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61.
The goal of this research was to assess the feasibility of using lyophilization to stabilize an exploratory compound, CNK-20402,
with a minimal amount of impurity (CNK-20193) formation. A mixed-level full factorial experimental design was used to screen
excipients of glycine, mannitol, lactose monohydrate, and povidone K-12. Cryostage microscopy, powder X-ray diffraction, Karl
Fischer titration, HPLC, and water vapor sorption were used to assess the formulations' physicochemical properties and stability.
Initial physical characterization from powder X-ray diffraction revealed that the mannitol- and glycine-containing formulations
were crystalline with the patterns of the pure excipient, whereas the remaining formulations were amorphous in structure.
Chemically, the formulations stored at 50°C for 1 month had 2.36%, 1.05%, 0.81%, 0.79%, and 0.49% CNK-20193 for glycine, mannitol,
drug alone, povidone K-12, and lactose formulations, respectively. The formulations containing drug-mannitol, drug alone,
and druglactose were selected for accelerated stability study based on statistical analysis. Recovery of CNK-20193 in these
formulations was 1.22%, 1.00%, and 0.55%, respectively, when stored at 40°C/75% relative humidity storage conditions for 3
months. Water vapor sorption analysis revealed weight gains of over 7%, 21%, and 24% for the mannitol, lactose, and drug alone
formulations, respectively. Testing formulations with different concentrations of lactose by water vapor sorption indicated
that CNK-20402 concentrations as low as 10% (wt/wt) could inhibit the recrystallization of lactose. The lactose-containing
formulation exhibited the best stability among the formulations tested. The protective mechanism of lactose on the CNK-20402,
based on water vapor sorption studies, is believed to be a result of (1) the drug-lactose interaction, and (2) competition
between lactose and drug for the residual water in the formulation.
Published: September 20, 2005 相似文献
62.
63.
Relation between gamma- and alpha-chymotrypsin 总被引:1,自引:0,他引:1
B W Matthews G H Cohen E W Silverton H Braxton D R Davies 《Journal of molecular biology》1968,36(1):179-183