UI 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.
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.