CONTEXT: It is well known that microemulsions are mainly utilized for their transdermal rather than their dermal drug delivery potential due to their low viscosity, and the presence of penetration enhancing surfactants and co-surfactants. OBJECTIVE: Applying quality by design (QbD) principles, a @entity555 microemulsion formulation for local skin delivery was optimized by creating a control space. MATERIALS AND METHODS: @entity3124 ( @entity3124 ) were oil, surfactant/co-surfactant ( @entity5475 / @entity6862 ), and water percentages. @entity3124 attributes (CQA) were globular size, microemulsion viscosity, @entity555 skin deposition, permeation, and local accumulation efficiency index. RESULTS AND DISCUSSION: Increasing oil percentage increased globular size, while the opposite occurred regarding @entity5475 / @entity6862 , (p   =   0.001). Microemulsion viscosity was reduced by increasing oil and water percentages (p   <   0.05), due to the inherent high viscosity of the utilized @entity5475 / @entity6862 . Drug deposition in the skin was reduced by increasing @entity5475 / @entity6862 due to the increased hydrophilicity and viscosity of the system, but increased by increasing water due to hydration effect (p   =   0.009). Models with very good fit were generated, predicting the effect of @entity3124 on globular size, microemulsion viscosity, and drug deposition. A combination of 40% oil and 45% @entity5475 / @entity6862 showed the maximum drug deposition of 75.1%. Clinical skin irritation study showed that the aforementioned formula was safe for topical use. CONCLUSION: This article suggests that applying QbD tools such as experimental design is an efficient tool for drug product design.

Optimizing the dermal accumulation of a XXXX microemulsion using skin deposition modeling.

@entity3124 :: ('MESH:D016638', 'Disease') :: ['Critical formulation factors', 'CFF', 'Critical quality'] @entity555 :: ('MESH:C086827', 'Chemical') :: ['tazarotene'] @entity6862 :: ('CHEBI:16573', 'Chemical') :: ['CoS'] @entity5475 :: ('6287', 'Gene') :: ['SAA']
@entity555 :: (MESH:C086827,Chemical) :: ['tazarotene']
