Multiparticulates like pellets and micropellets are an ideal approach to provide oral solid dosage forms, which are most suitable for the pediatric and the geriatric population. Micropellets are a versatile, integrated technology platform allowing a wide variety of oral drug products. A broad range of dosage strengths can be achieved when different quantities of a micropellet product are filled into capsules, stickpacks, or sachets. Micropellets can be administered as such into the mouth directly, sprinkled on food, or dispersed in a liquid. With one basic micropellet core formulation concept, different drug release profiles, such as immediate release, controlled, or modified release, can be realized. Established technologies with proven scale-up concepts are capable of providing modern micropellet-based medicines to developing countries at a viable cost. Compared to micropellet technologies, the production of mini-tablets is technically more complicated and challenging. Simpler containment concepts are applicable to very effective “high potent” drug compounds with the micropellet concept. Intelligent formulation and development concepts for formulation and clinical development would ideally go with the final market formulations from the very beginning. This strategy can avoid preliminary simple enabling formulations and reduce bioavailability bridging studies to the minimum.

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Micropellets: A Modern Multiparticulate Technology Platform for Pediatric Medicines

  • Norbert Pöllinger

摘要

Multiparticulates like pellets and micropellets are an ideal approach to provide oral solid dosage forms, which are most suitable for the pediatric and the geriatric population. Micropellets are a versatile, integrated technology platform allowing a wide variety of oral drug products. A broad range of dosage strengths can be achieved when different quantities of a micropellet product are filled into capsules, stickpacks, or sachets. Micropellets can be administered as such into the mouth directly, sprinkled on food, or dispersed in a liquid. With one basic micropellet core formulation concept, different drug release profiles, such as immediate release, controlled, or modified release, can be realized. Established technologies with proven scale-up concepts are capable of providing modern micropellet-based medicines to developing countries at a viable cost. Compared to micropellet technologies, the production of mini-tablets is technically more complicated and challenging. Simpler containment concepts are applicable to very effective “high potent” drug compounds with the micropellet concept. Intelligent formulation and development concepts for formulation and clinical development would ideally go with the final market formulations from the very beginning. This strategy can avoid preliminary simple enabling formulations and reduce bioavailability bridging studies to the minimum.