Many approaches, such as co-formulating with solubilizing agents, using salts, co-crystals, and amorphous solid dispersions, have been employed to enhance solubility. 1 As a result, formulation scientists often formulate drugs to overcome solubility limitations. Orally administered drugs must dissolve in the gastrointestinal tract before they can be absorbed into the body’s circulation, and yet 40% of approved drugs are considered insoluble nearly 90% of developmental compounds are considered poorly soluble. The research results are also helpful for the regulatory assessment and evaluation of the bioinequivalence risk of the test drug products compared to the reference drug products. Findings from the research create a valuable foundation for understanding the impact of biologically relevant media on solution phase behavior of poorly soluble drugs which can assist in the development of generic drug products that will use ASDs. Recent research conducted by FDA’s Office of Generic Drugs in the Center for Drug Evaluation and Research explored the mechanistic understanding and prediction of in vivo performance of ASD drug products. Important drugs that treat cancer, cystic fibrosis, and organ transplant rejection, to name a few, use ASDs in their formulation to help overcome the solubility limitations of drugs when they are administered orally. IntroductionĪmorphous solid dispersions (ASDs) are a popular mechanism for enhancing the solubility and bioavailability of drugs that are poorly soluble in water. Recent CDER research explores the potential for using amorphous solid dispersions to formulate generic drug products that may include ingredients that are poorly water-soluble. CDER scientists are seeking ways to improve the bioavailability of drugs that on their own do not dissolve well in water.
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