OSD
Whether they need to tackle poor solubility or manage the bioavailability of active pharmaceutical ingredients (APIs), pharma companies need specialist partners equipped with the knowledge to solve their challenges during oral solid dosage (OSD) development.
As no two APIs are the same, drug developers and their development partners must explore new paths to overcome drug product formulation challenges, whether they be poor solubility, or bioavailability issues resulting from decisions made during dosage form development.
While exploring new formulation solutions, it is key for developers to hold to the principles of Quality by Design (QbD) and Design of Experiments (DoE). By ensuring these are followed, developers are better positioned to lay a systematic foundation to identify solubilisation approaches that are both effective and able to scale to ensure commercial viability.
In part one of a recent roundtable discussion with The Manufacturing Chemist, our Senior Director, Technology Officer and Strategic Investments, Torkel Gren spoke alongside other industry leaders on the challenges facing OSD formulations and ways to overcome them. Our team has extensive experience of developing and manufacturing most types of oral solid dosage forms of drugs including coated and uncoated tablets, bi-layer tablets, mini-tablets, capsules, granules and powders.