Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Strategies for Solid Formulation

The complexity of manufacturing solid formulation has become ever more challenging due to limitations around active pharmaceutical ingredient (API) stability, release kinetics and bioavailability. Also, manufacturers of solid dose drugs (especially generics) need to find ways to reduce manufacturing costs and optimize process efficiency. Our expertise can help you overcome some of these challenges.


1. Use Direct Compression to Improve Manufacturing Efficiency

Wet granulation is the most commonly used technology for the manufacture of tablets for oral medication. However, direct compression is gaining popularity among oral solid dose manufacturers because it is a time-saving process with fewer manufacturing steps. When should you use this newer methodology for mixing ingredients in a final formulation?

Solution

Learn about the benefits of direct compression tableting technology, when to use and and how to optimize a formulation for good manufacturing efficiency and better yield.

2. Enhance Solubility with Hot Melt Extrusion

Approximately 40% of marketed drugs and roughly 60% of drugs in development exhibit poor solubility, limiting their therapeutic efficacy and clinical prospects. New technologies are required to improve solubility to enable manufacturers to bring next generation therapeutics to the market.

Solution

API water solubility can be improved using hot melt extrusion (HME). In this process, the API is dispersed within a matrix polymer through heating and mixing. The resulting amorphous solid dispersion - with the API incorporated in its stabilized amorphous state - exhibits enhanced API dissolution properties and apparent solubility. Explore an excipient grade of polyvinyl alcohol specifically designed for HME.