Context
Enhancing the dissolution, solubility, and bioavailability of poorly soluble drugs classified under the Biopharmaceutical Classification System (BCS) Class 2 is a critical challenge in pharmaceutical development. Amorphous Solid Dispersions (ASDs) offer a promising solution by stabilizing drugs in their amorphous state using polymers and low-molecular-weight excipients, such as amino acids. However, their thermodynamic instability and the complexity of processing steps make ASD preparation particularly challenging.
Dry ball-milling, while useful in the preformulation phase, has notable limitations. This study highlights the innovative use of the Precellys Evolution, a high-energy 3D bead-beating system, coupled with Cryolys Evolution, which provides precise temperature control during milling (Eur J Pharm Biopharm. 2023, 189, 1-14). This system enables rapid, parallel processing of small-volume samples, minimizes material requirements, and overcomes the constraints of conventional methods. By achieving consistent and efficient amorphization, this approach streamlines excipient screening for ASDs in pharmaceutical preformulation.
