title: Development of medicated foams that combine incompatible hydrophilic and lipophilic drugs for psoriasis treatment.
abstract: The focus was on the development of medicated foam for incorporation of two incompatible active agents for psoriasis treatment; i.e., lipophilic cholecalciferol, and hydrophilic salicylic acid. Emphasis was given to formulation of a propellant-free foam, with sufficient foaming properties, physical and chemical stability, and low irritancy potential to maintain relevance for later translation into clinical practice. Various excipients and concentrations were examined to achieve suitable foam stability parameters, viscoelasticity, and bubble-size, which relate to foamability and spreadability. The major positive impact on these properties was through a combination of surfactants, and by inclusion of a viscosity-modifying polymer. Incorporation of the incompatible drugs was then examined, noting the instability of cholecalciferol in an acidic environment, with the design aim to separate the drug distributions among the different foam phases. Cholecalciferol was stabilized in the emulsion-based foam, with at least a 30-fold lower degradation rate constant compared to its aqueous solution. The composition of the emulsion-based foam itself protected cholecalciferol from degradation, as well as the addition of the radical-scavenging antioxidant tocopheryl acetate to the oil phase. With the patient in mind, the irritancy potential was also examined, which was below the set limit that defines a non-irritant dermal product.
authors.affiliation: University of Ljubljana, Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Janja
authors.initials: J
authors.lastname: Mirtič
authors.affiliation: Aristotle University of Thessaloniki, Faculty of Pharmacy, University Campus 54124 Thessaloniki, Greece.
authors.forename: Foteini
authors.initials: F
authors.lastname: Papathanasiou
authors.affiliation: University of Ljubljana, Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Žane
authors.initials: Ž
authors.lastname: Temova Rakuša
authors.affiliation: University of Ljubljana, Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Mirjam
authors.initials: M
authors.lastname: GosencaMatjaž
authors.affiliation: University of Ljubljana, Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Robert
authors.initials: R
authors.lastname: Roškar
authors.affiliation: University of Ljubljana, Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia. Electronic address: Julijana.Krist@ffa.uni-lj.si.
authors.forename: Julijana
authors.initials: J
authors.lastname: Kristl
mesh_terms: D002762:Cholecalciferol / Q000008:administration & dosage; D004655:Emulsions / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry*; D006801:Humans; D011565:Psoriasis / Q000188:drug therapy*; D013501:Surface-Active Agents / Q000737:chemistry*; D055682:Viscoelastic Substances
chemical_list: D004655:Emulsions; D005079:Excipients; D013501:Surface-Active Agents; D055682:Viscoelastic Substances; D002762:Cholecalciferol
keywords: Cetyl alcohol (PubChem CID: 2682); Cholecalciferol; Cholecalciferol (PubChem CID: 5280795); Cocamidopropylbetaine (PubChem CID: 20280); Dermal drug delivery; Disodium laurethsulfosuccinate (PubChem CID: 174873); Foam; Glycerol (PubChem CID: 753); Hydroxopropylmethyl cellulose (PubChem CID: 57503849); Irritancy; Rheology; Salicylic acid (PubChem CID: 338); Sodium dodecyl sulfate (PubChem CID: 3423265); Stability; Tocopheryl acetate (PubChem CID: 86472)