ArticlePharmaceutics2023
Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation.
Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Use of Benzene-Free Carbomer 980 in the Formulation of Metronidazole Gel 0.75% and Demonstration of Equivalence with Carbomer 940.AAPS PharmSciTech · 2026Article
- Development and Study of Hydrophilic Ointment Compositions with a Dextrin/Polyvinyl Alcohol/Iodine Complex (D/PVA/I).Pharmaceuticals (Basel, Switzerland) · 2026Article
- A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities.Therapeutic innovation & regulatory science · 2026Article
- Interfacial Molecular Interactions as Determinants of Nanostructural Preservation in Ibuprofen-Loaded Nanoemulsions and Nanoemulsion Gels.Pharmaceutics · 2025Article
- Development and Characterization of a Wound-Healing System Based on a Marine Biopolymer.Gels (Basel, Switzerland) · 2025Article
- AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study.Pharmaceutics · 2025Article
- Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile.Life (Basel, Switzerland) · 2025Article
- A review of research methods for elucidating the microstructure of pharmaceutical preparations.Journal of pharmaceutical analysis · 2025Review
- Unlocking the Rich Potential of a Soft Gel-Cream Enriched with Royal Jelly for Topical Use.Gels (Basel, Switzerland) · 2025Article
- Novel Buccal Xanthan Gum-Hyaluronic Acid Eutectogels with Dual Anti-Inflammatory and Antimicrobial Properties.Gels (Basel, Switzerland) · 2025Article
- Impact of Time on Parameters for Assessing the Microstructure Equivalence of Topical Products: Diclofenac 1% Emulsion as a Case Study.Pharmaceutics · 2024Article
- Hydrogel Formulations for Topical Insulin Application: Preparation, Characterization and In Vitro Permeation across the Strat-MPolymers · 2023Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is a dire need to take a step forward in rheology method development and validation procedures. This paper aims to apply Analytical Quality by Design (AQbD) principles towards the development and validation of rheology methods for topical creams, as complex semisolid formulations. Risk assessment was carried out through an Ishikawa diagram and an estimate failure mode, effects, and criticality analysis (FMECA). Sample application, peltier temperature control, and sample rest time were identified as critical method variables (CMVs), and a 2
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Registered trials
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