For drugs nearing the end of their patent life, creating an improved formulation with an advanced technology can generate new drug product intellectual property. This strategy protects the asset and extends its market exclusivity long after the original molecular patent expires.
Pharma teams often fear changing formulations late in development due to perceived regulatory hurdles. However, the path, which involves a relative bioavailability study to bridge the old and new formulations, is a well-established and manageable process if key safety and efficacy metrics are maintained.
In amorphous solid dispersions, drug developers often reduce polymer content to increase the active drug percentage. This is a critical mistake, as the polymer actively enhances absorption. Less polymer can lead to poorer bio-performance, negating the benefit of a higher drug load.
A contract development and manufacturing organization (CDMO) that began as a sponsor company developing its own drugs possesses a unique understanding of the entire asset lifecycle. This "sponsor DNA" enables them to provide more strategic, consultative guidance beyond simply fulfilling a manufacturing contract.
Many companies knowingly use inefficient spray-dried formulations to quickly enter Phase 1 trials, deferring major manufacturing and volumetric challenges until later development stages. This "good enough for now" approach often necessitates a complete, costly reformulation later on.
Spray drying requires post-processing like secondary drying and roller compaction. These steps necessitate adding external excipients, leading to two distinct dilution phases that increase final tablet size and patient pill burden, a frequently overlooked drawback compared to denser technologies.