Editorial: Quality Assurance of Ointments, Creams, and Gels

Editor's Note: This is the third in a series of brief quality-assurance notes and reminders on different compounded dosage forms. Many of the testing methods can be done in-house and some may need to be outsourced; this is up to the individual pharmacist. However, a program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.

Ointments, creams, and gels are in wide use today with many novel formulations available for compounding. There are many relatively simple tests that can be done in-house, including observation, weight, etc. Other tests can be conducted either in-house with proper equipment or outsourced to an analytical laboratory. The pharmacist can select the appropriate tests, conduct or outsource them, and document the results on the compounding record for the individual compounded preparation.

Quality-control assessment generally used for ointments, creams, and gels may include the following:

1. Theoretical weight compared to actual weight
2. pH, as appropriate
3. Specific gravity
4. Active drug assay
5. Color
6. Clarity (gels)
7. Texture of the surface
8. Texture when spread out with a spatula on a pill tile
9. Appearance
10. Feel
11. Rheological properties
12. Physical observations

Procedures for these tests are described and a worksheet to be used in association with the compounding record is provided in a publication of the International Journal of Pharmaceutical Compounding,¹ as well as on www.CompoundingToday.com.

Reference
1. Allen LV Jr. Standard operating procedure for performing physical quality assessment of ointments/creams/gels. IJPC 1998; 2(4): 308-309.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

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�according to the latest data, prescription sales volume in 2008 was $291 billion dollars in the U.S. If compounding (all types) composes only 5% of the prescription drug market, the compounding is a $14.5 billion dollar service today.

Formulaic History
From the 1902 edition of Secrets of Wise Men, Chemists and Great Physicians, the following is the formula for Rarey's Original Horse Liniment: