OSD
Optimising drug formulation: The critical role of granulation
In pharmaceutical development, the journey from active pharmaceutical ingredient (API) to a stable, effective oral solid dosage (OSD) form presents many challenges. Among the processes central to this transformation, granulation is a fundamental technique for overcoming common formulation hurdles and ensuring the quality and performance of oral solid medicines. It involves forming primary powder particles into larger, multi-particle units, or “granules,” which improves their physical and chemical attributes.
Implementing effective granulation is not an easy task. Choosing the correct granulation technology, optimising process parameters and successfully scaling up from laboratory to commercial production requires deep knowledge and a precise understanding of material science and engineering principles. Variations in raw materials, the need for precise control over granule characteristics and adherence to strict regulatory requirements all add layers of difficulty to this crucial process
This whitepaper provides a detailed look at granulation, highlighting its vital role in modern drug formulation.
What you will learn:
- The range of granulation technologies, including wet granulation, dry granulation and specialised methods such as high-shear granulation and fluid bed granulation.
- The core reasons for choosing granulation over direct compression, outlining the specific advantages each method provides in addressing formulation issues.
- The inherent challenges associated with each granulation technique and the broader applicability of granulation processes.
- How Recipharm assists pharmaceutical developers in handling these complexities to deliver successful execution of granulation in drug formulation development.