title: Effects of high hydrostatic pressure on several sensitive therapeutic molecules and a soft nanodispersed drug delivery system.
abstract: OBJECTIVE
  According to the development in the last decade of industrial processes using high hydrostatic pressure (HHP) for preservation of several commercial food products, novel sterilization or decontamination processes for pharmaceutical products could be conceivable. The aim of this work is to evaluate the effects of HHP on the integrity of insulin and heparin solutions, suspension of monoclonal antibodies and Spherulites.
  
  
  METHODS
  High performance liquid chromatography, thin layer chromatography, capillary electrophoresis assays, ELISA tests, laser granulometry and spectrophotometry analyses have been performed to compare HHP treated drugs (in a domain of pressure and temperature ranging respectively from 20 up to 500 MPa and from 20 degrees C up to 37 degrees C) vs. untreated ones.
  
  
  RESULTS
  No difference has been detected except for monoclonal antibodies that are altered above 500 MPa.
  
  
  CONCLUSIONS
  The structure integrity of sensitive molecule due to the small energy involved by HHP and the development of industrial plants (intended for the decontamination of food products) confer to this technology the potential of a new method for sterilization of fragile drugs and an original alternative to aseptic processes and sterilizing filtration.
authors.affiliation: LPCHP Laboratoire de Physico-Chimie des Hautes Pressions (Interface Hautes Pressions ENSCPB-ICMCB), Ecole Nationale Supérieure de Chimie et de Physique de Bordeaux (ENSCPB), 16 Avenue Pey Berland, 33608 Pessac, France.
authors.forename: Yohan
authors.initials: Y
authors.lastname: Rigaldie
authors.forename: Alain
authors.initials: A
authors.lastname: Largeteau
authors.forename: Gilles
authors.initials: G
authors.lastname: Lemagnen
authors.forename: Fabienne
authors.initials: F
authors.lastname: Ibalot
authors.forename: Patrick
authors.initials: P
authors.lastname: Pardon
authors.forename: Gérard
authors.initials: G
authors.lastname: Demazeau
authors.forename: Luc
authors.initials: L
authors.lastname: Grislain
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D004339:Drug Compounding; D016503:Drug Delivery Systems; D019075:Electrophoresis, Capillary; D004797:Enzyme-Linked Immunosorbent Assay; D006244:Hardness; D006493:Heparin / Q000008:administration & dosage / Q000737:chemistry; D006874:Hydrostatic Pressure; D007328:Insulin / Q000008:administration & dosage / Q000737:chemistry; D010316:Particle Size; D010455:Peptides / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012996:Solutions; D013535:Suspensions; D013696:Temperature
chemical_list: D000911:Antibodies, Monoclonal; D007328:Insulin; D010455:Peptides; D004364:Pharmaceutical Preparations; D012996:Solutions; D013535:Suspensions; D006493:Heparin