The University of Maryland School of Pharmacy's Applied Pharmaceutics Lab (APhL) is equipped for both research and discovery (R&D) and good manufacturing practice (GMP) activities.

The facility has three 500 square-foot research laboratories, one 500 square-foot GLP laboratory, and six GMP pharmaceutical manufacturing suites. It also includes rooms for the receipt and storage of GMP materials.

The labs are equipped to perform pre-formulation research, excipient screening, physical characterization of polymorphs, formulation and process development, GMP manufacturing, packaging and labeling. The analytical labs are equipped for methods development, testing and validation.

There are also validated stability cabinets to conduct stability studies in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Analytical:

  • GC
  • GC-MS
  • HPLC
  • HPLC-MS
  • UV/Vis Spectrophotometer

Blending Equipment:

  • 5-cubic foot PK V-Blender
  • 8-quart V-Blender
  • 16-quart V-Blender
  • Niro-Fielder GP-1 (high shear granulator)

Capsule Filling Machines:

  • Harro Hofliger-KFM/3 Model
  • Zanasi LZ64

Coating:

  • For small clinical lots: ca 1 kg capacity
  • Hi-Coater HT-30
  • Niro Aeromatic MP-1 Fluid Bed Processor

Density Characterization:

  • Bulk density
  • Tapped density
  • True density

Dissolution System:

  • (1) SR8 Plus Dissolution Test Station (2) with VK8000 Autosampler

Dry Granulation:

  • Particle Size
    • Laser diffraction (dynamic and static)
    • Microscopy
    • SEM
    • Sieve analysis
  • Powder Characterization
  • Surface area
    • Porosity measurement

Mechanical Characterization:

  • Instron Flow Characterization
    • Angle of repose
    • Annular shear cell
    • Carr index
    • Minimum orifice diameter

Milling Equipment:

  • Quadro Comil 197S (development/clinical scale)

Miscellaneous Equipment:

  • Environmental chambers for stability, temperature, and humidity
  • Granulation equipment: high shear, low shear, and fluid bed
  • Milling: hammer and fluid energy
  • Vacuum drying

Preformulation:

  • Moisture Content
    • Carl Fisher titration
    • Loss on drying (LOD)
    • Moisture absorption isotherm determination
  • Solubility
    • Osmolarity
    • pH and ion selective techniques
    • Viscosity measurement
  • Thermal Analysis
    • DSC and MDSC

Tableting:

  • Elasticity and other standard tests
  • Heckel analysis
  • Manesty Betapress
    • High-speed rotary tablet press (16 stations)
  • Stoke's B2 Rotary Tablet Press (16 stations)
    • Instrumented compression and ejection
    • Colton Single Station Tablet
    • Fully instrumented upper and lower force and displacement
  • Tableting Test capabilities

USP and Non-USP Test Capabilities:

  • Foss NIR Spectrophotometer RCA 6500
    • Content variation
    • Tablet disintegration
    • Tablet dissolution for IR and CR
    • Tablet hardness
    • Weight variation