Objective: To establish a method and limit for droplet size test of tacrolimus ointment; to compare the droplet size quality of products from 9 manufacturers; to analyze the causes of differences in formulation composition and homogenization processes, and to analyze the correlation between the content uniformity and droplet size. Methods: An electron microscope equipped with automatic counting and equivalent diameter calculation function was used to determine the droplet size of 15 batches of tacrolimus ointments from 9 manufacturers, and samples stored under accelerated conditions for 3 months. Results: The droplet sizes of products from 4 manufactures were generally consistent with the reference formulation. Products from 2 manufacturers showed significant differences compared to the reference, while samples from 3 manufacturers exhibited notable droplet aggregation after 3 months of accelerated storage. Conclusion: A comprehensive assessment of droplet size should include three aspects uniformity of droplet distribution, droplet count, and droplet size. Formulation composition, homogenization temperature, homogenization time, and homogenization rate are key factors affecting droplet size, reducing droplet aggregation under high temperature and high humidity conditions, and ensuring uniform content in the product.
WU Xiao-luan
,
WU Jing-wen
,
LIU Chao-yi
,
GAO Xuan
,
CHEN Xiao-ping
,
REN Fei-liang
,
QIN Feng
,
GU Song-qing
. Study on the key quality attribute-droplet size of tacrolimus ointment[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(7)
: 1214
-1220
.
DOI: 10.16155/j.0254-1793.2024-1094
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