Hot melt extrusion (HME) has emerged as a pivotal technology in the pharmaceutical industry, particularly for addressing the solubility challenges posed by poorly soluble drugs. As a solvent-free process, HME enables the formulation of solid amorphous dispersions (ASDs), which are crucial for improving solubility and oral bioavailability, especially for BCS Class II and IV compounds. Traditional solubilization methods often fall short in achieving the necessary supersaturation levels, making HME a vital alternative.
Recent advancements have seen over 20 drugs successfully launched utilizing HME technology, including notable examples like Kaletra® (lopinavir/ritonavir). This technology not only streamlines the formulation process but also enhances stability and reduces pill burden, thereby addressing dose variability. As the industry continues to explore innovative polymers and formulations, HME stands out as a versatile platform for developing a wide range of dosage forms, from immediate release tablets to controlled-release implants.
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