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The goal of the THERAPEUTEX Preclinical Core Lab is to characterize properties of new therapeutic compounds in animal models by focusing on drug delivery and
pharmacokinetic/pharmacodynamic (PK/PD) studies.   Efforts include drug formulation and optimization of delivery method as well as development of various
disease related animal models with expertise in infectious disease and cancer/angiogenesis, evaluation of optimal drug concentrations, toxicity, efficacy, and target validation by tissue analysis of drug accumulation, metabolism, and elimination.

Drug Formulation Characterization

THERAPEUTEX offers a variety of methods to characterize the physicochemical properties of pharmaceutical materials.  These techniques can be applied for pre-formulation, formulation, or device testing.  Inhaled formulation characterization is a specific area where THERAPEUTEX has extensive resources and a high level of expertise.

• USP Dissolution  
• HPLC analysis 
• Geometric Particle Size Analysis (micron and submicron)
  -Inhalation Cell and Wet Sample Dispersion Unit
• Aerodynamic Particle Size Analysis
• Aerosol Dose Uniformity
• Differential Scanning Calorimetry
• Rheometry
• Texture Analysis
• Powder Flowability
• Bulk, Tap, and True Density
• Moisture Sorption
• Powder Surface Energy Characterization
• Atomic Force Microscopy

Preclinical and Proof-of-Concept Studies

The THERAPEUTEX Preclinical Core Lab can help transition compound studies to the next level of preclinical and proof-of-concept studies.  With faculty and staff expertise in pulmonary disease, cancer/angiogenesis, and infectious disease, the
THERAPEUTEX team can help with nearly all aspects of the study, including: experimental design and implementation, animal colony management and genotyping, surgical technique, and data analysis.

• Rodent Vivarium with General Husbandry
• Ectopic and Orthotopic Tumor Models
• Rodent Drug Delivery
• Routes include intravenous (tail vein, jugular cannulation), subcutaneous, intraperitoneal, intramuscular, oral gavage
  - Nose-only pulmonary dosing
  - Rodent Surgery and Blood Collection
• Tumor 3D Histoculture
• Cell Culture
  - Pulmonary and cancer cell lines
  - Viability, proliferation, and cytotoxicity assays
• Microplate Photometer
• Horizontal and Vertical Electrophoresis
• Polymerase Chain Reaction
• Western Blotting
• Refrigerated Clinical Benchtop Centrifuge and Refrigerated MicroCentrifuge 
• Stereomicroscope System
  - Whole tissue/animal and live cell imaging with imaging software 
• Cryogenic Storage, Chromatography Refrigerator, Enzyme/Lab Freezer, Ulra Low Freezer

Lab-Scale Formulation Production

THERAPEUTEX also offers small scale formulation production for use in R&D studies.  Some of the production capabilities include the following:

• Mechanical particle size reduction (ball milling, jet milling, high pressure homogenization, cryogenic)
• Tableting
• Lyophilization
• pMDI packaging
• Stability chambers

Histology Services

Once tissue and blood samples have been collected, several different forms of target validation by analysis of drug accumulation, metabolism, and elimination can be evaluated.

• Tissue Processing
• Paraffin and Glycol Methacrylate Embedding 
• Microtome and Cryotome Sectioning
• Immunostaining (IHC and ICC) and Custom Staining
• Inverted Fluorescent Microscope with Imaging Software 

Mailing Address:

Drug Dynamics Institute
College of Pharmacy
The University of Texas
at Austin
2409 University Ave.
Stop A1900
Austin, TX, USA
78712-1113