Rheology by Design: A Regulatory Tutorial for Analytical Method Validation.
TLDR
The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition, which provided a standard framework for the development of a reliable and robust rheological profile acquisition.Abstract:
The increasing demand for product and process understanding as an active pursuit in the quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of topical products, has unveiled the tremendous potential of rheology methods as a tool for microstructure characterization of topical semisolid dosage forms. Accordingly, procedure standardization is a dire need. This work aimed at developing and validating a methodology tutorial for rheology analysis. A 1% hydrocortisone cream was used as model cream formulation. Through a risk assessment analysis, the impact of selected critical method variables (geometry, temperature and application mode) was estimated in a broad range of rheological critical analytical attributes-zero-shear viscosity, upper-shear thinning viscosity, lower-shear thinning viscosity, infinite-shear viscosity, rotational yield point, thixotropic relative area, linear viscoelastic region, oscillatory yield point, storage modulus, loss modulus, and loss tangent. The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition. The thixotropic relative area, oscillatory yield point, flow point and viscosity related endpoints proved to be highly sensitive and discriminatory parameters. This rationale provided a standard framework for the development of a reliable and robust rheology profile acquisition.read more
Citations
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The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence
TL;DR: In this article, a comprehensive review of the literature focused on amending regulatory positions concerning the demonstration of extended pharmaceutical equivalence and equivalence with respect to the efficacy of topical semisolids is presented.
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Intranasal Zolmitriptan-Loaded Bilosomes with Extended Nasal Mucociliary Transit Time for Direct Nose to Brain Delivery.
TL;DR: In this article, Bilosomes were loaded into a muco-adhesive in situ gel consisting of poloxamer 407 and hydroxypropyl methylcellulose to deliver intranasal zolmitriptan directly to the brain.
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Decellularized liver ECM-based 3D scaffolds: Compositional, physical, chemical, rheological, thermal, mechanical, and in vitro biological evaluations
TL;DR: In this article , a macroporous 3D scaffold originating from decellularized bovine liver ECM (dL-ECM), with defined compositional, physical, chemical, rheological, thermal, mechanical, and in vitro biological properties was developed.
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Clozapine-Encapsulated Binary Mixed Micelles in Thermosensitive Sol–Gels for Intranasal Administration
Madeleine S. A. Tan,Preeti Pandey,James R. Falconer,Dan Siskind,Alexandra Balmanno,Harendra S. Parekh +5 more
TL;DR: Binary mixed PS20-P407 micelles showed better drug permeation across the nasal mucosa tissue and may be a preferable carrier system for the intranasal administration of clozapine.
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Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms.
Zhengguo Xu,Victor Mangas-Sanjuan,Victor Mangas-Sanjuan,Matilde Merino-Sanjuán,Matilde Merino-Sanjuán,Virginia Merino,Virginia Merino,Alfredo García-Arieta +7 more
TL;DR: The objective of this work is to establish the number of batches and units per batch to be compared based on different inter-batch and intra-batch variability to demonstrate equivalence in the physical characteristics of the products that ensure a similar microstructure of the semisolid.
References
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Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
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