Case Study 2 - Increase Bioavailability
Customer Need:
A large pharmaceutical company was in the pre-clinical stage of developing a new small molecule therapeutic (NCE) for either an oral or IV administration. The NCE showed very poor bioavailability in the recent animal studies. The project was in jeopardy.
Formatech's goal was to develop a toxicology formulation that would increase aqueous solubility and enhance bioavailability. Realizing that increased solubility does not necessarily translate into improve bioavailability, a multi-pronged development effort was launched.
Formatech Plan:
Working with the existing pre-formulation and solubility data, the Formatech development team designed a series of experiments to manipulate solubility. This systematic screening protocol contained various mixtures of GRAS solvents and co-solvents, oils, combination matrices and emulsions.
Each was assayed for stability using the existing Reversed Phase HPLC method to ascertain solubility and stability relative to freshly made samples.
Solution:
Three potential new formulation matrices showing improved solubility and stability characteristics were given back to the customer to dose the animals. The bioavailability improved in all cases and one of the toxicology formulations was committed to on-going development into a clinical dosage form.
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