Effects of high hydrostatic pressure on several sensitive therapeutic molecules and a soft nanodispersed drug delivery system.
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.
Rigaldie
Yohan
Y
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.
Largeteau
Alain
A
Lemagnen
Gilles
G
Ibalot
Fabienne
F
Pardon
Patrick
P
Demazeau
Gérard
G
Grislain
Luc
L
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
D000911:Antibodies, Monoclonal; D007328:Insulin; D010455:Peptides; D004364:Pharmaceutical Preparations; D012996:Solutions; D013535:Suspensions; D006493:Heparin