title: Formulation and optimization of a novel oral fast dissolving film containing drug nanoparticles by Box-Behnken design-response surface methodology.
abstract: OBJECTIVE
  The purpose of this study was to design and optimize a novel drug nanoparticles-loaded oral fast dissolving film (NP-OFDF) using Box-Behnken design-response surface methodology.
  
  
  METHODS
  Drug nanosuspensions produced from high pressure homogenization were transformed into oral fast dissolving film containing drug nanoparticles by casting methods. Herpetrione (HPE), a novel and potent antiviral agent with poor water solubility that was extracted from Herpetospermum caudigerum, was studied as the model drug. The formulations of oral fast dissolving film containing HPE nanoparticles (HPE-NP-OFDF) were optimized by employing Box-Behnken design-response surface methodology and then systematically characterized.
  
  
  RESULTS
  The optimized HPE-NP-OFDF was disintegrated in water within 20 s with reconstituted nanosuspensions particle size of 299.31 nm. Scanning electron microscopy (SEM) images showed that well-dispersed HPE nanoparticles with slight adhesion to each other were exposed on the surface of film or embedded in film. The X-ray diffractogram (XRD) analysis suggested that HPE in the HPE-NP-OFDF was in the amorphous state. In-vitro release study, approximate 77.23% of HPE was released from the HPE-NP-OFDF within 5 min, which was more than eight times compared with that of HPE raw materials (9.57%).
  
  
  CONCLUSIONS
  The optimized HPE-NP-OFDF exhibits much faster drug release rates compared to HPE raw material, which indicated that this novel NP-OFDF may provide a potential opportunity for oral delivery of drugs with poor water solubility.
authors: 302 Hospital of PLA&PLA Institute of Chinese Materia Medica , Beijing , China .
authors: Chengying
authors: C
authors: Shen
authors: Baode
authors: B
authors: Shen
authors: He
authors: H
authors: Xu
authors: Jinxia
authors: J
authors: Bai
authors: Ling
authors: L
authors: Dai
authors: Qingyuan
authors: Q
authors: Lv
authors: Jin
authors: J
authors: Han
authors: Hailong
authors: H
authors: Yuan
mesh_terms: D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D005663:Furans / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D008855:Microscopy, Electron, Scanning; D008954:Models, Biological; D053758:Nanoparticles / Q000008:administration & dosage* / Q000648:ultrastructure; D010316:Particle Size; D012995:Solubility; D013499:Surface Properties
chemical_list: D000998:Antiviral Agents; D005663:Furans; C582460:herpetrione