AllTranz, Inc. Contract Research Capabilities
AllTranz, Inc. is fully accredited and approved for Schedule I-V controlled substances, animal use, and human tissues/blood sample use.
Small Molecule Synthesis
AllTranz has the capabilities to design, synthesize and characterize novel dermal prodrugs for altered delivery rates through the skin as well as, novel intranasal, oral, ophthalmic, buccal, and injectable prodrugs for altered absorption or solubility.
Major Equipment
Biotage Isolera One –medium to large scale purification system
Waters HPLC systems with UV detectors
Waters HPLC semi-preparatory system with UV detector
Waters Micromass Quatro Micro API HPLC/MS/MS with photodiode array detector
Agilent HP5890 Gas Chromatograph with Flame Ionization Detector
Analytical Testing
AllTranz has many capabilities in analytical chemistry to characterize either API or formulated drug product:
HPLC or GC assay development, qualification, or validation
Residual solvent analysis
Development of LC- MS or LC-MS/MS assays for pharmacokinetic studies
ELISAs
Stability indicating method development
Stability testing of API or formulated products:
25°C, 60% R.H.
40°C, 75% R.H.
Formulation Development
AllTranz is skilled in the design and testing of pharmaceutical topical and transdermal formulations such as:
Gels and ointments
Creams and lotions
Suspensions and solutions
Matrix and reservoir type transdermal delivery systems
Once a formulation has been optimized with in vitro absorption studies, release testing and stability studies can be performed as requested.
In vitro Testing
AllTranz has the ability to provide a number of in vitro tests to analyze the physicochemical properties of a compound.
In vitro drug permeation studies in flow through diffusion systems using cells either 1, 1.77, or 6.25 cm2 in diffusional area (special size requests considered).
Skin models:
Human skin (surgical waste or cadaver)
Hairless mouse
Rat
Guinea pig
Weanling pig or Yucatan pig
Polymeric membrane
Permeation and toxicity studies using cultured human skin (EpiDerm) and tracheal/bronchial tissue (EpiAirway) to study: TEER, epithelial potential difference (PD), TEWL, sodium fluorescein permeation, MTT assay (mitochondrial dehydrogenase activity) testing, including corrosivity testing. mattek.com
In vivo Testing
AllTranz has a number of animal testing models for drug product evaluation following topical application, intranasal application, intravenous administration, and other routes of delivery:
Mice
Hairless rats and other rats
Hairless guinea pigs
Yucatan miniature pigs
Barrier function (irritation) studies can be determined by transepidermal water loss (TEWL)
Additionally, in vivo toxicity and dermal tolerance studies in all animal models, including skin irritation and sensitization protocols can be performed.