08 - Rohrbasser - Electrophorese capillaire_projet PHARMELP

Capillary Electrophoresis project
HES – Fribourg / Geneva University
14ème journée scientifique du CCCTA
Les Diablerets
16 – 09 2010
Counterfeits medecines : situation
The proportion of counterfeit medicines is dramatically increasing these days, in
particular in some African countries pharmaceutical wholesalers where it was
reported up to 80% of counterfeiting.
Counterfeit Medecines
A counterfeit medicine is a medicine that is deliberately and fraudulently
mislabeled with respect to identity and/or source.
Both branded and generic products can be concerned by the
counterfeiting.
Counterfeits may include products
(i)with correct ingredients/components,
(ii)with wrong ingredients/components,
(iii)without active ingredients,
(iv)with incorrect amounts of active ingredients or
(v)with fake packaging.
Drug quality control
Project Context
Countefeits drugs / Drug Quality control
The methods actually used such as spectrophotometric based analysis (UV),
Thin Layer Chromatography (TLC) or mainly liquid chromatography (LC)
present numerous important drawbacks making them difficult to be used
efficiently in the daily practice.
Major problems are related to:
the availability of reference substances,
the maintenance of analytical instruments,
the consumables availability and costs
(analytical solvents of high quality grade)
The most important issue of this project regards counterfeit medicines where
Capillary Electrophoresis (CE) is perfectly adapted to rapidly evaluate
the quality of the drugs and to give evidence for the presence of significant
amounts of degradation impurities or absence of the active principle.
Capillary Electrophoresis
Acteurs principaux
Convention 2006
Prof.C.
C.Rohrbasser
Rohrbasser
Prof.
Technologieindustrielle
industrielle
Technologie
Ecoled’ingénieurs
d’ingénieurset
et
Ecole
d’architectesde
deFribourg
Fribourg
d’architectes
Section
Sectiondes
dessciences
sciences
Pharmaceutiques
Pharmaceutiques
Université
Universitéde
deGenève
Genève
Université
de
Université deLausanne
Lausanne
Dr
DrS.
S.Rudaz
Rudaz
Prof.
J.-L.
Prof. J.-L.Veuthey
Veuthey
Pharmaciede
de
Pharmacie
l’HôpitalCantonal
Cantonal
l’Hôpital
HUGGenève
Genève
HUG
Prof.P.
P.Bonnabry
Bonnabry
Prof.
Prototype 1
2007 - 2008
Chef de projet et
chimie analytique
Claude Rohrbasser
Systèmes intégrés
Dominique Rhême
Développement
Raoul Buffat
Samuel Roth
Mattia Marangone
Développement de
méthodes, validation
Jean-Luc Vauthey
Serge Rudaz
Energie
Hubert Sauvain
Chimie industrielle
et appliquée,
Olivier Vorlet, Olivier Naef
Institut TI N 15 octobre 2008
Prototype
ECB I
+ LED
Detection
Nouveauté
mondiale
Priorités
Hauteur des Vials
Pression
De l’ordre de
4-5 mm max
Système Vis ?
Etanchéité ?
(actuel sans)
Système de rotation des carrousels
Manipulation des vérins
Changement
De capillaire
: Fragile
Carrousels placés sur les côtés
Ouverture de l’appareil sur l’arrière
ECB 2 in « real »
The data acquisition and
processing software was
also developed in house
at HES-SO Fribourg by
extending a program
initially created for Gas
and LC (Chromatos).
Apparatus Comparison acidic conditions
Methods development and validation
DEVELOPMENT AND VALIDATION OF
A METHOD FOR A NOVEL CAPILLARY
ELECTROPHORESIS DEVICE FOR
PHARMACEUTICAL ANALYSIS OF
DRUGS
BY MARÍA DE LOURDES AJA MONTES
Birth of Pharmelp
The Pharmelp association was born on September 22nd, 2009.
LNS Bamako Mali 2009
Electrophorèse low cost
The new devices ECB 4 & 5
Discussion
Capillary electrophoresis (CE) is an attractive and complementary alternative
to chromatographic techniques in different fields such as environmental, clinical,
forensic, biochemical and more particularly pharmaceutical analysis and the
Field of Counterfeits detection
CE is now recognized by the regulatory authorities and can therefore be used in
a validated analytical procedure according to ICH recommendations.
Selectivity / Linearity / Precision – Trueness / Robustness, Accuracy
Detection and quantification limits (LOD and LOQ) etc.
2010 Prototypes (2):
1.Cambodia : Dr. H. Ing / Prof. Bonnabry
2.Congo : Dr. R. Marini / Prof. PH. Hubert
July 2010
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