How Adept Formulation Helps Overcome Manufacturability Challenges In Multi-Particulate OSDs

By Gus LaBella and Alok Kapadia, MIKART

Multi-particulate oral solid dose (OSD) systems offer significant therapeutic flexibility but present complex manufacturing and formulation challenges. Successful development relies heavily on strategic polymer selection to achieve precise drug release profiles, especially when adapting existing therapies into new dosage forms for pediatric or geriatric populations.

Choosing the right manufacturing process is critical; for instance, heat-sensitive drugs require alternatives to hot melt extrusion, such as coating solutions onto pellets. Scaling up or transferring production requires meticulous optimization of equipment geometry and spray parameters, as lab-scale efficiency may not translate directly to commercial volumes. Finally, precision packaging and encapsulation are vital to prevent damaging delicate polymer coatings and to ensure strict content uniformity, making collaboration with an experienced CDMO essential for mitigating these operational risks.