5
Citric acid (C 6 H 8 O 7 H 2 O, citric acid monohydrate) occurs as
colorless or translucent crystals or as white, crystalline, efflorescent powder that is odorless and has a strong, tart, acidic
taste. The hydrated form of citric acid may contain up to
8.8% water, and the pH of a 1% w/v aqueous solution is about
2.2. Depending on the degree of humidity in the air, the hydrated form of citric acid effloresces; and the anhydrous form
is hygroscopic. If stored in air that is too dry, citric acid may
lose its water if the temperature reaches about 40C. The
melting point of citric acid is about 100C, but it softens at
about 75C. One gram is soluble in less than 1 mL of water
and in 1.5 mL of ethanol. 6

When this preparation is stored at room temperature, a

beyond-use date of 2 months (commercial product was 2
months) can be used. 1

Purified water is a clear, colorless, odorless, and tasteless liquid

water that is obtained by distillation, ion exchange, reverse osmosis, or some other suitable process. Water has a specic
gravity of 0.9971 at room temperature and a melting point at
0C. It is miscible with most polar solvents and is chemically
stable in all physical states (ice, liquid, and steam). 7

USE

References

STABILITY

Tetracycline topical solution is used in the treatment of mild,

papular acne of puberty and early adolescence (acne vulgaris)
and papular-pustular acne in adult women. The safety and efficacy of topical tetracycline in children younger than 11 years
of age have not been established. 1

QUALITY CONTROL
Quality-control assessment can include weight and/or volume, pH, active-drug assay, color, physical observation, and
physical stability (discoloration, foreign materials, gas formation, and mold growth). 2

DISCUSSION
Tetracycline hydrochloride (C 22 H 24 N 2 O 8 , MW 444.4) occurs as a
yellow, crystalline, moderately hygroscopic powder. It is soluble in water (100 mg/mL) and in solutions of alkali hydroxides
and carbonates. It is slightly soluble in alcohol (10 mg/mL). It
is stable in air, but exposure to strong sunlight in moist air
causes it to darken. In solution at a pH of less than about 2, it
loses potency; and it is also rapidly destroyed by alkali hydroxide solutions. The pH of a 10-mg/mL solution is between 1.8
and 2.8. The hydrochloride salt form is more soluble than
the tetracycline base and is used for parenteral and topical

224

International Journal of Pharmaceutical Compounding

Vol. 7 No. 3 May/June 2003

1. Ashworth LD. Medications discontinued in the United States. IJPC

2002;4:286-287.
2. Allen LV Jr. Standard operating procedure for performing physical
quality assessment of oral and topical liquids. IJPC 1999;3:146-147.
3. Parfitt K, ed. MARTINDALE: The Extra Pharmacopoeia. 32nd ed.
London:The Pharmaceutical Press; 1999:259-262.
4. Stewart JT. Sodium metabisulfite. In: Kibbe AH, ed. Handbook of
Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:490-492.
5. Weller PJ. Alcohol. In: Kibbe AH, ed. Handbook of Pharmaceutical
Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:7-9.
6. Amidon GE. Citric acid monohydrate. In: Kibbe AH, ed. Handbook of
Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:140-142.
7. Ellison A, Nash RA, Wilkin MJ. Water. In: Kibbe AH, ed. Handbook of
Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:580-584.