When manufacturing safe and effective drugs, it is essential that the amount of active pharmaceutical ingredient present in every dose is exactly the same. During production of solid oral dosage forms, the key challenge is to obtain a homogeneous blend before tableting or filling, in order to achieve the required content uniformity of the final product.
Commonly, all ingredients are blended with pre-set rotation speeds and blending times. Blending parameters are often based more on experience than on analytical data. With Quality by Design (QbD) now being frequently required by regulatory bodies to ensure that pharmaceutical products are of the quality necessary for patient use, blending specifications would ideally be based on a data-driven approach.
The article was published in PMPS no. 4, winter edition, pages 58–63, 2014.