Abstract
A moisturizing cream containing 25 wt% of an organic solvent, diethylene glycol monoethyl ether (DEGEE), is observed to be stabilized by an emulsifying wax blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate (tradename Crodafos CES). Polarized light microscopy indicates that the Crodafos CES helps to produce a liquid-crystal stabilized oil-in-water emulsion, which is physically stable for months under accelerated aging conditions and chemically stable over the full topical pH range of 3.5 to 9. Emulsion globule size in the cream is observed to be dependent on the degree of emulsifying wax neutralization, with the globule size decreasing with increasing cream pH. The superior solubilizing properties of DEGEE combined with the full pH range and liquid-crystal stabilizing properties of the Crodafos CES give this formulation the potential for a wide range of applications in the topical delivery of active pharmaceutical ingredients.
Highlights
Diethylene glycol monoethyl ether (DEGEE) is a compendial excipient that is being used increasingly as a solvent in FDA approved topical pharmaceutical products [1]
Polarized light microscopy indicates that the Crodafos CES helps to produce a liquid-crystal stabilized oil-in-water emulsion, which is physically stable for months under accelerated aging conditions and chemically stable over the full topical pH range of 3.5 to 9
Due to diethylene glycol monoethyl ether (DEGEE) being such a good solvent for lipophilic materials, the oil phase of the emulsion tends to dissolve when this solvent is added to a traditional oil-in-water emulsion
Summary
Diethylene glycol monoethyl ether (DEGEE) is a compendial excipient that is being used increasingly as a solvent in FDA approved topical pharmaceutical products [1]. The advantages of formulating with DEGEE for application to oily skin sites quickly becomes a disadvantage when formulating for skin conditions that are characterized by “dry skin” For these dermatological applications, a moisturizing formulation such as an oil-in-water cream or lotion is required [2]. Due to DEGEE being such a good solvent for lipophilic materials, the oil phase of the emulsion tends to dissolve when this solvent is added to a traditional oil-in-water emulsion This property has made DEGEE a preferred solvent for formulating microemulsions and nanoemulsions [3], development of an oil-in-water emulsion that contains a significant amount of DEGEE represents a significant challenge for the topical dermatological product formulation scientist
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