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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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July 25, 2022
On this article you will find how pharmaceutical companies can improve the efficiency of their entire product development and drug commercialisation process with the ever-rising costs of bringing a drug to market. A well-known source of bottlenecks, delays, and technical setbacks is process scale-up, where production moves from the laboratory to full-scale GMP manufacturing
July 20, 2022
Tablets are by far the most widely used pharmaceutical dosage form, followed by capsules. Tablets are cost-effective, stable, and easy-to-administer. The main advantage is that compression allows for high speed manufacturing with a very high level of quality control. As such, tablets have been popular among pharmacists since the emergence of the tablet compression industry in the mid-20th century. Despite this long history, the industry is continually improving this dosage form to advance patient care. Meanwhile, the processes and equipment it uses to manufacture these products are also advancing.