Progress in the application of rheological study for the quality equivalence evaluation of topical semi-solid preparations
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.
RheologyTopical semi-solid preparationsDesign of formulationManufacturing processQuality evaluationFlow curveYield stress
NETL
NSTL
万方数据
