Part 5: Quality-control Considerations
We are continuing our series on "Compounding Cosmetics for Special populations and for Use as Compounding Vehicles." There are many opportunities available, including:
- Compounding cosmetics for ingredient-sensitive patients,
- Compounding special vehicles to meet patient-specific needs, and
- Compounding cosmeceuticals, as appropriate.
This week, we will look at quality-control considerations.
Quality Control
Many of the same quality-control procedures used for regular pharmaceutical dosage forms can be used in the preparation of cosmetics. Preparation of extra product that can be placed in storage for periodic observation over its expected use or life is useful; if adverse changes occur, a patient could be contacted, and the remaining product recalled.
Incorporation of Active Ingredients
The incorporation of any active ingredient into a cosmetic used as a vehicle must follow all the considerations of any compounded pharmaceutical because the cosmetic is being converted to a drug preparation. Chemical and physical characteristics must be considered as well as stability. Chemical properties to consider include the structure, form, and reactivity of the active drug in the presence of the vehicle. Physical properties to consider include particle size, crystalline structure, melting point, and solubility. The active drug must be physically and chemically compatible with the cosmetic vehicle.
Ointments/Creams/Gels
Quality-control assessment can include theoretical weight compared to actual weight, pH, specific gravity, active drug assay, color, clarity, texture-surface, texture-spatula spread, appearance, feel, rheological properties, physical observations, and preservative effectiveness tests for creams and gels.
Topical Liquids
Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, clarity, globule-size range, rheological properties/pourability, physical observation, physical stability (discoloration, foreign materials, gas formation, mold growth), and preservative effectiveness test.
Sticks
Quality-control assessment can include weight, specific gravity, active drug assay, color, clarity, texture of surface, appearance, feel, melting test, dissolution test, physical observation, and physical stability.
References
Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations, part 1: Physical and chemical testing. IJPC. 2019; 23(3): 211-216.
Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations, part 2: Microbiological testing. IJPC. 2019; 23(4): 299-303.
Next week, "Storage and Labeling of Compounded Cosmetics and Special Ingredients."
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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