title: Self-microemulsifying systems of Finasteride with enhanced oral bioavailability: multivariate statistical evaluation, characterization, spray-drying and in vivo studies in human volunteers.
abstract: OBJECTIVE
  To develop Finasteride-loaded self micro-emulsifying drug delivery systems (SMEDDS) for the treatment of hormonal associated problems.
  
  
  METHODS
  Ternary phase diagrams were constructed to obtain self-emulsification regions. Multivariate statistical methods viz. Principal component analysis and agglomerative hierarchy clustering analysis were used to evaluate the microemulsions stability. In vitro redispersibility study was adopted and two formulations were selected for spray-drying. Further investigations were performed (Fourier transform infrared, x-ray diffraction and transmission electron microscopy). Finally, the in vivo performance was tested in human volunteers.
  
  
  RESULTS
  Multivariate statistical methods selected stable SMEDDS. Spray-drying utilizing maltodextrin/leucin carrier system yielded a flowable product. Selected solid SMEDDS scored 129.35% relative bioavailability compared with a commercial tablet.
  
  
  CONCLUSIONS
  The developed SMEDDS poses successful platform for glucosteroid analogs oral delivery.
authors.forename: Wael
authors.initials: W
authors.lastname: Fagir
authors.forename: Rania M
authors.initials: RM
authors.lastname: Hathout
authors.forename: Omaima A
authors.initials: OA
authors.lastname: Sammour
authors.forename: Ahmed H
authors.initials: AH
authors.lastname: ElShafeey
mesh_terms: D000284:Administration, Oral; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D004355:Drug Stability; D004655:Emulsions / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D018120:Finasteride / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D064368:Healthy Volunteers; D006801:Humans; D012995:Solubility; D014961:X-Ray Diffraction
chemical_list: D004655:Emulsions; D018120:Finasteride