a technological platform dedicated to Advanced Galenic

Why GALA®?

The pharmaceutical development

Pharmaceu)cal  dosage  form  example  

Auxiliary  substances  

Ac)v  drug  

+  

Pharmaceutical Development Process

Drug  Discovery  

Preformula2on  Research  

Analy2cal  Development  

Process  Research  

Formula2on  Development  

Bioavailability  

Phisyco-­‐chemical    Characteriza2on  

Pharmaceu2cal  form    concep2on   =  

+  API  

EXCIPIENTS  

Pharmaceutical dosage forms

~ 40% of pharmaceutical products never reach the clinical level due to a bad absorption by the human body

Increasing difficulty since last 15 years

REASONS  FOR  DRUG  FAILURE  

Why GALA®?

Advanced Galenic is seen as a market of major importance in the field of drug delivery

Engineered particle for drug delivery

The galenic improvement of the existing products also constitutes one possibility to avoid the high cost of the development of new molecular entities.

What is GALA®?

1. A network of competences

Chemical    synthesis  

Physico-­‐chemistry  of  powders  

Galenic    formula2on  

 Processes  engineering  

   

Physico-­‐chemistry  of  colloidal    systems  

   

SPCMIB  UMR  CNRS  5068  

LGC  UMR  CNRS  5503    

CIRIMAT  UMR  CNRS  5085  

       RAPSODEE  UMR  CNRS  5302  

IMRCP  UMR  CNRS    5623  

GALA®,  an  Advanced  Galenic    Technology  PlaSorm      

Associated laboratories: •  RAPSODEE, UMR CNRS 5302 •  CIRIMAT, UMR 5085 CNRS/INPT/UPS (Equipe PPB) •  LGC, UMR 5503 CNRS/INPT/UPS •  I.M.R.C.P., UMR 5623 CNRS/UPS (Groupe S.M.O.D.D.) •  LSPCMIB , UMR 5068 CNRS/UPS

Other funding members: •  Communauté d’agglomération de Castres-Mazamet Technopole

What is GALA®?

dedicated  equipment  and  lab  space  for  manipula3on  of  API  in  compliance  with  safety  rules  and  in  GMP  condi3ons  

•  Laboratories  area    -­‐ 1  area  for  small  equipments    -­‐ 1  area  for  analysis  and  characterisa3on  

•  Area  for  produc2on            -­‐  2  pilot  areas  

2. An innovative infrastructure

•   Development  of  oral  dosage  forms  

•   Development  of  monodispersed  microcapsules  

•   Characterisa2on  of  pharmaceu2cal  dosage  forms  

§   Laboratory  Area  I    (42  m2)  §   Laboratory  Area  II  (29  m2)  §   Weight  Area  (5,2  m2)  §   Laundry  (5  m2)  §   Storage  Area  (12  m2)  

§   Pilotes  Areas  ISO  7  (29  m2;  36  m2)  §   Weight  Areas  ISO  7    (6,2  m2;  4,4  m2)  §   Equipments  Storage  Area  ISO  8  (11m2)  § Laundry  ISO  8  (  11m2)  

Technical  center  in  CASTRES  

Plateforme  GALA  ®    :    innova3ve  equipments  available  to  experiment  and  characterize  processes  and  materials  and  manipulate  pharmaceu3cal  ac3ve  drugs  in  safety  condi3ons  

What is GALA®?

Innovative  technologies in galenic

•  Hot-­‐Melt  Extrusion  Line  in  GMP  configura3on    

•  Prilling  microencapsula3on  machine  (from  liquid  phase)  

•  Spray  Dryer  

 

• Raman  confocal  –AFM  Microscope    

CHARACTERISATION MEANS

PROCESSES

Spheronisator M BRACE

Extrudeuse Pharma 16 THERMOFISHER

Atomiseur de séchage B-290 - BUCHI

Microscope Alpha 300AR WITEC

10   21/02/2014  

What is GALA®?

Solid dispersion (HME)

Modular  concept  with  screw  and  Sheath  Flow:  0,5  to  5  kg/h  Gravimetrics  Feeders:    

Flexwall  single  screw  ;  flow  from  0,5  to  10  kg/h  MiniTwin  twin  screw;  flow  from  0,05  to  2,5  kg/h  

Twin  screw  Extruder  Pharma  16  Thermofisher  

Solid dispersion (HME)

MEB  Images   Raman  Images  

Red  =  no  material  Blue  =  material  

Solid dispersion (HME): Characterisation

Spray drying  

From  liquid  …to  powder  

...  In  few  seconds!  

Ini3al  state:  liquid  product    (‘pumpable’  product)  

Final  State:  pulverulent  product  (powder  with  uniform  quality)  

Solid dispersion (SD)

From liquid to powder with controled properties…

Aims:    ü  Control  the  solid’s  proper2es  

ü  Protec2on  with  encapsula2on  

Solid dispersion (SD)

Aim  of  the  project:    Improve  the  flowability  

Pharmaceutical product (industriel R&D project)

Exemple  of  Applica3on  

Solid dispersion (SD)

Diagram of the liquid flow through an opening, function of the speed flow

PRILLING SPRAY DRYING

Vitesse du jet

laminaire turbulent

Prilling

Diagram of the Prilling principle

•  Microspheres or Microparticules with spherical geometry and narrow granulometric distribution

•  Process Comparison

Prilling: Spheronisator M- Brace

Alimenta3on  du  noyau  

Prilling:

Microsphere exemples

Microcapsule exemples

GALA®: scientific meetings

Meeting Place and exchange between Academic world and industrials actors

1st  MEETING  (déc  2009)  –  théma2c  workshop    

• Formula3on/Galénic/  Coa3ng/Encapsula3on  • Analyse  and  Characterisa3on  

2nde  MEETING    (déc  2011)  

How  to  improve  the  biodisponibility  of  the  bioac3ves  molecules  few  soluble  in  aqueous  solu3on  ?    

From  the  molecule  to  the  drug  :    Part  of  genera3on  and  shaping  of  solids  

3rd  MEETING  (june  2013)  

Co-­‐organised  with    the  SFGP  Solides  Divisés  group  

17&18  APRIL  2013    GALA&WITEC  Days  Confocal  Raman-­‐AFM  Microscopy    05  APRIL  2013  

APGI  –  SANOFI  –  GALA    Day  Industrial  Drying  

23&24  APRIL  2014  2nd  GALA&WITEC  DAYS  Confocal  Raman-­‐AFM  Microscopy  

ü   A  network  of  competences  in  innova3ve  galenic  that  gathers  various      laboratories  with  complementary  exper3se  and  that  relies  on  an  equipped  new  laboratory  dedicated  to  the  manipula3on  of  ac3ve  pharmaceu3cal  ingredients...  

 There  is  no  other  exis2ng  Galenic  Technology  PlaSorm  of  this  type  

(market  survey  performed  by  ALCIMED,  April  2009)  

ü       A  support  plakorm  of    the  Cancer-­‐Bio-­‐Santé  Cluster                  in  Midi-­‐Pyrénées  (project  labelled  in  April  2009)    

In  summary,   is  

www.plateforme-gala.com

Thanks for your attention