The protection of sensitive APIs is crucial, especially given that many modern drug molecules, including biologics, peptides, and certain small-molecule drugs, are highly susceptible to environmental factors like light, moisture, oxygen, or heat.
The development of these sensitive APIs is becoming more frequent with advances in precision medicine and biologics. Protecting them through formulation techniques like encapsulation, or stabilizing excipients is essential to maintaining their therapeutic value. These strategies ensure that sensitive drugs can be safely stored, transported, and administered without losing potency, making the protection of unstable APIs a critical aspect of drug development in today’s pharmaceutical landscape.
Protection against acid, humidity, or light can be achieved using coatings, anhydrous processes such as dry powder layering or an organic solvent process.
“Legally sensitive” APIs, ie. controlled substances, such as narcotics, require special handling. They play a vital role in medical treatments, particularly in pain management and anesthesia. These drugs, while essential for patient care, are subject to strict regulatory control due to their potential for misuse, addiction, and diversion. Handling narcotics requires rigorous security measures, meticulous record-keeping, and adherence to legal requirements to prevent unauthorized access or abuse.