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

 

Powder In A Bottle

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

 

Filling API into BottlesPowder in a Bottle

To accelerate products to the clinic for early concept testing it is not uncommon to fill individual doses of API into glass or plastic bottles. 

  • These doses are then reconstituted in the clinic or by the patient by adding water (or some other solvent system) and administered to the patient. 
  • This approach offers the advantage of alleviating the need to develop a formulation and the analytical testing methodologies required to test a formulation. 
  • UIP has experience preparing such products and this approach can be especially valuable when the initial goal is proof of concept. 
  • These materials are prepared in our cGMP manufacturing facility under batch record, standard operating procedure and cGMP control with full Quality Assurance oversight. 
  • Once proof of concept has been shown, UIP has the capability to develop formulations and produce clinical supplies.

 

Filling API into BottlesFor more information about our ability to prepare powder in a bottle supplies please Contact Us.