Abstract
This study aimed to develop a stable lyophilized formulation and the tableting process of lyophilized powder to improve the stability of the enzyme alpha-chymotrypsin (ACT). The impacts of the bulking agent and stabilizer on the freeze-drying process and the stability of ACT were determined. The effects of the filler excipients and the compression force on the activity of ACT tablets containing lyophilized powder were also evaluated. The findings revealed that arginine HCl, which had a multipoint interaction with the surface of ACT, and the crystalline excipient mannitol stabilized the structure of the enzyme and the lyophilized cake. The dehydration process through freeze-drying effectively protected the active substance against denaturing factors such as heat, moisture, and mechanical force. The study also demonstrated that the use of elastic fillers such as compressuc and a minor compression force contributed to the enhancement of ACT tablet stability. In summary, the study successfully developed a formulation for tablets containing ACT lyophilized powder, initially overcoming the poor stability of this enzyme to environmental factors, showing the applicability of lyophilization and stabilizing excipients in enhancing the stability of biomolecules.
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