Objective: To compare the results of uniformity of dosage units for single-dose inhalation suspension obtained by two methods, and to put forward a reasonable method for the uniformity test. Methods: The uniformity of dosage units of the aerosol suspensions for inhalation produced by two manufacturers were prepared by complete transfer method and extractable method for HPLC determination, as well as filling quantity. The results were discussed according to content uniformity testing program requirements of Chinese Pharmacopoeia, USP, and European Pharmacopoeia. Results: Suspension was different from solution in that it was a non-homogeneous system. The uniformity of dosage units by filling quantity and complete transfer method could not reflect the practical clinical application. The uniformity of dosage units of single-dose inhalation suspension should be determined by extrusion method and evaluated according to General Rule 0941 of Chinese Pharmacopoeia 2020 edition. The new method could reflect the quality of the uniformity of dosage units. Conclusion: The new method proposed in this study is more suitable for the uniformity of dosage units t of single-dose inhalation suspension.
YAN Ju-jiao, LI Miao, GENG Ying, LU Jin-tao, CHEN Lu, WEI Ning-yi
. Analysis of the sampling plan and evaluation on uniformity of dosage units for single-dose inhalation suspension*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(8)
: 1465
-1471
.
DOI: 10.16155/j.0254-1793.2022.08.21
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