WHITEPAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers
The biopharmaceutical classification system classifies drugs according to their permeability and solubility. Drugs with poor solubility and/or permeability are class II or IV type drugs, and these require special formulation technologies for solubility enhancement. In the past 25 years the number of poorly water-soluble drug candidates has increased to the extent that as many as 70 – 80% of small molecule drug candidates may be classified as poorly water-soluble today.1 Solubility enhancement technologies are therefore gaining increasing importance and are needed to unlock the potential of drug candidates and enable their release on the market.
When examining technologies used for solubility enhancement since the 1980s, lipids are the first choice for formulators.2 However, the application of solid dispersions by polymeric carriers is growing rapidly due to their versatility and effectiveness with a variety of different APIs.
There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.
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