The University of Iowa

UI Pharmaceuticals Knows Speed to Clinic is Critical and Provides Powder in a Bottle Dosage Forms

University of Iowa Pharmaceuticals can speed your program to clinical by preparing powder for reconstitution with the proper supporting studies to ensure complete delivery to the patient and stability studies.  Let us help you get to the clinic faster.

powder in a bottle process
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 administered to the patient.
  • This approach offers the advantage of alleviating the need to develop a complex 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 strict 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 to support further development of a product.

powder in a bottle process
For more information about our ability to prepare pharmaceutical powder for reconstitution by filling API into bottles, please Contact Us.