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Discover the IMCD Molecule to Market approach for upadacitinib generic development.
Study and solution rationale
Upadacitinib is a selective Janus kinase 1 (JAK1) inhibitor indicated for the treatment of moderately to severely active rheumatoid arthritis. Despite being classified as a BCS Class I drug—exhibiting both high permeability and high solubility—the development of an extended-release (ER) dosage form presented significant formulation challenges.
For chronic conditions such as rheumatoid arthritis, patients require predictable therapeutic levels throughout the day to manage symptoms effectively. Variability in drug release due to pH fluctuations in different regions of the GI tract could compromise efficacy and patient outcomes. The primary technical challenge was designing a robust ER tablet capable of delivering pH-independent drug release across the gastrointestinal tract whilst maintaining consistent 24-hour drug exposure.
Additionally, the formulation needed to demonstrate resistance to alcohol-induced dose dumping—a critical safety consideration where co-ingestion with alcohol could potentially cause rapid, uncontrolled drug release. The development team at our Pharmaceutical Technical Centre (PTC) in Mumbai was tasked with creating a formulation that would meet these performance requirements whilst ensuring manufacturability and scalability for commercial production.
Target market
Ideal for generic drug developers looking to accelerate market entry, this solution combines formulation expertise, risk-based development strategies, and access to all key formulation details, enabling faster decision-making, reduced development effort, and a streamlined path to commercialisation.
Formulator benefits
- Reduces R&D timelines with pre-developed formulation solution.
- Simplifies regulatory processes through ready-to-use documentation.
- Accelerates speed to market, critical in competitive post-patent scenarios.
- Enhances formulation success with proven excipients from leading suppliers.
- Detailed technical package available following initial discussion.
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CPHI Solutions
Explore IMCD's CPHI solutions