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May 15, 2023
Key challenges of development and commercial manufacturing of oral solid dosage forms:
2 key trends can currently be identified in the pharmaceutical market:
Differentiated technologies for complex therapeutic systems and better bioavailability
Most of the drug substances in research and development belong to biopharmaceutical classification system (BCS) class II (low solubility / high permeability) and IV (low solubility / low permeability). To formulate these substances as solid dosage forms, three key technology solutions have been successfully applied:
The formation of amorphous solid dispersions has been gaining increasing attention in the last decade. Key technologies to generate amorphous solid dispersions are Hot Melt Extrusion, spray drying or co-precipitation.
In the field of complex solid dosage forms, intelligently encapsulated mini tablet systems (EMTS, see photo 1) or multi-unit pellet systems (MUPS) can control the release of the active ingredient(s).
Challenges in the development and production of HPAPIs
HPAPIs are on the rise and will play an important role in drug therapy in the future. The development and production of drugs with HPAPIs in the field of oncology is highly complex and often must be achieved under time pressure, as many of these new molecular entities (NMEs) are approved as "breakthrough therapy" in a fast-track process to quickly meet the high medical demand.
Three pillars for safe and efficient handling of HPAPIs:
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