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Discover more about a sustainable option for low-dose APIs
STUDY AND SOLUTION RATIONALE
Apixaban is a blockbuster molecule with market size of around USD 2.93 billion in 2024 and is predicted to grow to around USD 7.05 billion by 2034. (1) The Reference Listed Drug (RLD-originator) is produced via roller compaction, a rather cumbersome process typical for low-dose drugs. Roller compaction consists of more than eight manufacturing steps and has high occupational hazard. Direct compression, on the contrary, has not more than five steps, is environmentally friendlier, has lower energy consumption, cleaning and reduces production time.
IMCD has used Apixaban as a case study to conclude an LCA comparison by Cradle to Gate approach and demonstrated that not only greener solvents or reduced carbon footprint are main measuring points for sustainable solutions.
FORMULATOR BENEFITS
- DC is a manufacturing process that reduces inventory, manufacturing steps, reduce cleaning, reduce production time and reduce energy consumption by 30% (via LCA app measurements)
- Tested both lab and pilot scale, with demonstrated comparative characteristics in terms of dissolution profile with the originator.
- Additionally, blend uniformity, content uniformity, tablet weight and hardness uniformity are all in the acceptable range.
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