CASE STUDY 5:
Parenteral Dosage Form Development of a Highly Insoluble Molecule
A publicly traded New England biotechnology company with approximately 70 employees and one approved product had four additional compounds in various stages of development.
The client’s approved product was an oral dosage form, and they wanted to develop a parenteral dosage form of the drug for a different indication. Our client wanted to have a formulation ready to go into toxicology studies in under five months from contacting Wolfe Laboratories.
Because of the drug’s extremely low solubility, development of an intravenous dosage form at the required concentrations presented an obstacle. The client sought Wolfe Laboratories’ expertise in improving the solubility of the drug for the parenteral dosage form, and optimizing and evaluating the formulation.
WLI recommended and screened a series of vehicles that are generally recognized as safe for intravenous delivery, including mechanistically diverse solubility-enhancing agents. We worked with our client’s scientific and clinical team to fine-tune the product requirements. We prepared and characterized small scale batches of three different formulations. We worked closely with our client to design and implement accelerated stability studies on the three prototype formulations to identify the optimal formulation as quickly as practicable.
An optimal, stable formulation was developed less than five months after Wolfe Labs was contacted. We worked closely with our client to ensure seamless technology transfer to the toxicology facility.
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