Enhancing Drug Bioavailability and Solubility

Approximately 40% of drugs on the market place and a high percentage of APIs in development are poorly soluble. Optimization of drug solubility and BA of therapeutics stands as one of the top challenges faced by the pharmaceutical and biotech industry today. A number of new chemical entities (NCEs) and new biological entities (NBEs) in clinical development are facing challenges in late phase of development (Phase II) due to a poor release profile and inability to achieve the desired Bioavailability. Additionally, many pharmaceutical and biotech companies are heavily investing in strategies to extend patents and stifle generic competition at the outset of product life cycles.

From a technology standpoint, there are a number of Bioavailability-enhancement approaches strategies which are demonstrating success. These include drug solid dispersions, liposomal formulations, selfemulsification, nanoparticle utilization, chemical complexation, and the use of nanocarriers, excipients, and targeting carriers amongst others. Ultimately, industry is in need of an integrated range of formulation and delivery strategies that can be cost effectively implemented as a complete toolkit in the drug development process for a wide range of drugs.

By way of followup, this week’s available deck is titled “Enhancing Drug Bioavailability and Solubility” from Stephen Byrn at Purdue University. Steve was a past speaker at our Global Drug Bioavailability Enhancement Summit. This presentation overviews pharmaceutical formulation development strategies, patent opportunities for solubility solutions, addresses amorphous, nanoparticle & cocrystal technology, solubilization approaches for parenteral routes of administration and solubilities of crystalline drugs in polymers. It also addresses challenges and solutions for toxicology .formulation development. To view this presentation and other novel delivery and bioavailability enhancement approaches, click below.