The University of Iowa Pharmaceuticals can speed your program to clinical by preparing powder for reconstitution. Let us help you get to the clinic faster.

 

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

 

Powder Drug Reconstitution

Filling API into BottlesPowder in a Bottle

To accelerate products to the clinic for early concept testing, it is not uncommon to utilize a drug reconstitution approach. The University of Iowa Pharmaceuticals prepares powder for reconstitution by filling individual doses of active pharmaceutical ingredients, or “API,” into glass or plastic bottles.

  • Drug reconstitution is performed in the clinic, or by the patient, by adding water (or some other solvent system) to the drug product and then administration 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 pharmaceutical powder for reconstitution by filling API into bottle supplies, please Contact Us.