To accelerate products to the clinic for early concept testing, it is not uncommon to utilize a drug reconstitution approach. The UI Pharmaceuticals prepares powder for reconstitution by filling individual doses of active pharmaceutical ingredients, or “API,” into a 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. 
• UI Pharmaceuticals 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, UI Pharmaceuticals has the capability to develop formulations and produce clinical supplies to support the further development of a product.