By Fabiana Banov, RPh, MS, PCCA Senior Formulation Pharmacist

Lip balms are important to prevent drying and protect the lips against environmental factors, such as the sun or wind. When clinically necessary, compounders can create custom lip balms with active pharmaceutical ingredients to meet the needs of patients with various conditions. To formulate compounded lip balms, you need to balance the ingredients, including oils, flavors, waxes and other excipients. They are not intended to be ingested, but contact of the lip balm with the taste buds through the saliva occurs when the patient touches their lips with their tongue, and because of this, a palatable formula will help with the acceptability of the treatment. Flavoring a lip balm can therefore be an important aspect of the formulation.

Lip Balm Flavors

When flavoring a lip balm formula, it is important to analyze all the ingredients that will be added to the compound and evaluate which flavors and sweeteners would be ideal to use. Oil flavors are always the first choice since the composition of lip balms are mainly wax and oils. The table below lists the oil-soluble flavors that PCCA carries. The amount of oil-soluble flavor that you can use in compounded lip balm formulations varies between 0.1–0.4%.

NF-grade anise oil, clove oil and orange oil are flavoring options for lip balms as well.

Lip Balm Sweeteners

Flavors improve the taste of the formulation, but in some cases, the bitterness of the active ingredient or even the strong taste of some oils or waxes used in the formula can be very strong and end up overpowering the final taste. In cases like that, a sweetener can build a foundation to cover the taste buds and enhance the flavor sensation. Steviol Glycosides 95% (PCCA #30-4539) is a sweetener that would help to cover the undesirable taste of some substances of the formulation. NF-grade acesulfame potassium would be another suitable option. The amount of sweetener varies between 0.1–0.5%.

Incorporating Immiscible Powders

When a powder that is not miscible with the substances of the formula is added to the lip balm, it is important to use silica gel (PCCA #30-1009) in the composition to help incorporate the substance uniformly into the formulation. The recommended concentration varies between 0.4–0.6%.

Recommended Lip Balm Bases

The correct choice of the vehicle of your lip balm formulas is very important, too. It is crucial that the balm will be stable and solid in the dispensing container and able to melt on the lips for application. PCCA carries two oral bases that can be used in compounded lip balms and help with the taste. MucoLox ^™ has a unique polymer network that improves moisturization and mucoadherence while providing superior film-forming action, which provides long-lasting coverage and contact time. This base contains isomalt, which helps to improve the taste of formulations. With this in mind, the PCCA Formulation Development department created lip gel formulas using MucoLox as the base. PCCA Formula #12045 uses hydroxyethyl cellulose (PCCA #30-1766) in MucoLox as the vehicle along with active ingredients, giving an example of how to incorporate actives and flavors when using this PCCA base in formulations.

Another PCCA base that can be used in lip balm formulas is NataTroche ^® . This oral base is made with natural ingredients, is rich in fatty acids and helps to cover the undesirable taste of some medicines due its ability to mask bitterness and promote sweetness in formulations. PCCA Formula #13969, which combines cocoa butter, bees wax and NataTroche, can be a base for a custom lip balm or a final cosmetic product. PCCA members with access to Clinical Services can find these lip balm formulas with PCCA bases in our formula database.

Customizable Lip Balm Formulas

We have general formulas using a variety of other bases that we have tested in the PCCA formulations lab and that are options to be used for custom lip balms as well. PCCA members with Clinical Services access can also find these compounded lip balm formulas in our formula database.

Recommended Dispenser

Our suggested container to dispense lip balm formulas is our 5 Gm lip balm tube with cap (PCCA #35-1048). This will facilitate the application of the preparation.

As you can see, there are many options for flavoring compounded lip balms. PCCA members with Clinical Services support can contact our clinical compounding pharmacists with any questions.

Also on The PCCA Blog: Unique Dosage Forms and Flavor Ideas That Are Perfect for Summer

Fabiana Banov, RPh, MS, PCCA Senior Formulation Pharmacist and flavors expert, earned her pharmacy degree from the College of Pharmaceutical Science of the University of Mogi das Cruzes in Brazil. She also obtained specialization in cosmetic science from São Paulo State University and completed post-graduate work in the technology of cosmetic products from Osvaldo Cruz College. Prior to joining the PCCA team, Fabiana was the owner of Fórmula Médica Compounding Pharmacy in São Paulo, where she was instrumental in the development of unique cosmetic products. She is also the author of Pharmaceutical Veterinary Formulary.

This article originally appeared in PCCA’s members-only magazine, the Apothagram.