Nano Transformer® Formulation for Poorly Soluble Drugs
More than 70% of new chemical entities (NCEs) have poor water solubility and therefore have reduced bioavailability. Poor bioavailability due to the insolubility is one of the major causes of attrition in the drug development pipeline. It is reported that the failure rate of drugs entering Phase I trials is over 90%.1 Modifying the water solubility of Biopharmaceutics Classification System (BCS) Class 2 and 4 compounds (low solubility) directly impacts the bioavailability of drugs within these classes. Consequently, formulators regularly explore various approaches to improve the solubility of APIs in the preclinical stage to provide the potential for maximum exposure in safety studies, which often include strong solvents and emulsifiers that are not suitable for clinical formulation. Changing formulations between preclinical studies and the first-in-human clinical study delays time to clinical initiation and thus results in increased cost to the program and company.
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