Successful Formulation Strategies

<p>Poor aqueous solubility remains a major barrier in the formulation of many BCS Class II and IV drugs, often resulting in low oral bioavailability and challenging development timelines. Traditional strategies such as spray drying to create amorphous solid dispersions or salt formation of acidic or basic drugs offer potential solutions but come with limitations&mdash;namely, increased cost, longer development times, and the risk of salt precipitation in gastrointestinal fluids.</p> <p>This case study explores a third, more efficient approach: modifying the micro-environment of the drug during dissolution by incorporating acidic excipients through conventional manufacturing techniques such as high-shear granulation and compression. By using excipients like citric acid, sodium citrate, and sodium bromide, the pH and solubility conditions at the diffusion layer were successfully adjusted, resulting in a significant improvement in dissolution rate. To learn more about this effective and scalable formulation strategy, download the full case study now.</p>