Consistency investigation on rheological properties of adapalene gel original drug and generic drugs

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Author: WANG Jingwei ¹ CHEN Xiaoyong ^2, ³ YUAN Yi ^2, ³ LIU Chenxi ^2, ³  HU Min ^1, ^2, ³

Affiliation: 1. College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065, China 2. Hubei Institute for Drug Control, Wuhan 430075, China 3. Hubei Engineering Research Center for Drug Quality Control, Wuhan 430075, China

Keywords: Adapalene gel Rheology Pseudoplastic fluids Generic drugs Original drug Consistency evaluation Viscosity

DOI: 10.12173/j.issn.2097-4922.202407152

Reference: WANG Jingwei, CHEN Xiaoyong, YUAN Yi, LIU Chenxi, HU Min. Consistency investigation on rheological properties of adapalene gel original drug and generic drugs[J]. Yaoxue QianYan Zazhi, 2025, 29(1): 33-39. DOI: 10.12173/j.issn.2097-4922.202407152.[Article in Chinese]  Copied

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Abstract

Objective To establish reasonable and effective rheological methods for evaluating adapalene gel, and to investigate the consistency of rheological properties between the original drug and domestic generic drugs from several different domestic enterprises.

Methods A rheometer was used to conduct shear flow test, viscosity test, strain sweep test, frequency sweep test, 3 interval thixotropy test, etc, and the differences between the original drug and generic drugs were analyzed.

Results The original drug and the generic drugs were all pseudoplastic fluids (shear-thinning non-Newtonian fluids). All of them had certain yield stress, and all strain sweep tests showed that the elastic modulus of the samples was higher than the viscous modulus, and could resist deformation to some extent. Among all samples, there was a large gap between generic drug 4 and the original drug and other generic drugs, with the lowest viscosity and poor deformation resistance.

Conclusion The established method has good reproducibility and can be used to compare the rheological difference between the original drug and generic drugs. There are certain differences in the rheological properties of adapalene gel generic drugs produced by different manufacturers and the original drug.

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References

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