The University of Iowa Pharmaceuticals offers a full range of contract pharmaceutical services. Let us help you meet your needs.

 

Preformulation Studies

Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

Preformulation Studies

Preparing to Perform an IR ScanThe University of Iowa Pharmaceuticals (UIP) has the capability to systematically build quality into products from inception by performing various preformulation studies.  All studies are performed according to FDA and ICH guidelines, client approved protocols, and standard operating procedures. 

 

 

 

Typical preformulation studies include:

  • Excipient Compatibility Studies – These studies typically assess the stability of an API with individual and groups of commonly used pharmaceutical excipients in various accelerated stability conditions.  The exact choice of excipients depends on the known stability and solubility characteristics of the active pharmaceutical ingredient (API) and the type of dosage form planned.
  • Physical/Chemical Characterization – A sample being loaded in the TGA.These studies focus on the crystal structure of the API.  The tests which are typically performed include powder x-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier transform infrared spectroscopy (FTIR), microscopy, Raman spectroscopy, and Karl Fischer moisture analysis.  Additional tests can be performed if requested.
  • Solubility – Solubility of the API is determined as a function of pH in water, buffers and/or various solvents.  The choice of solvents depends on the anticipated dosage form and the known solubility characteristics of the API or similar compounds.

 

Placing a Sample in the X-ray Diffraction Machine

Once preformulation studies have been completed on an API, UIP has the capability to develop product formulations and manufacture clinical supplies to meet clinical trial needs. 

 

For more information about our ability to conduct preformulation studies please Contact Us.