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Progress in the application of rheological study for the quality equivalence evaluation of topical semi-solid preparations

Published on Nov. 08, 2024Total Views: 199 times Total Downloads: 12 times Download Mobile

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

Affiliation: 1. School 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: Rheology Topical semi-solid preparations Design of formulation Manufacturing process Quality evaluation Flow curve Yield stress

DOI: 10.12173/j.issn.2097-4922.202406156

Reference: WANG Jingwei, CHEN Xiaoyong, YUAN Yi, LIU Chenxi, HU Min.Progress in the application of rheological study for the quality equivalence evaluation of topical semi-solid preparations[J].Yaoxue QianYan Zazhi,2024, 28(2):300-309.DOI: 10.12173/j.issn.2097-4922.202406156.[Article in Chinese]

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Abstract

Topical semi-solid preparations include creams, ointments, gels and other dosage forms, which contain various excipients such as emulsifiers, preservatives, thickeners or emollient agents, etc. They can be single-phase system, or multiple system consisting of continuous phase and disperse phase thanks to its complex design of formulation and manufacturing process. Rheology properties are critical quality attributes of topical semi-solid preparations, which can comprehensively reflect the difference in microstructure such as the substance distribution and aggregation state of the product, and is related to other attributes such as in vitro release, in vitro penetration, stability and cutaneous sense. It is one of the most effective means to evaluate the quality equivalence between generic drugs and innovator drugs. After reviewing domestic, foreign literature and relative policies, this paper described the research status and test methods of rheology, analyzed the possible factors affecting rheological properties, discussed the quality differences reflected in rheological data, in order to guide pharmaceutical manufacturers to improve their formulations and processes and provide help for the development and quality equivalence research of such preparations.

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References

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