Application Note

Developing Oral Dosage Forms: An Approach For Faster Path To Market

Source: Catalent

Oral solid dosage form is the most preferred route because of ease of administration and patient compliance. With the emphasis on developing treatments for complex diseases, the nature of the molecules in the global pharmaceutical pipeline is changing and formulating an oral dose has become more challenging - currently, 90% of NMEs are poorly water soluble, poorly permeable, or both. Innovations in drug development have provided a wide variety of techniques and tools to address the bioavailability, stability and manufacturability challenges. Bioavailability enhancing technologies have brought more than 100 drug products to the market. However, each drug molecule has unique physicochemical and biopharmaceutical properties and scientists have to weigh multiple factors including the drug development cost, development cycles, and amount of API available before identifying a suitable delivery technology. An agnostic and data-driven approach early on enables formulation scientists to screen formulations and find a technology with optimal bioavailability suitable for animal studies and to enable further development of clinical trial materials.