Optimized formulation for topical application of a fixed combination halobetasol/tazarotene lotion using polymeric emulsion technology

Abstract

Background

Successful clinical data on halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis are published. This article charts its formulation development.

Methods

Dermal deposition, clinical efficacy, and synergistic effect of HP and TAZ delivered by polymeric emulsion technology was compared to HP 0.05% cream (Ultravate) and TAZ 0.1% cream (Tazorac); skin hydration and barrier maintenance with vehicle lotion through Trans Epidermal Water Loss (TEWL) and corneometry using human cadaver tissue; and steroid potency by vasoconstrictor assay (VCA) in healthy volunteers. Safety and tolerability evaluated in clinical studies and patient preference questionnaire.

Results

HP/TAZ lotion, using polymeric emulsion technology demonstrated better active ingredient delivery than HP 0.05% or TAZ 0.1% creams; supported by synergistic clinical data, with high HP potency outcome. Efficacy was rapid and sustained posttreatment. Layering TAZ 0.1% cream onto HP 0.05% cream had a negative effect on receptor phase levels. HP/TAZ lotion provided rapid and sustained increases in skin moisturization and gradually decreases in TEWL. Most subjects responded favorably to questions on the physical attributes of the vehicle lotion.

Conclusions

Fixed combination HP 0.01%/TAZ 0.045% lotion formulation utilizing innovative polymeric emulsion technology and optimal selection of solvents/emollients/humectants, has recently been developed. Features inherent in technology translate into rapid, sustained efficacy, low irritation, and good patient acceptance.

Keywords:

• Psoriasis
• halobetasol
• tazarotene
• lotion
• formulation

Acknowledgments

We thank Brian Bulley, MSc (Konic Limited, UK) for assistance with the preparation of the manuscript. Ortho Dermatologics funded Konic’s activities pertaining to this manuscript.

Ethical approval

General principles of Good Laboratory Practice (GLP) were followed. Informed consent was obtained.

Disclosure statement

Drs. Tanghetti, Gold, and Del Rosso are advisors and/or investigators with Ortho Dermatologics. Dr Lin and Pillai and Mr Angel are employees of Bausch Health.

Additional information

Funding

The studies were funded by Bausch Health Americas, Inc.