API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution

摘要

As defined in the International Conference on Harmonization(ICH) Guidance for Industry, Q7A Good Manufacturing PracticeGuidance for Active Pharmaceutical Ingredients (APIs), an API isany substance or mixture of substances intended to be used inthe manufacture of a drug (medicinal) product.1 The API, whenused in the production of a drug, becomes an active ingredientthat is intended to furnish pharmacological activity or other directeffect in the diagnosis, cure, mitigation, treatment, or preventionof disease or to affect the structure and function of the body.While many APIs have therapeutic potential, that doesn’t meanthey automatically function as effective drugs. Some APIs are innately hydrophobic, with poor bioavailability. Others are morehydrophilic, which results in higher bioavailability leading to alower dose requirement to exhibit the intended pharmacologicaleffect.