Multicenter Trial of Fluocinonide in an Emollient Cream Base

Abstract

Working independently, eight investigators evaluated the clinical effectiveness of fluocinonide 0.05% in a three-week double-blind paired comparison trial of 240 patients. Half the investigators compared fluocinonide emollient cream with betamethasone valerate 0.1% cream in the treatment of atopic dermatitis, while the remaining four compared the study drug with triamcinolone acetonide 0.1% cream in the treatment of psoriasis. Statistical analysis showed clinical responses favored fluocinonide p = 0.021 (Wilcoxon Signed Rank) for the atopic dermatitis group and p = 0.001 (Wilcoxon Signed Rank) for the psoriasis group.

Interplay of Aging and Lot-to-Lot Variability on the Physical and Chemical Properties of Excipients: A Case Study of Mono- and Diglycerides

“…This is true even though the design, development, and scale-up of stable emulsion products remain challenging. , Emulsifying agents are amphiphilic molecules and are the most critical components of emulsions that stabilize the droplets of the dispersed phase in the continuous phase. − Mono and diglycerides (MDGs) are widely used as oil-soluble emulsifying agents to stabilize mayonnaise, margarine, peanut butter, lubricants, etc. − Moreover, owing to the unique properties, MDGs are also used as a stabilizer of foam or air in liquid emulsions such as ice creams and cakes . In addition, MDGs are used as excipients in pharmaceutical dosage forms with roles as emulsifiers, emollients, and stabilizers , and as carriers in lipid-based drug delivery systems . MDGs are oil-soluble emulsifying agents that can reduce interfacial tension between water and oil. ,, They are used as an oil phase structurant in water in oil emulsions by providing steric stabilization to prevent coalescence of the dispersed phase .…”

“…8−10 Moreover, owing to the unique properties, MDGs are also used as a stabilizer of foam or air in liquid emulsions such as ice creams and cakes. 11 In addition, MDGs are used as excipients in pharmaceutical dosage forms with roles as emulsifiers, emollients, and stabilizers 12,13 and as carriers in lipid-based drug delivery systems. 14 MDGs are oil-soluble emulsifying agents that can reduce interfacial tension between water and oil.…”

Crystallization and Rheology of Mono- and Diglycerides and Their Role in Stabilization of Emulsion Droplets in Model Topical Ointments

“…Blends of mono- and diglycerides (MDGs), due to their amphiphilic nature and biocompatibility, are widely used as stabilizers in topical formulations and other pharmaceutical, cosmetic, and food products. − MDGs are produced by esterification of glycerol and fatty acids at high temperatures. , As per the USP-NF, MDGs are mixtures of monoglycerides (MG), diglycerides (DG), and a small fraction of triglycerides (TG), containing not less than 40% of MG . A commercial MDG commonly contains a mixture of glycerides with acyl chains from stearic acid (C 17 H 35 COOH) and palmitic acid (C 15 H 31 COOH).…”

Quantitative Chemical Profiling of Commercial Glyceride Excipients via 1H NMR Spectroscopy

“…MDGs are widely used stabilizer in products such as ice creams, cakes, mayonnaise, and peanut butter (8). In addition, MDGs are extensively used in the pharmaceutical industry as emulsifiers, solubilizers, emollients, and stabilizers (9,10). Due to its wide application, several reports are available regarding the presence of α and β polymorphs of the MDGs resulting in altered water holding capacity (11,12).…”