multiparticulate

Multiparticulate refers to dosage forms composed of many small, discrete units, such as granules, pellets, or beads, each containing drug substance and excipients. These units, typically 0.1–2 mm in diameter, are combined into a single dosage form, often filled into capsules, packed into sachets, or compressed into tablets. Multiparticulates can be designed to release drug substance immediately, delayed, or in a sustained manner, and may be coated to modify release.

Manufacturing methods include pelletization and granulation: extrusion–spheronization to form uniform beads, wet or dry granulation followed by drying, fluidized-bed pelletization, and spray-drying to produce microgranules or beads. Beads can be arranged in capsules or compressed with appropriate excipients; coatings such as polymer films create controlled-release beads, reservoir coatings, or diffusion barriers.

Advantages include improved dose uniformity, flexibility in dosing, ability to mix beads with different release characteristics, reduced peak-to-trough variability, easier taste masking, and better tolerance in the GI tract. The small unit size also supports scalable manufacturing and robust blending with other materials. Disadvantages or challenges include the need for specialized production equipment, stringent quality control for content uniformity and bead size distribution, and rigorous dissolution testing to ensure consistent release profiles.

Applications span oral solid dosage forms for human and veterinary use, especially sustained- or controlled-release products, drug combinations using beads with different release rates, pediatric dosing using fixed bead-number adjustments, and nutraceutical formulations.