Formulations

Ibuprofen 5% Topical Cream

Rx
Ibuprofen
Gelot 64
Labrafil M 1944
Octyldodecyl myristate
Sodium methylparaben
Sorbic acid
Stearic acid
Ethoxydiglycol
Lavender oil
Purified water

qs

For 100
5
24
5
3
70
30
1
15
0.15
100

mL
g
g
g
g
mg
mg
g
mL
mL
mL

METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the total
amount to be prepared.
2. Weigh and/or measure each ingredient accurately.
3. Place about 45 mL of purified water in a suitable container and heat
to 80C.
4. Stir in the Gelot 64, Labrafil M 1944, octyldodecyl myristate, sodium
methylparaben, sorbic acid, and stearic acid and mix well.
5. Homogenize briefly and cool to room temperature.
6. Add the ibuprofen to the ethoxydiglycol separately and add the lavender oil; then add to the vehicle and mix thoroughly.
7. Add sufficient purified water to final volume and mix well.
8. Package and label.

PACKAGING

Gelot 64 is a mixture of glyceryl stearate and PEG 75 stearate and is used

as an o/w emulsifier, stabilizer, and is self-emulsifying. It is compatible
with high percentages of essential oils, menthol, and camphor, and can
improve the stability of emulsion-based dosage forms.3
Labrafil M 1944 (apricot kernel oil PEG-6 esters) occurs as a complex
mixture formed from the transesterification of apricot kernel oil and
PEG-6. It is used as a solvent, coemulsifier, solubilizer, bioavailability
enhancer, and penetrating enhancer.3
Octyldodecyl myristate (C34H68O2, MW 508.9, myristic acid, 2-octyldodecyl myristate, tetradecanoic acid, 2-ocytyldodecyl ester) is an ester of
octyldodecanol and myristic acid. It is used as an emollient and plasticizer.3
Sodium methylparaben (C8H7NaO3, MW 174.13, 4-hydroxybenzoic
acid, methyl ester, sodium salt) occurs as a white, hygroscopic powder that
is freely soluble in water, sparingly soluble in alcohol, and insoluble in
fixed oils. The pH of a 1% aqueous solution is in the range of 9.5 to 10.5.3,4
Sorbic acid (C6H8O2, MW 112.13) occurs as a free-flowing, white, crystalline powder, having a characteristic odor. It is slightly soluble in water,
soluble in alcohol and soluble 1 in 19 of propylene glycol.1,5
Stearic acid (C18H36O2, MW 284.47) occurs as a hard, white or faintly
yellow-colored, somewhat glossy, crystalline solid or a white or yellowish
white powder. It has a slight odor and taste suggesting tallow. It is soluble
in 95% ethanol and propylene glycol and practically insoluble in water.6
Ethoxydiglycol (C6H14O3, CH2OHCH2OCH2CH2OC2H5, MW 134.20)
occurs as a colorless liquid with a mild pleasant odor. It is hygroscopic and
is miscible with water and with common organic solvents.3

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

Lavender oil is the volatile oil distilled with steam from the fresh flowering tops of Lavandula officinalis Chaix ex Villars. It occurs as a colorless or
yellow liquid, with the characteristic odor and taste of lavender flowers. It
has a specific gravity of 0.875 to 0.888. It is soluble 1 volume in 4 volumes
of 70% alcohol.7

STABILITY

REFERENCES

Package in tight, light-resistant containers.1

LABELING

A beyond-use date of 30 days can be used for this preparation.1

USE
This preparation is used as a topical anti-inflammatory agent.

QUALITY CONTROL
Quality-control assessment can include theoretical weight compared
to actual weight, pH, specific gravity, active drug assay, color, texturesurface, texture-spatula spread, appearance, feel, rheological properties,
and physical observations.2

DISCUSSION
Ibuprofen (C13H18O2, MW 206.28) is a nonsteroidal anti-inflammatory
agent with analgesic and antipyretic activity. It occurs as a white to offwhite, crystalline powder with a slight, characteristic odor. It is practically
insoluble in water but very soluble in alcohol and acetone.

244

International Journal of Pharmaceutical Compounding

Vol. 15 No. 3 | May/June 2011

1. United States Pharmacopeial Convention, Inc. USP Pharmacists Pharmacopeia.

2nd ed. Rockville, MD: US Pharmacopeial Convention, Inc.; 2008: 775779,
797831, 1461.
2. Allen LV Jr. Standard operating procedure for performing physical quality
assessment of ointments/creams/gels. IJPC 1998; 2(4): 308309.
3. Ash M, Ash I. Handbook of Pharmaceutical Additives. 3rd ed. Endicott, NY: Synapse Information Resources, Inc.; 2007: 152, 191, 462, 484, 780, 814, 903.
4. Haley S. Methylparaben. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook
of Pharmaceutical Excipients. 6th ed. London, UK: Pharmaceutical Press; 2009:
441445, 1448.
5. Reynolds JE, ed. MARTINDALE: The Extra Pharmacopoeia. 30th ed. London,
UK: The Pharmaceutical Press; 1993: 1138.
6. Allen LV Jr. Stearic acid. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook of
Pharmaceutical Excipients. 6th ed. Washington, DC: Pharmaceutical Press; 2009:
697699.
7. Reilly WJ Jr. Pharmaceutical necessities. In: Remington: The Science and Practice
of Pharmacy. 21st ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006:
1065.

www.IJPC.com