Research Facilities

Pharmaceutical Research and Manufacturing Capabilities

My laboratory at the University of Maryland School of Pharmacy includes fully equipped, modern research facilities for analytical chemistry, preformulation, and formulation development, as well as suites for non‑clinical manufacturing research and development and selected GMP manufacturing activities.

The School of Pharmacy houses the Applied Pharmaceutics Laboratory (APhL), a fully equipped facility comprising five 500‑sq‑ft laboratories and six GMP pharmaceutical manufacturing suites, along with warehouse space for the receipt and storage of GMP materials. The APhL supports preformulation studies, excipient screening, physical characterization of raw materials, formulation and process development, GMP manufacturing, and the packaging and labeling of clinical supplies.

The laboratory contains instrumentation to characterize a wide range of dosage forms using official USP methods, including assay and dissolution testing. We can manufacture from small‑scale batches to quantities suitable for clinical trials (from milligram amounts up to ~20 kg). We also maintain temperature‑ and humidity‑controlled cabinets for stability studies in accordance with ICH guidelines under refrigerated, room‑temperature, intermediate, and accelerated conditions.

All of the above-mentioned facilities and other facilities on campus are readily available for all personnel working on a project.

Equipment at the University of Maryland School of Pharmacy Labs and GMP Facilities

Research Capabilities for Formulation Development

Preformulation Capabilities

  • Thermal analysis: DSC (TA Instruments DSC2500 with modulated MDSC)
  • Microbalance (Mettler Toledo)
  • Thermal gravimetric Analysis TGA (TA Instruments TGA 250)
  • Viscosity measurement (Discovery HR-2)
  • Brookfield DV-III Rheometer
  • RheoSense® slit viscometer/rheometer
  • Tribological measurements (Discovery HR-2)
  • pH and ion selective electrodes
  • Loss on drying (Mettler Toledo Moisture Balance HB43)
  • Water activity / moisture adsorption isotherm determination (LabMaster-aw neo, Novasina)
  • Solubility and intrinsic solubility determination

Particle characterization capabilities

  • Optical Microscopy. Nikon eclipse ME600 and Olympus SZH stereoscope
  • Particle size: laser diffraction (Mastersizer 2000), Horiba LA910 microscopy and sieve analysis (ATM SonicSifter)

Powder characterization capabilities

  • Flow Characterization: angle of repose, Carr index, and minimum orifice diameter
  • Porosity measurement
  • Density: true (AccuPyc 1330), taped (Stav 2003), envelope (Geopyc 1360) and bulk (Scott Volume meter)
  • SEM
  • Surface area (Gemini VII, Floprep 060)

Particle Engineering milling and granulation

  • Quadro Comil 197S (development / clinical scale)
  • Lab grinder
  • Ball mill
  • High shear granulator Freund Vector GMS- Lab Micro
  • Low shear granulator Erweka
  • Fluid bed granulator (Bosch MycroLab)

Standard USP methods of formulation testing

  • Tablet hardness tester, Key HT-300
  • Weight variation
  • Content Uniformity
  • Tablet disintegration
  • Friability (Vankel)
  • Dissolution apparatus, Hanson – SR8 plus dissolution test station. Apparatus is equipped with AutoPlus autosampler.
  • Vertical Diffusion cells, Hanson Research

Taste Evaluation

  • Electronic Tongue (Insent SA402B)

Stability cabinets for ICH conditions (monitored)

  • 25°C ± 2°C/60% RH ± 5% RH, 40°C ± 2°C/75% RH ± 5% RH and 5°C ± 3°C
  • Caron 6017, 10 cu. ft.
  • Thermo Fisher Scientific
  • Compaction Simulator
  • Styl’One Evolution

Blending equipment

  • 16qt V-Blender
  • 8qt V-Blender

Transdermal patch manufacturing and testing

  • Pneumatic pressure rollers for making laminated patches
  • Draw down bars for precisely coating polymer backing with adhesive layers
  • ASTM testing apparatus for determining adhesion strength

Tableting equipment

  • Rotary tablet press, Stokes B2 Rotary Press

Tablet analysis

  • Heckel analysis
  • Elasticity and other standard tests

Miscellaneous equipment

  • Spray Drying
  • Buchi minispray dryer B-290 with solvent trap and moisture dryer
  • Hot Melt Extrusion
    • Thermo Scientific Pharma 11
  • 3D printer (FabRx M3DIMAKER2, multiple printheads)
  • Mechanical testing – Instron
    • Can be used to measure the strength of abuse deterrent formulations, film strength and syringeability

Analytical

  • UPLC (Waters Acquiity diode array detector, fluorescence detector, TUV, ELSD)
  • HPLC-MS
  • GC (Agilent 6890N, FID)
  • NIR Foss 6500 with RCA sampling unit
  • NIR Foss XDS with RCA and RLA sampling units
  • FTIR Jasco FTIR 6100 with ATR
  • Raman Metrohm MIRA
  • UV/Vis Spectrophotometer
  • HPLC (Shimadzu LC-10AS)

Encapsulation equipment

  • Harro Hofliger-KFM/3 with instrumented compression pins

Pan tablet coating

  • Hi-Coater HT-30 (for small clinical lot only has about 1 kg capacity)

Fluid bed equipment

  • Bosch Mycrolab
  • Magnaflow® fluid bed processor, Model 002 (Fluid Air® Inc., Aurora, IL)

Packaging

  • PVT Vacuum sealer – Packaging Aids Corporation
  • Induction sealer for sealing HDPE bottles with foil