title: Development of a prospective isopropyl alcohol-loaded pharmaceutical base using simultaneous in vitro/in vivo characterization methods of skin performance.
abstract: BACKGROUND
  Approaching of pharmaceutical and cosmetic industries in some aspects inevitably influence formulation of topical pharmaceuticals, urging researchers to introduce novel excipients with proven benefits over traditional ones. In that context, alkyl polyglucosides (APG) emerge as prominent natural-origin emulsifiers with numerous favorable features (biodegradability, dermatological acceptability, desirable sensory properties).
  
  
  OBJECTIVE
  To evaluate APG-stabilized bases (alone and upon addition of isopropyl alcohol) and their impact on skin performance. A simultaneous in vitro/in vivo skin absorption study was conducted to evaluate whether the tape stripping technique could be recommended as an in vivo tool for skin penetration assessment during formulation optimization process.
  
  
  METHODS
  After a comprehensive physicochemical characterization, biopharmaceutical properties of APG-bases versus reference ones were assessed through a combined in vitro (release/permeation) and in vivo approach.
  
  
  CONCLUSIONS
  Physicochemical characterization revealed substantial difference in structural ordering due to the formation of various mesomorphic phases. The enhancer-loaded APG base resulted in significantly higher drug levels at all depths into the stratum corneum, indicating that the selected enhancer along with specific colloidal structure has increased the extent of drug delivery.
  
  
  CONCLUSIONS
  Results recommend the investigated emulsifier for stabilization of topical drug delivery systems, not only for their ability to sustain the addition of isopropyl alcohol which proved to be a valuable enhancer, but also satisfactory skin absorption and tolerability when compared to samples stabilized by conventional emulsifier. Tape stripping proved to be a useful and yet inexpensive tool for in vivo trials, able to discriminate subtle differences in dermal availability.
authors.affiliation: Department of Pharmaceutical Technology and Cosmetology and.
authors.forename: Ivana
authors.initials: I
authors.lastname: Pantelic
authors.forename: Milica
authors.initials: M
authors.lastname: Lukic
authors.forename: Bojan
authors.initials: B
authors.lastname: Markovic
authors.lastname: Lusiana
authors.forename: Christine
authors.initials: C
authors.lastname: Hoffmann
authors.forename: Christel
authors.initials: C
authors.lastname: Müller-Goymann
authors.forename: Jela
authors.initials: J
authors.lastname: Milic
authors.forename: Rolf
authors.initials: R
authors.lastname: Daniels
authors.forename: Snezana
authors.initials: S
authors.lastname: Savic
mesh_terms: D019840:2-Propanol / Q000737:chemistry*; D002152:Calorimetry, Differential Scanning; D004008:Diclofenac / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D004339:Drug Compounding / Q000379:methods*; D065546:Drug Liberation; D045703:Emulsifying Agents / Q000737:chemistry*; D005233:Fatty Alcohols / Q000737:chemistry*; D005260:Female; D006017:Glycolipids / Q000737:chemistry*; D006801:Humans; D066298:In Vitro Techniques; D012212:Rheology; D012867:Skin / Q000378:metabolism*; D012869:Skin Absorption; D012995:Solubility; D013818:Thermogravimetry
chemical_list: D045703:Emulsifying Agents; D005233:Fatty Alcohols; D006017:Glycolipids; C542322:cetearyl glucoside; D004008:Diclofenac; C419308:cetearyl alcohol; D019840:2-Propanol
keywords: Alkyl polyglucosides; artificial skin constructs, Franz diffusion cells, isolated stratum corneum, tape stripping