Madrid Tech R&D Center

Center Activities

 

  • New R&D facility, built in 2008 and acquired in July 2011

Scope 

  • Analytical development

  • Small Scale Formulation development Solid Dosage Forms

  • Technical R&D Headquarters / Innovation central point

  • Formulation development solids:  batch sizes from 250 g – 10 kg

  • Fully integrated in Site Quality System

  • Close collaboration with Pilot sites France & Greece and QA/QC operations.

Small scale formulation development (lab scale)

  • Weighing area.

  • Blending capacities -- Bin blender. Bohle 1 – 40L.

  • Sieving and milling capacities -- Conical mill, 360 Kg/h ; oscillating mill ; vibro sifter, 20 Kg/h.

  • Dry granulation: Roller compactor. Freund Vector, 1 Kg/h.

  • Wet granulation: High Shear Granulation. Diosna 1 – 6L, jacketed bowl.

  • Fluid bed: Midi-Glatt, 0.3 – 1.2 Kg.

  • Tabletting: Riva Piccola, small scale 8 D stations tablet press

  • Encapsulation machine: Zanassi encapsulation equipment with every format and capacity for pellets and microtabs.

  • Blistering machine: manual Alu/Alu, PVC/Alu blistering equipment.

 Analytical development

  • Instrumental analytics:

    -   HPLC (several detector technologies), UPLC, GC, UV, IR

    -   AAS, HPLC-MS, NMR (1H, 13C, 31P), CHNS analysis

  •  Physico-Chemical Methods:

    -   Dissolution, Hardness, Moisture (KF, LoD),

    -   Particle Size Distribution (Sieve Sizes, Malvern),

    -   Rheology, Disintegration, Friability,

    Bulk/tapped density, Potentiometrie, TLC

  • Stability Conditions:

            25°C /60%RH,   30°C/65%RH,    40°C/75%RH

            25°C/40%RH,    30°C/35%RH,    40°C/25%RH

            30°C/75%RH  

    -   Accelerated degradation: 50°C to 80°C

    -   Photostability testing

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