Scientific papers
The amorphous solid dispersion (ASD) method proves effective in enhancing the solubility, dissolution, and bioavailability of poorly water-soluble medications. However, these forms are prone to transitioning into more thermodynamically stable, less soluble crystalline structures. Despite this challenge, there is a notable gap in research concerning the conversion of ASDs into solid dosage forms, such as tablets. This research paper seeks to address this gap by examining how common diluents affect the tableting behavior, dissolution, and physical stability of ASDs containing itraconazole and hypromellose acetate succinate. Four widely utilized diluents present in commercially available ASD tablets were chosen for the investigation: microcrystalline cellulose (MCC), anhydrous lactose, starch, and mannitol. The performance of ASD tablets varied significantly depending on the chosen diluent. Notably, tablets prepared with MCC demonstrated superior mechanical strength compared to those formulated with other diluents. ASD tablets containing mannitol and lactose exhibited accelerated release rates compared to those containing MCC or starch. Additionally, the study highlighted that the physical stability of ASDs within a tablet is not solely determined by the level of sorbed water; crystalline diluents like lactose and mannitol were observed to facilitate ASD recrystallization within a tablet. In conclusion, the study emphasizes the critical role of excipient selection, considering aspects such as mechanical strength, dissolution rate, and physical stability of ASD tablets. These findings provide valuable insights for selecting excipients for subsequent ASD tablet development, ultimately enhancing manufacturability, physical stability, and the overall quality of ASD drug products.
Comments
No comments posted yet.
Add a comment
Articles you may like
Related products
Looking for additional information?
Let us help you