Powder 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.
For more information about our ability to prepare powder in a bottle supplies please Contact Us.