Granulation

In the development of generic oral solid dosage forms, wet granulation remains the method of choice—particularly for formulations involving low-dose actives or APIs with poor flow properties. However, the effectiveness of this method largely depends on how excipients are selected and utilized during the formulation process. Drawing insights from the Handbook of Pharmaceutical Generic Development,…

In the development of oral solid dosage forms, particularly generics, wet granulation remains one of the most reliable and scientifically justified approaches. It offers superior compressibility, flow properties, and batch reproducibility—especially when dealing with challenging APIs like Metformin and Famotidine. Formulation Case Study: Metformin and Famotidine Tablets An optimized wet granulation approach is demonstrated in…

In pharmaceutical R&D, wet granulation is a fundamental process, especially for oral solid dosage forms where flow, compressibility, or uniformity challenges exist. One of the most critical early decisions during formulation development is the choice of granulating solvent—either aqueous or alcoholic—as this directly impacts product stability, impurity levels, granule integrity, and manufacturing scalability. Below is…